Formulation Development Options for Speed to Phase I Studies

Formulation Development Options for Speed to Phase I Studies

Driven by pipeline productivity objectives and financial constraints, pharmaceutical companies of all sizes are under pressure to reach critical milestones faster in spite of challenging molecular properties associated with their candidate, and with limited active pharmaceutical ingredient (API).

The ability to work smarter has become a critical survival skill in order to move drug development candidates forward faster and to maximize the chance for success.

Though not all are relevant for commercial scale, there are a host of formulation development options to consider that enable speed to first-in-human studies while conserving API and other resources. API in bottle, powder in bottle, API into capsule, and traditional formulations are all approaches worthy of consideration as possible formulation options for clinical supplies for a Phase I clinical trial.

This webinar will address considerations for prototype formulation development, formulation options for phase I studies, a prototype formulation approach, strategies to overcome poorly soluble compounds, liquid in capsule, and controlled release formulations.

Speaker

Paul F. Skultety, PhD, Director, Pharmaceutical Development Services, Xcelience, LLC

Paul Skultety has a unique background in Pharmaceutical development combining extensive experience with contract development and pharmaceutical companies. At Xcelience, his role is to provide leadership to Pharmaceutical Development Services. This includes analytical chemistry and formulation development.

Prior to Xcelience, he has held such positions as Vice President of Pharmaceutics at Quintiles, Director of Solids Formulation Development for Hoechst Marion Roussel and various management positions within Marion Merrell Dow and Marion Labs which were predecessors to HMR.

Dr Skultety has a successful track record of developing new chemical entities from pre-IND to commercialization. He has 9 US formulation and composition patents. He has written a number of publications and made numerous scientific presentations. He has been a member of AAPS since its inception.

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