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Title: Taking your active from the lab to scale-up formulation development of a topical delivery system

Robert Houlden

Formulytica Pty. Ltd., Australia

Biography

Robert is Formulation Director at Formulytica, a leading contract R&D company in Melbourne serving Australia, USA and South East Asia. Previously with GlaxoSmithKline and Stiefel Laboratories he has been in the formulation area for over 30 years and is experienced in development of pharmaceutical emulsions, gels and aerosols for drug delivery. One of Robert’s main passions is rheology and he has spent 10 years using this technique to characterize emulsions to predict their attributes when applied to the skin and develop more cosmetic elegant emulsions for his customers. Robert has 8 patents principally in the area of dermatology and is the author of multiple papers.

Abstract

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.