Tick Tock, Watch the Clock!
It is well recognised that a reduction in the development cycle leading to a faster time to market of a drug product reaps both commercial and patient wellbeing benefits. This task becomes even more challenging for a complex combination product such as a pressurised metered dose inhaler (pMDI); in which multi-functional expertise is required in terms of device, drug formulation and manufacturing process development together with appropriate analytical techniques and regulatory affairs management.
Why are pMDI products challenging?
Essentially, because they require a holistic approach which take into consideration the primary packaging components, challenges in formulation and process development all in harmony right at the outset. However, the traditional approach has been to take a series of steps in isolation whereby a formulation is “fixed” first and then attempts are made to “shoe horn” the device elements to the fixed formulation. Of course, the development of an aerosol formulation itself is highly complex and needs to take into consideration various factors. When the products contain more than one API – triple therapies are the current trend in asthma/COPD medications – the complexity increases significantly. Remember that most pMDI products have a shelf life of at least 2 years so up to 200 consistent (i.e. accurate and repeatable) doses have to be delivered over this time in a variety of environmental conditions.