Excipients: Usually inert substances added to a prescription in order to provide suitable consistency to the dosage form. These include binders, matrix, base or diluent in pills, tablets, creams, salves, etc.Chemistry, Pharmaceutical: Chemistry dealing with the composition and preparation of agents having PHARMACOLOGIC ACTIONS or diagnostic use.Technology, Pharmaceutical: The application of scientific knowledge or technology to pharmacy and the pharmaceutical industry. It includes methods, techniques, and instrumentation in the manufacture, preparation, compounding, dispensing, packaging, and storing of drugs and other preparations used in diagnostic and determinative procedures, and in the treatment of patients.Drug Compounding: The preparation, mixing, and assembling of a drug. (From Remington, The Science and Practice of Pharmacy, 19th ed, p1814)Drug Carriers: Forms to which substances are incorporated to improve the delivery and the effectiveness of drugs. Drug carriers are used in drug-delivery systems such as the controlled-release technology to prolong in vivo drug actions, decrease drug metabolism, and reduce drug toxicity. Carriers are also used in designs to increase the effectiveness of drug delivery to the target sites of pharmacological actions. Liposomes, albumin microspheres, soluble synthetic polymers, DNA complexes, protein-drug conjugates, and carrier erythrocytes among others have been employed as biodegradable drug carriers.Delayed-Action Preparations: Dosage forms of a drug that act over a period of time by controlled-release processes or technology.Drug Delivery Systems: Systems for the delivery of drugs to target sites of pharmacological actions. Technologies employed include those concerning drug preparation, route of administration, site targeting, metabolism, and toxicity.Capsules: Hard or soft soluble containers used for the oral administration of medicine.Pharmaceutical Preparations: Drugs intended for human or veterinary use, presented in their finished dosage form. Included here are materials used in the preparation and/or formulation of the finished dosage form.Solubility: The ability of a substance to be dissolved, i.e. to form a solution with another substance. (From McGraw-Hill Dictionary of Scientific and Technical Terms, 6th ed)Tablets: Solid dosage forms, of varying weight, size, and shape, which may be molded or compressed, and which contain a medicinal substance in pure or diluted form. (Dorland, 28th ed)Particle Size: Relating to the size of solids.Liposomes: Artificial, single or multilaminar vesicles (made from lecithins or other lipids) that are used for the delivery of a variety of biological molecules or molecular complexes to cells, for example, drug delivery and gene transfer. They are also used to study membranes and membrane proteins.Powders: Substances made up of an aggregation of small particles, as that obtained by grinding or trituration of a solid drug. In pharmacy it is a form in which substances are administered. (From Dorland, 28th ed)Equipment Design: Methods of creating machines and devices.Dosage Forms: Completed forms of the pharmaceutical preparation in which prescribed doses of medication are included. They are designed to resist action by gastric fluids, prevent vomiting and nausea, reduce or alleviate the undesirable taste and smells associated with oral administration, achieve a high concentration of drug at target site, or produce a delayed or long-acting drug effect.Drug Stability: The chemical and physical integrity of a pharmaceutical product.Freeze Drying: Method of tissue preparation in which the tissue specimen is frozen and then dehydrated at low temperature in a high vacuum. This method is also used for dehydrating pharmaceutical and food products.Methylcellulose: Methylester of cellulose. Methylcellulose is used as an emulsifying and suspending agent in cosmetics, pharmaceutics and the chemical industry. It is used therapeutically as a bulk laxative.Pharmaceutical Solutions: Homogeneous liquid preparations that contain one or more chemical substances dissolved, i.e., molecularly dispersed, in a suitable solvent or mixture of mutually miscible solvents. For reasons of their ingredients, method of preparation, or use, they do not fall into another group of products.Emulsifying Agents: SURFACE-ACTIVE AGENTS that induce a dispersion of undissolved material throughout a liquid.Emulsions: Colloids formed by the combination of two immiscible liquids such as oil and water. Lipid-in-water emulsions are usually liquid, like milk or lotion. Water-in-lipid emulsions tend to be creams. The formation of emulsions may be aided by amphiphatic molecules that surround one component of the system to form MICELLES.Pharmaceutic Aids: Substances which are of little or no therapeutic value, but are necessary in the manufacture, compounding, storage, etc., of pharmaceutical preparations or drug dosage forms. They include SOLVENTS, diluting agents, and suspending agents, and emulsifying agents. Also, ANTIOXIDANTS; PRESERVATIVES, PHARMACEUTICAL; COLORING AGENTS; FLAVORING AGENTS; VEHICLES; EXCIPIENTS; OINTMENT BASES.Wettability: The quality or state of being wettable or the degree to which something can be wet. This is also the ability of any solid surface to be wetted when in contact with a liquid whose surface tension is reduced so that the liquid spreads over the surface of the solid.Cellulose: A polysaccharide with glucose units linked as in CELLOBIOSE. It is the chief constituent of plant fibers, cotton being the purest natural form of the substance. As a raw material, it forms the basis for many derivatives used in chromatography, ion exchange materials, explosives manufacturing, and pharmaceutical preparations.Drug Storage: The process of keeping pharmaceutical products in an appropriate location.Lecithins: A complex mixture of PHOSPHOLIPIDS; GLYCOLIPIDS; and TRIGLYCERIDES; with substantial amounts of PHOSPHATIDYLCHOLINES; PHOSPHATIDYLETHANOLAMINES; and PHOSPHATIDYLINOSITOLS, which are sometimes loosely termed as 1,2-diacyl-3-phosphocholines. Lecithin is a component of the CELL MEMBRANE and commercially extracted from SOYBEANS and EGG YOLK. The emulsifying and surfactant properties are useful in FOOD ADDITIVES and for forming organogels (GELS).Preservatives, Pharmaceutical: Substances added to pharmaceutical preparations to protect them from chemical change or microbial action. They include ANTI-BACTERIAL AGENTS and antioxidants.Biological Availability: The extent to which the active ingredient of a drug dosage form becomes available at the site of drug action or in a biological medium believed to reflect accessibility to a site of action.Thermogravimetry: Technique whereby the weight of a sample can be followed over a period of time while its temperature is being changed (usually increased at a constant rate).Povidone: A polyvinyl polymer of variable molecular weight; used as suspending and dispersing agent and vehicle for pharmaceuticals; also used as blood volume expander.Calorimetry, Differential Scanning: Differential thermal analysis in which the sample compartment of the apparatus is a differential calorimeter, allowing an exact measure of the heat of transition independent of the specific heat, thermal conductivity, and other variables of the sample.Polysorbates: Sorbitan mono-9-octadecanoate poly(oxy-1,2-ethanediyl) derivatives; complex mixtures of polyoxyethylene ethers used as emulsifiers or dispersing agents in pharmaceuticals.Dry Powder Inhalers: A device that delivers medication to the lungs in the form of a dry powder.Powder Diffraction: Method of using a polycrystalline powder and Rietveld refinement (LEAST SQUARES ANALYSIS) of X-RAY DIFFRACTION or NEUTRON DIFFRACTION. It circumvents the difficulties of producing single large crystals.Desiccation: Removal of moisture from a substance (chemical, food, tissue, etc.).Monoglycerides: GLYCEROL esterified with a single acyl (FATTY ACIDS) chain.Nanoparticles: Nanometer-sized particles that are nanoscale in three dimensions. They include nanocrystaline materials; NANOCAPSULES; METAL NANOPARTICLES; DENDRIMERS, and QUANTUM DOTS. The uses of nanoparticles include DRUG DELIVERY SYSTEMS and cancer targeting and imaging.Hardness: The mechanical property of material that determines its resistance to force. HARDNESS TESTS measure this property.Carboxymethylcellulose Sodium: A cellulose derivative which is a beta-(1,4)-D-glucopyranose polymer. It is used as a bulk laxative and as an emulsifier and thickener in cosmetics and pharmaceuticals and as a stabilizer for reagents.Chitosan: Deacetylated CHITIN, a linear polysaccharide of deacetylated beta-1,4-D-glucosamine. It is used in HYDROGEL and to treat WOUNDS.Polymers: Compounds formed by the joining of smaller, usually repeating, units linked by covalent bonds. These compounds often form large macromolecules (e.g., BIOPOLYMERS; PLASTICS).Polyethylene Glycols: Polymers of ETHYLENE OXIDE and water, and their ethers. They vary in consistency from liquid to solid depending on the molecular weight indicated by a number following the name. They are used as SURFACTANTS, dispersing agents, solvents, ointment and suppository bases, vehicles, and tablet excipients. Some specific groups are NONOXYNOLS, OCTOXYNOLS, and POLOXAMERS.Mannitol: A diuretic and renal diagnostic aid related to sorbitol. It has little significant energy value as it is largely eliminated from the body before any metabolism can take place. It can be used to treat oliguria associated with kidney failure or other manifestations of inadequate renal function and has been used for determination of glomerular filtration rate. Mannitol is also commonly used as a research tool in cell biological studies, usually to control osmolarity.Administration, Oral: The giving of drugs, chemicals, or other substances by mouth.Lubricants: Compounds that provide LUBRICATION between surfaces in order to reduce FRICTION.Poloxalene: A copolymer of polyethylene and polypropylene ether glycol. It is a non-ionic polyol surface-active agent used medically as a fecal softener and in cattle for prevention of bloat.Humidity: A measure of the amount of WATER VAPOR in the air.Starch: Any of a group of polysaccharides of the general formula (C6-H10-O5)n, composed of a long-chain polymer of glucose in the form of amylose and amylopectin. It is the chief storage form of energy reserve (carbohydrates) in plants.Stearic Acids: A group of compounds that are derivatives of octadecanoic acid which is one of the most abundant fatty acids found in animal lipids. (Stedman, 25th ed)Viscosity: The resistance that a gaseous or liquid system offers to flow when it is subjected to shear stress. (From McGraw-Hill Dictionary of Scientific and Technical Terms, 6th ed)Hardness Tests: A test to determine the relative hardness of a metal, mineral, or other material according to one of several scales, such as Brinell, Mohs, Rockwell, Vickers, or Shore. (From McGraw-Hill Dictionary of Scientific and Technical Terms, 6th ed)Therapeutic Equivalency: The relative equivalency in the efficacy of different modes of treatment of a disease, most often used to compare the efficacy of different pharmaceuticals to treat a given disease.Cyperus: A plant genus of the family CYPERACEAE. SESQUITERPENES are found in some of the species.Tanacetum parthenium: An aromatic perennial plant species that has been used to treat migraines, arthritis, and as a febrifuge. It contains TANNINS, volatile oils (OILS, ESSENTIAL), and sesquiterpene lactones, especially parthenolide.Surface-Active Agents: Agents that modify interfacial tension of water; usually substances that have one lipophilic and one hydrophilic group in the molecule; includes soaps, detergents, emulsifiers, dispersing and wetting agents, and several groups of antiseptics.Water: A clear, odorless, tasteless liquid that is essential for most animal and plant life and is an excellent solvent for many substances. The chemical formula is hydrogen oxide (H2O). (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)Propylene Glycol: A clear, colorless, viscous organic solvent and diluent used in pharmaceutical preparations.Terminalia: A plant genus of the family COMBRETACEAE. Members contain arjunin, an ellagitannin (TANNINS).Flavoring Agents: Substances added to foods and medicine to improve the quality of taste.Laurates: Salts and esters of the 12-carbon saturated monocarboxylic acid--lauric acid.Polyglycolic Acid: A biocompatible polymer used as a surgical suture material.Administration, Buccal: Administration of a soluble dosage form between the cheek and gingiva. It may involve direct application of a drug onto the buccal mucosa, as by painting or spraying.Polyglactin 910: A polyester used for absorbable sutures & surgical mesh, especially in ophthalmic surgery. 