9/9/2013 The Delivery of Drugs, Skin Sensory Benefits and Increased Mildness through Topical Pharmaceutical Excipient Selection - Romanski Ph.d and Richardson MS
Abstract: The formulation of topical pharmaceutical products for dermatology is an inherently complex process where in many cases the excipient selection can be as important as the active drug in order to reach the desired drug delivery profile, formulation mildness, and even the sensory perception of the end product. BASF, a company with a strong global pharmaceutical presence, has recently built an extensive topical pharmaceutical excipients portfolio offering a wide variety of compendial-grade emollients, emulsifiers, and consistency factors to find solutions to ubiquitous pharmaceutical industry problems. In this presentation, highlights from a series of ongoing laboratory activities at our Global Dermatology Laboratory in Tarrytown, NY will be presented, showcasing the depth and importance of excipients in the formulation design of topical pharmaceutical products. Specifically, a battery of membrane penetration studies used to determine the effect of emollients and emulsifiers on drug diffusion through the stratum corneum, as well as surface wetting and lateral drug transport will be presented. These results will be further corroborated by the use of commercially available software for the temporal modeling of drug penetration in multi-phase formulations. Furthermore, the irritation potential of several excipients will be discussed utilizing a series of trans-epithelial cell permeability assays, where epithelial cell monolayers are cultured onto a semi-permeable membrane to form tight cell-cell junctions and used to study the penetration rate of Na-fluorescein after cell monolayers are exposed to excipients in our portfolio and a known irritant (Sodium Lauryl Sulfate). Finally, a series of sensory perception studies are quantified using a collection of trained and untrained panel members for the evaluation of important sensory parameters such as greasiness, cushion, and overall skin comfort; each with a unique impact on patient compliance Watch Video