Topical Products and their Critical Quality Attributes ABSTRACT The microstructure in topical products is highly influenced by the manufacturing process variables. The microstructural differences between products with or without same composition could be investigated by evaluating certain critical quality attributes of the product. The critical quality attributes also influence the product performance in vivo. Therefore, there is need for a systematic investigation to understand the potential failure modes, the reasons, the quality attributes that are critical in determining the product performance and manufacturing process variables. From the regulatory perspective, Q3 difference could possibly exist between the products even when the products are Q1 and Q2 equivalent. We propose two specific aims in this project to address the above discussed areas.
In aim 1 we propose to classify the topical formulations based on their nature and composition. To identify the potential failure modes for each class and to identify the quality attributes that are critical in determining the product performance in vivo. To identify the most appropriate methods for measuring the physical and chemical properties of the topical product is also one of the goals.
In aim2 we propose to investigate the effect of process variables on the critical quality attributes (CQAs) and the performance attributes of the product. We also propose to establish design space for each class of the products using QbD approach.

Public Health Relevance

PRODUCT NARRATIVE The objective of the project is to determine the quality attributes that define the structure of a topical semisolid product. It is important to investigate the method of characterizing topical products to provide better quality medicine to the public.

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01FD005233-04
Application #
9340994
Study Section
Special Emphasis Panel (ZFD1)
Program Officer
Ghosh, Priyanka
Project Start
2014-09-10
Project End
2019-08-31
Budget Start
2017-09-01
Budget End
2018-08-31
Support Year
4
Fiscal Year
2017
Total Cost
Indirect Cost
Name
University of Mississippi
Department
Type
DUNS #
067713560
City
University
State
MS
Country
United States
Zip Code
38677