3rd Annual Conference 2017
3rd – 5th October 2017
Crowne Plaza Hotel – Blanchardstown, Dublin, Ireland

Teaching Old Drugs New Tricks: Applications of ASAP in OTC Product Development

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Teaching Old Drugs New Tricks: Applications of ASAP in OTC Product Development

Teaching Old Drugs New Tricks: Applications of ASAP in OTC Product Development

Jonathan Clark
Scientist, Procter & Gamble
Cincinnati, OH, USA

The Over the Counter (OTC) drug market is changing. USP OTC Drug Product monographs are evolving to contain better control of API degradation products. OTC products are complex formulations, often containing solvents, dyes, flavors, and sweeteners.

The OTC category is ~$40 billion and continues to grow annually. Deep understanding of these products and their stability is critical, as there are thousands of OTC drug products used by ~90% of American families.

To aid in our technical diligence, Procter & Gamble has implemented ASAPprime® as a tool for rapid evaluation of API vulnerability, packaging options, and overall formulation stability. ASAPprime® strategy and experimental execution for existing and new OTC products will be discussed.  Discussion of synergies between ASAPprime® and novel physical models for evaluation of in-process stability will also be presented.