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Formulation and optimization of mouth dissolve tablets containing rofecoxib solid dispersion
Faculty
Not Specified
Year:
2006
Type of Publication:
Article
Pages:
Authors:
Zidan, Ahmed S, Sammour, Omaima A, Hammad, Mohammed A, Megrab, Nagia A
Journal:
AAPS PHARMSCITECH AMER ASSOC PHARMACEUTICAL SCIENTISTS
Volume:
7
Research Area:
Pharmacology \& Pharmacy
ISSN
ISI:000238975900024
Keywords :
rofecoxib, polyvinyl pyrrolidone K30, solid dispersion, solvent method, mouth dissolve tablets, factorial design
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 3(2) 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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