Development and Characterization of Solid Dispersions of Azithromycin Using Poloxamer 407 and Syloid 244FP®

Abstract

Purpose

Azithromycin, a macrolide antibiotic, exhibits dissolution-limited oral absorption due to its poor solubility, and that affects its therapeutic performance. The present study aimed to develop and optimize azithromycin solid dispersions using Poloxamer 407 as a hydrophilic polymer and Syloid^® 244FP as a novel mesoporous silica carrier to enhance solubility and dissolution.

Methodology

Solvent evaporation method in integration with design of experiments was used to prepare solid dispersion of azithromycin, evaluated for percentage drug loading and cumulative drug release at 30 min and solid-state characterization.

Results

The optimized formulation (Fopt) exhibited 93.5 ± 0.5% drug content, 23.9% drug loading, and rapid drug release of 89.9 ± 0.95% within 30 min, significantly higher than the pure drug. Solubility studies revealed a 2.59-fold enhancement in aqueous solubility. Solid-state characterization using FTIR, PXRD, and SEM confirmed drug–excipient compatibility, reduced crystallinity, and uniform drug entrapment within the mesoporous carrier. Precompression and Kawakita analysis demonstrated acceptable flow and compressibility characteristics. Antimicrobial evaluation against Streptococcus mutans showed that the optimized formulation exhibited dose-dependent antibacterial activity, closely comparable to standard streptomycin. Short term stability studies for 3 months further confirmed the integrity of the optimized formulation.

Conclusion

Hence it can be concluded that the combination of Poloxamer 407 and Syloid^® 244FP has been proved effective in improving the solubility, dissolution, and antibacterial performance of azithromycin, and has established the potential of mesoporous carrier-based solid dispersions for enhancing the oral delivery of azithromycin.

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Bhattacharyya, S., S, L. & KR, V. Development and Characterization of Solid Dispersions of Azithromycin Using Poloxamer 407 and Syloid 244FP^®. J Pharm Innov 22, 59 (2027). https://doi.org/10.1007/s12247-026-10929-9

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