In-Vitro Characterization of Novel Liposomal Alpha Lipoic Acid Formulation by WBCIL for Enhanced Bioavailability
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Abstract
The clinical use of Alpha Lipoic Acid (ALA), a potent antioxidant, is limited by its poor oral bioavailability due to low water solubility and rapid degradation. To address these issues, West Bengal Chemical Industries Ltd., Kolkata, India (WBCIL) developed a novel Liposomal ALA formulation using a spray-drying process. This study evaluates the physical and chemical properties of this formulation at different production scales, from a small R&D batch to larger commercial batches. The study focused on assessing morphological changes, elemental composition, and in-vitro release profiles. The results showed that the liposomal formulation significantly improved ALA release in simulated salivary fluid, with the large-scale spray-dried batches releasing 55% to 57% of ALA in one minute, compared to only 9% for normal ALA. The large-scale batches also demonstrated superior and consistent sustained release over two hours (42%) and complete release over four hours (86-89%) in dialysis studies, proving the formulation's controlled and efficient delivery. Furthermore, the liposomal batches, particularly the large-scale ones, showed enhanced oxidative stability, recovering 67% of ALA after two hours, compared to 25% for normal ALA. EDAX elemental analysis confirmed a consistent composition and more efficient encapsulation in the large batches, while SEM imaging revealed a successful morphological transformation from the crystalline raw material to a uniform, spherical liposomal product. This study also demonstrates that liposomal ALA exhibits superior antioxidant activity, improved systemic exposure, and enhanced tissue delivery over non-liposomal ALA, highlighting its potential as a more effective nutraceutical formulation. These findings validate the potential of the Liposomal ALA formulation by WBCIL as a reliable and high-performing nutraceutical with consistent quality across various manufacturing scales.
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