According to a latest market report published by Persistence Market Research, titled "Global Market Study on Pharmaceutical Excipients: Increased Drug Demand in Emerging Asia Pacific Market to Fuel Demand Multi-Functional Excipients", revenue from the global pharmaceutical excipients market is expected to expand at a CAGR of 6.7% during the forecast period 2015 - 2021.. In the report, the global pharmaceutical excipients market is analyzed on the basis of chemistry type (i.e. source of origin), application type, functionality, and region. Based on chemistry type, the overall market has been segmented into plant-based, animal-based, mineral-based and synthetically derived excipients. Based on functionality, the market has been segmented into binders (binders, coatings, and fillers), glidents, diluents, disintegrants, and others (solvents, co-solvents, anti-microbial agents, lubricants, colorants, emulsifiers, and humectants). By application type, the market has been segmented into oral, topical, ...
Webinar: Introducing the Co-processed Excipient Guide! Friday, December 15, 2017 - 11:00am to 12:00pm EST Featuring Joseph Zeleznik, Manager of Technical & Regulatory Affairs, Meggle USA, Inc., and Chair, IPEC-Americas QbD Committee Description IPEC-Americas and IPEC Europe have jointly published a guide for excipient makers and users on co-processed excipients. This guide offers best practice and voluntary guidance on the development, manufacture and use of co-processed excipients and provides support to both manufacturers and users of co-processed excipients. Webinar Objectives: ...
In order to develop the enhanced understanding necessary to demonstrate an acceptable Design Space and Control Strategy required for Quality by Design (QbD) marketing applications, it will be necessary to incorporate the variability in potentially critical excipient parameters into the Design of Experiments (DoE). Methods are described that allow samples to be engineered such that potentially critical excipient parameters can be included in the DoE. However, it must be acknowledged that not all such excipient parameters will be amenable to sample engineering. The excipient manufacturer may be able to provide non-GMP samples which help define the necessary limits for the formulation. The nature of QbD as it relates to excipients is such that communication under a confidentiality agreement between excipient users and excipient makers will be necessary. The necessity for good communication between the excipient user and manufacturer is also emphasized.. ...
Global Market Study on Pharmaceutical Excipients: Pharmaceutical excipients are substances other than pharmacologically active drug components, which are included in the drug manufacturing process or contained in a finished pharmaceutical product dosage form.
Data & statistics on Chinese Pharmaceutical Excipients: 1504 310 ความรูพื้นฐานทางเภสัชภัณฑ หนวยกิต 4 (3-3-6) Fundamentals to Pharmaceutical Dosage Forms สาขาเภสัชศาสตร ชั้นปที่ 3 จํานวน 107 คน อ.ดร.จินตนา นภาพร และ อ.ดร.วริษฎา ศิลาออน ทุกวันศุกร เวลา 08.00-16.00 น. ศึ ก ษาความรู พื้ น ฐานทางเภสั ช ภั ณ ฑ ใ นด า นคุ ณ สมบั ติ ท างกายภาพและเคมี (Physicochemical properties) ของสารที่เปนยาและสารชวยทางเภสัชกรรม (Pharmaceutical excipients) กฏทางฟสิกสเคมีและทฤษฎีที่เกี่ยวข
3. Why are excipients important in a drug product?For many reasons. Some, for example, comprise the products delivery system. These transport the active drug to the site in the body where the drug is intended to exert its action. Others will keep the drug from being released too early in the assimilation process in places where it could damage tender tissue and create gastric irritation or stomach upset. Others help the drug to disintegrate into particles small enough to reach the blood stream more quickly and still others protect the products stability so it will be at maximum effectiveness at time of use. In addition, some excipients are used to aid the identification of a drug product. Last, but not least, some excipients are used simply to make the product taste and look better. This improves patient compliance, especially in children. Although technically "inactive" from a therapeutic sense, pharmaceutical excipients are critical and essential components of a modern drug product. In many ...
