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Formulation and optimization of mouth dissolve tablets containing rofecoxib solid dispersion.
AAPS PharmSciTech. 2006 Jun 16; 7(2):E55.AP

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.

Authors+Show Affiliations

School of Pharmacy, Zagazig University, Zagazig, Egypt.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

16796372

Citation

Sammour, Omaima A., et al. "Formulation and Optimization of Mouth Dissolve Tablets Containing Rofecoxib Solid Dispersion." AAPS PharmSciTech, vol. 7, no. 2, 2006, pp. E55.
Sammour OA, Hammad MA, Megrab NA, et al. Formulation and optimization of mouth dissolve tablets containing rofecoxib solid dispersion. AAPS PharmSciTech. 2006;7(2):E55.
Sammour, O. A., Hammad, M. A., Megrab, N. A., & Zidan, A. S. (2006). Formulation and optimization of mouth dissolve tablets containing rofecoxib solid dispersion. AAPS PharmSciTech, 7(2), E55.
Sammour OA, et al. Formulation and Optimization of Mouth Dissolve Tablets Containing Rofecoxib Solid Dispersion. AAPS PharmSciTech. 2006 Jun 16;7(2):E55. PubMed PMID: 16796372.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Formulation and optimization of mouth dissolve tablets containing rofecoxib solid dispersion. AU - Sammour,Omaima A, AU - Hammad,Mohammed A, AU - Megrab,Nagia A, AU - Zidan,Ahmed S, Y1 - 2006/06/16/ PY - 2006/6/27/pubmed PY - 2006/7/21/medline PY - 2006/6/27/entrez SP - E55 EP - E55 JF - AAPS PharmSciTech JO - AAPS PharmSciTech VL - 7 IS - 2 N2 - 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. SN - 1530-9932 UR - https://www.unboundmedicine.com/medline/citation/16796372/Formulation_and_optimization_of_mouth_dissolve_tablets_containing_rofecoxib_solid_dispersion_ L2 - https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/16796372/ DB - PRIME DP - Unbound Medicine ER -