- 著者
- Takuro Okada Masahito Nakazaki Asami Funaki Mariko Kawana Masateru Ito Hirokazu Ishizuka Junko Nagai Atsushi Tanaka Ryokan Funakoshi Tadanori Sasaki
- 出版者
- Japanese Society of Drug Informatics
- 雑誌
- Iyakuhin Johogaku (ISSN:13451464)
- 巻号頁・発行日
- vol.19, no.3, pp.104-110, 2017 (Released:2017-12-27)
- 参考文献数
- 11
Objective: Although generic drugs are considered bioequivalent to the original drugs, for formulations such as adhesive agents, the sensation during use (hereinafter, “sensation”) and handling characteristics (hereinafter, “handling”) are usually not investigated during the approval process. Therefore, we established new drug evaluation criteria for transdermal adhesive agents, which included those relevant to handling and sensation, and investigated their usefulness.Methods: This study assessed four test samples: the original loxoprofen sodium 100 mg tape (hereinafter, “LX-P 100 mg”) and three generic versions considered economically acceptable by our hospital. The formulations were evaluated based on our criteria for generic drugs. The handling and sensation were evaluated using a questionnaire with six parameters related to sensation and seven parameters related to handling. The enrolled subjects comprised 20 pharmacists from our hospital. Furthermore, a parallel evaluation using loxoprofen sodium 50 mg tape (hereinafter, “LX-P 50 mg”) was performed to explore the variance in the results of each individual criterion.Results: The evaluation revealed differences between the formulations with regard to the thickness of the adhesive agent and stability after opening the package. Various differences were observed by evaluation of the handling and sensation. Based on the parameters used, the differences between the various formulations of LX-P 100 mg occurred in the following criteria: tactile sensation commensurate to the degree of adhesion; superficial resemblance to other agents; ease of adhesion; and ease of package opening. For LX-P 50 mg, the differences were found in superficial resemblance to other agents and ease of liner removal.Conclusion: Our newly established criteria for the evaluation of LX-P 100 mg revealed differences between the samples, which were used to identify products with poor handling and sensation. Thus, this study successfully demonstrated the usefulness of the criteria for the purpose of medicine selection.
- 著者
- Mariko Kawana Akime Miyasato Miyui Funato Keigo Nagatani Norifumi Suzuki Chiharu Onoda Hidenori Fujimoto Rintaro Ohno Ayuko Kusakabe Mio Kiribayashi Kazuyo Nakamura Masayoshi Kondo Ayumi Ozeki Kousuke Okamoto Hideya Kokubun
- 出版者
- The Pharmaceutical Society of Japan
- 雑誌
- Biological and Pharmaceutical Bulletin (ISSN:09186158)
- 巻号頁・発行日
- vol.46, no.10, pp.1444-1450, 2023-10-01 (Released:2023-10-01)
- 参考文献数
- 13
In Japan, a low-dose transdermal fentanyl (TDF; 0.5 mg) has been approved to address pain in opioid-naïve patients with cancer; however, efficacy and safety data are lacking. To determine the efficacy and safety of TDF, patients with opioid-naïve cancer pain prescribed TDF (0.5 mg/d) and oral oxycodone sustained-release formulation (OXY) 10 mg/d were extracted from electronic medical and nursing records. Overall, 40 and 101 subjects were analyzed in the TDF and OXY groups, respectively. Compared with baseline (median [minimum, maximum]) values, changes in the Numerical Rating Scale (NRS) score on days 1, 3, and 7 post-administration were as follows: TDF (0 [−5, 4]) and OXY (−1.0 [−8, 3]); TDF (−1.5 [−6, 3]) and OXY (−2.0 [−8, 4]); and TDF (−2.0[−6, 3]) and OXY (−3.0[−8, 5]), respectively. No significant difference was observed between the groups on days 1 and 3; however, the change in the NRS on day 7 was significantly higher in the OXY group than that in the TDF group. Regarding adverse events, nausea occurred in 12.5 and 13.9% of patients in the TDF and OXY groups, respectively, while 12.5% of TDF- and 10.9% of OXY-treated patients experienced somnolence, revealing similar occurrence in both groups. However, constipation was more common in the OXY group (TDF: 50.0%, OXY: 71.3%). No serious adverse events (e.g., respiratory depression) were observed in either group. Low-dose TDF (0.5 mg), available only in Japan, showed comparable efficacy and safety to OXY (10 mg/d) and can be a first choice for opioid-naïve patients with cancer pain.