Accelerated in-vitro release testing methods for extended-release parenteral dosage forms.
OBJECTIVE
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.


RESULTS
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.


CONCLUSIONS
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.
Department of Pharmaceutical Sciences, University of Connecticut, Storrs, CT, USA.
Jie
J
Shen
Diane J
DJ
Burgess
D002626:Chemistry, Pharmaceutical; D003692:Delayed-Action Preparations / Q000737:chemistry* / Q000592:standards; D006801:Humans; D007263:Infusions, Parenteral / Q000379:methods* / Q000592:standards; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D011786:Quality Control
D003692:Delayed-Action Preparations; D004364:Pharmaceutical Preparations