Improving consistency for a Mefenamic acid immediate release formulation

Prasad, Elke and Robertson, John and Halbert, Gavin (2020) Improving consistency for a Mefenamic acid immediate release formulation. Journal of Pharmaceutical Sciences. ISSN 0022-3549 (In Press)

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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.