Improving Powder Flow Properties of a Direct Compression Formulation Using a Two-Step Glidant Mixing Process

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  • Abe Hidaka
    Pharmaceutical Research Department, Mitsubishi Tanabe Pharma Corporation
  • Yasui Shinichiro
    Pharmaceutical Research Department, Mitsubishi Tanabe Pharma Corporation
  • Kuwata Aya
    Laboratory of Pharmaceutical Engineering, Gifu Pharmaceutical University
  • Takeuchi Hirofumi
    Laboratory of Pharmaceutical Engineering, Gifu Pharmaceutical University

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To improve powder flow of a high-dose direct compression formulation (drug content 30%), we compared a two-step operation for mixing glidants with a conventional one-step glidant mixing process. This two-step mixing operation was studied with two kinds of mixtures; an active pharmaceutical ingredient (API)-glidant combination and a direct compression excipient-glidant combination. The two-step operation permitted the selection of the optimum glidant type and concentration in each glidant-mixing procedure even though the formulation had different powder properties such as micronized API and enlarged direct compression vehicles, whereas the conventional approaches forced the selection of a certain glidant type and concentration at one-step mixing. The addition of 0.5% nonporous silica markedly improved API flow. In contrast, 1.0% porous silica was the appropriate glidant to enhance excipient flow at direct compression excipient-glidant mixing. The two-step operation dominantly enhanced powder flow when the appropriate API-glidant mixture and the suitable direct compression excipients-glidant mixture were blended compared to the one-step operation with its optimum glidant concentration. The results showed that the angle of repose was 43° and the critical orifice diameter was 10 mm in the two-step operation, whereas it was 47° and 16 mm in the one-step operation. The two-step operation of glidant mixing enhanced powder flow of the high-dose direct compression formulation compared with the one-step operation. The two-step operation eliminates the bottleneck of powder flow and allows direct compression to be more worth applying for formulation and process development trials.

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