In Vitro Drug Release Testing of Veterinary Pharmaceuticals
In vitro drug release testing for veterinary pharmaceuticals is a regulatory requirement to aid in the understanding of the in vivo performance of a dosage form. The in vitro release test is used throughout development for formulation and process characte
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In Vitro Drug Release Testing of Veterinary Pharmaceuticals Shannon Higgins-Gruber, Michael J. Rathbone, and Jay C. Brumfield
Abstract In vitro drug release testing for veterinary pharmaceuticals is a regulatory requirement to aid in the understanding of the in vivo performance of a dosage form. The in vitro release test is used throughout development for formulation and process characterization and post-approval to ensure product quality and therapeutic effect. The current recommended in vitro test equipment and conditions are better suited for mimicking human gastric system physiology but not that of the patients being dosed with veterinary pharmaceuticals. Veterinary dosage forms and delivery systems tend to be more complex and varied because of the diversity of species, size of the animals, and prevalence of unconventional excipients often not used in human health drug products. Therefore, the development of in vitro release tests specific for use with veterinary medicines can be challenging and unconventional with respect to the expectations from the regulatory agencies. Regardless of the analytical approach to development, the final in vitro release test is expected to be discriminating with respect to the impact of critical quality attributes on in vivo behavior and easily performed in quality control environments.
S. Higgins-Gruber (*) • J.C. Brumfield Merck Animal Health, Summit, NJ, USA e-mail: [email protected] M.J. Rathbone International Medical University, Kuala Lumpur, Malaysia M.J. Rathbone and A. McDowell (eds.), Long Acting Animal Health Drug Products: Fundamentals and Applications, Advances in Delivery Science and Technology, DOI 10.1007/978-1-4614-4439-8_9, © Controlled Release Society 2013
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Introduction
In vitro drug release testing is used to characterize release of a drug from a dosage form. The most commonly used technique for in vitro drug release testing is dissolution. According to the United States Pharmacopeia (USP), disintegration, dissolution, and drug release testing is required for “…dosage forms in which absorption of the drug is necessary for the product to exert the desired therapeutic effect” [1]. Disintegration is most often used as a quality control test with immediate release drug products that contain a drug substance that is highly soluble, highly permeable, and dependent solely on disintegration of the dosage form for absorption. While dissolution was originally intended for use with solid oral dosage forms with an immediate release profile, its use has since been extended to include controlled release and other novel dosage forms such as transdermal patches, semisolid topicals, chewable tablets, suppositories, suspensions, and vaginal implants [1–4]. For most solid oral dosage forms, both immediate and controlled release, the test is often referred as “dissolution.” However, for novel dosage forms, the term “drug release testing” or “in vitro release testing” is preferred to differentiate it from the more standard
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