Biopharmaceutics Aspects of Sugar Alcohols: Implementation of Patient-Centricity in Pharmaceutical Development and Clinical Use.

Abstract

Sugar alcohols such as mannitol and sorbitol are frequently used as pharmaceutical excipients in oral dosage forms. Their versatility stems from extensive evidence of use in humans. However, investigations over many years have clearly indicated their osmolarity-derived biopharmaceutics effects on oral drug absorption. Despite this, these accumulated insights have not been fully integrated into pharmaceutical formulation development or clinical use, leading to suboptimal industrial and clinical practices. This review provides a comprehensive summary of the biopharmaceutics of sugar alcohols, detailing their mechanisms of action and the magnitude of their osmotic effects on the oral absorption of various drugs. Additionally, the review discusses the implications for bioequivalence studies, BCS-based biowaiver guidelines, drug-excipient interactions in pediatric polypharmacy, and pharmaceutical compounding. The aim is to guide future successful and patient-centric pharmaceutical formulation development.