Development and validation of thermoanalytical methods applicable to the quality control of excipients and thermoresponsive bioadhesive gels using the quality by design tool

• Grant number: 24/02864-7
• Support Opportunities: Regular Research Grants
• Start date: September 01, 2024
• End date: August 31, 2026
• Field of knowledge: Health Sciences - Pharmacy - Medicines Analysis and Control
• Principal Investigator: Leonardo Miziara Barboza Ferreira
• Grantee: Leonardo Miziara Barboza Ferreira
• Host Institution: Faculdade de Ciências Farmacêuticas (FCFAR). Universidade Estadual Paulista (UNESP). Campus de Araraquara. Araraquara , SP, Brazil
• Associated researchers: Lucas Amaral Machado ; Valéria de Carvalho Santos Ebinuma

Abstract

The market for innovative cosmetic and pharmaceutical products is growing and fundamentally dependent on the use of excipients with properties capable of conferring physical-chemical stability to the active ingredient and the finished product while also bringing benefits for cosmeceutical and/or therapeutic actions. In this aspect, materials such as poloxamers and amphiphilic meglumine salts are notably recognized for their thermoresponsiveness, a property frequently used for the development of bioadhesive formulations for topical application. Due to the innovative properties, stability control and biopharmacotechnical performance have not yet been consolidated. Therefore, the development of analytical methods for quality control of this product category and the main critical attributes of the resulting formulations is an essential activity for evaluations for in-process and finished product control routines. In this sense, the objective of this project is to develop and validate methods based on Thermal Analysis (TA) on thermoresponsive formulations as an alternative to meet this demand. Thermogravimetric and calorimetric methods are widely accepted within the Pharmaceutical Industry in pre-formulation and quality control sectors for evaluating thermodynamic parameters associated with phase transitions. However, when compared to other pharmaceutical analysis techniques such as chromatography and spectrophotometry, the processes for validating AT methods are not yet very well established and, therefore, they require research to consolidate knowledge in determining the main critical analytical attributes. To this end, the project proposes to use the Analytical Quality by Design (AQbD) tool for the development and validation of methods for quality control of thermoresponsive materials and formulations. When combined with Quality Risk Management (QRM), space is created for the establishment of a systemic and systematic strategy, which enables the precision and robustness necessary for regulatory bodies. The general design of the project is organized into 3 types of studies: 1 - Development of thermogravimetric methods, 2 - Development of differential scanning calorimetry methods and 3 - Development of thermoanalytical methods indicative of stability of the thermogelation process depending on the thermal history of the samples. (AU)