Title : Taking your active from the lab to scale-up formulation development of a topical delivery systems
The presentation will discuss (with practical examples) the steps required to take a pharmaceutical active from the research lab to developing a topical oil-in-water vehicle or gel for drug delivery. Preformulation steps such as methods to increase solubility and skin penetration will be examined. Stability and in-vitro performance testing methods are discussed including suitable animal models which can predict efficacy prior to incurring the high clinical costs in late stage development. The issue of identifying critical process parameters prior to scale-up to batch sizes for toxicity testing will be introduced.
Audience take away:
• The presentation gives practical examples of Topical delivery of an NCE obtained from over 20 years of formulating experience with pharmaceutical actives. While the examples will be for a new drug entity, the techniques are applicable to new topical formulations of existing actives.
• Insights on how to solubilize a new molecule or salt will be presented offering insights into how to overcome common low solublility issues.
• Common pitfalls and methods for performance testing against a reference listed drug will be discussed
• Critical Process Parameters that should be explored during development prior to scale-up will be detailed.