Drug Stability

Stability testing (pharmaceutical)

Longitudinal stability

Climate change and infectious diseases

Estramustine phosphate

Morphine

Mandelic acid

Furonazide

SpaceShipOne

List of Virgin Galactic launches

Ship stability

Activity coefficient

War on drugs

Nanoparticles for drug delivery to the brain

Physical pharmacy

Crime in Bolivia

Solubility equilibrium

Hexahydrocannabinol

Receptor activated solely by a synthetic ligand

Salvadoran gang crackdown

Coiled coil

Nanoparticle drug delivery

Progesterone carboxymethyloxime

EDTMP

Flunitrazepam

Santa Muerte

Kofi Bentum Quantson

Velomobile

Panfilo Lacson

Cyclohexane conformation

Iran-Saudi Arabia proxy conflict

20232

• Medically reviewed by Drugs.com on Mar 6, 2023. (drugs.com)
• Medically reviewed by Drugs.com on May 22, 2023. (drugs.com)

Biologics7

• MDXG ) said this week that it completed the divestiture of its subsidiary, Stability Biologics, back to the former stockholders of Stability, Inc. (drugdeliverybusiness.com)
• The deal, which closed on Sept. 30, included a promissory note issued by Stability Biologics for $3.5 million in favor of MiMedx. (drugdeliverybusiness.com)
• When we signed the definitive agreement for the divestiture, we communicated that if the transaction closed in the third quarter, we would maintain our full year revenue guidance, and even without the Stability Biologics revenue contribution in the fourth quarter, we were confident in our ability to meet our revenue guidance for the year," chairman & CEO Parker Petit said in prepared remarks. (drugdeliverybusiness.com)
• Our new 'private label' distribution agreement with Stability Biologics whereby we have retained the Stability Biologics key sales relationships for the spine and orthopedics areas of our surgical business, will also be an asset to the company in our exclusive focus on our biopharma strategy," president & COO Bill Taylor added. (drugdeliverybusiness.com)
• We are dedicating our efforts to continuing down the Investigational New Drug/Biologics License Application (IND/BLA) regulatory pathways for numerous new therapeutic applications of our human placental-based technology. (drugdeliverybusiness.com)
• FDA has also established guidance for industry for " Analytical Procedures and Methods Validation for Drugs and Biologics . (qualityhub.com)
• Small molecules" are organic compounds with traditional drug-like properties, while "biologics" may include vaccines and recombinant therapeutic proteins. (nih.gov)

National Insti2

• The development of medications for the treatment of drug addiction is one of the major missions of the National Institute on Drug Abuse (NIDA). (nih.gov)
• Through this funding FOA, the National Institute on Drug Abuse (NIDA) is committed to making significant advances in the development of safe and efficacious products for the treatment of disorders stemming from tobacco, cannabis, cocaine, methamphetamine, heroin, or prescription opiate use or abuse. (nih.gov)

Efficacy5

• The purpose and objective of the Programme is to provide evidence on the efficacy and stability of agents and devices used in the OPAT and other medical arena as provided for by the Yellow Cover Document. (e-opat.com)
• Your patent application should detail the optimal dosage that ensures prolonged stability without affecting drug efficacy. (patentpc.com)
• The ICH guidelines for stability lay out the requirements for identifying and maintaining drug efficacy by understanding the pathways of degradation. (sepmag.eu)
• Some drugs are more unstable than others, and require very specific storage conditions in order to maintain efficacy. (sepmag.eu)
• The irreversible aggregation has a more immediate response in decreasing the efficacy of the drug product. (websarticle.com)

