Developing a modified release formulation of an existing immediate release oral solid dosage form is a common request. Often, modified release formulations offer patient compliance, marketing, and exclusivity/patent benefits over their immediate release predecessors. However, modified release dosage forms can also present their own unique set of complications, nuances, and regulatory expectations. By sharing examples and perspectives from decades of industry experience, this presentation will provide insight into strategic decisions, key data to acquire during API characterization and preformulation, and health authority expectations for modified release formulations compared to existing immediate release dosage forms.
Identify key strategic decisions during development of oral solid dosage forms
Understand the benefits of appropriate API characterization and preformulation work in oral solid dosage form development, particularly for modified release dosage forms
Recognize the key CMC development data that health authorities expect to properly evaluate regulatory submissions