レボチロキシンナトリウム錠粉砕後の安定性と分散性

概要

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The Levothyroxine sodium (T_4) tablet is the remedy of the dysthyreosis. When we prescribe that tablet to an infant and the patient who cannot swallow it, we provide the preparation of that obtained by crushing tablet. In this study, we examined the dispersibility and the stability of T_4 in that preparations. The dispersibility of T_4 in that preparations was influenced in the kind of the constituents. However, the coefficient of variation were 2-3%. The stability of T_4 in that preparations was influenced in various cases. However, in all of the 3 kinds of the constituents examined, ingredient content ratio of T_4 was more than 98%, 30 days later. Using lactose+starch as the constituents, with preservation under total shading, ingredient content ratio of T_4 was 94.2%, 30 days later. On the other hand, with preservation in the light of indoors being scattered, ingredient content ratio of T_4 was 85.8%, 30 days later. Ingredient content ratio of T_4 was 91.6% under mild condition (5℃, C.R.H. 52%), 81.8% under medium condition (20℃, C.R.H. 75%), 77.3% under severe condition (30℃, C.R.H. 92%), 30 days later.
日本医療薬学会の論文