4.5 Article

Studies on the pH-Dependent Solubility of Various Grades of Calcium Phosphate-based Pharmaceutical Excipients

Journal

JOURNAL OF PHARMACEUTICAL SCIENCES
Volume 111, Issue 6, Pages 1749-1760

Publisher

ELSEVIER SCIENCE INC
DOI: 10.1016/j.xphs.2021.12.005

Keywords

Solubility; Excipients; Calcium phosphates; Tribasic calcium phosphate; Dibasic calcium phosphate

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Calcium phosphate-based pharmaceutical excipients have been widely used in pharmaceutical technology and have beneficial biocompatible and biodegradable properties. However, there is limited information on their solubility under different pH conditions.
Calcium phosphate-based pharmaceutical excipients, including calcium hydrogen phosphate anhydrous and dihydrate, calcium hydroxide phosphate have been well established in pharmaceutical technology for a very long time. Nowadays, they are of increasing interest to the pharmaceutical industry because, in addition to their advanced functional properties, they offer beneficial biocompatible and biodegradable properties. Yet, there is limited availability of embracing information regarding the solubility of these popular excipients, especially in variable pH conditions, reflecting those of the gastrointestinal tract (GIT). The study has shown that the solubility of calcium phosphates as well as their dissolution rate decreases significantly with increas-ing pH of dissolution fluids. The highest solubility was observed for dibasic calcium phosphate dihydrate, the lowest for tribasic calcium phosphate. This article provides also a comparison of various calcium phosphate types originating from different manufacturers, which may prove to be useful and help formulation scientists to design new medicinal products.(c) 2021 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.

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