Impact of Formulation Composition on the Structure and Performance Attributes of Topical Products

Project Summary/AbstractThe main objective of the project is to investigate the effect of compositional differences in topical products onthe physical, structural and functional properties. The other objective is to It develop additional, product specificcharacterization tools and methodologies to explore the structural and thermodynamic changes that occur duringmetamorphosis of topical products. As the risk of failure modes for BE is relatively higher in compositionallydifferent products, there is need to systematically investigate the potential failure modes and approaches tomitigate them.We propose three specific aims in this project. In aim 1 we propose to investigate the influence ofsystematic compositional alterations, on the microstructural characteristics, metamorphosis, and performanceattributes of topical products. To develop a theoretical framework to describe the fundamental factors that governtopical dosage form performance. Different case studies will be formulated to consider various products withdifferent levels of complexities. Different product types, such as solutions, colloidal products, gels, suspensions,creams, microemulsions, foams, and nanotechnology products, will be considered. In each case, a sequenceof products will be prepared by systematic alteration in the product composition. Some of the ways (not limitedto) of changing the composition would include: a) changing the amount of one or more ingredients or b) byreplacing one or more of the ingredients with an ingredient that is of same chemical class/ pharmaceuticalcategory and c) by using an ingredient of different grades/quality/source. The thermodynamical characterizationwould be of major emphasis in the proposed experiments. Finally, a theoretical framework to describe thefundamental principles that govern the performance of topical products will be developed. In aim 2, we proposeto develop novel tools and methods to characterize the microstructural attributes of topical products. One of theobjectives is to modify the standard conventional methods and validate them for application across broadcategories of topical products. Novel methods will also be developed to understand the differences inmicrostructure and thermodynamic characteristic between products of different compositions. In aim 3, Toidentify the potential failure modes in nonQ1 and/or non-Q2 products and to investigate the approaches tomitigate the risk. Potential failure modes would be assessed in individual case studies, proposed in this project,and potential approaches to mitigate the risk would be explored as well.The successful completion of the proposed studies, is believed to generate information that would be used todevelop a theoretical framework to describe the fundamental principles that govern the performance of topicalproducts.