2-Hydroxy-propanoic acid polymer with polymerized hydroxyacetic acid, which forms 3,6-dimethyl-1,4-dioxane-dione polymer with 1,4-dioxane-2,5-dione copolymer of molecular weight about 80,000 daltons.Polymethacrylic Acids: Poly-2-methylpropenoic acids. Used in the manufacture of methacrylate resins and plastics in the form of pellets and granules, as absorbent for biological materials and as filters; also as biological membranes and as hydrogens. Synonyms: methylacrylate polymer; poly(methylacrylate); acrylic acid methyl ester polymer.Insulin, Short-Acting: Insulin derivatives and preparations that are designed to induce a rapid HYPOGLYCEMIC EFFECT.Diclofenac: A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.Chromatography, High Pressure Liquid: Liquid chromatographic techniques which feature high inlet pressures, high sensitivity, and high speed.Skin Absorption: Uptake of substances through the SKIN.Methylene Chloride: A chlorinated hydrocarbon that has been used as an inhalation anesthetic and acts as a narcotic in high concentrations. Its primary use is as a solvent in manufacturing and food technology.Porosity: Condition of having pores or open spaces. This often refers to bones, bone implants, or bone cements, but can refer to the porous state of any solid substance.Lactose: A disaccharide of GLUCOSE and GALACTOSE in human and cow milk. It is used in pharmacy for tablets, in medicine as a nutrient, and in industry.Hexuronic Acids: Term used to designate tetrahydroxy aldehydic acids obtained by oxidation of hexose sugars, i.e. glucuronic acid, galacturonic acid, etc. Historically, the name hexuronic acid was originally given to ascorbic acid.Glucuronic Acid: A sugar acid formed by the oxidation of the C-6 carbon of GLUCOSE. In addition to being a key intermediate metabolite of the uronic acid pathway, glucuronic acid also plays a role in the detoxification of certain drugs and toxins by conjugating with them to form GLUCURONIDES.Tensile Strength: The maximum stress a material subjected to a stretching load can withstand without tearing. (McGraw-Hill Dictionary of Scientific and Technical Terms, 5th ed, p2001)Drug Contamination: The presence of organisms, or any foreign material that makes a drug preparation impure.Microspheres: Small uniformly-sized spherical particles, of micrometer dimensions, frequently labeled with radioisotopes or various reagents acting as tags or markers.Microscopy, Electron, Scanning: Microscopy in which the object is examined directly by an electron beam scanning the specimen point-by-point. The image is constructed by detecting the products of specimen interactions that are projected above the plane of the sample, such as backscattered electrons. Although SCANNING TRANSMISSION ELECTRON MICROSCOPY also scans the specimen point by point with the electron beam, the image is constructed by detecting the electrons, or their interaction products that are transmitted through the sample plane, so that is a form of TRANSMISSION ELECTRON MICROSCOPY.Aerosols: Colloids with a gaseous dispersing phase and either liquid (fog) or solid (smoke) dispersed phase; used in fumigation or in inhalation therapy; may contain propellant agents.Pharmaceutical Vehicles: A carrier or inert medium used as a solvent (or diluent) in which the medicinally active agent is formulated and or administered. (Dictionary of Pharmacy, 1986)Alginates: Salts of alginic acid that are extracted from marine kelp and used to make dental impressions and as absorbent material for surgical dressings.Phase Transition: A change of a substance from one form or state to another.Ibuprofen: A nonsteroidal anti-inflammatory agent with analgesic properties used in the therapy of rheumatism and arthritis.Spectrophotometry, Ultraviolet: Determination of the spectra of ultraviolet absorption by specific molecules in gases or liquids, for example Cl2, SO2, NO2, CS2, ozone, mercury vapor, and various unsaturated compounds. (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)Administration, Intravaginal: The insertion of drugs into the vagina to treat local infections, neoplasms, or to induce labor. The dosage forms may include medicated pessaries, irrigation fluids, and suppositories.Tablets, Enteric-Coated: Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed)beta-Cyclodextrins: Cyclic GLUCANS consisting of seven (7) glucopyranose units linked by 1,4-glycosidic bonds.Benzyl Alcohol: A colorless liquid with a sharp burning taste and slight odor. It is used as a local anesthetic and to reduce pain associated with LIDOCAINE injection. Also, it is used in the manufacture of other benzyl compounds, as a pharmaceutic aid, and in perfumery and flavoring.Absorption: The physical or physiological processes by which substances, tissue, cells, etc. take up or take in other substances or energy.Hydrogen-Ion Concentration: The normality of a solution with respect to HYDROGEN ions; H+. It is related to acidity measurements in most cases by pH = log 1/2[1/(H+)], where (H+) is the hydrogen ion concentration in gram equivalents per liter of solution. (McGraw-Hill Dictionary of Scientific and Technical Terms, 6th ed)Adhesiveness: A property of the surface of an object that makes it stick to another surface.Drug Evaluation, Preclinical: Preclinical testing of drugs in experimental animals or in vitro for their biological and toxic effects and potential clinical applications.Resins, Plant: Flammable, amorphous, vegetable products of secretion or disintegration, usually formed in special cavities of plants. They are generally insoluble in water and soluble in alcohol, carbon tetrachloride, ether, or volatile oils. They are fusible and have a conchoidal fracture. They are the oxidation or polymerization products of the terpenes, and are mixtures of aromatic acids and esters. Most are soft and sticky, but harden after exposure to cold. (From Grant & Hackh's Chemical Dictionary, 5th ed & Dorland, 28th ed)Magnesium Silicates: A generic term for a variety of compounds that contain silicon, oxygen, and magnesium, and may contain hydrogen. Examples include TALC and some kinds of ASBESTOS.Rheology: The study of the deformation and flow of matter, usually liquids or fluids, and of the plastic flow of solids. The concept covers consistency, dilatancy, liquefaction, resistance to flow, shearing, thixotrophy, and VISCOSITY.Suspensions: Colloids with liquid continuous phase and solid dispersed phase; the term is used loosely also for solid-in-gas (AEROSOLS) and other colloidal systems; water-insoluble drugs may be given as suspensions.Spectroscopy, Fourier Transform Infrared: A spectroscopic technique in which a range of wavelengths is presented simultaneously with an interferometer and the spectrum is mathematically derived from the pattern thus obtained.Oils: Unctuous combustible substances that are liquid or easily liquefiable on warming, and are soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils. Depending on their behavior on heating, they are volatile or fixed. (Dorland, 28th ed)Pseudoephedrine: A phenethylamine that is an isomer of EPHEDRINE which has less central nervous system effects and usage is mainly for respiratory tract decongestion.Solvents: Liquids that dissolve other substances (solutes), generally solids, without any change in chemical composition, as, water containing sugar. (Grant & Hackh's Chemical Dictionary, 5th ed)Plant Gums: Polysaccharide gums from PLANTS.Compressive Strength: The maximum compression a material can withstand without failure. (From McGraw-Hill Dictionary of Scientific and Technical Terms, 5th ed, p427)Administration, Topical: The application of drug preparations to the surfaces of the body, especially the skin (ADMINISTRATION, CUTANEOUS) or mucous membranes. This method of treatment is used to avoid systemic side effects when high doses are required at a localized area or as an alternative systemic administration route, to avoid hepatic processing for example.Acrylic ResinsDextrinsChromatography, Reverse-Phase: A chromatography technique in which the stationary phase is composed of a non-polar substance with a polar mobile phase, in contrast to normal-phase chromatography in which the stationary phase is a polar substance with a non-polar mobile phase.
"Excipient General Information Chapter: Powder Flow Mark Gibson (2001). Pharmaceutical Preformulation and Formulation: A ... Practical Guide from Candidate Drug Selection to Commercial Dosage Form. Boca Raton: CRC Press. ISBN 1-57491-120-1. ... S.L. Rough, D.I. Wilson and D.W. York (2005) "Effect of solids formulation on the manufacture of high shear mixer agglomerates ...
The formulation itself is made up of the drug, a liquefied gas propellant and, in many cases, stabilising excipients. The ... The deposition of the content of drug formulation on the canister surface can result in a shorter shelf life of an MDI inhaler ... This coating ensures that the drug formulation does not stick to the interior wall of the MD inhaler and results in the patient ... where the formulation resides; the metering valve, which allows a metered quantity of the formulation to be dispensed with each ...
The two-vial and one-vial formulations contain the same drug substance, docetaxel trihydrate, and the same excipients (ethanol ... Drug interactions may be the result of altered pharmacokinetics or pharmacodynamics due to one of the drugs involved. Cisplatin ... Recently Sanofi has got approval for one-vial formulation. With this one-vial formulation, the preparation of ... The one-vial formulation is administered as an aqueous intravenous solution that contains the same drug substance in the same ...
In some SR formulations, the drug dissolves into the matrix, and the matrix physically swells to form a gel, allowing the drug ... Delivery is usually effected by dissolution, degradation or disintegration of an excipient in which the active compound is ... When the drug is covered with some slow dissolving coat, it will eventually release the drug. Instead of diffusion, the drug ... The therapeutic index also factors whether a drug can be used as a time release drug. A drug with a thin therapeutic range, or ...
The moisture sorption properties of pharmaceutical materials such as excipients, drug formulations and packaging films are ... P. Young, H. Chiou, T. Tee, D. Trainj, H.-K. Chan, F. Thielmann, and D. Burnett, Drug Development and Industrial Pharmacy. 33 ( ... manufacturability and dissolution characteristics of the formulated drug product. The moisture sorption properties of food ...
... to the sodium salt which is more stable and has better compatibility with other excipients used in the drug formulation. ... The advantage is the pharmaceutical formulation of the drug, which is based on a dual release technology, with the first quick ... Silverman, Richard B. (2004). "Receptors". The organic chemistry of drug design and drug action (2nd ed.). Academic Press. p. ... These drugs have emerged as the treatment of choice for acid-related diseases, including gastroesophageal reflux disease (GERD ...
Excipient. References. *^ a b Spernath A; Aserin A (December 2006). "Microemulsions as carriers for drugs and ... SMEDDS in research or development include formulations of the drugs anethole trithione, oridonin, curcumin, ... malaria drugs beta-Artemether and halofantrine, anti-HIV drug UC 781, nimodipine, exemestane, ... That is, by an intrinsic property of the drug formulation, rather than by special mixing and handling. It employs the familiar ...
This process in tablet or capsule formulations enhance the disintegration of the drug/excipient bulk and so enhance the rate of ... Hydrophilization is a process used for hydrophobic drugs to increase their release rate from capsules, which is dependent on ... The process is accomplished by vigorous mixing of the hydrophobic drug with the aqueous solution of the hydrophilic polymer ... "Effect of hydrophilization of hydrophobic drugs on release rate from capsules". Journal of Pharmaceutical Sciences. 67 (7): 935 ...
Before a drug can be manufactured at any scale, much work goes into the actual formulation of the drug. Formulation development ... The range of materials that may be blended (excipients, API), presents a number of variables which must be addressed to achieve ... ISBN 978-0-444-53242-8. "Pharmaceutical Drug Formulation, Development & Drug Delivery". Particle Sciences. Retrieved 2015-10-24 ... Drug manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs by pharmaceutical companies. The ...
Physical properties of the drug (hydrophobicity, pKa, solubility). *The drug formulation (immediate release, excipients used, ... of a certain drug when compared with another formulation (B) of the same drug, usually an established standard, or through ... Bioavailability of drugs versus dietary supplements. In comparison to drugs, there are significant differences in dietary ... Therefore, a drug given by the intravenous route will have an absolute bioavailability of 100% (f = 1), whereas drugs given by ...
... drug metabolism, drug preformulation and formulation, and drug-excipient interactions in various dosage forms. Recent ... His research group's work includes drug design and synthesis, encapsulation of drugs in macrocyles, attachment of drugs to ... He is best known for his work on multinuclear platinum-based drugs and the drug delivery applications of cucurbiturils. In 2013 ... nanoparticles, drug solid state stability and polymorphism (materials science), drug mechanisms of action, improving drug ...
