The Evolution of an NCE’s Suspension Formulation, from pre-GLP Studies to the Pharmacy Shelf
This presentation focuses on the development of suspension formulations of an NCE for oral administration.
Starting with the simple formulations used in safety studies, moving through the multi-dose product used for clinical programs and onto the advanced, long shelf-life product that is commercialized. Both formulation and analytical aspects will be covered.
Suspensions for other routes of administration, e.g., IM or SC injections and eye drops, are outside of the remit of this presentation.
Key Learning Objectives:
- The formulation complexity increases during development of a compound
- Analytical testing requirements also increase during development
- Multiple aspects of API characterization need to be considered
Who Should Attend:
- Formulation Scientist
- Chief Scientific Officer
- VP Research and Development
David Barnes, Ph.D., Vice President of Scientific Affairs
Dave has a degree in pharmacy and a Ph.D. from The School of Pharmacy, U. of London (“The Square”).
He has over thirty years of pharmaceutical product development experience, first with Pfizer in the UK, later with Pfizer in the USA and for the past 14 years as co-founder and Chief Scientist at Velesco Pharma Services.
Velesco’s focus on liquid and semi-solid products has provided much experience with and insights into the development of suspension formulations and the changes that occur as the compound progresses towards the marketplace.
In 2021 Velesco became a part of the Pace® Life Sciences laboratory network. Dave is now Vice President of Scientific Affairs at Pace® Life Sciences in Wixom, MI.