(115c) A Strategy for Tablet Active Film Coating Formulation Development Using a Content Uniformity Model and Quality-By-Design Principles
Tablet active film coating is becoming a common approach to overcome some formulation stability and/or manufacturing process challenges for fixed dose combinations of oral solid dosage forms in pharmaceutical industry. If a drug molecule is prone to acid or alkali based degradation, one of the commercially viable formulation approaches is to enhance the chemical stability of a drug molecule by incorporating the active pharmaceutical ingredient in the coating layer of the film coated tablets. The aqueous active film-coating has been shown to be an effective strategy to minimize chemical interactions between different drug molecules by physically separating one active compound from other core tablet components during the development of a fixed dose combination for tablets. There are three common challenges associated with an aqueous active film-coating process. They are: (1) to accurately determine the active coating end-point to consistently achieve the target potency; (2) to achieve satisfactory and consistent tablet content uniformity; and (3) to maximize the amount of active deposited during the coating process. The mechanistic understanding through engineering modeling and thorough control of the coating operation not only address all these issues satisfactorily, but also provide tools to a model-based scale-up to commercial production scale.