... a target inside a mixture such as an active ingredient of a drug inside the inert excipients in a pharmacological formulation ... Examples include in vivo, whole organism (e.g. mouse or other subject injected with a drug) ex vivo body part (e.g. leg of a ... Testing for Illegal Drugs Radioligand binding assay When multiple assays measure the same target their results and utility may ... The analyte can be a drug, a biochemical substance, or a cell in an organism or organic sample. The measured entity is ...
... most formulations include excipients. Normally, a pharmacologically inactive ingredient (excipient) termed a binder is added to ... Dry granulation requires drugs or excipients with cohesive properties, and a 'dry binder' may need to be added to the ... Such drugs may need to be given in very high doses or by injection. For drugs that need to have rapid onset, or that have ... Such drugs cannot be made into tablets. Some drugs may be deactivated by the liver when they are carried there from the ...
... and have excellent solvent properties for many hard-to-solubilize drugs, making them valuable as excipients in improving the ... formulation of certain pharmaceuticals. The most common forms of acylglycerol are triglycerides, having high caloric value and ... Sasol Olefins & Surfactants - Excipients for Pharmaceuticals. Partial glycerides (page 10) Archived 2009-02-05 at the Wayback ...
... is also widely used for detection and quantification of excipients or inactive ingredients used in pharmaceutical formulations ... Therefore, IC has been employed in drugs in the form of tablets and capsules in order to determine the amount of drug dissolve ... Drug development. An ion chromatography system used to detect and measure cations such as sodium, ammonium and potassium ... There has been a growing interest in the application of IC in the analysis of pharmaceutical drugs. IC is used in different ...
... but they can be particularly conducive to custom formulation with various possible excipients, in addition to custom drug/dose ... The drug does not appear on a list published by FDA of unsafe or ineffective drugs. The drug is not "essentially a copy" of one ... Compounding drugs that are essentially copies of a commercially available drug product. Compounding drugs in advance of ... The drug does not appear on the FDA list of drugs or categories of drugs that present "demonstrable difficulties" for ...
In food and drug applications, malonic acid can be used to control acidity, either as an excipient in pharmaceutical ... formulation or natural preservative additive for foods. Malonic acid is used as a building block chemical to ...
... hypromellose has been used as an excipient in oral tablet and capsule formulations, where, depending on the grade, it functions ... Reddy, Indra K.; Riz̤ā Miḥvar (2004). Chirality in Drug Design and Development. p. 21. ISBN 9780824750626. .. ... Weiner, Myra L.; Lois A. Kotkoskie (1999). Excipient Toxicity and Safety. p. 8. ISBN 9780824782108. .. ... Excipient/tableting ingredient. In addition to its use in ophthalmic liquids, ...
... but they can be particularly conducive to custom formulation with various possible excipients (in addition to custom drug/dose ... have wide discretion to prescribe customized drug products containing unique drug-dosage combinations and/or formulations ... Physicians in most jurisdictions have wide discretion to prescribe customized drug products containing unique drug-dosage ... if a customized drug product is produced for a specific patient in response to a prescription specifying said patient's drug(s ...
... helps relate the formulation of drugs to their delivery and disposition in the body. Pharmaceutics deals with the ... CS1 maint: Extra text: authors list (link) Excipient selection for injectable / parenteral formulations. ... formulation of a pure drug substance into a dosage form. Branches of pharmaceutics include: Pharmaceutical formulation ... Historically before the advent of medicine as a science it was common for pharmacists to dispense drugs as is, most drugs today ...
... a matrix-forming agent for the controlled release of water-soluble drugs and as a lubricant in oral solid dosage formulations. ... Behenic acid Handbook of pharmaceutical excipient, 5th edition 21 C.F.R. 184.1328. ... In pharmaceutical formulations, glyceryl behenate is mainly used as a tablet and capsule lubricant and as a lipidic coating ... excipient. It has been investigated for the encapsulation of various drugs such as retinoids. It has also been investigated for ...
In formulation development, Rubicon has a presence in all therapeutic areas excluding cytotoxic drugs, beta-lactum antibiotics ... In 2006-07 Rubicon licensed its Orodispersible excipient, RubiODT to Mallinckrodt Baker, Inc. Ms. Pratibha Pilgaonkar (Chief ... Ltd.) is a contract research and a Drug delivery company Located in Mumbai, India. ... Pharmaceutical online : Mallinckrodt Baker And Rubicon Research Sign Agreement For Performance Excipient Development Bloomsberg ...
... is also widely used for detection and quantification of excipients or inactive ingredients used in pharmaceutical formulations ... Therefore, IC has been employed in drugs in the form of tablets and capsules in order to determine the amount of drug dissolve ... There has been a growing interest in the application of IC in the analysis of pharmaceutical drugs. IC is used in different ... Detection of sugar and sugar alcohol in such formulations through IC has been done due to these polar groups getting resolved ...
The drug formulation (immediate release, excipients used, manufacturing methods, modified release - delayed release, extended ... of a formulation (A) of a certain drug when compared with another formulation (B) of the same drug, usually an established ... When Tmax is given, it refers to the time it takes for a drug to reach Cmax. While the mechanisms by which a formulation ... Whether a drug is taken with or without food will also affect absorption, other drugs taken concurrently may alter absorption ...
Ron Liu (18 January 2008). Water-Insoluble Drug Formulation, Second Edition. CRC Press. pp. 73-4. ISBN 978-1-4200-0955-2. ... and sometimes the excipients) contained in the dosage form being tested. During the dissolution testing, "sink condition" is a ... Absorption (pharmacokinetics) Dissolution testing Pharmaceutical formulation Tablet (pharmacy) Tablet hardness testing "Shear ...
... drugs not approved by the FDA, even "banned" by the FDA. In the US, Biodyl is neither an illegal drug nor a banned drug, but ... Excipient. Legal status. In the United States, Biodyl is not FDA approved, "in that there is not in effect an approval of ... It is manufactured in two formulations: a powder for use in an individual animal's drinking water, and an injectable solution. ... 608.400 - Compounding of Drugs for Use in Animals (CPG 7125.40)". Compliance Policy Guidance. U.S. Food and Drug Administration ...
Rising Prevalence Of Skin Diseases And Technological Advancement In Drug Formulation And Development To Drive The Topical ... The combination of excipients that can change the stratum corneum to promote drug delivery is also studied for developing ... The selection of topical excipients used for transdermal drug delivery is very difficult due to the complex anatomy of skin. ... Home / Press Release / Rising Prevalence Of Skin Diseases And Technological Advancement In Drug Formulation And Development To ...
Novel cyclodextrin-based excipients for drug formulations Novel cyclodextrin-based excipients for drug formulations. ... Novel cyclodextrin-based excipients for drug formulations. Tech ID #: 1094.2 CONNECT WITH A MANAGER FOR LICENSING Cyclodextrins ... This class of excipients can be readily tailored for use in drug formulations. ... This class of excipients can be readily tailored for use in drug formulations. ...
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... we have the skills and resources to make drug manufacturing more efficient, robust, and cost-effective. ... Today we solve unmet formulation needs and offer intelligent solutions for today and tomorrows challenges in drug formulation ... Focusing Your Formulation Needs. We produce excipients and active ingredients of outstanding quality and performance. With our ... Solubilizers and co-solvents are the most widely employed excipients in the formulation of parenterals. BASF offers a wide ...
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Drug formulation experts. *Regulatory affairs professionals. Related Links. *Laboratory Services. *Pharmaceutical Development ... Excipients are used in most drug products and the quality of the materials, manufacturing processes, and test methods are vital ... Routine testing of excipients, therefore, is crucial. Drug manufacturers must not only verify compendial test methods, but also ... Home › Events › Best Practices for Effective Excipient Sourcing and Testing Best Practices for Effective Excipient Sourcing and ...
Novel formulations of Valsartan-loaded supersaturable self-mircroemulsifying drug delivery systems granules and tablets were ... Solid formulation of a supersaturable self-microemulsifying drug delivery system for valsartan with improved dissolution and ... Solid formulation of a supersaturable self-microemulsifying drug delivery system for valsartan with improved dissolution and ... Solid formulation of a supersaturable self-microemulsifying drug delivery system for valsartan. ...
Drug products combine active pharmaceutical ingredients with excipients in a final formulation for delivery to patients in ... Novel Excipients Prevent Aggregation in Manufacturing and Formulation of Protein and Peptide Therapeutics. ...
... is a surfactant commonly used as an excipient to improve API stability. However, degradation of PS-80 can lead to decreased... ... A Solution To Ensure Quantity & Quality Of The Excipient Polysorbate-80 In Drug Formulations. Source: Catalent ... Excipients are utilized during drug manufacture for a variety of purposes, including stabilization, bulking up or enhancing of ... Bioanalytical Services CMOs Biologic API CMOs Biologic Drug Product CMOs Cell & Gene CMOs Clinical Supply CMOs Fill/Finish CMOs ...
10.4 Formulation Variables 196. 10.4.1 Excipients 197. 10.4.2 Interactions 199 ... 3 Physicochemical Properties, Formulation, and Drug Delivery 35. Dewey H. Barich, Mark T. Zell, and Eric J. Munson ... 16.1.1 Cellular Barriers to Drug Delivery in the CNS 354. 16.1.2 General Approaches for Increasing Brain Penetration of Drugs ... Adds new chapters on nanoparticles, controlled drug release systems, theranostics, protein and peptide drugs, and biologics ...
Evonik launches Resomer Precise custom functional excipients 15-Jun-2020. By Jenni Spinner ... The presented program is laid out as integrated Drug Substance, Particle Engineering and Drug Product services, enabling drug ... Drug delivery, formulation. Merck to acquire $1bn equity stake in Seattle Genetics; announces two oncology collaborations 14- ... Formulation and development strategies for amorphous solid dispersions A large and increasing fraction of orally administered ...
Excipients and Related Methodology, Volume 30 - 1st Edition. Print Book & E-Book. ISBN 9780122608308, 9780080522630 ... Presents comprehensive reviews covering all aspects of drug development and formulation of drugs ... Physical profiles of drug substances and excipients; Analytical profiles of drug substances and excipients; Drug metabolism and ... and Reviews of the uses and applications for individual drug substances, classes of drug substances, or excipients. ...
Impact of internal vial pressure and excipient formulation on chemical contamination risk for injectable drugs manufactured in ... 3 excipient formulations were specifically manufactured: viscous solution, foaming solution and aqueous solution as a control. ... vial internal pressure and special excipient formulations, including viscous and foaming) concerning chemical contamination ... The aim of our study was to assess the impact of the use of worst cases formulations (i.e. ...
Synthesis, processing and solid state excipient interactions of cucurbituril and its formulation into tablets for oral drug ... Synthesis, processing and solid state excipient interactions of cucurbituril and its formulation into tablets for oral drug ... Synthesis, processing and solid state excipient interactions of cucurbituril and its formulation into tablets for oral drug ... T1 - Synthesis, processing and solid state excipient interactions of cucurbituril and its formulation into tablets for oral ...
Verma RK, Garg S. Selection of excipients for extended release formulations of glipizide through drug-excipient compatibility ... Excipient-drug interactions in parenteral formulations. J Pharm Sci. 2002;91:2283-300.CrossRefGoogle Scholar ... Drug-excipient compatibility studies in binary mixtures of Avobenzone. J Cosmet Sci. 2013;64:317-28.PubMedGoogle Scholar ... Analytical profiles of drug substances and excipients, vol. 24. San Diego: Academic Press; 1996. p. 579-613.Google Scholar ...
Industry Description Pharmaceutical Excipients Market to ease the pain while physiological Absorption Pharmaceutical Excipients ... one needs to choose wisely among the several excipients for a drug formulation. It is an important step in drug development. It ... Pharmaceutical Excipients are crucial to drug delivery within the body. Generally, an excipient has no medicinal properties. ... Based on the type of material, the pharmaceutical excipient market is segmented into organic excipients, inorganic excipients ...
