Functionality assessment of systematically developed site-specific intelligent biodegradable long-acting formulation (SIBLAF)

Abstract

Abstract Background Patient convenience is the primary focus of the pharmaceutical industry. Current research was conducted to develop a site-specific, intelligent, biodegradable, and long-acting formulation (SIBLAF) for treating periodontitis, taking into account industry viability and patient convenience. Amoxicillin (AMX) and Metronidazole (MTZ) were used to treat periodontitis. The minimum inhibitory concentration (MIC) of AMX-MTZ was chosen as the suitable dose for this study. The SIBLAF was designed to incorporate polylactic co-glycolic acid 50:50 (PLGA). Critical quality attributes, material attributes, and process parameters were systematically identified, and a statistical design was applied to determine the correlation between the chosen attributes. SIBLAF was characterized for its varied parameters, and stability with the MIC of the optimized formulation was assessed. Results N-methyl 2 pyrrolidone (NMP) was chosen as the solvent. MTZ: AMX (1:1) effectively killed gram-positive and gram-negative microorganisms. The application of a factorial design demonstrated that the amount of PLGA and pH played a crucial role in the functionality of SIBLAF. An acidic pH was found to increase the degradation rate, thereby causing a quicker release of the drug from the SIBLAF. The optimum SIBLAF consists of 42% PLGA with a pH of 6.2. Conclusion The designed SIBLAF is promising due to its long-lasting effect, controlled release, better stability, biodegradability, and immediate implant-forming properties. It was designed with consideration for recent regulatory guidelines, industrial feasibility, and patient suitability.

Keywords

• Intelligent system
• Long-acting formulation
• Biodegradable
• PLGA
• Statistical tools