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Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
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Improving Consistency for a Mefenamic Acid Immediate Release Formulation.

Elke Prasad1, John Robertson1, Gavin W Halbert1

  • 1EPSRC Future Manufacturing Research Hub, University of Strathclyde, Technology and Innovation Centre, 99 George Street, Glasgow G1 1RD, UK; Strathclyde Institute for Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow G4 0RE, UK.

Journal of Pharmaceutical Sciences
|August 28, 2020
PubMed
Summary
This summary is machine-generated.

Developing a simplified Mefenamic acid (MFA) solid dispersion formulation using hot melt extrusion improved drug release consistency to ±6% compared to commercial products. This approach retains the active pharmaceutical ingredient's crystalline properties.

Keywords:
DissolutionExtrusionFormulationOral drug deliverySolid dispersionSolid dosage form

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Mefenamic acid (MFA) is a nonsteroidal anti-inflammatory drug (NSAID) commonly formulated for pain relief.
  • Achieving consistent and improved drug release from immediate-release dosage forms remains a formulation challenge.
  • Commercial MFA products may exhibit variability in drug release profiles.

Purpose of the Study:

  • To develop a simplified, immediate-release dosage form of Mefenamic acid (MFA) containing 250 mg.
  • To enhance the consistency of drug release using a crystalline solid dispersion.
  • To compare the developed formulation against a commercial MFA product.

Main Methods:

  • Hot Melt Extrusion (HME) process utilizing an MFA-Soluplus®-Sorbitol polymer matrix.
  • Rheological screening assays for physical mixture evaluation.
  • Physico-chemical characterization including thermal analysis, FTIR, mechanical testing, and SEM image analysis.
  • Comparative in vitro drug release studies.

Main Results:

  • Successful development of an MFA-Soluplus®-Sorbitol polymer matrix via HME.
  • Confirmation of crystalline character and stable polymorphic form I of MFA within the polymer matrix.
  • Demonstrated faster drug release and significantly improved release consistency (±6%) compared to a commercial MFA product (±17%).

Conclusions:

  • The HME process effectively retained the crystalline properties of MFA in the solid dispersion.
  • The developed simplified formulation offers superior and consistent drug release performance.
  • A structured development approach is advantageous for maintaining API physical properties in the final dosage form.