Setting Dissolution Specifications for Modified-Release Dosage Forms

Abstract

Dissolution specifications are limits for the percent of drug released at specific times. Setting these boundaries assures that all formulations which meet these limits perform similarly. For years dissolution specifications have served as an in vitro quality assurance (e.g., in stability testing). As a quality control measure, dissolution specifications are defined by the Sponsor and the Food and Drug Administration (FDA). Acceptance criteria is often based on three time points: 1) an early time point to identify if dose dumpingccurs, 2) a time point to characterize the release profile and demonstrate the extension of release, and 3) a time point to prove that most of the intended entire dose is delivered. The USP dissolution acceptance criteria for diltiazem hydrochloride extended release capsules is based on time points at 3, 9, and 12 hours. The following chart describes the USP dissolution specifications for diltiazem hydrochloride¹;