Fast Determination of Phase Stability of Hydrates Using Intrinsic Dissolution Rate Measurements

Research output: Contribution to journalArticle

Abstract

The critical water activity (aw,c) at a fixed temperature and transition temperature (Tt) in water between an anhydrate and its corresponding hydrate determine their physical stability. Hence, their accurate determination enables the efficient development of robust crystallization processes and formulation of drugs. The commonly used methods for determining the two parameters are either labor- A nd material-intensive or cannot be accurately measured due to slow kinetics. Thus, a material-sparing and fast method is desirable for adoption in the early stage of drug development when the materials and time are limited. In this study, we show that intrinsic dissolution rate (IDR) measurement is a fast (a few days) and material-sparing (<1 g) method for accurate determination of aw,c, Tt, as well as free energy, enthalpy, and entropy of hydration. Overall, the IDR measurement is an advantageous technique for characterizing the stability of pharmaceutical hydrates in an early stage of drug development.

Original languageEnglish (US)
Pages (from-to)5471-5476
Number of pages6
JournalCrystal Growth and Design
Volume19
Issue number10
DOIs
StatePublished - Oct 2 2019

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Phase stability
Hydrates
hydrates
dissolving
Dissolution
drugs
Pharmaceutical Preparations
Superconducting transition temperature
transition temperature
Water
labor
Crystallization
Hydration
Drug products
water
Free energy
hydration
Enthalpy
Entropy
enthalpy

Cite this

Fast Determination of Phase Stability of Hydrates Using Intrinsic Dissolution Rate Measurements. / Wen, Hongliang; Wang, Chenguang; Sun, Changquan Calvin.

In: Crystal Growth and Design, Vol. 19, No. 10, 02.10.2019, p. 5471-5476.

Research output: Contribution to journalArticle

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