Chemical7

• Both the physical and chemical stability are acceptable for up to 60 days at room temperature. (medscape.com)
• They anticipate that joining forces on protein stability systems will lower development costs and bring forward a cutting-edge technology centered around a chemical melt protein stability system. (ddw-online.com)
• The objective of this research proposal is to gain a more thorough understanding of designer drugs with respect to their chemical exposure profile and biological elimination pathways. (ojp.gov)
• Aims/objectives To determine the chemical compatibility/stability of a total of 40 commonly encountered drug combinations. (bmj.com)
• With this deeper understanding of chemistry and drug development we have realized the importance of preserving the chemical molecules via proper storage conditions. (sepmag.eu)
• Stability testing depends upon the environmental factors like, light source, humidity and ambient temperature as well as the physical and chemical properties of the active drug product. (wikipedia.org)
• Thus post-dilution or reconstitution stability data are frequently limited to 24 h only for bacteriological reasons, regardless of the true chemical stability, which could, in many cases, be longer. (bmj.com)

Potency3

• It involves conducting stability studies to determine the shelf life of the product, as well as establishing appropriate storage conditions and testing frequencies to ensure the quality and potency of the drug is maintained throughout its labeled shelf life. (qualityhub.com)
• Stability-indicating assays are analytical methods that can detect changes in the quality and potency of a drug product over time. (qualityhub.com)
• The method should be able to accurately and reliably detect any changes in the quality or potency of the drug product. (qualityhub.com)

Aggregation1

• During the production of ADCs, payload conjugation often increases the hydrophobicity of the antibody molecule, leading to reduced stability and increased aggregation. (pharmaceuticalonline.com)

Reproducible2

• New data shows that Oral-Eze oral fluid testing provides consistent, reproducible drug recovery and stability of THC (marijuana) from collection to lab testing. (employersolutions.com)
• Compared with the previous yeast display proteolysis method 18 , cDNA display proteolysis resolves a wider dynamic range of stability and is more reproducible even at a 50-fold larger experimental scale. (nature.com)

Testing to establish1

• FDA requires stability testing to establish an expiration date on drug products per 21 CFR 211.166. (qualityhub.com)

Assays1

• These assays are used to monitor the stability of the drug product and ensure that it meets the established acceptance criteria throughout its shelf life. (qualityhub.com)

Reconstitution1

• As reconstitution of the drug product is a key evaluation parameter, the speed and reproducibility of reconstitution will be assessed throughout process development. (pacelabs.com)

Substances6

• The treatment drugs include both bulk drug substances (e.g. (nih.gov)
• In a special high-level event of the Commission on Narcotic Drugs, UNODC Executive Director Yury Fedotov urged concerted action to prevent the manufacture, trafficking and abuse of these substances. (unodc.org)
• Since new harmful substances have been emerging with unfailing regularity on the drug scene, the international drug control system is now challenged by the speed and creativity of the NPS phenomenon. (unodc.org)
• The ICH guidelines for stability testing of new drug substances and products were first written in 1992 and adopted in 1993. (sepmag.eu)
• With stability testing, pharmaceutical industry inspects the quality of drug substances and drug products as per the guidelines outlined by US Food and Drug Administration and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use to make sure that they retained the quality over the period of time. (wikipedia.org)
• This ICH Guideline describes the science and risk-based approaches for developing and maintaining analytical procedures suitable for testing the quality of drug substances and drug products. (qualityhub.com)

Pharmaceutical industry2

• In pharmaceutical industry, stability testing is a process that is used to determine the quality of a drug substance or drug product over a period of specified time under specific environmental conditions. (wikipedia.org)
• Stability studies performed by the pharmaceutical industry are only designed to fulfil licensing requirements. (bmj.com)

Guidelines for stability3

• The specific goal of the ICH guidelines for stability is to define the information that must be submitted with the application for the registration of each new drug molecule. (sepmag.eu)
• The ICH guidelines for stability provide a roadmap for completing this process , and they harmonize the registration process for all drugs within the EU, USA, and Japan. (sepmag.eu)
• The ICH guidelines for stability allow for the process to be harmonized among regions so that these new drugs can be brought to market sooner. (sepmag.eu)

