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Yasser AL-Domini* and Manal AL-Yosofy


The aim of this study was to develop and evaluate a new formulation for an immediate release Tadalafil 20 mg tablets to enhance dissolution rate according to USP37 NLT 40% (Q) of the labeled amount of Tadalafil is dissolved in 10 minutes and NLT 80% (Q) of the labeled amount of Tadalafil is dissolved in 30 minutes. Tadalafil a PDE-5 inhibitor, belongs to BCS II. It is poorly soluble in water and hence requires enhancement in dissolution rate for increasing its oral bioavailability. Formulations were prepared by wet granulation method. Tadalafil 20 mg tablets were formulated with various materials used to enhance dissolution rate. In F1, F2 and F3 was used Croscarmellose sodium as superdisintegrants; F4, F5 and F6 used Kleptose lincaps to improve the solubility and F7 to F10 was used Ludipress as diluent and disintegrant. In this study a formulation F10 was developed by increase batch size subjected to the official monograph requirements like: appearance, thickness, diameter, hardness, friability, disintegration, assay, content uniformity and dissolution rate. The results obtained were: 101.12%, 101.66% for assay and content uniformity respectively and the dissolution results after 10 minutes were 84.83% and after 30 minutes 98.53%.Whereas the results of the innovator products were 84.92% after 10 minutes and 94.23% after 30 minutes. Similarity factor (f2) values of the dissolution profiles of F10 compared with that of the innovator was 55. The results obtained indicate the compliance of F10 with the new standards set by USP37 for Tadalafil 20mg tablets.

Keywords: Dissolution rate, Tadalafil, Tablet, Similarity factor.

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