The global pharmaceuticals excipients market is projected to post a phenomenal CAGR through 2022. The market is poised to rake in a healthy share of the revenue pie with robust growth of the pharmaceutical industry worldwide. Soaring uptake of oral and parenteral products owing to increasing occurrence of lifestyle and chronic disorders can escalate the growth of the market over the forecast period (2017 to 2022).. Browse Full Research Report With TOC On "Pharmaceutical Excipients Market Size, Report, 2017" at: https://www.radiantinsights.com/research/global-pharmaceutical-excipients-market-professional-survey-report-2017. Emergence of novel therapeutics, especially in the form of oral dispersible tablets, is one of the key factors driving the market. Surging use of functional excipients is likely to provide an upthrust to the market. A raft of pharmaceutical companies is focusing on innovations in these excipient categories, which is expected to further bolster their use. Improving R&D ...
These are just a few examples of many newer multifunctional or high-functioning excipients. Methods used to engineer these products include modification of particle size distribution by milling, seiving, agglomerating, spray drying, or roller compacting; selection of certain crystal polymorphic forms; cocrystallization, isolation of the crystal portion of the cellulose chain; modifications of the cooking process; modifications of the drying process; and nanosize water dispersion.2 Using multifunctional excipients simplifies the formulation process. Cost savings are not necessarily realized in reducing the amount of excipient used, which is a very small fraction of the cost of the tablet, but in reducing the total number of ingredients. Simple formulations are more straightforward to prepare, and fewer ingredients reduce the odds of adverse drug-excipient or excipient-excipient interactions. Multifunctional excipients are especially valuable in the manufacture of generic drugs, where there are ...
A microcrystalline cellulose-based excipient having improved compressibility, whether utilized in direct compression, dry granulation or wet granulation formulations, is disclosed. The excipient is an agglomerate of microcrystalline cellulose particles and from about 0.1% to about 20% silicon dioxide particles, by weight of the microcrystalline cellulose, wherein the microcrystalline cellulose and silicon dioxide are in intimate association with each other. The silicon dioxide utilized in the novel excipient has a particle size from about 1 nanometer to about 100 microns. Most preferably, the silicon dioxide is a grade of colloidal silicon dioxide.
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. While industry guidances, excipient monographs, and compendial test methods provide some direction, sourcing and testing of excipients is an ongoing challenge for drug manufacturers.. A complex supply chain, raw materials quality concerns, and lot-to-lot and supplier-to-supplier variability are just some of the factors that can affect the consistency of excipient quality and performance. Routine testing of excipients, therefore, is crucial. 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.. In this webcast, experts will review measures drug manufacturers must take to comply with regulatory requirements; outline best practices for selecting and ...
The aim of study was for the development of any formulation, techniques such as thermal and isothermal stress testing were used to assess the compatibility of drug with excipients. Differential scanning calorimetry (DSC) and Fourier transformation infrared spectroscopy (FTIR) were the common methods for the study of compatibility. Isothermal stress testing (IST) is also a method for the compatibility study during proto type formulation. In the present study drug excipients compatibility study of gatifloxacin was conducted with different controlled release excipients. The drug and excipients mixtures were stored at 50°C for 4 weeks. The samples were then characterized using DSC, FTIR and UV spectrophotometric methods. The results show that gatifloxacin was compatible with the all the excipients used in the study. The excipients used in the present study were definitely incorporated in the extended release gatifloxacin formulation.
Manufacturer of Cellulose Derivatives and Excipients, Microcrystalline Cellulose, Sodium Starch Glycolate, Croscarmellose Sodium, Spirulina, Magnesium Stearate Etc.
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As biotherapeutics are usually delivered by injection at relatively high concentrations, formulation viscosity is critically important, and a variety of small molecule excipients may be used to reduce viscosity by inhibiting protein aggregation," said Dr Leszczyszyn. "Having the ability to screen formulations for viscosity issues or against a particular viscosity threshold at an early stage of development when sample volumes are limited, using a system such as the Viscosizer 200, will facilitate and expedite candidate selection and contribute to quicker, more cost-effective routes to market ...
