著者
鈴木 一衛 宮嵜 靖則 内野 智信 賀川 義之
出版者
公益社団法人 日本薬学会
雑誌
YAKUGAKU ZASSHI (ISSN:00316903)
巻号頁・発行日
vol.131, no.11, pp.1645-1651, 2011 (Released:2011-11-01)
参考文献数
11
被引用文献数
1 2

Marketing authorization holders do not disclose any information on the pharmaceutical properties of over-the-counter drugs (OTC). When a drug is switched from a prescription drug to OTC, pharmacists can acquire that information from the corresponding ethical drug (ED) through the package insert, interview form, and so on. However, the pharmaceutical equivalence between ED and OTC is unclear. In this study, we examined the drug dissolution behavior of both ED and OTCs containing scopolamine butylbromide. Dissolution tests were performed by the paddle method using Japanese Pharmacopeia (JP) XV test fluids at pH 1.2, 4.0 and 6.8 and water based on the guidelines for bioequivalence studies of generic products. The dissolution profiles of OTCs differed significantly from ED showing a similarity factor (f2) value ranging from 8.9 to 42.9. Time until 85% dissolution ranged from 23 to 95 min and from 17 to 174 min at pH 1.2 and pH 6.8, respectively. Then JP XV disintegration tests were conducted to investigate differences in the disintegration process. The disintegration time of preparations showing delayed dissolution was prolonged compared to that of others, suggesting that the disintegration of the tablet or capsule is one of the important factors affecting the drug dissolution. These differences in the disintegration and drug dissolution might cause differences in the bioavailability of the drug. For patient safety, more detailed product information of OTCs should be supplied by the manufacturer, and not be assumed from that of corresponding ED.
著者
山本 吉章 家田 直幸 三島 信行 松田 一己 高橋 幸利 賀川 義之
出版者
一般社団法人日本医療薬学会
雑誌
医療薬学 (ISSN:1346342X)
巻号頁・発行日
vol.37, no.7, pp.411-418, 2011 (Released:2012-08-30)
参考文献数
25
被引用文献数
1

This study was designed to evaluate the persistence and safety of topiramate therapy in children and adults with epilepsy. It was a retrospective cohort study undertaken from October 2007 in which we analyzed the clinical records of 726 patients (216 children and 510 adults) who received topiramate for the treatment of epilepsy at the National Epilepsy Center, Shizuoka Institute of Epilepsy and Neurological Disorders. Factors associated with discontinuation of topiramate therapy determined from the results of the log-rank test (p<0.1) were subjected to multivariate Cox regression analysis in order to calculate hazard ratios and 95% confidence intervals (95% CI).Suspension (Discontinuation) or dose reduction of topiramate were necessary due to adverse effects in 85 children (39%), of which the major ones were drowsiness (16.2%), anorexia (10.7%), hypohidrosis (4.7%), and irritability (4.2%). There was a higher incidence of hypohidrosis and a lower incidence of speech disorders in children as compared with adults (both p < 0.05). According to Cox proportional hazards analysis, the adjusted hazard ratio for discontinuation of topiramate therapy in children was 0.92 (95% CI : 0.75-1.23 ; p=0.76). In conclusion, this comparative study showed that the persistence and safety of topiramate therapy were similar in children and adults.