Effect of Variations in Backfill on Dissolution for an Over-Encapsulated Comparator Product

This article concerns the blinding of the comparator product by placing the product (tablet or capsule) into a capsule and backfilling the remaining capsule void space with excipients. Backfilling is required for over-encapsulation to eliminate the potential rattling of the comparator product in the capsule, and also eliminate the ability of the patient to feel the comparator product if the capsule were squeezed.