... or to any excipients of bevacizumab formulation; or to any other study drugs. ... Drug: XELOXA-A XELOXA-A Bevacizumab: 7,5 mg/kg, day 1 Oxaliplatino: 130 mg/m2 ; day 1 Capecitabine: 1000 mg/m2 bid, oral, day 1 ... Drug: XELOXA XELOXA Bevacizumab: 7,5 mg/kg, day 1 Oxaliplatino: 130 mg/m2 ; day 1 Capecitabine: 1000 mg/m2 bid, oral, day 1-14 ... Received any investigational drug or agent/procedure, i.e. participation in another treatment trial within 30 days of ...
Known hypersensitivity to study drug, metabolites or formulation excipients. Contacts and Locations ... Drug: Elvitegravir Drug: Raltegravir Drug: EVG placebo Drug: RAL placebo Drug: Background regimen Phase 3 ... Drug: EVG placebo Placebo to match elvitegravir administered orally once daily. Drug: Background regimen Background Regimen ( ... Drug: RAL placebo RAL placebo administered orally twice daily.. Drug: Background regimen Background Regimen (administered ...
Known hypersensitivity to any excipients of the drug formulations. *Treatment with another investigational drug within 30 days ... Physiological Effects of Drugs. Anti-Anxiety Agents. Tranquilizing Agents. Psychotropic Drugs. Anesthetics, Intravenous. ... The purpose of this study is to assess whether a cocktail of seven approved drugs (so-called Basel cocktail) can be used for ... Negative results from urine drug screen. *Ability to communicate well with the investigator and to understand and comply with ...
9:50 DRUG FORMULATION TECHNOLOGY. Dr David Cipolla, Senior Director, Pharmaceutical Sciences , ARADIGM. *Platforms of drug ... DRUG FORMULATION TECHNOLOGY: Discover through a case study presentation how to effectively administer drugs and the best route ... 11:00 FORMULATION DEVELOPMENT *Strategies for preformulation and formulation assessment of poorly water soluble drugs at the ... SMis 2nd annual Optimising Drug Formulation conference seeks to provide attendees with the latest advances key formulation ...
JRS Pharma offers a wide range of high-functionality excipients and drug coatings, as well as biopharmaceutical technical ... Binders for solid drug dose formulations. JRS Pharmas line of wet and dry binders keep drug components together, achieving a ... High-functionality excipients for simplified formulation development. High-functionality excipients (HFE) help simplify the ... PRUV®, sodium stearyl fumarate, is designed for formulations in which other lubricants lead to formulation and/or manufacturing ...
Known hypersensitivity to any excipients of the drug formulations used.. *Inability to personally provide written informed ... Drug: Endotoxin At T=0 1 ng/kg E. Coli type O113 lipopolysaccharide is administrated intravenously as a bolus, followed by 1 ng ... Drug: Endotoxin At T=0 1 ng/kg E. Coli type O113 lipopolysaccharide is administrated intravenously as a bolus, followed by 1 ng ... Drug: Endotoxin At T=0 1 ng/kg E. Coli type O113 lipopolysaccharide is administrated intravenously as a bolus, followed by 1 ng ...
Using Raman to Identify Excipients for Food and Drug Formulations. Posted on December 9, 2013 by kyle ...
Using Raman to Identify Excipients for Food and Drug Formulations Ever since the European Medicines Agency (EMA) recommended ... Formulation development - support QbD initiatives in quantifying API and excipient concentrations in finished dosage forms ... Counterfeit detection - calculate API quantity to ensure correct drug and correct dosage ... excipients, intermediates, & finished products. Compact and agile, the NanoRam can be used by non-technical users to rapidly ...
See the process of assigning a USAN to a new drug beginning with a pharmaceutical firm or its representative files an ... Drug delivery mechanisms. *Excipients alone. *Prophylactic vaccines. *Product formulations* (emulsions, suspensions, etc.) ... Consequently, drugs have been named by different means over the last several decades. Early on, many drug names were coined by ... If new indications are found for a stem class or drug, the name of the drug or the definition of the stem does not usually ...
Selection of excipientsStabilityTabletsSolubleActive ingredientsAPIsPharmaceuticalsPharma excipients2017Global Pharmaceutical Excipients marketHypersensitivity to any excipientsLipid-based formulationsDeliveryDegradationSodium Stearyl FumarateCharacterizationPhysicochemicalMannitolAggregationMoleculesRange of excipientsTabletInvestigational newBiologicsRight excipientPURITY EXCIPIENTSDifferent excipientsAbsorptionDosageMuscle relaxantProductsCommonlyAqueousInteractionsTopicalMethodsChemicalAnalyticalManufactureDoseDissolutionMonographsMedicinalConcentrationSolubility enhancementAmorphousHigh throughputInorganicStabilizationPowderBiopharmaceuticalTherapeuticsVitroEfficacySolubilizationFTIRInhalation
- Mechanistic understanding-based selection of excipients may improve formulation development strategies for generic drug products and potentially accelerate their approval. (bioportfolio.com)
- Drug-excipient compatibility testing at an early stage helps in the selection of excipients that increase the probability of developing a stable dosage form [ 1 ]. (alliedacademies.org)
- Traditionally, the selection of excipients relies on a trial-and-error-based approach involving a number of research-based methodologies to determine the ideal excipients. (pharmtech.com)
- Polysorbate-80 (PS-80) is a surfactant commonly used as an excipient to improve API stability. (outsourcedpharma.com)
- However, degradation of PS-80 can lead to decreased drug potency or stability, and there is inconsistency in the quality and composition of PS-80 provided by different vendors. (outsourcedpharma.com)
- Trace levels of this impurity may affect drug product stability, safety, efficacy, and performance. (hindawi.com)
- At Dow Water & Process Solutions, our pharmaceutical-grade ion exchange resins (IX) are used as functional excipients in numerous formulations that help to improve the delivery of drugs by offering formulation flexibility in five key areas: taste masking, controlled release, abuse deterrence, solubility and stability. (dow.com)
- The production of formulations may be limited by the solubility and stability of drugs requiring taste-masking agents, preservatives and solubility of excipients. (sbir.gov)
- It makes sense, then, that these ingredients are of primary importance in a formulation, and appropriate measures should be taken to maintain their stability and efficacy. (drug-dev.com)
- That's why the quality and stability of your formulations are your ultimate challenge, and ours too. (roquette.com)
- It was also a prerequisite to establish a platform that could provide conclusive information about a compound's chemical stability in varying solvents and excipients. (pharmtech.com)
- In deciding whether to buffer the drug in this form, one should take into account the stability of active ingredient and the tissue tolerance to the preparation [ 7 - 9 ]. (hindawi.com)
- Recipharm's formulation scientists set out to establish a methodology that would require the use of minimal amounts of API and could provide conclusive information about a compound's stability in varying solvents and excipients. (outsourcing-pharma.com)
- The technique is also able to provide an insight into the stability of a compound in an excipient and offer a greater understanding of the solubility and stability of a drug in water, as well as in acidic and basic buffers. (outsourcing-pharma.com)
- This six-day (two part) module provides basic formulation principles, including preformulation studies, bioavailability considerations and the effect of excipients on physical and chemical stability. (rsc.org)
- 10. A method of improving the stability of a micronized, aerosol inhalation drug suspension in 1,1,1,2-tetrafluoroethane consisting essentially of the addition of a 1,1,1,2-tetrafluoroethane-soluble, perfluoronated surfactant to said suspension. (google.com)
- Solving challenges of insufficient solubility, poor stability, identifying excipient candidates, and particle design topped their list of offerings. (drug-dev.com)
- Captisol ® , a Ligand product, is a chemically modified cyclodextrin proven to improve the solubility and stability of drugs. (prnewswire.com)
- Also factors such as particle size, polymorphism, pH stability and pH solubility can influence active ingredient bioavailability and hence drug activity, and our laboratories can help you optimise these parameters. (rssl.com)
- Drawing on the expertise of RSSL in areas such as method development and validation, physical sciences , stability testing, microscopy, metals analysis and flavour analysis, our dedicated and knowledgeable teams have the capability, techniques and equipment to support a wide range of formulation types throughout the drug development lifecycle from early phase to finished product release and import testing. (rssl.com)
- Thermogravimetry (TG) and differential scanning calorimetry (DSC) are useful techniques that have been successfully applied in the pharmaceutical industry to reveal important information regarding the physicochemical properties of drug and excipient molecules such as polymorphism, stability, purity, formulation compatibility among others. (mdpi.com)
- Assessing the drug degradation kinetics, the drug had a shelf life (t 90 ) of 56.7 years and a pharmaceutical formulation showed t 90 of 6.8 years showing their high stability. (mdpi.com)
- It was concluded that the preparation methods of co-amorphous formulations have a profound effect on physical properties like stability, physicochemical properties like solubility, dissolution rate, and pharmacokinetic properties like AUC and Cmax. (springer.com)
- Only one of the previous methods was used as a stability indicating method for the determination of pazufloxacin in pharmaceutical formulation and in presence of its degradation products [ 19 ]. (omicsonline.org)
- The ICH guideline Q1A on stability testing of new drug substances and products emphasizes that the testing of those features that are susceptible to change during storage and are unlikely to influence quality, safety and/or efficacy must be done by validated stability-indicating testing methods. (omicsonline.org)
- It is also mentioned that forced decomposition studies (stress testing) should be performed on the drug substance to establish the inherent stability characteristics and degradation pathways to support the suitability of the proposed analytical procedures [ 20 ]. (omicsonline.org)
- 2. ABSTRACT Pharmaceutical excipients are inactive substances in the drug which helps in modulating solubility, bioavailability and stability of active substances for formulating final drug dosage forms. (slideshare.net)
- Excipients are also used in applications where the in-vitro integrity and stability of drugs need to be preserved. (mynewsdesk.com)
- Protein Formulation and Delivery, Second Edition provides a comprehensive review of mechanisms and causes of protein instability in formulation development, coverage of accelerated stability testing methods, and relevant analytical methods. (worldcat.org)
- The synthesis, processing, and solid state excipient interactions of cucurbituril (CB) and its formulation into oral tablets has been examined using a range of physical chemistry techniques. (strath.ac.uk)
- Microcrystalline CB can be formulated into tablets suitable for oral delivery with a CB content of 1-50% w/w, with the other excipients including lactose, talc, Avicel, magnesium stearate and Ac-Di-Sol. (strath.ac.uk)
- Roquette's PEARLITOL®Flash, a combination of mannitol and starch, is a ready-to-use excipient for orodispersible tablets. (pharmaceutical-technology.com)
- Formulations containing PROSOLV® SMCC produce distinctive, uniform, and cost-effective tablets. (pharmaceutical-technology.com)
- Excipients play a major role in the development of tablets and capsules for the health science industry. (pharmaceutical-technology.com)
- Many drugs are supplied as tablets for oral administration. (dow.com)
- Drugs administered by oral route are solid oral dosage forms particularly tablets, the preferred class of product. (bartleby.com)
- Different time lags of the press-coated tablets from 1.0 to 16.3 hours could be modulated by changing the type and amount of the excipients. (pubmedcentralcanada.ca)
- 1. Jivraj M, Martini LG, Thomson CM. An overview of the different excipients useful for the direct compression of tablets. (pubmedcentralcanada.ca)
- One of these include orodispersible tablet technology which offers the advantages of both solids and liquids such as quick disintegration and dissolution of tablets, no residue in mouth, requires no water intake, provides a pleasant mouth feel and even allows high drug loading 2 . (ispub.com)
- The development of the formulation focused on patient safety, drug efficiency and bioequivalence to the WHO recommended comparator product (Sovaldi® 400 mg Film-coated Tablets). (who.int)
- The Functional Additives Division of Asahi Kasei's Specialty Solutions SBU supplies Ceolus™ microcrystalline cellulose to pharmaceutical manufacturers around the world for use as an excipient for drug tablets. (biospectrumasia.com)
- As a result of the study presented here, the potassium-salt form of Compound XY was reformulated to yield tablets of acceptable dissolution, weight, properties, and appearance without adding any new excipients to the formulation. (drug-dev.com)
- In order to resolve this issue, scientists studied the formulation composition of these tablets to identify the root causes of the stickiness. (drug-dev.com)
