Evolution of supersaturation of amorphous pharmaceuticals: nonlinear rate of supersaturation generation regulated by matrix diffusion

Molecular Pharmaceutics
Dajun D Sun, Ping I Lee

Abstract

The importance of rate of supersaturation generation on the kinetic solubility profiles of amorphous systems has recently been shown by us; however, the previous focus was limited to constant rates of supersaturation generation. The objective of the current study is to further examine the effect of nonlinear rate profiles of supersaturation generation in amorphous systems, including (1) instantaneous or infinite rate (i.e., initial degree of supersaturation), (2) first-order rate (e.g., from dissolution of amorphous drug particles), and (3) matrix diffusion regulated rate (e.g., drug release from amorphous solid dispersions (ASDs) based on cross-linked poly(2-hydroxyethyl methacrylate) (PHEMA) hydrogels), on the kinetic solubility profiles of a model poorly soluble drug indomethacin (IND) under nonsink dissolution conditions. The previously established mechanistic model taking into consideration both the crystal growth and ripening processes was extended to predict the evolution of supersaturation resulting from nonlinear rates of supersaturation generation. Our results confirm that excessively high initial supersaturation or a rapid supersaturation generation leads to a surge in maximum supersaturation followed by a rapid decr...Continue Reading

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Citations

Mar 26, 2016·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Stefania MaranoDuncan Q M Craig
Jun 10, 2015·Journal of Controlled Release : Official Journal of the Controlled Release Society·Dajun D Sun, Ping I Lee
Sep 24, 2016·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·K WlodarskiW Sawicki
Jan 4, 2017·Molecular Pharmaceutics·Yi Rang Han, Ping I Lee
May 20, 2017·Pharmaceutical Research·Khadijah EduengChristel A S Bergström
Aug 21, 2020·Journal of Pharmaceutical Sciences·Andrew Toye Ojo, Ping I Lee

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