ピロキシカムカプセル剤の剤形変更による物理化学的特性変化の評価

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  • ピロキシカムカプセルザイ ノ ザイケイ ヘンコウ ニ ヨル ブツリ カガクテキ トクセイ ヘンカ ノ ヒョウカ
  • Evaluation of Physicochemical Property by Changing Dosage Form of a Piroxcam Capsule

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カプセル剤の剤形変更は製剤特性に影響を与える可能性がある．本研究では，ピロキシカム（製剤A，B，C）のカプセル，脱カプセル物および粉砕物を用いて，安定性，製剤特性およびチューブ通過性の検討を行った．製剤特性評価は水分含量測定，色差測定，粒度分布および走査型電子顕微鏡測定を行った．安定性試験・水分含量測定より，4 週間保存後の各製剤の主薬含量は，97.5～100.6％となり，各脱カプセル物および粉砕物は，保存初期に比べ約1～2％水分含量が増加した．色差測定より，40°C 相対湿度82％保存下の粉砕物は，保存初期と比べ製剤A の2，4 週間および製剤B の4 週間に色調変化を認めた．粒度分布・走査型電子顕微鏡測定より，各製剤は粉砕により小径化を認め，水分含量の増加および色調に寄与すると推察した．チューブ通過性試験より，製剤A および製剤C の脱カプセル物の主薬通過率は約80％，他試料では91％以上であった．この通過性の差は各試料の懸濁性に起因すると推察した．Dosage form change of capsules influence the formulation property. The purpose of the present study was to evaluate the formulation stability, property and tube passing test using piroxicam capsule (formulation A, B, C) in its capsule, de-capsule and crushing capsule. Formulation property was evaluated the measurement of water content, color difference, particle size distribution and scanning electron microscope. In stability, piroxicam content of each formulation was 97.5–100.6% after storage for 4 weeks. Measurement of water content revealed that each formulation in de-capsule and crushing capsule after storage for 4 weeks were increased about 1–2% compared to their formulation after storage for 0 week. Measurement of color difference revealed that formulation A of 2, 4 weeks and formulation B of 4 weeks were changed color in crushing capsule stored under 40°C, relative humidity 82%. Measurement of particle size distribution and scanning electron microscope revealed that each formulation reduce the particle size by crushing capsules. Therefore, crushed capsules were assumed to affect the color and increasing water content. Results of the tube passing test, formulation A and formulation C were tube passing rate about 80%, the other sample was 91% or more. This difference in permeability was presumed to be derived from the suspension of each formulation.

source:The Journal of Community Pharmacy and Pharmaceutical Sciences

identifier:JOS-18843077_7_15

収録刊行物

  • 薬局薬学

    薬局薬学 7 (1), 15-25, 2015-04

    日本薬局学会

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