Preclinical Evaluation on Rabbit of Lakshadi Anjana Drops: Physico-Chemical, Histopathological, and Anti-Inflammatory Insights for Ocular Therapeutic Applications.

Abstract

Introduction: Lakshadi Anjana Drops, a traditional Ayurvedic ocular formulation, is designed to alleviate eye-related conditions. Composed of herbal ingredients with therapeutic properties, this study aimed to evaluate the formulation's quality, safety, and efficacy through physico-chemical, microbiological, and preclinical analysis.

Methods: Formulation was analyzed for physico-chemical parameters such as pH, refractive index, peroxide value, saponification value, and iodine value. Preclinical testing was conducted using New Zealand white rabbits, where the Draize test was used to evaluate ocular safety and carrageenan-induced ocular inflammation model was employed to assess anti-inflammatory efficacy. Histopathological analysis of ocular tissues was performed to assess potential tissue damage.

Results: pH of Lakshadi Anjana Drops was found to be 7.82, confirming its suitability for ocular use. Physico-chemical parameters, including refractive index (1.4542), peroxide value (2.18 meq/kg), saponification value (210), and iodine value (38.49), were within acceptable limits, ensuring stability. Preclinical results indicated minimal ocular irritation and significant anti-inflammatory activity, comparable to a marketed formulation. Histopathological analysis showed minimal epithelial thickening, with no significant tissue damage.

Conclusion: Lakshadi Anjana Drops exhibited strong physico-chemical stability, and biocompatibility, supporting its therapeutic potential for ocular applications. The combination of traditional Ayurvedic ingredients with modern scientific validation highlights its promise for clinical use in ocular therapeutics.