Improving consistency for a Mefenamic acid immediate release formulation

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Abstract

The objective of this study was to develop an immediate release dose form containing 250 mg Mefenamic acid (MFA) presented as a crystalline solid dispersion in order to achieve improved consistency in drug release through a simplified formulation compared to a commercial product. An MFA-Soluplus®-Sorbitol polymer matrix was developed using an HME process based on rheological screening assays of physical mixtures. The physico-chemical properties of these formulations were assessed by thermal analysis, FTIR, mechanical testing and SEM image analysis, confirming the crystalline character and stable polymorphic form I of the API in the polymer matrix. A faster release and a significant improvement in consistency (± 6 %) of drug release was observed compared to a commercially available MFA product (± 17 %) (250 mg capsule). This study illustrates advantages of applying a structured development program aimed at retaining API physical properties in the final dosage form.
Original languageEnglish
JournalJournal of Pharmaceutical Sciences
Publication statusAccepted/In press - 19 Aug 2020

Keywords

  • extrusion
  • solid dosage form
  • oral drug delivery
  • solid dispersion
  • dissolution
  • formulation

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