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Formulation and evaluation of mucoadhesive vaginal tablets of tenofovir disoproxil fumarate | Abstract
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Abstract

Formulation and evaluation of mucoadhesive vaginal tablets of tenofovir disoproxil fumarate

Author(s): Arshad B. Khan and Ram S. Thakur

Mucoadhesive vaginal tablets of tenofovir disoproxil fumarate (TDF) have been formulated using hydroxypropyl methylcellulose (HPMC K100) as the matrix forming retarding agent with various mucoadhesive polymers such as carbopol 934, 940, chitosan and sodium carboxymethylcellulose and evaluated. Wet granulation method was employed to make the tablets. Drug-excipient compatibility, precompression parameters such as percentage yield, bulk density and tapped density of the granules, Carr’s index, Hausner’s ratio, angle of repose, post compression parameters such as colour, shape, physical dimensions, weight variation, hardness, friability, swelling index, assay, in vitro dissolution study and ex vivo mucoadhesion studies were performed. Based on the evaluation studies, B1 was selected as the best formulation and evaluated further for release kinetics and curve fitting analysis. B1 followed zero- order kinetics. Accelerated stability study was conducted as per ICH guidelines by keeping B1 at 40 oC ± 2 oC and 75 % RH ± 5% RH. After accelerated stability study, based on the evaluation tests, it was found that B1 remained stable for a period of six months.