- The original formulation of the tablets contained silicified microcrystalline cellulose (Prosolv SMCC 90), mannitol, and Avicel HFE as inactive excipients. (drug-dev.com)
- Therefore, we suggest that the optimized S-SuSMEDDS formulations offer great potential for developing solid dosage forms, with improved oral absorption of poorly water-soluble drugs such as VST. (pharma-excipients.ch)
- About 70% of the new chemcial ntities are recognized as poorly water-soluble about 40% of commercially available immediate-release oral formulations are recognized as practically insoluble in water (Kawabata et al. (bartleby.com)
- Therefore, enhancing the aqueous solubility and dissolution rate of poorly water-soluble drugs is one of the major challenges in pharmaceutical industry. (bartleby.com)
- The dissolution performance of crystallized xylitols formulated with a model poorly water-soluble drug, i.e. indomethacin, in comparison to commercial xylitol were also evaluated. (bartleby.com)
- Povidone is also used as a solubilizer in oral and parenteral formulations to improve dissolution of poorly soluble drugs from solid-dosage forms. (bartleby.com)
- 1 Therefore, with about 70 to 90 percent of the drugs in development falling in the two low-solubility classes of the Biopharmaceutical Classification System (BCS), 2 it is critical that formulation scientists use the most appropriate solubility enhancement technology and formulation strategies to improve the bioavailability of poorly soluble drugs. (drugdiscoveryonline.com)
- The present invention discloses a stable, soluble formulation comprising a medically useful peptide or protein, a hydrophobic preservative, and nicotinamide. (google.com)
- Said storage-stable, soluble formulation is useful as a multi-use pharmaceutical product. (google.com)
- 1. A soluble formulation comprising a medically useful GLP-1 molecule, a hydrophobic preservative, and nicotinamide. (google.com)
- 2. The soluble formulation of claim 1 wherein the GLP-1 molecule is selected from the group consisting of GLP-1 analogs and GLP-1 derivatives. (google.com)
- 3. The soluble formulation of claim 1 wherein the GLP-1 molecule is a GLP-1 analog. (google.com)
- 4. The soluble formulation of claim 3 wherein the GLP-1 analog is selected from the group consisting of Val 8 -GLP-1(7-37)OH, Gly 8 -GLP-1(7-37)OH, and Asp 8 -GLP-1(7-37)OH. (google.com)
- 5. The soluble formulation of claim 4 wherein the GLP-1 analog is Val 8 -GLP-1(7-37)OH. (google.com)
- 11. The soluble formulation of claim 10 wherein the GLP-1 analog is acylated on the epsilon-amino group of lysine. (google.com)
- 12. The soluble formulation of claim 1 , wherein the concentration of the medically useful GLP-1 molecule is between 0.01 mg/mL and 100 mg/mL. (google.com)
- 13. The soluble formulation of claim 1 , wherein the preservative is selected from the group consisting of phenol, cresol, alkylparaben, benzyl alcohol, benzoic acid, chlorobutanol and mixtures thereof. (google.com)
- Used for treating testicular, lung, and ovarian cancer, there are more than 300 marketed products incorporating this sparingly water-soluble active, with the bulk of the formulations incorporating polysorbate 80. (drug-dev.com)
- Excipients can be used to optimize the solubility of poorly soluble compounds. (pharmtech.com)
- The screening list involved excipients with varying solubilization mechanisms, including water-soluble organic solvents, non-ionic surfactants, water-insoluble lipids, organic liquids/semi-solids, cyclodextrins, and phospholipids. (pharmtech.com)
- Here, computational modelling and High-throughput screening (HTS) were combined to identify and rank the ideal coformers and stoichiometric ratios for cocrystals of poorly water-soluble drugs, before being scaled-up via Hot-melt extrusion (HME) for continuous manufacture. (ddfevent.com)
- This increases solubility, permeability, and bioavailability of poorly soluble drugs [ 1 - 4 ]. (hindawi.com)
- This invention relates to aerosol inhalation drug formulations comprising one or more drugs and one or more soluble surfactants in propellant 134a. (google.com)
- 1. An aerosol inhalation drug formulation consisting essentially of a physiologically effective amount of a micronized inhalation drug and a 1,1,1,2-tetrafluoroethane-soluble, perfluoronated surfactant in suspension in 1,1,1,2-tetrafluoroethane. (google.com)
- 9. A formulation of claim 1 wherein said 1,1,1,2-tetrafluoroethane-soluble, perfluoronated surfactant is potassium perfluoroalkyl sulfonates, ammonium perfluoroalkyl carboxylates or a combination thereof. (google.com)
- 12. A method of claim 11 wherein said drug is albuterol, salmeterol or amiloride and said surfactant is a 1,1,1,2-tetrafluoroethane-soluble, perfluorinated surfactants. (google.com)
- 18. A formulation of claim 17 wherein said 1,1,1,2-tetrafluoroethane-soluble, perfluoronated surfactant is perfluoroctanoic acid, perfluorodecanoic acid, ammonium perfluoroalkyl carboxylates or potassium perfluoroalkyl sulfonates. (google.com)
- An orodispersible tablet form would thus be advantageous, as salbutamol sulphate is water-soluble drug and its formulation into an orodispersible tablet form would render it to disintegrate rapidly and thereby result in rapid absorption without any lag time 3 . (ispub.com)
- Semifluorinated alkanes (SFAs) are potentially new excipients for formulations of poorly soluble, lipophilic drugs. (dovepress.com)
- The aim of the present study was to investigate transfersomes as a transdermal delivery system for the poorly soluble drug, sertraline, in order to overcome the troubles associated with its oral delivery. (nih.gov)
- We produce excipients and active ingredients of outstanding quality and performance. (basf.com)
- As a long-established global provider of plant-based excipients and life-saving active ingredients for the pharmaceutical and biopharmaceutical industries, Roquette offers a competitive broad-range of customer-focused solutions. (roquette.com)
- Next possibility to modify the ophthalmic forms active ingredients' bioavailability involved introducing excipients to formulation, which enhanced drugs' penetration into the eyeball. (hindawi.com)
- The NanoRam is a state-of-the-art handheld Raman instrument for nondestructive identification and verification of materials such as APIs, excipients, intermediates, & finished products. (bwtek.com)
- However, some APIs are suffering from the risk of transformation of their target forms during processing, formulation and storage. (bioportfolio.com)
- Driven by federal legislation that now requires evaluation of most drugs in children, renewed attention has been focused on the active pharmaceutical ingredients (APIs). (sbir.gov)
- Many APIs are extremely bitter, which can make the development of palatable formulations extremely difficult. (sbir.gov)
- The effectiveness of new medicines depends on the active pharmaceutical ingredients (APIs) but also on the associated excipients used in the formulation. (roquette.com)
- However, there are still problems associated with their formulation design, including the interaction between the active pharmaceutical ingredient(s) (APIs), excipients and devices. (wiley.com)
- RSSL offers a broad range of analytical techniques and expertise to characterise the physical and structural features of excipients, APIs, medical devices and finished products. (rssl.com)
- With our unique expertise in polymer chemistry, our research & development capabilities and our clear commitment to developing excipients, BASF has continuously created solutions that contribute to our customers' success and to more efficient pharmaceuticals. (basf.com)
- The synergetic combination of polymers and pharmaceuticals provides a means to address significant unmet medical needs such as continuous sustained drug release, or delivery of high drug payloads to specific tissues. (sigmaaldrich.com)
- The conjunction of polymers and medicine enables the development of new materials that display novel features, opening new ways to administrate drugs, design implants and biosensors, to deliver pharmaceuticals impacting cancer treatment, regenerative medicine or gene therapy. (springer.com)
- With The Pharmaceuticals Market comfortably poised to reach annual revenues of US$400 bn before the end of 2020 (according to the World Health Organization), the demand for excipients is expected to exhibit steady growth. (mynewsdesk.com)
- DURECT Signs Long Term Excipient Supply Agreement With King Pharmaceuticals for. (bio-medicine.org)
- Pain Therapeutics sublicensed the commercialization rights of REMOXY and other licensed drug candidates to King Pharmaceuticals in November 2005. (bio-medicine.org)
- The latest market report published by Credence Research, Inc. " Topical Excipients Market - Growth, Future Prospects, Competitive Analysis, 2017 - 2025," the global topical excipients market is expected to grow at a CAGR of 5.72 % from 2017 to 2025. (credenceresearch.com)
- Sir, we are very much intrigued by the spectrum of side effects reported to the French national safety agency when the new formulation of Merck´s levothyroxine was introduced in March 2017. (bmj.com)
- The global Pharmaceutical Excipients market report has its foundation in a segmentation based on type and route of Administration, dosage and end users. (medgadget.com)
- This report creates a holistic perspective of the current dynamics that govern the global pharmaceutical excipients market. (mynewsdesk.com)
- Besides this factor, a slight but steady decline in the investment inflow in pharmaceutical R&D projects could act against the growth of the global pharmaceutical excipients market. (mynewsdesk.com)
- While these two restraints remain a major concern, the scenario is anything but gloomy for companies operating in the global pharmaceutical excipients market. (mynewsdesk.com)
- Opportunities in the global pharmaceutical excipients market are primarily centered on the growing scientific understanding of functionality excipients. (mynewsdesk.com)
- Oral Lipid-Based Formulations covers the theoretical and practical aspects of oral lipid-based formulations for use in industry, and provides further insights into a developing technology expected to assume increasing prominence in years to come. (chipsbooks.com)
- For the therapeutic delivery of lipophilic active moieties (BCS class II drugs), lipid based formulations are inviting increasing attention. (isciii.es)
- The selection of topical excipients used for transdermal drug delivery is very difficult due to the complex anatomy of skin. (credenceresearch.com)
- The physicochemical parameters of excipients such as molecular weight, hydrogen bonding, polarizability and particle charge are duly considered for making a transdermal drug delivery system. (credenceresearch.com)
- The combination of excipients that can change the stratum corneum to promote drug delivery is also studied for developing transdermal drug delivery products. (credenceresearch.com)
- Surfactants have been subjected to chemical modification in the last 2 decades while its application in novel drug delivery systems. (credenceresearch.com)
- We deliver value added functional solutions to our customers' formulation challenges by leveraging our expertise in delivery systems and related technologies. (basf.com)
- Find the answer to your Instant and Modified Release , Solubilization , Skin Delivery and Softgels related formulation challenges. (basf.com)
- Drug products combine active pharmaceutical ingredients with excipients in a final formulation for delivery to patients in liquid or lyophilized (freeze-dried) packaged forms - with the latter requiring reconstitution in the clinical setting. (bioprocessintl.com)
- In order to improve the dissolution and oral bioavailability of valsartan (VST), and reduce the required volume for treatment, we previously formulated a supersaturable self-microemulsifying drug delivery system (SuSMEDDS) composed of VST (80 mg), Capmul® MCM (13.2 mg), Tween® 80 (59.2 mg), Transcutol® P (59.2 mg), and Poloxamer 407 (13.2 mg). (pharma-excipients.ch)
- Following its successful predecessor, this book covers the fundamentals, delivery routes and vehicles, and practical applications of drug delivery. (wiley.com)
- In addition to co-editing the first edition of Drug Delivery , he has written almost 195 journal papers and book chapters and received the 2014 PhRMA Foundation Award in Excellence in Pharmaceutics. (wiley.com)
- Pharmaceutical Excipients are crucial to drug delivery within the body. (medgadget.com)
- Based on route of administration, the pharmaceutical excipient market is segmented by-oral, injectable/parenteral, topical and advanced delivery systems. (medgadget.com)
- This work represents the first study of the physical processing and solid state chemistry of CB[n]s for pharmaceutical formulation and represents an important development step in the use of CB[n]s as drug delivery vehicles. (strath.ac.uk)
- As a leading manufacturer of drug delivery devices, Gerresheimer counts many of the world's leading. (pharmaceutical-technology.com)
- Discover through a case study presentation how to effectively administer drugs and the best route of delivery - pulmonary, oral or nasal? (smi-online.co.uk)
- and for drug delivery purposes, among other uses. (cosmeticsandtoiletries.com)
- This polymer is biodegradable, bioresorbable, biocompatible and non-toxic, and it is widely used in pharmaceutical applications as an excipient, for drug delivery applications, and as an active principle, i.e., fungistatic, bacteriostatic, wound healing agent and devices. (cosmeticsandtoiletries.com)
