Quality by Design Driven Development of Topical Gel Encompassing Papain and Bromelain to Elicit Wound Healing

Abstract

Abstract: Background: Topical gels are an efficient and targeted therapy for local dermatological problems because they distribute medications effectively and are easy to wipe off the skin. The presented study was aimed to use Quality by Design (QbD) features to develop, optimise, and evaluate a topical gel containing certain plant enzymes for wound healing activity. Objectives: The objective of this study was to use contour plots and multiple linear regression analysis to determine the relative relevance of selected independent variables on dependent variables, as well as to identify the desired zone where the product with required qualities produced. Materials and Methods: Quality Attributes (CQAs) were assigned to the patient-centric Quality Target Product Profile (QTPP). The quantities of chitosan and sodium carboxymethyl cellulose have been selected as Critical Material Attributes (CMA) based on early observations and were employing a 32-full factorial design. CQAS were chosen as viscosity, spreadability, extrudability, and bioadhesive strength, and using multiple linear regression analysis (MLRA) a quantitative association among CQAs and CMAs was observed. Results: The full factorial design aids in predicting the optimal chitosan and sodium carboxy methyl cellulose combination. The numerical response analysis aids in comprehending the impact of various factors on various replies. TGF-O showed higher wound healing activity than control and standard formulations in an excision and incision wound healing model. Conclusion: The current work successfully underlines the possibility of using a quality by design approach to synthesise and create topical gel formulations for plant enzymes in a simple and cost-effective manner. Keywords: Quality by design, Plant enzyme, Factorial design, Wound, Topical gel, Spreadability.