For a detailed understanding of the market, the excipients market has been divided into overall excipients and oral solid-dosage-form (OSDF) The report comprises a detailed analysis and forecast of the excipients market on a global as well as regional level. On a global level, the forecast demand is based on volume (tons) and revenue (USD million) for the period ranging from 2012 to 2018. For an insightful understanding of the market on a regional level, the demand has been forecasted based on volume (tons) and revenue (USD million). The study consists of drivers and restraints of the excipients market and their impact on the growth of the market over the forecast period. In addition, the study takes into account opportunities available on a global and regional level and its effect on the market over the forecast period ...
The global excipients market size is expected to reach USD 6.9 billion by 2025, expanding at a CAGR of 6.02% from 2017 to 2025, according to a new report by Grand View Research, Inc. Globally increasing reach of generic medicines has been a major factor driving market growth. In addition, rising demand for newer excipients owing to the advantages of drug delivery and stability has led to the growth of the market. Excipients are essential components for the improvement of overall pharmaceutical activity and performance, both of which directly impact the characteristics of pharmaceutical formulations. An excipient in the right proportion can improve the shelf life and bioavailability of a formulation. These can also be used in drug delivery mechanisms such as sustained release and rapid release drugs.. Polymers were the largest product category in 2016 and are expected to maintain a comparatively moderate growth rate over the forecast period. Microcrystalline cellulose was the leading polymer in ...
An excipient is an inactive substance formulated alongside the active ingredient ("API") of a medication, for the purpose of bulking-up formulations that contain potent active ingredients (thus often referred to as "bulking agents," "fillers," or "diluents"). Bulking up allows convenient and accurate dispensation of a drug substance when producing a dosage form. They also can serve various therapeutic-enhancing purposes, such as facilitating drug absorption or solubility, or other pharmacokinetic considerations.[1] Excipients can also be useful in the manufacturing process, to aid in the handling of the active substance concerned such as by facilitating powder flowability or non-stick properties, in addition to aidingin vitro stability such as prevention of denaturation over the expected shelf life. The selection of appropriate excipients also depends upon the route of administration and the dosage form, as well as the active ingredient and other factors. http://en.wikipedia.org/wiki/Excipient ...
Market Research Reports : Transparency Market Research published new market report "Oral Solid Dosage Forms (OSDF) and Pharma Excipients Market for Polymers (MCC, HPMC, CMC, Ethyl Cellulose, Povidone and Others), Alcohols (Glycerin, Sorbitol, Mannitol, Propylene Glycol), Minerals (Clay, Silicon Dioxide, Titanium Dioxide) and Sugars (Lactose, Sucrose) - Global Industry Analysis, Size, Share, Trends, Analysis, Growth and Forecast, 2012 - 2018," the global OSDF excipients demand was 93.8 kilo tons in 2011 and is expected to reach 126.8 kilo tons in 2018, growing at a CAGR of 4.5% from 2012 to 2018. In terms of revenue, the market was valued at USD 570.6 million in 2011 and is expected to reach USD 869.1 million in 2018, growing at a CAGR of 6.3% from 2012 to 2018. The overall pharmaceutical excipients demand was 519.5 kilo tons in 2011 and is expected to reach 685.6 kilo tons in 2018, growing at a CAGR of 4.1% from 2012 to 2018. ...
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Mannitol is a pharmaceutical excipient that is receiving increased popularity in solid dosage forms. This study contributes to the development of mannitol as a potential excipient of the first choice.
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A free-flowing directly compressible granulation useful as a slow release pharmaceutical excipient is disclosed. The excipient includes a hydrodrophilic matrix which includes a heteropolysaccharide and a polysaccharide material capable of cross-linking the heteropolysaccharide, and an inert diluent.
