Prediction of Tablet Dissolution from API and Excipient Polymer Properties
Purpose: Modified-release (MR) matrix tablets are typically produced using hydroxypropyl methylcellulose (HPMC) as rate-modifying polymer. HPMC effectively sustains release of a broad range of active pharmaceutical ingredients (APIs), but specific dissolution behavior varies depending on the API properties, excipient properties, and formulation. Recently, a new line of HPMC, METHOCEL™ DC2 grades, have been introduced to facilitate direct compression formulations given its enhanced flowability. The ability to predict performance based on properties of components could streamline formulation development and provide a more direct route to troubleshooting challenging APIs. Combined such a capability with a direct compression manufacturing technique would mean faster and less expensive development and manufacturing. The intent of this study was to identify the API and polymer properties that most directly impacted dissolution performance, connect the observed performance to fundamental API and polymer chemistry, and develop predictability that connects this fundamental understanding to efficient formulation design.
