병원약사회지

[특집] Vigabatrin 가루약 비닐포장의 안정성 The Stability of Powdered Vigabatrin Packaged in Vinyl Film

Authors: 양은영, 박광준, 조남춘 서울대병원 약제부 Eun Young Yang, Kwang Joon Park and Nam Chun Cho Department of Pharmacy, Seoul National University Hospital #28, Yongon-dong, Chongno-gu, 110-744, Seoul, Korea

Keyword: Vigabatrin, Light-shield, High temperature, Room temperature, Cool temperature, HPLC

Abstract: In Korea, vigabatrin dosage form is only 500mg tablet. But children's doses are small, we cannot use it directly to children. We should crush it and weighed and packaged it with vinyl films for patients use. If we crush tablet to powder form, we should know about stability test result of vigabatrin powder dosage form. But we don't have stability results. We studied about stability of vigabatrin powdered form. We did two kinds of studies. One condition is light shield. We powdered vigabatrin and packaged it with vinyl films and inserted into light-shield package, and the others are packaged without light-shield envelope. Powdered vigabatrin contents are not changed for 11 weeks. The results are 85~110% contents, but the contents at 12 week is 60%. We should study about this result. Second conditions related temperature such as high temperature (37℃), room temperature (24~30℃), cool temperature (4℃). The results are as follows. At high temperature condition, the content of vigabatrin at 12 weeks is 88.7%, room temperature 85.9%, cool temperature 86.4%. So we conclude that vigabatrin powder does not lose its strength from roomlight, high temperature, room temperature, cool temperature for 12 weeks.

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