- Today drug delivery companies are concentrating on solid oral drug delivery systems that suggestion increased patient amenability and effect. (bartleby.com)
- This FOA also encourages the development and testing of novel drug delivery systems in the pediatric population. (sbir.gov)
- The goal of this FOA is to complement and accelerate the development of appropriate pediatric drugs formulations and drug delivery systems. (sbir.gov)
- As a result of this work and the optimisation of our MDS methods and forcefields, we are now capable and confident in modelling complex and dynamic lipidic systems, including peptide formulations designed for oral delivery. (manufacturingchemist.com)
- The ultimate goal of adding excipients is delivery of drug in pure and safe form to the target. (alliedacademies.org)
- Drug therapy via inhalation route is at the cutting edge of modern drug delivery research. (wiley.com)
- The type of excipients used will depend on the drug delivery system. (pharmtech.com)
- This paper describes hitherto developed drug forms for topical ocular administration, that is, eye drops, ointments, in situ gels, inserts, multicompartment drug delivery systems, and ophthalmic drug forms with bioadhesive properties. (hindawi.com)
- The right excipient will often depend on the delivery system. (outsourcing-pharma.com)
- 3. Clausen AE, Bernkop-Schnurch A. Direct compressible polymethacrylic acid-starch compositions for site-specific drug delivery. (pubmedcentralcanada.ca)
- 6. Sangalli ME, Maroni A, Zema L, Busetti C, Giordano F, Gazzaniga A. In vitro and in vivo evaluation of an oral system for time and/or site-specific drug delivery. (pubmedcentralcanada.ca)
- Studies on the development of oral colon targeted drug delivery systems for metronidazole in the treatment of amoebiasis. (pubmedcentralcanada.ca)
- Chronopharmaceutical drug delivery from a pulsatile capsule device based on programmable erosion. (pubmedcentralcanada.ca)
- 9. Bussemer T, Otto I, Bodmeier R. Pulsatile drug-delivery systems. (pubmedcentralcanada.ca)
- 10. Baichwal A, Neville D. Advanced drug delivery technology infuses new life into product life-cycles. (pubmedcentralcanada.ca)
- Microsized and Nanosized Carriers for Nonsteroidal Anti-Inflammatory Drugs: Formulation Challenges and Potential Benefits provides a unique and complete overview of novel formulation strategies for improvement of the delivery of NSAIDs via encapsulation in microsized and nanosized carriers composed of different materials of natural and synthetic origin. (elsevier.com)
- The relatively crude nature of these devices also meant that the particles that they generated were relatively large, too large for effective drug delivery to the lungs. (wikipedia.org)
- Nonetheless these nebulizers paved the way for inhalation drug delivery providing the inspiration for the MDI. (wikipedia.org)
- The introduction of polymers into the biomedical field has opened new avenues in tissue engineering, implant design, biosensing, and drug delivery. (sigmaaldrich.com)
- The excellent properties of PAOx polymers enable their use in a wide variety of different biomedical applications, from targeted drug delivery and drug formulation to tissue engineering and tissue adhesives. (sigmaaldrich.com)
- 13,14 This overview on biomedical applications of PAOx presents a special emphasis on their contribution and potential impact on drug delivery applications. (sigmaaldrich.com)
- 16 This side-chain tunability enables the introduction of multiple functional groups along the polymer chain and the preparation of hydrogels or highly drug-loaded delivery vehicles. (sigmaaldrich.com)
- An improved adhesion-preventative physical barrier, wound dressing and drug delivery system comprising an oxidized cellulose film made up of multiple layers of a cellulose fabric or like material and a cellulose film. (google.com)
- According to Fran DeGrazio, vice-president, Global Scientific Affairs and Technical Services, West Pharmaceutical Services, the size of biologic drug products is particularly challenging when approaching drug delivery. (pharmtech.com)
- When developing large molecule formulations, and depending on the delivery route, there will be different challenges to address with implication on the respective excipient selection, explains Eunice Costa, director-RD Drug Product Development, Hovione. (pharmtech.com)
- There has been an upswing in the proportion of drugs in the pipeline to be administered via a subcutaneous (SC) delivery route, with biomolecules that are currently administered intravenously (IV) being formulated for SC instead. (pharmtech.com)
- Typically, a combination of both formulation optimization, and an appropriate delivery device, facilitates the transition from IV administration to SC. (pharmtech.com)
- The information was then carefully analyzed, highlighting the most important results in the formulation and development of self-micro emulsifying drug delivery systems as well as its therapeutic activity. (isciii.es)
- Self-emulsifying drug delivery system (SMEDDS) has gained more attention due to enhanced oral bio-availability enabling reduction in dose, more consistent temporal profiles of drug absorption, selective targeting of drug(s) toward specific absorption window in GIT, and protection of drug(s) from the unreceptive environment in gut. (isciii.es)
- Successful oral delivery of drugs has always remained a challenge to the drug delivery field, since approximately 40% of the new drug candidates have poor water solubility, and thus oral delivery is frequently associated with implications of low bioavailability. (isciii.es)
- Several new technologies for oral delivery have recently been available to address the problems of physicochemical and pharmacokinetic characteristic of drugs, while improving patient compliance. (ispub.com)
- A self-microemulsifying drug delivery system ( SMEDDS ) is a drug delivery system that uses a microemulsion achieved by chemical rather than mechanical means. (wikipedia.org)
- Microemulsions have significant potential for use in drug delivery, and SMEDDS (including so-called "U-type" microemulsions) are the best of these systems identified to date. (wikipedia.org)
- Actual applications of Self-microemulsifying drug delivery system' (SMEDDS) remain rare. (wikipedia.org)
- The commercialization of HA nanogel would expand the product lineup by adding a drug delivery system (DDS) base material for injection formulations. (biospectrumasia.com)
- Analysts have also evaluated the projected impact of disruptive drug delivery techniques on those in the business of pharmaceutical excipients. (mynewsdesk.com)
- For instance, the rising interest in nanotechnology in drug delivery and endeavors to reduce the toxicity of drugs are initiatives that will pave the way for the use of innovative excipients. (mynewsdesk.com)
- The current study was conducted to investigate the in vitro biocompatibility of F6H8-cEM and their drug delivery properties. (dovepress.com)
- Antioxidant capacity and drug delivery properties were measured with an oxidation assay. (dovepress.com)
- DURECT's proprietary oral, transdermal and injectable depot delivery technologies enable new indications and superior clinical/commercial attributes such as abuse deterrence, improved convenience, compliance, efficacy and safety for small molecule and biologic drugs. (bio-medicine.org)
- The pulmonary route by oral inhaler delivery of salbutamol sulphate was considered as another route of non invasive systemic drug delivery method. (ijpsonline.com)
- Including an overview of the drug substance manufacturing process, this text also examines preformulation and the development of traditional solutions and lyophilized formulations frequently used for intravenous delivery - non-traditional formulations are also addressed. (worldcat.org)
- These impurities include formaldehyde which could be generated by autoxidation degradation of many pharmaceutical excipients such as polyvinylpyrrolidone (PVP) and polyethylene glycol (PEG) [ 1 - 4 ]. (hindawi.com)
- Residual catalyst that isn't removed from an excipient can trigger side reactions and perpetuate degradation of not just the API, but everything else in the formulation. (drug-dev.com)
- This chemical interaction may lead to degradation of active ingredient of the formulation thus reduction in efficient therapeutic response. (alliedacademies.org)
- Excipients may have functional group that interacts with Active Pharmaceutical Ingredient (API) which results into formation of degradation product. (alliedacademies.org)
- Studies on stress degradation were found to be reported in the literature whereas no mention of excipient compatibility was elucidated [ 6 ]. (alliedacademies.org)
- 15 mg/mL was set as the maximum amount, with degradation of the drug indicated in red. (pharmtech.com)
- They were then shaken for a further 48 hours, centrifuged and analysed by high performance liquid chromatography (HPLC) to determine the solubility of the drug in the selected excipient, or mix of excipients, and detect any degradation. (outsourcing-pharma.com)
- The drug showed degradation when subjected to oxidizing conditions, suggesting that the degradation product is 3,4-dimethoxybenzoic acid derived from alkyl side chain oxidation. (mdpi.com)
- The second method was based on TLC separation of pazufloxacin from its degradation products followed by Densitometric measurement of the intact drug spot at 249 nm. (omicsonline.org)
- Organic chemicals find huge applications in drug formulations due to its enhanced compatibility with API and ability to modify the physical and chemical characterization of the drug formulation. (credenceresearch.com)
- Traditional contributions will now also be augmented by publication of critical review chapters that summarize information related to the characterization of drug substances and excipients. (elsevier.com)
- This paper constitutes an overview and characterization of the hitherto developed ophthalmic drug forms. (hindawi.com)
- From drug discovery to post-marketed products, the scientific fields and technologies involved require fast and innovative characterization tools. (horiba.com)
- Characterization and Mapping of active pharmaceutical ingredients and excipients in a tablet by Raman and infrared spectroscopy on the same microspectrometer. (horiba.com)
- Circumventing phenomena, such as denaturation, aggregation, and other forms of structural change, are of key importance when processing and developing formulations with biological molecules, Cacela further explains. (pharmtech.com)
- The need for high concentrations results in increases of viscosity and challenges in maintaining isotonicity of the liquid formulation as well as in preventing aggregation. (pharmtech.com)
- HA nanogel is expected to improve the quality of life (QOL) for patients by enabling the low-toxicity solubilization of insoluble drugs, facilitating the formulation of biopharmaceuticals such as proteins and peptides by suppressing their aggregation and denaturation, and reducing the frequency of injection when repeated administration is required. (biospectrumasia.com)
- In contrast to previously licensed adjuvants, current successful adjuvant formulations often consist of several molecules, that when combined, act synergistically by activating a variety of immune mechanisms. (mdpi.com)
- the position of drug molecules of varying lipophilicity in surfactant micelles or in oil-rich formulations dispersed in water. (manufacturingchemist.com)
- Low aqueous solubility is a major problem encountered during the formulation development of drug molecules. (drugdiscoveryonline.com)
- However, biologics raise unique challenges in formulation and development, not least as a result of the large size of the molecules but also due to other characteristics of the complex API. (pharmtech.com)
- Development of drug products : similarities and differences between protein biologies and small synthetic molecules / Eugene J. McNally, Jayne E. Hastedt. (worldcat.org)
- JRS Pharma offers a wide range of excipients and tablet coatings, as well as technical support and biopharma services to the health science industry. (pharmaceutical-technology.com)
- What is suitable for an orally administered product might not necessarily be suited to an injectable product, so during testing an extensive screening list, including a diverse range of excipients with varying solubilisation mechanisms, was developed. (outsourcing-pharma.com)
- In some cases, the effectiveness of the drug depends on the rate at which the tablet disintegrates in the gastrointestinal tract. (dow.com)
- Adult formulations are frequently taste masked by coating the tablet or by formulating in a capsule which are generally not useful for young children. (sbir.gov)
- This press-coated tablet containing sodium diclofenac in the inner core was formulated with an outer shell by different weight ratios of hydrophobic polymer of micronized ethylcellulose (EC) powder and hydrophilic excipients such as spray-dried lactose (SDL) or hydroxypropyl methylcellulose (HPMC). (pubmedcentralcanada.ca)
- The release profile of the press-coated tablet exhibited a time period without drug release (time lag) followed by a rapid and complete release phase, in which the outer shell ruptured or broke into 2 halves. (pubmedcentralcanada.ca)
- The predetermined time lag prior to the drug release from a press-coated tablet prepared by using a micronized EC as a retarding coating shell can be adequately scheduled with the addition of hydrophilic excipients according to the time or site requirements. (pubmedcentralcanada.ca)
- All the excipients used in the manufacture of the finished pharmaceutical product are well known pharmaceutical excipients with established uses in tablet formulations. (who.int)
- the tablet weight of the 25-mg formulation was 160 mg. (drug-dev.com)
- The drug products are formed mainly to facilitate physiological absorption of the drug. (medgadget.com)
- 2001). Therefore, several potentially promising drug candidtates were rejected as pharmaceutical products due to ther poor solubilitty in GI fluid, poor dissolution in GI tract, low systemic absorption and thus poor oral bioavailability (therapeutically ineffective) (Hörter and Dressman, 2001). (bartleby.com)
- Literature suggests that cis-etoposide is biologically inactive in vitro, so any unwarranted conformation can have direct consequences on drug absorption and effectiveness. (drug-dev.com)
- Ideally excipients should be chemically inert but they may alter absorption, distribution, metabolism, and excretion of drug. (alliedacademies.org)
- Low capacity of conjunctival sac, that is, approximately 30 L without blinking [ 4 ], and the aforementioned defence mechanisms cause decrease in drug concentration in the place of application and shorten the time during which the active ingredient stays in the place of absorption. (hindawi.com)
- The primary purpose for the development of ophthalmic drug forms is to achieve the required drug concentration in the place of absorption and sustaining it for appropriately long time, which in turn contributes to smaller application frequency [ 1 - 5 ]. (hindawi.com)
- For injectables, concentration and viscosity of subcutaneous formulations are the main points to address and optimize, whereas for oral enzymatic and acidic degradations low absorption needs to be addressed as well," she says. (pharmtech.com)
- SMEDDS are of particular value in increasing the absorption of lipophilic drugs taken by mouth. (wikipedia.org)
- The key features of the products is that it must suit the intended dosage form of the drug, demonstrate great organoleptic properties, conform to pharmacopeial regulations, be easy to source, and work effectively. (medgadget.com)
- By dosage forms, the pharmaceutical excipients the market segmentation includes solid dosage forms, liquid dosage forms, semi-solid dosage forms, and others. (medgadget.com)
- The company provides drug manufacturers a variety of solutions for oral dosage forms, including several innovations developed by JRS' research and development team. (pharmaceutical-technology.com)
- High-functionality excipients (HFE) help simplify the formulation of oral dosage forms, improving overall costs and preserving quality. (pharmaceutical-technology.com)
- is widely used in pharmaceutical formulations, mainly used in solid-dosage forms. (bartleby.com)
- Substances which are of little or no therapeutic value, but are necessary in the manufacture, compounding, storage, etc., of pharmaceutical preparations or drug dosage forms. (bioportfolio.com)
- In general, there is a need in pediatrics to develop flexible dosage forms that are oro-dispersible or can be prepared as oral liquid formulations. (sbir.gov)
- Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form. (wikipedia.org)
- Oral route has always been the favorite route of drug administration in many diseases and till today it is the first way investigated in the development of new dosage forms. (isciii.es)
- Excipients are used in most drug products and the quality of the materials, manufacturing processes, and test methods are vital to the production of safe, effective therapies. (sgs.com)
- Fluorescent spots were mainly found on work surfaces, vials adaptors and waste containers with foaming solution and positive pressure vials (Table I). Conversely, end-products were not contaminated on surfaces whatever the formulation except one time on a syringe produced from a positive pressure vial. (gerpac.eu)
- MCC products EMCOCEL® and VIVAPUR® have a wide range of benefits for formulations, including high compactability, high-production yields, cost savings, and compatibility with most active pharmaceutical ingredients (API). (pharmaceutical-technology.com)
- These products are manufactured at Dow's facilities in Chauny, France and are fully supported by Drug Master Files (DMF). (dow.com)
- Safety assessment of excipients (SAFE) for orally inhaled drug products. (bioportfolio.com)
- The development of new orally inhaled drug products requires the demonstration of safety which must be proven in animal experiments. (bioportfolio.com)
- The Biopharmaceutics Classification System (BCS), the scientific framework for classifying drug substances based on their intestinal permeability and solubility/dissolution rates, is widely used to assure bioequivalence of drug products in adults. (sbir.gov)
- Vibhakar Shah, Ph.D. Pulmonary and Allergy Drug Products Division of New Drug Chemistry II Office of New Drug Chemistry, OPS, CDER, FDA. (slideserve.com)
- During preparation and storage of drug products, new impurities may be generated. (alliedacademies.org)
- There has been significant progress on the understanding of drug therapy via inhalation products. (wiley.com)
- The Qualified Person should have a thorough knowledge of formulation and processing of the medicinal products they are asked to certify. (rsc.org)
- Products and product candidates in this category include inhaled drugs for the treatment of such diverse conditions as pulmonary arterial hypertension, neurological disorders, hereditary diseases and pain management. (giiresearch.com)
- This applies to all drugs - immunological products ( these days commonly called vaccines. (bmj.com)
- The evidence suggests that the US Food and Drug Administration (FDA) accepted products such as a nicotine inhaler may be a safer way to give nicotine than e-cigarettes. (wikipedia.org)
- Hovione also provides proprietary product development and licensing opportunities for drug products . (prnewswire.com)
- The size of biologic drug products-ranging from 3000 atoms to more than 25,000 atoms-has meant that the primary route of administration is via injection, states DeGrazio. (pharmtech.com)
- This puts considerable pressure on manufacturers of pharmaceutical excipients who have to follow numerous process-related and regulatory procedures to bring their products to the market. (mynewsdesk.com)
- This method is characterized by using simple and economic GC-FID technique instead of MS detection, and it is successfully used to analyze formaldehyde in commonly used pharmaceutical excipients. (hindawi.com)
- Before we could apply MDS to key areas of formulation development, we worked to develop proprietary computational methods and molecular forcefields (sets of equations and parameters that model intramolecular and interatomic interactions) that are applicable and accurately model drugs and commonly used lipidic excipients. (manufacturingchemist.com)
- The HPLC study showed, drug interacts with some commonly used pharmaceutical excipients. (alliedacademies.org)
- In the development of liquid formulations, solvent modifications and carrier systems are most commonly used because they affect only the solvation characteristics of a drug rather than its solid-state properties. (pharmtech.com)
- 3 excipient formulations were specifically manufactured: viscous solution, foaming solution and aqueous solution as a control. (gerpac.eu)
- Low aqueous solubility can, therefore, be a major challenge in drug development. (pharmtech.com)
- Although a critical aspect in formulation development, solubility remains one of the most difficult obstacles to overcome due to many compounds possessing low aqueous solubility. (outsourcing-pharma.com)
- The major problem in oral drug formulations is low and erratic bioavailability, which mainly results from poor aqueous solubility, thereby pose problems in their formulation. (isciii.es)
- Interactions and incompatibilities of pharmaceutical excipients with active pharmaceutical ingredients: a comprehensive review. (springer.com)
- Further investigations into the use of high sensitivity differential scanning calorimetry as a means of predicting drug-excipient interactions. (springer.com)
- In the solid state microcrystalline CB does not interact significantly with the talc, Ac-Di-Sol or Avicel, but significant interactions are observed when mixed or ground with either magnesium stearate or lactose, resulting in the lowering of the melting points of both excipients. (strath.ac.uk)
- Due to known drug interactions, participants in the Elvitegravir group receiving RTV-boosted atazanavir (ATV) or RTV-boosted lopinavir (LPV) as part of their background regimen will receive elvitegravir at a lower dose (85 mg). (clinicaltrials.gov)
- No other marketed PIs are allowed as part of the background regimen due to unknown drug interactions. (clinicaltrials.gov)
- Interactions of Oral Molecular Excipients with Breast Cancer Resistance Protein, BCRP. (bioportfolio.com)
- This is in addition to the endogenous compounds in the gut that perform key interactions with drugs and formulations, such as bile salts and phospholipids. (manufacturingchemist.com)
- Domicile of pharmaceutical companies primarily engaged in the production of topical excipients and rising prevalence of chronic ailments requiring long term therapy regimen. (credenceresearch.com)
- Asia Pacific showcases tremendous potential to fortify its market share in topical excipients market on account of competitive market created due to domestic players and government healthcare agencies are proactively engaged in the development of medical facilities for the low and middle income population. (credenceresearch.com)
- Compatibility studies of lapachol with pharmaceutical excipients for the development of topical formulations. (springer.com)
- The company has a long and stellar reputation for delivering quality and results for clients from formulation through manufacturing, which is why people say, "Think Topical. (a2zinc.net)
- While industry guidances, excipient monographs, and compendial test methods provide some direction, sourcing and testing of excipients is an ongoing challenge for drug manufacturers. (sgs.com)
- Drug manufacturers must not only verify compendial test methods, but also assess the suitability of these test methods to meet the requirements of excipients, manufacturing processes, and analytical instruments currently used. (sgs.com)
- DSC and IST-FTIR are suitable and simple methods for the detection of potential incompatibilities between active pharmaceutical ingredient (API) and excipients. (springer.com)
- The drug formulation industry has seen a 38 per cent growth in the past five years and is expected to continue to expand as drug companies begin to seek advanced methods of delivering drugs effectively, as well as different ways of marketing both new and old compounds by devising new formulations. (smi-online.co.uk)
- However, some of these methods have limited selectivity or have suffered from difficulty handling and injecting excipient samples which form viscous solution (such as PVP). (hindawi.com)
- Also co-formulations of multiple monoclonal antibodies into a single drug product brings certainly convenience to the patients, however brings also the need for new analytical methods. (ddfevent.com)
- All processing methods yielded homogeneous co-amorphous formulation, which was confirmed by single glass transition (Tg) event and diffuse halo in DSC and XRPD, respectively. (springer.com)
- Reviewing the literature revealed that, few methods have been reported for the determination of pazufloxacin in raw material, pharmaceutical formulation and/or human plasma. (omicsonline.org)
- Diverting from the previous formulation process would have affected the analytical methods. (drug-dev.com)
- Stabilizers and emulsifiers are widely used in liquid and semisolid drug formulation to prevent chemical and oxidative deterioration of active pharmaceutical ingredient. (credenceresearch.com)
- The aim of our study was to assess the impact of the use of worst cases formulations (i.e. vial internal pressure and special excipient formulations, including viscous and foaming) concerning chemical contamination risk using KIRO Oncology® robot. (gerpac.eu)
- Early on, many drug names were coined by condensing the systematic chemical name. (ama-assn.org)
- During early stages of drug formulation development, excipients are evaluated for appropriateness by studying their physical and chemical compatibility with drug substances under stressed and accelerated conditions. (hindawi.com)
- Chemical incompatibility with drug substances may result not only from direct reaction with excipients but also from reaction with excipient impurities. (hindawi.com)
- The Drug, Chemical & Associated Technologies Association (DCAT) is a not-for-profit, global business development association whose unique membership model integrates both innovator and generic drug manufacturers and suppliers of ingredients, development and manufacturing services, and related technologies. (dcat.org)
- However these excipients can initiate, propagate and participate in chemical and physical interaction with active part of the formulation which result into interaction that affect the quality or shelf life of the drug product. (alliedacademies.org)
- The method selected will be based on the compound's chemical properties, the physical state of the formulation, and the route of administration. (pharmtech.com)
