Open AccessAccelerated in‐vitro release testing methods for extended‐release parenteral dosage forms
Author(s) -
Shen Jie,
Burgess Diane J.
Publication year - 2012
Publication title -
journal of pharmacy and pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.745
H-Index - 118
eISSN - 2042-7158
pISSN - 0022-3573
DOI - 10.1111/j.2042-7158.2012.01482.x
Subject(s) - dosage form , ivivc , in vitro , pharmacology , controlled release , drug , parenteral nutrition , in vivo , medicine , chemistry , biomedical engineering , surgery , biology , dissolution testing , biochemistry , microbiology and biotechnology , biopharmaceutics classification system
Objectives This review highlights current methods and strategies for accelerated in‐vitro drug release testing of extended‐release parenteral dosage forms such as polymeric microparticulate systems, lipid microparticulate systems, in‐situ depot‐forming systems and implants. Key findings Extended‐release parenteral dosage forms are typically designed to maintain the effective drug concentration over periods of weeks, months or even years. Consequently, ‘real‐time’ in‐vitro release tests for these dosage forms are often run over a long time period. Accelerated in‐vitro release methods can provide rapid evaluation and therefore are desirable for quality control purposes. To this end, different accelerated in‐vitro release methods using United States Pharmacopeia (USP) apparatus have been developed. Different mechanisms of accelerating drug release from extended‐release parenteral dosage forms, along with the accelerated in‐vitro release testing methods currently employed are discussed. Summary Accelerated in‐vitro release testing methods with good discriminatory ability are critical for quality control of extended‐release parenteral products. Methods that can be used in the development of in‐vitro–in‐vivo correlation (IVIVC) are desirable; however, for complex parenteral products this may not always be achievable.