Profiller 1100/1120 Hand-Held Capsule Filling System for Use in Selection and Laboratory Development of Over-Encapsulated Products

Over-encapsulation (OE) is a widely used, cost-effective technique which involves the blinding of a solid dosage form into a capsule shell to eliminate bias from comparative clinical trials while maintaining study integrity and efficacy. However, there are many variables that can affect the complexity of the OE process. Important for consideration during the selection and development of OE products include capsule shell type and size, appropriate backfill selection, variables in commercial dosage comparators used, as well as any impact these variables may have to the analytical methodology itself.

Almac’s Analytical Services team works on the development and phase appropriate validation of analytical methods to support release testing as well as stability studies for API, Drug Products and reference standard certification on behalf of external clients. Learn more in our latest Almac Voice authored by Joseph Forth, Director of Operations, Almac Sciences.