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

> **NIH FDA U01** · UNIVERSITY OF MISSISSIPPI · 2020 · $102,122

## Abstract

Project Summary/Abstract
The main objective of the project is to investigate the effect of compositional differences in topical products on
the physical, structural and functional properties. The other objective is to It develop additional, product specific
characterization tools and methodologies to explore the structural and thermodynamic changes that occur during
metamorphosis of topical products. As the risk of failure modes for BE is relatively higher in compositionally
different products, there is need to systematically investigate the potential failure modes and approaches to
mitigate them.We propose three specific aims in this project. In aim 1 we propose to investigate the influence of
systematic compositional alterations, on the microstructural characteristics, metamorphosis, and performance
attributes of topical products. To develop a theoretical framework to describe the fundamental factors that govern
topical dosage form performance. Different case studies will be formulated to consider various products with
different 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 sequence
of products will be prepared by systematic alteration in the product composition. Some of the ways (not limited
to) of changing the composition would include: a) changing the amount of one or more ingredients or b) by
replacing one or more of the ingredients with an ingredient that is of same chemical class/ pharmaceutical
category and c) by using an ingredient of different grades/quality/source. The thermodynamical characterization
would be of major emphasis in the proposed experiments. Finally, a theoretical framework to describe the
fundamental principles that govern the performance of topical products will be developed. In aim 2, we propose
to develop novel tools and methods to characterize the microstructural attributes of topical products. One of the
objectives is to modify the standard conventional methods and validate them for application across broad
categories of topical products. Novel methods will also be developed to understand the differences in
microstructure and thermodynamic characteristic between products of different compositions. In aim 3, To
identify the potential failure modes in nonQ1 and/or non-Q2 products and to investigate the approaches to
mitigate 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 to
develop a theoretical framework to describe the fundamental principles that govern the performance of topical
products.

## Key facts

- **NIH application ID:** 9990545
- **Project number:** 5U01FD006507-03
- **Recipient organization:** UNIVERSITY OF MISSISSIPPI
- **Principal Investigator:** Sathyanarayana N Murthy
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2020
- **Award amount:** $102,122
- **Award type:** 5
- **Project period:** 2018-09-01 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9990545

## Citation

> US National Institutes of Health, RePORTER application 9990545, Impact of Formulation Composition on the Structure and Performance Attributes of Topical Products (5U01FD006507-03). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/9990545. Licensed CC0.

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