Formulation and optimization of mouth dissolve tablets containing rofecoxib solid dispersion |
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Authors: | Omaima A Sammour Mohammed A Hammad Nagia A Megrab Ahmed S Zidan |
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Institution: | (1) Center of Relevance and Excellence in NDDS, Pharmacy Department, The M. S. University of Baroda, G H Patel building, Donor’s Plaza, Fatehgunj, Vadodara, Gujarat, 390 002, India |
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Abstract: | The purpose of the present investigation was to increase the solubility and dissolution rate of rofecoxib by the preparation
of its solid dispersion with polyvinyl pyrrolidone K30 (PVP K30) using solvent evaporation method. Drug-polymer interactions
were investigated using differential scanning calorimetry (DSC), x-ray diffraction (XRD), and Fourier transform infrared spectroscopy
(FTIR). For the preparation of rofecoxib mouth dissolve tablets, its 1∶9 solid dispersion with PVP K30 was used with various
disintegrants and sublimable materials. In an attempt to construct a statistical model for the prediction of disintegration
time and percentage friability, a 32 randomized full and reduced factorial design was used to optimize the influence of the amounts of superdisintegrant and subliming
agent. The obtained results showed that dispersion of the drug in the polymer considerably enhanced the dissolution rate.
The drug-to-carrier ratio was the controlling factor for dissolution improvement. FTIR spectra revealed no chemical incompatibility
between the drug and PVP K30. As indicated from XRD and DSC data, rofecoxib was in the amorphous form, which explains the
better dissolution rate of the drug from its solid dispersions. Concerning the optimization study, the multiple regression
analysis revealed that an optimum concentration of camphor and a higher percentage of crospovidone are required for obtaining
rapidly disintegrating tablets. In conclusion, this investigation demonstrated the potential of experimental design in understanding
the effect of the formulation variables on the quality of mouth dissolve tablets containing solid dispersion of a hydrophobic
drug. |
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Keywords: | rofecoxib polyvinyl pyrrolidone K30 solid dispersion solvent method mouth dissolve tablets factorial design |
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