A free-flowing directly compressible granulation useful as a slow release pharmaceutical excipient is disclosed. The excipient includes a hydrodrophilic matrix which includes a heteropolysaccharide and a polysaccharide material capable of cross-linking the heteropolysaccharide, and an inert diluent.
The global excipients market is anticipated to reach USD 5.22 billion by 2020, growing at a CAGR of 6.0% from 2014 to 2020, according to a new report by Grand View Research, Inc. Growing developments in the field of medicine formulation and rise in research in the field of dosage technology are expected to drive this industry through the forecast period. Introduction of novel technologies for utilization of generic drugs in the development of new formulations is expected to boost growth of this industry over the forecast period. Furthermore, increasing global geriatric population base is anticipated to significantly raise demand for pharmaceuticals as this segment of the population is prone to high risk of organ disorders and infections, thereby propelling market growth.. Full research report on excipients market analysis: http://www.grandviewresearch.com/industry-analysis/excipients-market-analysis. Increasing demand for diverse excipients pertaining to interaction with active pharmaceutical ...
The global excipients market is anticipated to reach USD 5.22 billion by 2020, growing at a CAGR of 6.0% from 2014 to 2020, according to a new report by Grand View Research, Inc. Growing developments in the field of medicine formulation and rise in research in the field of dosage technology are expected to drive this industry through the forecast period. Introduction of novel technologies for utilization of generic drugs in the development of new formulations is expected to boost growth of this industry over the forecast period. Furthermore, increasing global geriatric population base is anticipated to significantly raise demand for pharmaceuticals as this segment of the population is prone to high risk of organ disorders and infections, thereby propelling market growth.. Full research report on excipients market analysis: http://www.grandviewresearch.com/industry-analysis/excipients-market-analysis. Increasing demand for diverse excipients pertaining to interaction with active pharmaceutical ...
The processibility of 15 carbohydrates, more or less commonly used, was investigated as excipients in supercritical fluid drying. The focus was on the ability to produce amorphous powder, the stability of the powders towards crystallisation, and the residual water and ethanol content. The aqueous solutions were sprayed into a pressurised carbon dioxide-ethanol mixture flowing cocurrently through a coaxial two-fluid nozzle. The powder characteristics appeared to be influenced by the supersaturation level reached during the SCF-drying process and by the properties of the sugar species, such as water solubility and glass transition temperature, or the solution viscosities. The stability and the residual solvent content of a selected set of sugars and some mixtures were further analysed. The stability of amorphous powders was investigated at 4 degrees C, room temperature, 40 and 50 degrees C. Lactose, maltose, trehalose, raffinose, cyclodextrin, low-molecular-weight dextran and inulin could form ...
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Granulocyte-colony stimulating factor (G-CSF) is a cytokine which is therapeutically used in oncology and hematology. It tends to form soluble and insoluble aggregates particularly under high-stress conditions that occur during the pharmaceutical production process. Aggregates of therapeutic proteins can cause severe adverse reactions after administration, but they also reduce shelf life and pharmacological activity. Prevention of protein aggregation in drug formulations is of considerable importance in pharmaceutical industry. Therefore high effort for optimization of formulations is necessary to obtain an optimum of protein stability. Knowledge about the mechanism and the process kinetics of G-CSF aggregation could enable the improvement of algorithms for the prediction of protein aggregation and lead to cost reduction of formulation development. The simulation of process conditions was accomplished by agitation and exposure of G-CSF to gas-liquid interfaces. Size exclusion HPLC was employed ...
The internal pore structure of chars derived from many bituminous and sub-bituminous coals can be best described by bi-modal pore size distribution. Their macropores, which account for nearly all the porosity, are interconnected spherical cavities with diameters as large 100 or 200 microns for 500--750 micron particles. Most of the internal surface area of these chars, however, is associated with micropores that are usually smaller than 30 A. In order to elucidate the effect of process conditions on the internal pore structure of coal-derived char particles and ultimately their overall reactivities, staged and sequential combustion algorithms are designed using thermogravimetric reactor equipped with in-situ video microscopy imaging (TGA/VMI). Our experiments showed that coal-derived char particles treated with higher pyrolysis heating rates have more open macropore structure than those treated with lower heating rates. At low combustion temperature where the reaction was kinetic controlled, the ...
