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Mouth Dissolving Tablets of Tadalafil Solid Dispersion: Formulation and Optimization
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| Author:
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NARENDRA CHOTAI, VANIT M. PATEL, RAJNIKANT M. SUTHAR
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| Abstract:
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Tadalafil a newly approved oral selective phosphodiesterase (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) has lower oral bioavailability and slower onset of action due to poor water solubility (2µg/ml). The aim of the present work was to improve the solubility and dissolution behavior of tadalafil by solid dispersion (SD) technique and to formulate and optimize mouth dissolving tablets (MDTs) by direct compression method. SD of drug using carriers namely PVP K30, PEG 6000 and Poloxamer407 were prepared by solvent evaporation method. The prepared SD formulations were characterized by saturation solubility, fourier transform infrared spectroscopy (FTIR), x-ray powder diffraction (XRD), differential scanning calorimetry (DSC) and dissolution study. FTIR spectra showed no chemical interaction between the drug and carriers. XRD and DSC data indicated amorphous form of drug and revealed better dissolution from its SD as compared to pure drug. MDTs were prepared using SD of tadalafil: PVP K30 (1:3). The 32 factorial design was employed to evaluate the effect of independent variables namely concentration of kyron T-314 and concentration of crospovidone on dependent variables namely disintegration time, wetting time and % drug release in 30 min (Q30). The prepared MDTs were evaluated for various pharmaceutical parameters and drug release study. The F9 batch showed quick disintegration (25.66 s), minimum wetting time (6.66 s) and highest dissolution (99.18% drug release in 30 min) and can be considered as optimized formulation.
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| Keyword:
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Tadalafil, Solid dispersions, Mouth dissolving tablets, Superdisintegrants, 32 factorial design.
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| EOI:
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| DOI:
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