(759f) Design Space Approach to Continuous Manufacturing of Drug Loaded Terapeutic Films

Edible polymeric films are promising technology for the systemic delivery of active pharmaceutical ingredients (API).  These films are designed as composite materials with the precise systemic dosing in safe and effective format. Development of effective delivery system for API requires a control of the structure and morphology of polymer films at the interface with API. Manufacturing of thin films is a multi-step process that controls the thickness, drug concentration, residual volatiles,
mechanical strength, and disintegration rate of therapeutic films. We present a comprehensive analysis of the factors that impacts manufacturability and performance of the oral films, such as predictive understanding of maintaining particle stability and content uniformity in multi-component film precursors at various process conditions, based on the molecular and interfacial interactions between slurry components and understanding of what properties of the individual material and their combinations are critical to film formation performance for a given process (material properties and process suitability/selection).

All maor components of the formulation, processing conditions including colloidal cstability of BSC class II drug particles are discussed. We sucsessfully demonstrate optimozation of the mixing, drying, and particle astbilization methods to optimioza film performance.