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Aceclofenac microspheres: quality by design approach.

Rameshwar K Deshmukh1, Jitendra B Naik1

  • 1Department of Pharmaceutical Technology, University Institute of Chemical Technology, North Maharashtra University, Jalgaon 425 001, Maharashtra, India.

Materials Science & Engineering. C, Materials for Biological Applications
|January 18, 2014
PubMed
Summary

Polymeric microspheres containing aceclofenac were successfully prepared using ethylcellulose and Eudragit® RS100. Experimental design optimized formulation variables, achieving high encapsulation efficiency and prolonged drug release for enhanced aceclofenac delivery.

Keywords:
AceclofenacBiocompatible polymersEncapsulationPlackett–Burman designStatistical experimental design

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Area of Science:

  • Materials Science
  • Pharmaceutical Technology
  • Polymer Chemistry

Background:

  • Aceclofenac is a non-steroidal anti-inflammatory drug (NSAID) requiring effective drug delivery systems.
  • Polymeric microspheres offer controlled release potential for improved therapeutic outcomes.
  • Developing efficient methods for encapsulating drugs within microspheres is crucial for pharmaceutical formulations.

Purpose of the Study:

  • To prepare polymeric microspheres loaded with aceclofenac using a single emulsion solvent evaporation method.
  • To optimize the formulation of aceclofenac-loaded microspheres by investigating key processing factors.
  • To characterize the prepared microspheres for their physical properties, drug encapsulation, and release kinetics.

Main Methods:

  • Preparation of aceclofenac-loaded polymeric microspheres using ethylcellulose and Eudragit® RS100 via oil-in-water emulsion solvent evaporation.
  • Utilizing Plackett-Burman design (PBD) to identify significant formulation variables affecting encapsulation efficiency.
  • Characterization techniques including field emission scanning electron microscopy (FESEM), Fourier transform infrared (FTIR) spectroscopy, and X-ray powder diffractometry (XRPD).

Main Results:

  • Plackett-Burman design identified Eudragit® RS100 and polyvinyl alcohol (PVA) as significant factors influencing encapsulation efficiency.
  • High encapsulation efficiencies ranging from 70.15% to 83.82% were achieved.
  • Characterization confirmed discrete, oval microspheres with smooth surfaces, drug-polymer compatibility (FTIR), and drug dispersion (XRPD).
  • A prolonged drug release profile over 12 hours was observed.

Conclusions:

  • Polymeric microspheres containing aceclofenac can be successfully prepared using the emulsion solvent evaporation method.
  • Experimental design is an effective tool for optimizing formulation variables to enhance encapsulation efficiency.
  • The developed microspheres demonstrate potential for sustained release of aceclofenac, improving drug delivery efficacy.