著者
原田 康 垣内 祥宏 武田 光志 佐藤 信一 馬場 泰行 幸田 幸直
出版者
一般社団法人 日本医療薬学会
雑誌
病院薬学 (ISSN:03899098)
巻号頁・発行日
vol.25, no.4, pp.399-406, 1999-08-10 (Released:2011-08-11)
参考文献数
10

Recently, automatic tablet counting and packaging machines have come to be widely used for the one-dose packaging of tablets and capsules. However, coloration, i.e. changes in color, of such tablets repackaged by one-dose packaging machins for dispensing has been frequently observed in several kinds of tablets due to the light, humidity and temperature in the room. In this report, the changes observed over time in the controlled-release mesalazine product, Pentasa® tablets, repackaged with polyethylene-laminated cellophane and glassine films for the one-dose packaging was studied.The repackaged tablets changed color within a week at room conditions (22-25°C, 50-70% RH) under a 350 lux fluorescent white-1 amp ex posure for 12 h per day or in darkness. However, no coloration was observed for at least four weeks in a refrigerator (4°C, 20% RH) in dark ness. The weight of the repackaged tablets increased by about 1% at room conditions within a week, while no such weight increase in the tablets was observed while the tablets were kept in a refrigerator. No changes in the amounts of mesalazine and its degradates, gentigic acid and p-aminophenol, in the tablets were observed and the dissolution properties of mesalazine from the tablets also remained unchanged during the experimental period.Based on these findings, we conclude that the one-dose packaging of Pentasa® tablets is not a suitable procedure since it results in the absorption of moisture and changes in color.
著者
住谷 賢治 馬場 泰行 猪股 伸一 豊岡 秀訓 幸田 幸直
出版者
公益社団法人日本薬学会
雑誌
藥學雜誌 = Journal of the Pharmaceutical Society of Japan (ISSN:00316903)
巻号頁・発行日
vol.120, no.7, pp.652-656, 2000-07-01
参考文献数
17
被引用文献数
8

Orally-disintegrating tablets of clonidine hydrochloride, an α_2-adrenergic agonist, were prepared by the method of drying an aqueous suspension. The suspension was prepared using powdered lactose, and the composition ratio was 2 : 1 (powdered lactose : 0.048% clonidine hydrochloride solution). The suspension was dried under 4±1℃(72±15% R.H.). We obtained tablets containing clonidine hydrochloride (40μg/tablet). Physical properties of the tablets were as follows : hardness was 4.0 kgf, and disintegration time was 41.7 s (in vitro). In the clinical use, 8 patients, aged 1-2 year and weighing 9-11 kg, received approximately 4μg/kg body weight as clonidine hydrochloride. The tablet was administered 90 min before entering the operating room. All patients were willing to accept the tablet. The quality of separation from parents, sedation and a mask acceptance were excellent on all patients. These results suggest that the orally-disintegrating tablet of clonidine hydrochloride was useful in a clinical situation for the preanesthetic medication of pediatric patients aged 1-2 year.