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Search Results for "Physical Stability Of Pharmaceutical Products"

21:11 EDT 24th May 2013 | BioPortfolio

Original Source: Advanced Physical Stability Testing of Commercial Pharma Products

Stressing Your Drug Substance to the Limits to Discover What it Beholds

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Pharmaceutical Research: Effects of Excipients on the Chemical and Physical Stability of Glucagon during Freeze-Drying and Storage in Dried Formulations

Type: Original PaperPurposeTo evaluate the effects of several buffers and excipients on the stability of glucagon during freeze-drying and storage as dried powder formulations.MethodsThe chemical and...

Pharmaceutical Research: Beyond Glass Transitions: Studying the Highly Viscous and Elastic Behavior of Frozen Protein Formulations Using Low Temperature Rheology and Its Potential Implications on Protein Stability

Type: Original PaperPurposeA novel application of oscillatory shear rheology was used to directly monitor global phase behavior of protein formulations in the frozen state and study its correlation wi...

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AAPS PharmSciTech: Effect of Processing Parameters on the Physical Stability of Silicone Coatings

Type: Brief CommunicationNo abstract available.

Pharmaceutical Research: Liquid Formulations for Stabilizing IgMs During Physical Stress and Long-Term Storage

Type: Original PaperPurposeTo develop a liquid formulation for IgMs to survive physical stress and storage.MethodsStabilizing formulations for 8 monoclonal immunoglobulin (IgMs) were found using diffe...

Pharmaceutical Research: Effect of pH and Excipients on Structure, Dynamics, and Long-Term Stability of a Model IgG1 Monoclonal Antibody upon Freeze-Drying

Type: Original PaperPurposeTo investigate the mechanism of IgG1 mAb stabilization after freeze-drying and the interdependence of protein structural preservation in the solid state, glassy state dynami...

Generics Firms Raise Concerns About FDA’s Stability Testing Guidance

The generic drug industry needs to place more drug batches on stability for a longer time to meet the new, stricter stability testing requirements scheduled to take effect Jan. 1, 2014. However, indus...

Japan loosens stability testing requirements for devices

Japan will no longer require medtech companies to include stability testing data in order to get approval for devices after a -More- 

Matching PubMed Articles

High-throughput 96-well solvent mediated sonic blending synthesis and on-plate solid/solution stability characterization of pharmaceutical cocrystals.

A 96-well high-throughput cocrystal screening workflow has been developed consisting of solvent-mediated sonic blending synthesis and on-plate solid/solution stability characterization by XRPD. A stra...

Determination of aqueous stability and degradation products of series of coumarin dimers.

The stability in aqueous solution of five classes of coumarin dimers (I-V, compounds 1-29) was studied by HPLC-MS/MS at various pH values. The relationship between chemical structure and stability is...

Early drug development predictions of glass-forming ability and physical stability of drugs.

The purpose of this study was to investigate if rapidly measured physical properties can predict glass-forming ability and glass stability of drug compounds. A series of 50 structurally diverse drug m...

Application of a validated stability-indicating chromatographic method to evaluate the reproducibility between batches of small peptides in solution.

A stability-indicating reversed-phase high-performance liquid chromatographic method was developed and validated as per the International Conference on Harmonization (ICH) guidelines to evaluate the r...

Method for the evaluation of the stability and usability after opening packages of orally disintegrating tablets: case of amlodipine besilate products.

Orally disintegrating (OD) tablets are widely used in clinical practice. However, drug information on the choice and dispensing based on their stability after opening packages and usability in patient...

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