In vitro-in vivo correlation from lactide-co-glycolide polymeric dosage forms

Progress in Biomaterials
Susan D'SouzaPatrick DeLuca

Abstract

The objective of this study was to compare the in vitro behavior of four long-acting subcutaneous risperidone formulations with in vivo performance, with the intent of establishing an IVIVC. Two copolymers of PLGA (50:50 and 75:25) were used to prepare four microsphere formulations of risperidone, an atypical antipsychotic. In vitro behavior was assessed at the physiological temperature (37 °C) using the 'modified dialysis' technique. The in vitro release profile demonstrated rank order behavior with Formulations A and B, prepared using the 50:50 copolymer, exhibiting rapid drug release, while Formulations C and D, prepared using 75:25 PLGA, released drug in a slower manner. In vivo profiles were obtained by two approaches, i.e., deconvolution using the Nelson-Wagner equation (the FDA recommended approach) and using fractional AUC. With both in vivo approaches, the 50:50 PLGA preparations released drug faster than the 75:25 PLGA microspheres, exhibiting the same rank order observed in vitro. Additionally, profiles for the four formulations obtained using the deconvolution approach were nearly superimposable with fractional AUC, implying that the latter procedure could be used as a substitute for the Nelson-Wagner method. A comp...Continue Reading

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Citations

Sep 8, 2017·Biotechnology Journal·Dmitry GilAlexey Vertegel
May 15, 2018·Tissue Engineering. Part C, Methods·Maurits G L OlthofLichun Lu
Aug 8, 2021·Advanced Drug Delivery Reviews·Xiaoyi Wang, Diane J Burgess

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