Manufacturing & Analytical Characterization – Chemical
Adrian Goodey, PhD
Senior Principal Scientist
Merck
Sue Holmes, MS
CMC Consultant
GSK
Wake Forest, North Carolina
Parind Desai, PhD
Team Leader, GSK Fellow
GlaxoSmithKline
Collegeville, Pennsylvania
Inhaled drug products are combination products which consist of a device and a formulation. Specialized In-vitro characterization techniques needs to be employed to understand the clinical performance of the formulation in terms of its aerodynamic performance. The device also needs to be carefully considered and there are a number of inhaler devices in the market. This session will focus on the challenges faced in relation to changing a component of a complex drug product, such as an MDI to improve environmental sustainability and also address the fundamental limitations of the APSD metrics currently required by major health authorities.
Panelist 1 Adrian Goodey will discuss The in vitro performance of an orally inhaled product is best described by its aerodynamic particle size distribution (APSD). Accordingly, APSD metrics are regarded as critical quality attributes and feature prominently in quality control strategies. However, despite the considerable investment in APSD characterization, and the key role it plays in quality control, the metrics most commonly used to control APSDs are woefully poor at making batch-disposition decisions based on product performance. This presentation summarizes recent work by the IPAC-RS Cascade Impaction Working Group in which APSDs from real world inhalers are used to demonstrate the fundamental limitations of the APSD metrics currently required by major health authorities.
Panelist 2 Sue Holmes will discuss challenges with Metered Dose Inhalers (MDIs) that contain a propellant (HFA-134a or HFA-225, fluorinated gases or F-gas), to deliver medicine into a patient’s lungs. These F-gases have a high global warming potential (GWP) and so contribute to greenhouse gas emissions and climate change. To address the use of F-gases, the 2016 Kigali Amendment to the international Montreal Protocol committed countries to gradually reduce their production and consumption. Aligned to this, a number of countries and regions have been phasing down the use of F-gases, but medical exemptions have been in place for inhalers to date. Some countries are now looking to remove this exemption. This presentation will provide additional background on this phase down/out of F-gases, and the regulatory challenges associated with replacing the propellant in the currently approved MDIs.