Development of analytical methods applicable to the quality control of thermoresponsive semi-solids based on poloxamer and mucoadhesive polymers.

• Grant number: 25/11956-5
• Support Opportunities: Scholarships in Brazil - Master
• Start date: January 01, 2026
• Status: Discontinued
• Field of knowledge: Health Sciences - Pharmacy
• Principal Investigator: Lucas Amaral Machado
• Grantee: Maria Eduarda Ramalho
• Host Institution: Faculdade de Ciências Farmacêuticas (FCFAR). Universidade Estadual Paulista (UNESP). Campus de Araraquara. Araraquara , SP, Brazil
• Associated research grant: 24/02864-7 - Development and validation of thermoanalytical methods applicable to the quality control of excipients and thermoresponsive bioadhesive gels using the quality by design tool, AP.R
• Associated scholarship(s): 26/15619-6 - Rheological and Sprayability Assessment for the Functional Interpretation of Nano DSC Thermal Transitions in Thermoresponsive Poloxamer-Based Hydrogels, BE.EP.MS

Abstract

Thermoresponsive polymers have been widely studied due to their biocompatibility and applicability in several biomedical areas. Poloxamer, a triblock copolymer, is one of the most explored due to its self-assembly capacity and temperature-dependent sol-gel transition, allowing the controlled local release of drugs. However, it does not present good mucoadhesiveness, so it is necessary to combine mucoadhesive polymers in its formulation. Currently, there is a lack of thermoanalytical methods applicable to the quality control of these materials at the nano and molecular level, reinforcing the need to develop specific techniques for their characterization, since the phase transition of the polymer is based on hydrophobic interactions that occur at the nanomolecular level. The hydrogels will be prepared from the combination of poloxamers P407 and P188, with subsequent addition of chitosan. The characterization will include tests of rheology, clarity, pH, sol-gel transition temperature, mucoadhesiveness and gelation capacity. Thermogravimetric analysis (TGA) will be developed to evaluate the thermal stability and water content of the hydrogel at temperature variation, crucial parameters for the functionality of the gels. The Nano DSC method will be developed to evaluate the micellization temperature and sol-gel transition of the hydrogel at the nanomolecular level, comparing it with the inverted tube method, which evaluates this transition at the macroscopic level. The differential scanning calorimetric (DSC) method will be developed to evaluate the SOL-GEL transition temperature of the formulation and will be used for comparison with the results obtained in the nanocalorimetric method. The data will be analyzed with appropriate mathematical models to estimate the variability of the results, focusing on the accuracy and robustness of the developed methods. Analytical tools, such as FMEA and risk matrix, will be used in all development processes in order to ensure an effective application of analytical quality by design. (AU)