Formulation and evaluation of atorvastatin calcium trihydrate Form I tablets.

ABSTRACT: Solid forms transformations and new crystal structures of an active pharmaceutical ingredient (API) can occur due to various manufacturing process conditions, especially if the drug substance is formulated as a hydrate. The conversion between hydrate and anhydrate forms caused by changes in temperature and humidity must be evaluated because of the risk of dehydration and phase transitions during the manufacturing process. Differences in physicochemical, mechanical, and rheological properties have been observed between solid forms of the same API that can cause manufacturing and product-related issues. Atorvastatin calcium trihydrate (ACT) is a synthetic lipid-lowering agent that was discovered during Lipitor® (its anhydrous form) Phase 3 clinical trials after passing Phase I and II. This c

SUBMITTER: Salazar-Barrantes KA 

PROVIDER: S-EPMC11825022 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature