ニトログリセリン・β-シクロデキストリン複合体舌下錠の安定性及び生物学的同等性

概要

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Vaporization of nitroglycerin (TNG), thermoanalysis (DTA/TG) and X-ray diffractometry (X-RD) for the complex with TNG and β-cyclodextrin (TNG・β-CD) prepared by saturated solution method and kneading method, and TNG dispersed β-CD and lactose powder were evaluated. The stabilities of strip packaged sublingual tablet of TNG・β-CD (β-CD Tab, TNG content 0.3mg) and conventional sublingual tablet (JP Tab, TNG content 0.3mg, vehicle: lactose) were compared under the each storage condition of room temperature, 37° and 50℃. Pulse pressure in anesthetized dogs, and systolic blood pressure and plasma TNG concentration in 10 healthy male volunteers were measured after sublingual administration of β-CD Tab and JP Tab. The results showed that vaporization of TNG from TNG・β-CD was extremely smaller than that from TNG dispersed β-CD and lactose powder. DTA/TG and X-RD curves for TNG・β-CD showed specific patterns differed from dispersed powder. The decrease of TNG content in β-CD Tab was extremely lower than that of JP Tab under strip packaging. It is also ascertained that β-CD Tab has the same bioequivalency as JP Tab.
日本医療薬学会の論文
1989-02-20