ヘパリン類似物質含有半固形製剤と外用副腎皮質ステロイド剤の混合時間及び保存条件が及ぼす物性変化への影響

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  • Effect of Mixing Time and Storage Condition on Characterization of Heparinoid Admixtures with Corticosteroids
  • ヘパリン ルイジ ブッシツ ガンユウ ハンコケイ セイザイ ト ガイヨウ フクジン ヒシツ ステロイドザイ ノ コンゴウ ジカン オヨビ ホゾン ジョウケン ガ オヨボス ブッセイ ヘンカ エ ノ エイキョウ

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 In dermatologic therapy, several external preparations formulated as ointments or creams are prescribed. And they are often admixture to improve patient compliance. In this study, we prepared admixtures of moisturizer with steroids and examined their usability and the amount of principal agent in formulations, particularly focusing on the moisturizer content. Four heparinoid semisolid formulations were selected: Hirudoid® soft ointment 0.3% (Formulation A) and 3 generic agents [(Besoften® oil-based cream 0.3% (Formulation B), Kuradoido® ointment 0.3% (Formulation C), and Hepadaerm ointment 0.3% (Formulation D)], and Antebate® ointment 0.05% (Formulation E) were used as steroids. Formulation A and B are water-in-oil emulsions, and Formulation C and D are oil-in-water emulsions. Admixtures looked like to be mixed uniformly by visual observation. In the examination of heparinoid amount, admixture A+E and B+E were mixed uniformly. On the other hand, admixture C+E was remarkable un-uniformly. It was speculated that the emulsification of formulation C was broken. The phenomenon was supported by the result of malleability. After 8 weeks storage, the heparinoid ratio in each formulation could be expressed as follows: Admixture B≥Admixture A>Admixture C=Admixture D. A suitable storage temperature was 4°C. The results of physicochemical data analysis reveal the formulations composed of water-in-oil cream, i.e., Formulation A and Formulation B, to be the optimal choices for mixing with steroid ointments. Mixing time and storage conditions may be optimized to solve pharmaceutical problems. Moreover, understanding the emulsion type and character of semisolid formulations can expand the range of formulation options.<br>

収録刊行物

  • 薬学雑誌

    薬学雑誌 136 (10), 1391-1400, 2016-10-01

    公益社団法人 日本薬学会

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