Lipid-based Surface Modified Formulation for Reducing the Hygroscopicity of a Bile Acid Sequestrant Drug

Abstract

This research addresses the critical challenge of mitigating the hygroscopic nature of Drug X, a pivotal active pharmaceutical ingredient (API). Recognizing the detrimental impact of moisture absorption on the stability and efficacy of the drug, this study employs the advanced technique of melt granulation to achieve significant reductions in hygroscopicity. The primary objective revolves around thoroughly optimizing melt granulation parameters, including temperature, binder composition,and processing time. Through systematic experimentation and analysis, the study aims to establish a robust formulation strategy that effectively reduces moisture absorption by the API. Key findings indicate a noteworthy success in reducing the hygroscopicity of Drug X post-melt granulation. This achievement is attributed to the formation of a protective coating around the drug particles, offering a barrier against excessive moisture ingress. The research extends to a comprehensive characterization of the granulated formulation, encompassing physical and chemical properties. This project presents an innovative solution to the hygroscopicity challenge encountered by Drug X through the strategic application of melt granulation. The observed reduction in hygroscopicity not only contributes to the enhanced stability of the API but also holds substantial implications for the broader pharmaceutical landscape, particularly in the development of moisture-resistant formulations. The findings from this study underscore the potential for improved drug performance and longevity in diverse environmental conditions.