Shelf life5

• It's also about ensuring the drug remains efficacious and safe over its intended shelf life. (patentpc.com)
• As a startup exec navigating the complex waters of drug development, understanding patent considerations related to drug stability and shelf life is crucial. (patentpc.com)
• A longer shelf life can be a market differentiator, setting your drug apart from competitors. (patentpc.com)
• Many drugs incorporate stability-enhancing ingredients to prolong shelf life. (patentpc.com)
• This will depend on the stability characteristics of the product and the intended shelf life. (qualityhub.com)

Bioavailability1

• Then comes the problem of the bioavailability of such drugs. (websarticle.com)

Characterization1

• Development of the lyophilization process requires a thorough characterization of the drug substance (small molecule or biologic) and lyophilates to remove the necessary solvent molecules without disrupting or degrading the target species. (pacelabs.com)

Infusions1

• Stability of norepinephrine infusions prepared in dextrose and normal saline solutions. (medscape.com)

Evaluation6

• The Institute has been providing potential treatment drugs to investigators for use in preclinical toxicology evaluation, pharmacological studies and clinical trials. (nih.gov)
• Correction to: Evaluation of sonication on stability-indicating properties of optimized pilocarpine hydrochloride-loaded niosomes in ocular drug delivery. (nih.gov)
• Drug stability test chamber using a scientific method to create a temperature, humidity environment and light environment that requires long-term stability for the failure evaluation of batch drugs, it is suitable for the accelerated test, long-term test and high humidity test of drugs and new drugs by pharmaceutical companies. (laboaochina.com)
• An effective drug stability testing program is required for the evaluation of the stability of a drug product over time. (qualityhub.com)
• The evaluation of cannabinoids concentration and stability in standardized preparations of cannabis tea and cannabis oil was conducted using an easy and fast ultra-high performance liquid chromatography tandem mass spectrometry (UHPLC-MS/MS) assay. (degruyter.com)
• The consensus conference focused on the need to perform more studies on the stability of biotherapies, including a minimum of three complementary separating methods and careful evaluation of submicronic aggregates. (bmj.com)

Compounds4

• The study will initially focus on compounds from the JWH and AM series of synthetic cannabinoids and progress to synthetic cathinones, followed by emerging designer drugs as they become prevalent. (ojp.gov)
• By performing a thorough and systematic study, we may be able to predict markers of use for broad classes of compounds and help practitioners keep up with designer drug manufacturers. (ojp.gov)
• Photographs of each designer drug characterized and their mass spectra, including electron impact-mass spectrometry (EI-MS) spectra and liquid chromatography-mass spectrometry LCMS) fragmentation spectra indicating optimal transitions to monitor for identification of compounds, will be made available to forensic laboratories through an NIJ-funded Web-accessible database, www.forensicdb.org. (ojp.gov)
• that the transfer of weapons often occurs with the aid of security forces only compounds the risk to stability. (occrp.org)

Cannabinoids2

• Designer drugs such as synthetic cannabinoids and cathinones have become increasingly prevalent in recent years, as have their interrelated health and societal consequences. (ojp.gov)
• The stability of cannabinoids in oil samples was higher than that in tea samples since the maximum decrease (72% of initial concentration) was observed in THC coming from unheated flowering tops at ambient temperature. (degruyter.com)

Degradation products2

• For each anticancer drug, considering their therapeutic index, pharmacokinetics/pharmacodynamics (PK/PD) variability, specific clinical use and risks related to degradation products (DPs), the classic limit of 10% of degradation can be inappropriate. (bmj.com)
• It is essential to use validated stability indicating methods, separating degradation products being formed in the practical use of the drug. (bmj.com)

Physical1

• Physical stability, such as particle formation, should be systematically evaluated. (bmj.com)

Formulations1

• Developing stability-enhancing formulations or storage solutions can be costly. (patentpc.com)

