In-Use and Excursions: Stability Beyond ICH

In-Use and Excursions: Stability Beyond ICH

Kenneth C. Waterman Ph.D.
President, FreeThink Technologies, Inc.
Branford, CT USA

While there is a regulatory expectation that in-use shelf-life will be determined for multiuse packaging, there is little definition of what that testing entails. In-use conditions can be from opening of a package (e.g., breaking a heat-induction seal, HIS, on a bottle) or constituting a product (e.g., dispersing a powder in water). Similarly, scientific justification for acceptability (with few specifics) is required when shipping or storage conditions exceed specifications. The impact in both situations is effectively modeled based on accelerated data and understanding of the importance for a given product of temperature and humidity. Examples are shown illustrating this accelerated modeling approach for: (1) sudden drops in temperature, (2) tablets removed daily after a bottle seal is broken, (3) powder constituted after storage, and (4) high temperature excursion for tablets.