The focus of this thesis was to evaluate the impact of mechanical activation (milling and dry mixing) and spray drying on the crystallinity of selected active pharmaceutical ingredients (APIs) and to explore the feasibility of co-processing these drugs with low glass transition temperature (Tg) excipients as a strategy for preventing process induced amorphisation. Co-milling investigations were initially performed on sulfadimidine and salbutamol sulphate. Based on the data obtained for these two APIs, further analysis was conducted on budesonide to see if results could be generalised to other compounds. Co-spray drying experiments were performed with sulfadimidine as API. The excipients chosen were dicarboxylic acids (glutaric, adipic, succinic, pimelic and malic acid) and sugar alcohols (mannitol and xylitol ...
Chemical APIs (Active Pharmaceutical Ingredients) Spectrum Chemical manufactures and distributes over 400 chemical APIs (active pharmaceutical ingredients. These substances are the biologically active component of any drug product regardless of pharmaceutical formulation type (tablets, capsules, topical, etc.). Spectru
(EMAILWIRE.COM, December 14, 2017 ) Europe Sugar based Excipients Market was worth USD 301.21 million in 2016 and estimated to be growing at a CAGR of 4.1%, to reach USD 368.23 million by 2021. A certain formulation contains both an active pharmaceutical ingredient and an excipient. It is mainly...
Author: Geiger Christine M, Sorenson Bridget, Whaley Paul, Year: 2015, Abstract: The stability of 10 active pharmaceutical ingredients was studied in SyrSpend SF PH4 or SyrSpend SF Alka at room and/or refrigerated temperature (2°C to 8°C). An oral suspension of each active pharmaceutical ingredient was compounded in low actinic plastic bottles at a specific concentration in SyrSpend SF PH4 or SyrSpend SF Alka. Samples were assessed for stability immediately after preparation (day 0) followed by storage at room temperature and/or at refrigerated temperature. At set time point
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Product Description Antidiabetic Active Pharmaceutical Ingredients Nateglinide CAS 105816-04-4 Product Name: Nateglinide Synonyms: (-)-n-(trans-4-isopropylcyclohexanecarbonyl)-d-phenylalanine;ay4166;Nateglinide(H);trans-d-phenylalanin;trans-n-((4-(1-methylethyl)cyclohexyl)carbonyl)-d-phenylalanine;3-phenyl-2-(4-propan-2-ylcyclohexyl)carbonylamino-propanoic acid;A-4166;STARLIX CAS: 105816-04-4 MF: C19H27NO3 MW: 317.42 Product Categories: Active Pharmaceutical Ingredients;API;APIs;Health & Beauty;Amino Acids & Derivatives;Intermediates & Fine Chemicals;Pharmaceuticals;Aromatics;STARLIX;Antidiabetic Melting point : 137-141°C Storage temp. : Room temp Chemical Properties : White Cyrstalline Solid Usage : antidiabetic KATP channel blocker…
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(EMAILWIRE.COM, November 24, 2017 ) In this report, the global Active Pharmaceutical Ingredients market is valued at USD XX million in 2017 and is projected to reach USD XX million by the end of 2021, growing at a CAGR of XX% during the period 2017 to 2021. Active Pharmaceutical Ingredients...
Pharmaceutical Technology has released an eBook called "Solid Dosage and Excipients." The examines how advances in technology, equipment, excipients, analytical techniques, software, and manufacturing practices are facilitating the development, scale up, manufacturing, efficacy, and delivery of solid- and semi-solid dosage forms ...
