Particle To Patient: Overcoming Challenges In Generic Metered Dose Inhaler Development
Summary: Through expert content and case study examples this webinar highlighted strategies and capabilities required to reliably develop a generic Metered Dose Inhalers (pMDI). Experts in inhalation development provided an overview of the generic development process with emphasis on pulmonary and nasal products. The speakers reviewed the key aspects of product performance which must be met when developing a generic pMDI.
The focus is on the particular challenges encountered early in the development with respect to API selection and controls including review of considerations for the development of a well-controlled micronization process and the subsequent API characterization. Additionally the challenges of designing a suitable in-vitro characterization study are highlighted.