Pressurized metered dose inhalers (pMDIs) are a class of combination drug products dependent on the optimization of a formulation, device design and human usage to deliver an accurate, reproducible dose. In the case of pMDI suspension products, the shaking and shake-to-fire profiles are crucial for accurate dose delivery. Incorrect shaking can cause a dose to be over- or under-delivered. For example, when the active pharmaceutical (API) is denser it settles causing the drug product to fall to the bottom of the inhaler cannister. The result is over delivery at the start of product life and low delivery at end. When the API is less dense it floats to the top. The result here is under delivery at start of product life and over delivery at end.
Key to achieving high quality data is consistency in shaking and firing of the inhaler. The industry standard solution for addressing shaking and actuation in testing are Vereo® Automated Actuators. As standalone systems they provide consistent actuation that replicate human usage for a range of in vitro tests. They control the shaking and actuation function in critical laboratory equipment such as SprayVIEW® Measurement System for spray characterization, and Kinaero Cx™ Collection System for dose sample collection.
Today’s webinar will focus on techniques to increase reproducibility in delivered dose uniformity (DDU) and aerodynamic particle size distribution (APSD). These tests are critical quality attributes (CQAs) for pMDIs making them a primary focus for in vitro characterization. We will explain how the Kinaero Cx Collection System leverages Vereo actuator technology to automate shaking, priming, sample collection, and fire-down enabling consistent dose delivery for analysis. We will review drug content uniformity data from several pMDI products, highlighting the performance that can be achieved by holding the testing variables consistent.
Register today! Attend to learn about tools and techniques for improving consistency of quality control testing for pMDIs.
Learning Objectives:
- Apply processes to increase reproducibility in DDU and APSD
- Improve accuracy of results with consistent shaking and actuations
- Creating more robust submission packages
- Shorten time to market for inhaler products
