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Formulation and Stability of Solutions

Author(s):  Akers Michael J

Issue:  Mar/Apr 2016 - Volume 20, Number 2
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Page(s):  137-141

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Abstract:  Ready-to-use solutions are the most preferable and most common dosage forms for injectable and topical ophthalmic products. Drugs formulated as solution almost always have chemical and physical stability challenges as well as solubility limitations and the need to prevent inadvertent microbial contamination issues. The first in this series of articles took us through a discussion of optimizing the physical stability of solutions. This article concludes this series of articles with a discussion on foreign particles, protein aggregation, and immunogenicity; optimizing microbiological activity; and osmolality (tonicity) agents, and discusses how these challenges and issues are addressed.

Related Keywords: Michael J. Akers, PhD, ready to use solutions, physical stability, foreign particles, protein aggregation, protein aggregates, immunogenicity, protein adsorption, surfactants, protein denaturation, polysorbates, sodium dodecyl sulfate, cyclodextrins, solubility, bioavailability, serum albumin, stabilizer, multiple dose formulations, antimicrobial preservatives, compounded sterile preparations, preservative efficacy test, United States Pharmacopeia Chapter <51>, USP, European Pharmacopeia, drug contamination, osmolality agents, tonicity-adjusting agents, isotonic, hydrolysis, hydrolytic reactions, oxidation, oxidative reactions, buffers, antioxidants, chelating agents, inert gases, biopharmaceuticals, competitive binders, mechanical stress


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