title: Use of In Vitro-In Vivo Correlation (IVIVC) to facilitate the development of polymer-based controlled release injectable formulation.
abstract: In Vitro-In Vivo Correlation (IVIVC) is being increasingly used to predict bioperformance of dosage forms without conducting animal and/or human studies which are not only time-consuming and expensive but also might be considered ethically undesirable. The main aim of IVIVC methods is to develop in vitro drug release methods which are simple, robust, reproducible, inexpensive, in compliance with compendial and regulatory requirements and finally can be used in lieu of in vivo studies to direct formulation selection. This review provides a summary of currently marketed polymeric depot products and the patents related to these drug delivery systems in addition to currently available in vitro release methods used to study drug release from injectable controlled release drug delivery systems, currently available IVIVC methods and some examples of successful IVIVC for small molecules, peptides and proteins formulated in controlled release formulations administered subcutaneously or intramuscularly.
authors.affiliation: Biopharmaceutics Research and Parenteral Delivery, Pharmaceutical R&D, Merck & Co., West Point, PA 19486-0004, USA. amitava_mitra@merck.com
authors.forename: Amitava
authors.initials: A
authors.lastname: Mitra
authors.forename: Yunhui
authors.initials: Y
authors.lastname: Wu
mesh_terms: D000818:Animals; D003692:Delayed-Action Preparations; D016503:Drug Delivery Systems; D015195:Drug Design; D006801:Humans; D007267:Injections; D008962:Models, Theoretical; D010330:Patents as Topic; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000737:chemistry; D011108:Polymers / Q000737:chemistry*; D015203:Reproducibility of Results
chemical_list: D003692:Delayed-Action Preparations; D004364:Pharmaceutical Preparations; D011108:Polymers