DESIGN, DEVELOPMENT, OPTIMIZATION AND CHARACTERIZATION OF LINEZOLID MICRONEEDLE PATCH USING DESIGN EXPERT SOFTWARE FOR ACCELERATED WOUND HEALING PROCESS

Microneedles represent a promising advancement in wound healing treatment, combining precision drug delivery with minimally invasive techniques to enhance therapeutic outcomes. The study on the development of microneedle patches for the transdermal delivery of Linezolid aimed at improving localized drug therapy, especially for wound healing. The study's objective was to create and evaluate dissolving microneedle patches for the treatment of wound healing that are composed of polymers and Linezolid. Microneedle patches were developed by Solvent Casting and Micro molding technique. Linezolid was used as active constituent, and polymers like Hydroxyethyl Cellulose, Polyvinyl Alcohol and glycerol were used for the development of microneedle patches. Four formulations were created by altering the concentration of various polymers while maintaining a constant drug ratio. The optimization was performed by Design Expert software (DoE) using 22 full factorial design by taking 2 independent variable as factors and 2 dependent variables in-vitro Drug release(Y1) and Drug content(Y2). FTIR, as well as other metrics like drug content, moisture loss %, folding endurance, SEM analysis, in-vitro drug release, in-vitro release kinetics, and stability tests, were used to examine the produced Microneedle patches for the interaction study. Franz diffusion cell was used to conduct ex-vivo investigations on the optimal formulation F3, which was chosen based on the in-vitro release research and drug content. After eight hours, the created Microneedle patch displayed 97.51% drug release. FTIR, as well as other metrics like drug content, moisture loss %, folding endurance, SEM analysis, in-vitro drug release, in-vitro release kinetics, and stability tests, were used to examine the produced Microneedle patches for the interaction study. The optimized formulation F3 was chosen based on the in-vitro release research and drug content, and it was used in ex-vivo experiments. The patches exhibited anomalous transport mechanisms as suggested by the ‘R2’ values from various mathematical models, indicating diffusion-based drug release. Stability testing of formulation F3 was carried under accelerated conditions, demonstrated no appreciable alterations in the drug concentration, organoleptic characteristics, or physical texture in accordance with ICH criteria, indicating the stability of the manufactured microneedle patch. Thus, it was determined that the research could have a transdermal use. when compared to the conventional therapy for the treatment of accelerated wound healing.