Abstract

DESIGN AND DEVELOPMENT OF CHITOSAN COATED ALPHA LIPOIC ACID GRANULES

Manoj A. Sharon*, Parthasarathi K. Kulkarni, Tanuja A. J., Venkatesh K., Hanumanthachar Joshi

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Abstract

The present study focused on the development and evaluation of chitosan-coated Alpha Lipoic Acid (ALA) formulations for gastric resistance and sustained release. Preformulation studies confirmed the physicochemical properties of ALA, consistent with pharmacopoeial standards, while FTIR and DSC compatibility assessments showed no significant drug– excipient interactions, supporting chitosan as the coating polymer. Micromeritic evaluation indicated good flow and compressibility. Coating efficiency increased with polymer concentration, with F-II achieving 10.7% and F-III/F-IV showing higher percentages, enhancing acid resistance and delaying release. Drug content and assay values remained within 98.5–99.0% of the label claim. In vitro dissolution revealed that higher polymer levels reduced release in acidic medium and promoted sustained release in phosphate buffer; FIV showed good gastric resistance with most prolonged profile, and kinetic analysis with zero-order release (R² = 0.9585) and Korsmeyer–Peppas model fitting (R² = 0.9844), indicating non-Fickian diffusion. Overall, chitosan coating protected ALA from gastric degradation and modulated its release, indicating that further optimization of polymer concentration and coating thickness could achieve complete gastro-resistance and improve clinical applicability.

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