Development9

• To reduce the development of drug-resistant bacteria and maintain effectiveness of ZEMDRI and other antibacterial drugs, ZEMDRI should be used only to treat infections that are proven or strongly suspected to be caused by susceptible microorganisms. (nih.gov)
• We plan to Fast-Track MW189's development as an Orphan Drug by targeting a rare form of hemorrhagic stroke as an initial indication, and then using it as a beachhead market for expanding into lzheimer's disease and/or other neurodegenerative conditions. (nih.gov)
• Drug stability, although a technical aspect of drug development, has its roots in innovation. (patentpc.com)
• Review and approve the protocol: Have the stability protocol reviewed and approved by the appropriate parties, such as Product Development, Quality Assurance, and Regulatory Affairs. (qualityhub.com)
• Santé Laboratories is a specialty drug development and manufacturing organization focused on innovating pharmaceutical and mainstream nutraceutical products using their proprietary advanced drug delivery solution from formulation to commercialization. (santelabs.com)
• During implementation, many issues were uncovered, including the need to evolve from drug prioritization lists to drug development. (nih.gov)
• Robinson's areas of expertise include national security strategy, international affairs, U.S. foreign policy, security force assistance, joint force development, special operations forces, irregular warfare and stability operations. (smallwarsjournal.com)
• Newer formats, such as peptides, protein scaffolds, and aptamers, offer similar target recognition but have been specifically engineered to allow access to new targets, increased control in drug:antibody ratio (DAR), and reduced immunogenicity, for improved effectiveness in drug development. (pharmaceuticalonline.com)
• 3 Since the approval of the first ADC, many lessons have been learned in ADC development that can be translated to the next wave of these drugs, with additional lessons from antibody alternative development that can be heeded to speed future advances for the benefit of patients. (pharmaceuticalonline.com)

Proteins3

• In simple words it means the stability of drugs which are mainly formulated from proteins. (websarticle.com)
• Proteins cause numerous problems during the processing of a drug. (websarticle.com)
• We also examined how our approach could identify stability determinants in designed proteins and evaluate design methods. (nature.com)

Protein stability1

• Applied Photophysics (APP) and Fluorescence Innovations (FI) have entered into a joint venture agreement to develop and produce protein stability systems for leading researchers and industries around the globe. (ddw-online.com)

Therapeutic2

• Drugs that degrade over time can lose their therapeutic properties, rendering them ineffective. (patentpc.com)
• As the first and most important aim of the different cannabis preparations is to guarantee therapeutic continuity in treated individuals, a strictly standardized preparation protocol is necessary to assure the availability of a homogeneous product of defined stability. (degruyter.com)

Innovations3

• Why Patent Drug Stability Innovations? (patentpc.com)
• Innovations in packaging that protect the drug from detrimental external factors, like light or moisture. (patentpc.com)
• Innovations that continuously monitor and adjust storage conditions to ensure drug stability throughout distribution can be a goldmine in the patent world. (patentpc.com)

Pharmaceuticals2

• When medicines are being licensed, little attention is given to the practical use of these drugs and there is no recognition that pharmaceuticals start a new life once they are prepared for patient administration. (bmj.com)
• Provides the highest-quality chemistry and microbiology testing services following current good manufacturing practices (cGMP) to support complex pharmaceuticals, biologic, and drug-device combination therapies. (pacelabs.com)

Molecule1

• The timeline and conditions leading to the degradation of the drug molecule are throughly tested and defined via stress testing. (sepmag.eu)

Efficiency2

• They have been employed in encapsulating both hydrophilic and hydrophobic drugs, but their use is still plagued with challenges of stability and poor entrapment efficiency particularly with hydrophilic drugs. (nih.gov)
• All of these situations cause the protein to agglomerate together, resulting in decreased efficiency of the drug product. (websarticle.com)

Define1

• Define the scope of the stability studies: Identify the drug product(s) that will be included in the stability studies and the specific stability parameters that will be monitored (e.g., active ingredient content, pH, appearance). (qualityhub.com)

