Development and Optimization of Indian Propolis Formulation for Enhanced Immunomodulatory Potential

Propolis, a complex natural product that honey bees produce by mastication to protect and maintain their hive structures, comprises various bioactive constituents, including phenolic acids, flavonoids, diterpenes, sesquiterpenes, lignans, vitamins, minerals, etc. The objective of the current research was to extract crude propolis to enrich the total polyphenolic and flavonoid content, conduct preliminary phytochemical screening, and develop and evaluate dosage form to improve formulation characteristics and immunomodulatory potential. Total balsam, polyphenols, and flavonoids were found to be 46% w/w, 34.82 ± 0.078 mg equivalent of gallic acid/g, and 23.61 ± 0.045 mg equivalent of quercetin/g, respectively. DSC and FTIR studies demonstrated molecular dispersion of the propolis extract. Formulation was optimized with a 32 factorial design, and an optimized batch showed 92.20 ± 1.72% drug release in 1 h, an elevated hypersensitivity (DTH) response (p < 0.0001), increased phagocytic activity (p < 0.01), and a significantly (p < 0.001) higher total leukocyte count ((5.015 ± 0.19) × 103/mm3). The developed formulation showed significantly modulated immune modulatory potential compared with the propolis extract and conventional levamisole. This study can be further extended for clinical evaluations.