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

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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

Yasuharu Kashiwagura Shinya Uchida Shimako Tanaka Hiroshi Watanabe Masahiro Masuzawa Tadanori Sasaki Noriyuki Namiki

出版者

The Pharmaceutical Society of Japan

雑誌

Biological and Pharmaceutical Bulletin (ISSN:09186158)

巻号頁・発行日

vol.37, no.4, pp.666-670, 2014-04-01 (Released:2014-04-01)

参考文献数

12

被引用文献数

5 11

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This study aimed to elucidate the clinical efficacy and pharmacokinetics of levothyroxine (LT4) suppository, thus, we examined the pharmacokinetics of thyroxine (T4) after the administration of the suppository in thyroidectomized rats and examined dose and the levels of free T4 (FT4) in patients with hypothyroidism receiving suppositories. Thyroidectomized rats were administered with LT4 solution and LT4 suppository (30 µg/kg), and plasma T4 concentrations were measured using LC/MS. The AUC0–168 of T4 after rectal administration of the LT4 suppository was 64% lower than these values after oral administration. To evaluate clinical effect of LT4 suppository, we enrolled 6 Japanese patients with hypothyroidism (2 men and 4 women; age, 68.2±13.5 years) who were administered LT4 suppository at Kameda Medical Center from 2007 to 2013 in this case series. The FT4 level during the administration of suppositories was significantly lower than that during the administration of tablets (0.657±0.183 ng/dL vs. 1.25±0.51 ng/dL, p=0.034). The FT4/dose ratio for the suppository was significantly 44% lower than that for the tablet (p=0.020). In conclusion, although the bioavailability of LT4 is lower after administration of the suppository than after the oral formulation, it was suggested that T4 levels can be maintained in patients with hypothyroidism by administering LT4 suppositories at a dose 1.8 times higher than that of the tablet. Thus, the administration of LT4 suppository can be an alternative for treatment with oral medication in clinical practice.