1.Comparative Study on the Adequacy of Information and Dissolution Test between Original and Generic Drugs (I), Glibenclamide and Gliclazide
Natsuko Uehara ; Eiko Ohishi ; Yuko Sakashita ; Chuji Yanagawa ; Noriko Suzuki ; Yasushi Kanzaki
Japanese Journal of Drug Informatics 2009;11(1):39-48
Generic drugs have received much attention especially from an economic point of view. In Japan, the form of medical prescriptions has been revised twice in recent two years to disseminate generic drugs in recent two years. The pharmacists are irresistibly required the detail knowledge of various generic drugs. However, sufficient information on generic drugs has not always been provided in comparison with the original drugs. This study intends to reveal such problems with the generic drugs. Glibenclamide and gliclazide were selected as the model drugs for this study because these two drugs are often taken together with supplements. Two approaches were used to compare the original drug and the corresponding generic drugs. The first approach concerns the amount of information as well as the quality of the information that is provided from manufacturers. The second approach concerns the physicochemical properties, dissolution test and hardness test. Regarding the pharmacokinetic information in the package insert of glibenclamide, six generic drugs among eleven samples provided sufficient information while four samples seemed insufficient. As for gliclazide, three samples among eight did not provide AUC and the time dependence of the blood concentration curve. The results of the dissolution test revealed that all generic drugs satisfied most of the equivalence to the original drug except for one generic glibenclamide. On the other hand, different behaviors in the swelling property and the time required to completely disperse were observed. Two samples for glibenclamide and four samples for gliclazide required a fairly long time to completely disperse. Irregular and significant variations were observed in the hardness test. The difference in the dissolution process and hardness test suggested the different drug formulations among manufacturers.
2.A Case of Refractory Cancer Pain Successfully Treated with Opioid Switching by Adding Methadone
Yuko UEHARA ; Yoshihisa MATSUMOTO ; Tomofumi MIURA ; Naoko KOBAYASHI ; Takashi IGARASHI ; Nahoko YOSHINO
Palliative Care Research 2020;15(2):65-69
We report a case of refractory cancer pain that was successfully treated with opioid switching by adding methadone to the preceding opioid. A 38-year-old man had severe epigastric pain and back pain because of paraaortic lymph node metastasis of a gastroesophageal junctional carcinoma. His pain was treated with continuous intravenous morphine administration and the frequent use of a rescue dose. When the morphine dose was increased, respiratory depression developed; thus, his pain was considered refractory to the morphine, and methadone was added on. The pain was relieved after initiating methadone, and the frequency of the rescue dose was markedly decreased. The methadone dose was gradually increased in parallel, and the morphine dose was reduced and finally discontinued. No methadone-induced side effects were noted, and the patient was discharged with good analgesia. In our case, adding methadone without decreasing the preceding opioid dose under strict monitoring made it possible to stably switch the opioid without increasing pain.