Develop2

• In 2008, the Commission on Human Medicine (CHM) recommended that research should be commissioned to develop authoritative national advice on mixing of medicines to encompass compatibility and stability data (Commission on Human Medicines, 2008). (bmj.com)
• Under the 2002 legislation, the focus of the BPCA Program was to develop a master list of all off-patent drugs that lacked adequate pediatric labeling. (nih.gov)

Practice4

• We hope CMS finds the study results useful as they explore the issue of allowing pharmacists to incorporate newer evidence-based information about drug storage, stability, and beyond use dating into their practice settings. (medscape.com)
• Analysis of national practice identified commonly used drug combinations administered by CSCI that were included in this study. (bmj.com)
• The BSAC Drug Stability Testing Programme exists to provide evidence on the stability of agents and devices used in infection management practice, particularly those used in Outpatient Parenteral Antimicrobial Therapy (OPAT) services. (e-opat.com)
• The Programme will, for the first time, make available, open access stability data that will inform practice and offer the ability to improve patient safety and patient outcomes within a rapidly expanding area of infection management. (e-opat.com)

Molecules2

• Protein sequences vary by more than ten orders of magnitude in thermodynamic folding stability 2 (the ratio of unfolded to folded molecules at equilibrium). (nature.com)
• In an analysis of the cancer related BRD4 domain, we found that up to 29% of protein crystal structures bound with drug-like molecules present evidence of unmodeled, averaged, relatively isoenergetic conformations in ligand-receptor interactions. (osti.gov)

Variants1

• From 1.8 million measurements in total, we curated a set of around 776,000 high-quality folding stabilities covering all single amino acid variants and selected double mutants of 331 natural and 148 de novo designed protein domains 40-72 amino acids in length. (nature.com)

Substance1

• 26 June 2013 -The 2013 World Drug Report released today in Vienna shows that, while the use of traditional drugs such as heroin and cocaine seems to be declining in some parts of the world, prescription drug abuse and new psychoactive substance abuse is growing. (unodc.org)

Data3

• New data reveal that the prevalence of people who inject drugs and are also living with HIV in 2011 was lower than previously estimated: 14.0 million people between the ages of 15 and 64 are estimated to be injecting drugs, while 1.6 million people who inject drugs are also living with HIV. (unodc.org)
• Real-world stability data comparing your drug with and without the innovation can bolster your claims. (patentpc.com)
• Collect data that juxtaposes the stability of your drug with and without the innovation. (patentpc.com)

Ingredients1

• Powered by Santé® utilizes lipid encapsulation to get ingredients to the small intestine for proven optimal absorption with long-term room temperature stability. (santelabs.com)

Content1

• Identify the drug products that need to be included in the stability program and the specific stability parameters that will be monitored (e.g., active ingredient content, pH, appearance). (qualityhub.com)

Lyophilization1

• The solution can be lyophilization of the drug or mutagenesis. (websarticle.com)

Methods4

• A stability testing protocol is a document that outlines the methods and procedures for conducting stability studies on a drug product. (qualityhub.com)
• It provides guidance on the testing methods, sample storage conditions, and acceptance criteria for the stability studies. (qualityhub.com)
• Select the testing methods: Select the appropriate testing methods for the stability parameters that will be monitored. (qualityhub.com)
• New high-throughput experiments have the potential to transform our understanding of stability by quantifying the effects of mutations across a vast number of protein contexts, revealing new biophysical insights and empowering modern machine learning methods. (nature.com)

Exposure1

• Innovative package designs that minimize drug exposure to detrimental elements or that incorporate mechanisms to maintain optimal conditions within the package can stand out in the patent realm. (patentpc.com)