- The method was initially developed using six commercially available drugs (see Figure 1 ) with diverse chemical properties. (pharmtech.com)
- There are several techniques available to improve solubility including, chemical modifications, physical modifications, carrier systems and solvent modifications, however, generally speaking, the most widely used approach to identify and select these excipients is a trial and error-based technique, which can be both costly and time consuming. (outsourcing-pharma.com)
- During the method testing phase, six commercially available drugs with diverse chemical properties were selected and tested with over 30 excipients, dispensed on 96 well-plates via a fully automated TECAN-robotic system. (outsourcing-pharma.com)
- Raman hyperspectral imaging characterizes the sample in terms of chemical (actives and excipients identification, distribution and content, for example), and physical properties (solid state/polymorphism, particle size, etc.) by adding information on the spatial distribution. (horiba.com)
- The present study majorly focuses on the application of analytical techniques in reporting the incompatibilities that result due to drug- excipients in pharmaceutical formulations. (alliedacademies.org)
- There are, therefore, many facets to achieving the right formulation, and our analytical and development services and expertise can help with many of them. (rssl.com)
- This includes comprehensive, phase-appropriate analytical method development for both the active pharmaceutical ingredient (API) and the drug undergoing development. (rssl.com)
- Excipients are utilized during drug manufacture for a variety of purposes, including stabilization, bulking up or enhancing of the active pharmaceutical ingredient (API). (outsourcedpharma.com)
- S.L. Rough, D.I. Wilson and D.W. York (2005) "Effect of solids formulation on the manufacture of high shear mixer agglomerates" Adv. Powder Technol. (wikipedia.org)
- With four FDA inspected sites in the USA , China , Ireland and Portugal and development laboratories in Lisbon, Portugal and New Jersey, USA , the company provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs including highly potent compounds. (prnewswire.com)
- This agreement stipulates the terms and conditions under which DURECT will supply to King, based on DURECT's manufacturing cost plus a specified percentage mark-up, two key excipients used in the manufacture of REMOXY. (bio-medicine.org)
- In addition, if commercialized, DURECT will receive royalties for REMOXY and the other licensed drug candidates of between 6.0% to 11.5% of net sales of the drug candidate depending on sales volume as well as a mark-up on DURECT's supply of key excipients used in the manufacture of the licensed drug candidates. (bio-medicine.org)
- In order to expedite the reformulation development, it was decided to follow the same formulation process originally used to manufacture the free-form of Compound XY. (drug-dev.com)
- This difference can be explained by the fact the robot manufacturer was able to implement corrected settings adjusted to each formulation only for dose withdrawal step but not for vials reconstitution step. (gerpac.eu)
- Comparatively to previous studies1,2, our work highlights the need to adjust settings for the dose withdrawal step according to each pharmaceutical drug registered. (gerpac.eu)
- JRS Pharma's line of wet and dry binders keep drug components together, achieving a sturdy solid dose formulation. (pharmaceutical-technology.com)
- Liquid formulations facilitate dose adjustments and are easily administered and recommended for infants and younger children. (sbir.gov)
- Once a patient is stabilized on any dose level of FORTAMET ® , gastrointestinal symptoms, which are common during initiation of therapy, are unlikely to be drug related. (nih.gov)
- It was also important to ensure that the concentrations of the selected excipients were in line with the Generally Recognised As Safe (GRAS) recommendations, as too high a dose can cause side effects and impact on patient safety. (outsourcing-pharma.com)
- Actuation of the device releases a single metered dose of the formulation which contains the medication either dissolved or suspended in the propellant. (wikipedia.org)
- In the case of prescription medicines, it's largely about performance and shelf-life, ensuring that the product delivers the correct dose to the patient, for as long as the drug is in use. (rssl.com)
- Aerosol systems are specific but fail to deliver the actual dose of drug with only ten percent of administered dose deposited on the bronchi while rest of the drug is deposited in oropharynx and is swallowed. (ispub.com)
- The drug content were estimated to produce 1 mg sustained release salbutamol sulphate per dose. (ijpsonline.com)
- The survival follow-up phase consists of the 2-year period after the final dose of study drug. (mesothelioma.com)
- In the present study, by using Florite® PS-10 (119.1 mg) and Vivapur® 105 (105.6 mg) as solid carriers, VST-loaded solidified SuSMEDDS (S-SuSMEDDS) granules were successfully developed, which possessed good flow properties and rapid drug dissolution. (pharma-excipients.ch)
- SuSMEDDS composed of VST, Capmul® MCM, Tween® 80, Transcutol® P, and Poloxamer 407 was efficiently solidified with Florite® PS-10 and Vivapur® 105, and the resultant granules showed good flow properties and rapid drug dissolution. (pharma-excipients.ch)
- Therapeutic response of a drug depends upon the bioavailability which in turn depends upon the solubility and dissolution rate of drug. (bartleby.com)
- There are various techniques but liquisolid compact is a new and promising method that can change the dissolution rate of water insoluble drugs. (bartleby.com)
- Allesø M, Chieng N, Rehder S, Rantanen J, Rades T, Aaltonen J. Enhanced dissolution rate and synchronized release of drugs in binary systems through formulation: amorphous naproxen-cimetidine mixtures prepared by mechanical activation. (springer.com)
- The formulation was optimised, targeting the dissolution profiles of the comparator product. (who.int)
- He is Editor-in-Chief of the journal Medicinal Research Review and founding series editor of the Wiley Series in Drug Discovery and Development. (wiley.com)
- Generally, an excipient has no medicinal properties. (medgadget.com)
- The main reason of continuingly strong interest of scientists in these drug forms is the problem of a low bioavailability of medicinal substance after the application to the eyeball. (hindawi.com)
- The excipients form the major part of any medicinal product and proportion of it when compared to Active Pharmaceutical Agent (API) exceeds two to three fold in any pharmaceutical preparations. (slideshare.net)
- There is also a need to ensure that the final concentration of the selected excipients is within the generally recognized as safe (GRAS) list of recommended concentrations. (pharmtech.com)
- The identification of the correct excipient in its individual correct maximum concentration is important, especially for parenteral formulations, because doses that are too high can cause pain, hemolysis, or inflammation. (pharmtech.com)
- Polymorphism occurs when drugs change from one crystalline or amorphous form to another. (dow.com)
- Loading drugs onto our functional polymers eliminates crystal instability by creating a stable amorphous form, thereby providing reliable, consistent drug properties. (dow.com)
- Co-amorphous formulations of atorvastatin (ATV) and naringin (NRG) in the molar ratio 1:1 were prepared by quench cooling (ANQC), solvent evaporation (ANSE), and ball milling (ANBM) and characterized by differential scanning calorimetry (DSC), powder X-ray diffractometry (XRPD), and Fourier transform infrared spectroscopy (FTIR). (springer.com)
- Further, the performance of prepared co-amorphous formulations was evaluated in vitro and in vivo. (springer.com)
- Irrespective of processing method employed, all co-amorphous formulations were found stable at 30 °C for 90 days in dry conditions (under vacuum). (springer.com)
- Significant improvement in the solubility of ATV was observed in ANQC and ANSE co-amorphous formulations, highest being 56-fold for the later. (springer.com)
- The author discusses the advantages of high-throughput screening of drug formulation excipients by a fully automated Tecan-robotic system. (pharmtech.com)
- A high-throughput screening method has been established to overcome the challenges of selecting one or more excipients. (pharmtech.com)
- The high-throughput screening platform is based on identifying the solubilization capacity of each excipient for a compound. (pharmtech.com)
- In the last couple of years the development of Biotherapeutics moved away from standard monoclonal antibodies to more complex formats, which led to the need of miniaturized and high throughput screening systems in the early stage of formulation development. (ddfevent.com)
- From the stabilization of pharmaceutical preparations to enhanced solubility and disintegration, we have the expertise to handle your excipient needs. (dow.com)
- Our latest innovation, KLEPTOSE® BioPharma HPB & HP (hydroxypropyl β-cyclodextrins) for protein stabilization, brings established excipients for small molecule applications to the BioPharma formulation community. (roquette.com)
- Differential scanning calorimetry (DSC), isothermal stress testing-Fourier transform infrared spectroscopy (IST-FTIR), isothermal stress testing-high-performance liquid chromatography, and powder X-ray diffraction (PDRX) were used as screening techniques for assessing the compatibility of tobramycin with some currently employed ophthalmic excipients. (springer.com)
- Excipient General Information Chapter: Powder Flow Mark Gibson (2001). (wikipedia.org)
- The results were compared with solubility measurements performed using a manual shake flask method where 15 mg of powder and 2 mL of excipient were added. (pharmtech.com)
- Which therapeutic drugs are delivered via aerosol inhalers, dry powder inhalation and nebulizers for upper respiratory conditions? (giiresearch.com)
- The present research was aimed to develop and characterize a sustained release dry powder inhalable formulation of salbutamol sulphate. (ijpsonline.com)
- A special focus will also be placed on the unique challenges in Biopharmaceutical drug formulation, as innovations of today will prove to be the next decade's blockbusters. (smi-online.co.uk)
- To facilitate your successful biopharmaceutical formulation, Roquette offers expertise and innovation to all stages of development, backed by uncompromised quality standards and a secure supply chain. (roquette.com)
- North America holds the largest share in the pharmaceutical excipient market due to rising demand for pharmaceutical and biopharmaceutical drugs and presence of a large number of excipient manufacturers in this region. (slideshare.net)
- Although considered pharmacologically nonactive, pharmaceutical excipients have critical effects on drug product safety, efficacy, and quality. (hindawi.com)
- This certifies the drug will not degrade, and that efficacy and longevity are maintained. (drug-dev.com)
- Lloyd Waxman, PhD, and Vinod Vilivalam, PhD, believe a more promising application has been to label mAbs with a positron emitter for use in understanding the in vivo behavior and efficacy of targeted drugs in individual patients and for more effective drug development. (drug-dev.com)
- Multiple ongoing international Phase 3 clinical trials are evaluating the safety and efficacy of Veklury ® for the treatment of SARS-CoV-2 infection, the virus that causes COVID-19, in different patient populations, formulations, and in combination with other therapies. (prnewswire.com)
- We can also help underpin the quality, safety and efficacy of your new drug formulation by providing services that support your clinical trials and regulatory submissions. (rssl.com)
- Before this cut-off, the solubilization of the compound was more compound specific, which creates the need to also test on a larger set of excipients. (pharmtech.com)
- Many approaches have been meticulously explored to improve the oral bioavailability of such drugs including particle size reduction (micronization or nanosizing), complexation with cyclodextrins, salt formation, solubilization based on cosolvents, surfactants, etc. (isciii.es)
- Taking into account these results, it could be suggested that some of the changes observed in the IST-FTIR spectra of binary blends of tobramycin and some of the excipients would account for a possible interaction between the mixture component. (springer.com)
- The results were fairly good in agreement with the cyclobenzaprine hydrochloride-excipient interaction analysis, obtained from DSC, FTIR and UV-DRS. The HPLC method was validated as per ICH guidelines and applied for quality control of bulk and formulation of cyclobenzaprine hydrochloride. (alliedacademies.org)
- FTIR studies showed compatibility of the drug with excipients. (nih.gov)
- Written by leading international experts from both academia and industry, the book will help readers (formulation design scientists, researchers and post-graduate and specialized undergraduate students) develop a deep understanding of key aspects of inhalation formulations as well as detail ongoing challenges and advances associated with their development. (wiley.com)
- 6. A formulation of claim 1 wherein said inhalation drug is albuterol or a pharmaceutically acceptable salt thereof. (google.com)
- 19. A formulation of claim 1 wherein said inhalation drug is a fluticasone ester. (google.com)