Published May 25, 2023 | Version v1
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FORMULATION DEVELOPMENT AND EVALUATION OF ORODISPERSIBLE TABLETS OF FEXOFENADINE BY USING COMBINATIONS OF SUPERDISINTEGRANTS

Description

Fexofenadine is prescribed for the treatment of allergy symptoms in males. The liver plays a crucial role in fexofenadine's metabolism. Orodispersible tablets, which are not metabolised in the stomach, were a good choice of dosage form to counteract these limitations. With the goal of achieving rapid disintegration when held beneath the tongue and facilitating direct absorption of the active ingredient by the oral mucosa, the present study sought to design and develop a Fexofenadine Orodispersible Tablet using Croscarmellose Sodium, Cross povidone, and Sodium starch Glycolate as superdisintegrants. Fexofenadine Orodispersible granules were prepared using a wet granulation process, and evaluation findings indicated that all precompression parameters fulfilled the acceptance criteria, indicating that the granules had outstanding flow qualities. A variety of post-compression characterizations of tablets were performed and the results met the requirements of the pharmacopoeia. Different formulations were tested for in vitro release using a USP II paddle type dissolution equipment. Both a first order kinetic model and a zero-order kinetic model were tested in vitro for release kinetics. Compatibility between the medication and excipients was confirmed by FTIR analysis. following conducting DSC investigations to determine the drug and excipient thermal stabilities, it was determined that both were thermally stable following the aforementioned formulations. The optimized formulation was confirmed to be stable over an adequate time period in accelerated stability testing.

Key Words: Orodispersible, Fexofenadine, Croscarmellose Sodium, crosspovidone, Sodium starch glycolate

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