Parameters3

• But since pharmacists can't rely on drug companies to continually test new parameters for drug storage, stability, and beyond use dating, or to quickly update the package insert to reflect new findings, they do rely on up-to-date compendia to inform best practices on these matters. (medscape.com)
• Establish acceptance criteria: Establish the acceptance criteria for the stability parameters that will be monitored using the assay method. (qualityhub.com)
• Establish acceptance criteria: Establish the acceptance criteria for the stability parameters that will be monitored. (qualityhub.com)

Antibody1

• Antibody-drug conjugates (ADCs) are increasingly entering the oncologists' armamentarium. (pharmaceuticalonline.com)

Discovery2

• Of course, our medical understanding has deepened dramatically, our science has become more sophisticated, and we have developed tools to perform large scale drug discovery and screening . (sepmag.eu)
• Gain Therapeutics is redefining drug discovery with its SEE-Tx™ target identification platform. (websarticle.com)

Optimal1

• Studies to determine optimal routes and schedules of drug administration can be performed. (nih.gov)

Studies5

• The designer drugs will then undergo pyrolysis studies, and major pyrolysis products of each sample will be identified. (ojp.gov)
• Determine the storage conditions: Determine the storage conditions that will be used for the stability studies, based on the intended use and marketing conditions of the drug product. (qualityhub.com)
• Determine the testing frequency: Determine how often the drug product will be tested during the stability studies. (qualityhub.com)
• The goal of BPCA's initial implementation was to fund studies of off-patent drugs that needed labeling changes. (nih.gov)
• A European consensus conference was held in France in May 2010, under the auspices of the French Society of Oncology Pharmacy (SFPO), to propose adapted rules on stability in practical situations and guidelines for performing corresponding stability studies. (bmj.com)

Compatibility1

• ISMP will be sharing the results of this study with CMS and The Joint Commission to help inform any future changes in the CMS policy that involves drug storage, stability, compatibility, and beyond use dating. (medscape.com)

Room temperature1

• Stability of injection of parenteral admixture at room temperature (25°C) or refrigeration (4°C): 24 hours. (globalrph.com)

Product2

• These criteria should be based on the established specifications for the drug product. (qualityhub.com)
• Connect with Pace ® to learn how we can help enhance your drug product. (pacelabs.com)

Products4

• The oversight and regulation of organizations such as the European Medicines Agency and the Federal Drug Administration (FDA) have significantly improved the quality and safety of our medical and pharmaceutical products . (sepmag.eu)
• Regulations keep us safe, elevate the quality of our pharmaceutical products, and provide a clear path for the registration of new drug s. (sepmag.eu)
• Note that this article addresses real-time stability testing for drug products and not accelerated stability testing. (qualityhub.com)
• Furthermore, a non-justified limited stability for expensive products is obviously very costly. (bmj.com)

Storage2

• Drugs with short shelf lives or those requiring stringent storage conditions can result in increased costs for manufacturers and consumers. (patentpc.com)
• Typical storage of the drug under those conditions would bring a 20% loss of activity. (nih.gov)

Contribution1

• Steinbeck J, Liljenqvist U, Jerosch J. The anatomy of the glenohumeral ligamentous complex and its contribution to anterior shoulder stability. (medscape.com)

Concentration1

• Select an appropriate vial strength and final concentration of the drug according to the manufacturer's instructions. (drugs.com)

Increasingly2

• Mr. Fedotov called for international support to monitor the situation and to prevent the continent from becoming increasingly vulnerable to the drugs trade and organized crime. (unodc.org)
• Niosomes are increasingly explored for enhancing drug penetration and retention in ocular tissues for both posterior and anterior eye delivery. (nih.gov)

Reversible1

• generally develops gradually over several weeks and usually is reversible following discontinuance of the drug. (drugs.com)

Capabilities2

• Most forensic laboratories are not equipped with the research capabilities required to keep up with the rapid turnover of designer drugs being marketed for recreational use. (ojp.gov)
• Added stability and cooling capabilities are other benefits. (motortrend.com)