A Comprehensive Monograph on Hypromellose (DB11075): Physicochemical Properties, Pharmaceutical Applications, and Safety Profile

1.0 Executive Summary

Hypromellose, also known by its chemical name hydroxypropyl methylcellulose (HPMC), is a semisynthetic, inert, viscoelastic polymer derived from cellulose. It stands as a cornerstone of modern pharmaceutical science due to its remarkable versatility, functioning as both a primary therapeutic agent in ophthalmic formulations and an indispensable excipient in a vast array of oral and topical drug delivery systems.[1] This monograph provides a comprehensive analysis of Hypromellose, integrating its physicochemical characteristics, pharmacological mechanisms, pharmacokinetic profile, clinical applications, and safety data. The fundamental utility of Hypromellose is rooted in a predictable structure-function paradigm, where its molecular properties—specifically the degree of chemical substitution and polymer chain length—can be precisely modulated to control macroscopic behaviors such as viscosity, hydration rate, and thermal gelation. This tunability allows for the engineering of specific performance outcomes, from providing gentle, long-lasting lubrication for the ocular surface to orchestrating the complex, zero-order release of active pharmaceutical ingredients from once-daily oral tablets.