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Formulation and optimization of mouth dissolve tablets containing rofecoxib solid dispersion.

Omaima A Sammour1, Mohammed A Hammad, Nagia A Megrab

  • 1School of Pharmacy, Zagazig University, Zagazig, Egypt.

AAPS Pharmscitech
|June 27, 2006
PubMed
Summary

This study enhanced rofecoxib solubility and dissolution rates using solid dispersions with polyvinyl pyrrolidone K30. Optimized formulations yielded rapidly disintegrating mouth dissolve tablets, demonstrating the utility of experimental design in pharmaceutical development.

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Formulation Development

Background:

  • Rofecoxib exhibits poor solubility and dissolution rates, limiting its therapeutic efficacy.
  • Solid dispersions offer a promising strategy to enhance the bioavailability of hydrophobic drugs.
  • Polyvinyl pyrrolidone K30 (PVP K30) is a widely used polymer for solid dispersion formulations.

Purpose of the Study:

  • To improve the solubility and dissolution rate of rofecoxib through solid dispersion with PVP K30.
  • To develop and optimize rofecoxib mouth dissolve tablets (MDTs) using the prepared solid dispersion.
  • To investigate the impact of formulation variables on MDT properties using a factorial design.

Main Methods:

  • Rofecoxib-PVP K30 solid dispersions were prepared using the solvent evaporation method.

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  • Drug-polymer interactions were analyzed using Differential Scanning Calorimetry (DSC), X-ray Diffraction (XRD), and Fourier Transform Infrared Spectroscopy (FTIR).
  • A 3(2) factorial design was employed to optimize the amounts of superdisintegrant and subliming agent in MDTs.

    • Main Results:

    • Solid dispersion significantly enhanced the dissolution rate of rofecoxib, with the drug-to-carrier ratio being a critical factor.
    • FTIR confirmed no chemical incompatibility between rofecoxib and PVP K30.
    • XRD and DSC indicated that rofecoxib existed in an amorphous state within the solid dispersion, contributing to improved dissolution.
    • Optimization revealed that a specific concentration of camphor and a higher percentage of crospovidone were essential for rapid tablet disintegration.

    Conclusions:

    • Solid dispersion of rofecoxib with PVP K30 effectively enhances its dissolution rate.
    • The amorphous nature of rofecoxib in the solid dispersion is key to improved dissolution.
    • Experimental design is a valuable tool for optimizing the formulation of mouth dissolve tablets containing hydrophobic drugs.