Determinaion of Hard Gelatin Capsule Brittlenss Using a Motorized Compression Test Stand

Abstract

Hard gelatin capsules are solid dosage forms containing powders, granulations, or pellets enclosed in a hard soluble shell. Recent guidelines for submitting documentation for the stability of human drugs and biologics to the FDA have requested test data for capsule brittleness. A simple test has been developed using a compression gauge to quantify the force required to fracture and/or shatter hard gelatin capsules. The data generated from this test can be utilized for dosage form stability assessment as well as quality control and quality assurance of capsules prior to their use in dosage from manufacture.