Rapid, Science-Driven Success in Early Phase Pharmaceutical Development

THE CHALLENGE: Develop at least one dosage form that avoids first-pass metabolism in the gut and all analytical methods using a limited quantity API. THE STRATEGY: This program began with typical quality by design elements including excipient compatibility studies and API characterization allowing formulations development personnel to select the right excipients for initial prototype development. In fact, one excipient caused an API stability problem. Since the excipient compatibility study design was binary, the stability issue was easily isolated to a single excipient and eliminated from future formulation inclusion.