Orally inhaled drug performance testing for product development, registration, and quality control

Area of Science:

• Pharmaceutical Sciences
• Drug Delivery Systems
• Inhalation Technology

Background:

• Dry powder inhalers (DPIs) comprise device, formulation, and process modules developed in parallel.
• Product development involves evolving prototypes, while performance requirements are based on the final commercial product.
• Predicting final product performance during development presents significant challenges due to the dynamic nature of prototypes.

Purpose of the Study:

• To describe methods for managing the development of inhalation products.
• To provide approaches for predicting the in vitro and in vivo performance of final DPI products during the development phase.

Main Methods:

• The study focuses on managing parallel development of device, formulation, and process modules for DPIs.
• It outlines strategies for performance prediction using evolving prototypes throughout the development lifecycle.
• Methods address the challenges of testing incomplete products to forecast final performance.

Main Results:

• The proposed methods enable relevant predictions of in vitro and in vivo performance during product development.
• These approaches help mitigate confusion and misleading results from testing changing prototypes.
• Successful management of development allows for accurate forecasting of the final inhalation product's performance.

Conclusions:

• Effective management of DPI development requires specific strategies for performance prediction.
• The described methods facilitate reliable forecasting of in vitro and in vivo performance from early development stages.
• Accurate performance prediction is crucial for successful delivery of inhalation products meeting final requirements.