Tablets are not only made of active pharmaceutical ingredients (API) but also of excipients which improve the powder processing and the quality of the final dosage form. Tableting is a multiple step process whose success depends on the parameters of instruments used and powder handling. Granulation and drying, in particular, require a suitable combination of excipients. This application report investigates the moisture uptake capacity of the excipients milled and sieved lactose as well as methylcellulose in order to estimate their behavior during wet granulation. The same excipients were also tested at different temperatures to reproduce the drying effect of a fluidized bed dryer. It was found that the amount of moisture adsorbed during wet granulation and the consecutive temperature effect during drying have an impact on the flow and compression characteristics. Read more ...
Presentation. Main areas of interest include lipid biochemistry and applications of lipids, with special emphasis on the digestion and absorption of lipids and their impact on delivery of drugs and nutrients.. Primary research areas. Major current research is focused on effects of excipients on sustained drug release based on a better understanding of interactions between excipients and between drug molecules and excipients. The active research includes formulation strategies, in vitro models, in vivo studies, and diverse analytical methods.. http://pharmacy.ku.dk/research/section_pharm_design/rat_oral_drug_delivery/excipients-drug-delivery/. Teaching. ...
Anti-caking agents, carriers, preservatives, emulsifiers, lubricants, buffers and alkalinizing agents. We are a certified manufacturer and developer and produce in accordance with international pharmacopoeias, and also in low-endotoxin grades.
PROSOLV® EASYtab SP is an all-in-one, ready-to-use excipient composite. It effectively combines four individual components: binder/filler, superdisintegrant, glidant, and lubricant. Developed using JRS Pharmas proven PROSOLV® Technology, it is the first lubricated high functionality excipient on the market.
A stabilized bioadhesive composition containing an alkaline labile drug and a method for its preparation are provided. In one aspect, the composition is a hot-melt extruded (HME) composition comprising a preformed excipient mixture comprising an acidic component and an alkaline thermoplastic matrix-forming material, e.g. polymer. The excipient mixture is formed before blending with an alkaline labile drug. The blend is then hot-melt extruded to form the HME composition. By so doing, the acidic component is able to neutralize or render moderately acidic the excipient mixture. This particular process has been shown to substantially reduce the degradation of an alkaline labile drug during hot-melt extrusion. The excipient mixture softens or melts during hot-melt extrusion. It can dissolve or not dissolve drug-containing particles during extrusion. Various functional excipients can be included in the carrier system to improve process performance and/or improve the chemical or physical properties of the HME
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Capsugel is the first hard capsule manufacturer to receive the EXCiPACT™ certification. The certification provides independent validation that Capsugels European manufacturing sites maintain excipient Good Manufacturing Practices (GMPs) and comply with current European Union regulations in the manufacturing of empty, two-piece hard capsules.This webinar covers the regulatory background regarding the EU Directive on Falsified Medicines, the process and scope of the EXCiPACT™ excipient GMP certification, and the related benefits to companies marketing pharmaceutical products in the European Union.
The European Medicines Agency (EMA) on Monday updated its annex to the European Commissions guideline on excipient labeling, adding five new excipients and expanding the safety warnings required for 10 others.
The NIPTE-FDA Excipients Knowledge Base hosted at pharmaHUB. Ann Christine Catlin Meeting at the FDA August 15, 2011. A Publicly Available Database. Excipients Database. Where to Host the Database ?. Slideshow 1092936 by seoras
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This thesis presents four different studis describing the characteristics and processing opportunities of two widely available biopolymers: chitosan and wheat gluten. The interest in these materials is mainly because they are bio-based and obtained as co- or by-products in the fuel and food sector. In the first study, high solids content chitosan samples (60 wt.%) were successfully extruded. Chitosan extrusion has previously been reported but not chitosan extrusion with a high solids content, which decreases the drying time and increases the production volume. An orthogonal experimental design was used to assess the influence of formulation and processing conditions, and the optimal formulation and conditions were determined from the orthogonal experimental analysis and the qualities of the extrudates. The mechanical properties and processing-liquid mass loss of the optimized extrudates showed that the extrudates became stable within three days. The changes in the mechanical properties depended ...