Development and Assessment of Loratadine Fast-Disintegrating Tablets via β-Cyclodextrin Complexation with Superdisintegrants

Samiksha S. Amrutkar^*, Shivam K. Navale, Deepak S. Bhambere, Pooja Birari , Shweta Shevatkar , Sapana P. Ahirrao , Sanjay J. Kshirsagar , Sameer Vijay Darade

Department of Pharmaceutics, METs Institute of Pharmacy, Nashik Maharashtra, India

Corresponding Author E-mail: amrutkarsamiksha@gmail.com

DOI : http://dx.doi.org/10.13005/bbra/3298

ABSTRACT: This study aimed to enhance the solubility and consequent bioavailability of Loratadine, a widely used medication for seasonal allergic rhinitis and chronic idiopathic urticaria. The approach involved complexation with β-cyclodextrin to improve solubility and the formulation of fast-disintegrating tablets via the sublimation method. Crosspovidone acted as a superdisintegrant, while camphor served as a sublimating agent. Methodology: Pre-compression parameters were assessed to ensure adequate flow properties, while post-compression parameters were evaluated against IP acceptable limits for variations in hardness, weight, wetting time, friability, drug release, and disintegration time, drug content, FTIR, and DSC. Dissolution studies were conducted in 0.1N HCL, and statistical analysis employed a central composite design for optimization. Results: Formulation B14 emerged as the optimized batch, demonstrating favourable characteristics including wetting time, in vitro drug release, drug content, and disintegration time. Analysis of stability conducted in accordance with ICH guidelines affirmed the formulations' stability. Conclusion: The developed fast-disintegrating tablet formulation of Loratadine exhibited enhanced solubility, potentially translating to improved bioavailability. These advancements suggest increase efficacy and improved patient compliance in the management of allergic rhinitis and urticaria.

KEYWORDS: Central Composite Design; Disintegration time; Dissolution; Fast disintegrating tablet; Loratadine

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