Art

J-GLOBAL ID：201702269820817092   Reference number：17A0223188

Effect of Thiotriazinone Impurity on Insoluble Microparticle Generation Associated with Ceftriaxone-calcium Salt Precipitation in Original (Rocephin) and Japanese Generic Ceftriaxone Products

先発品セフトリアキソン(ロセフィン)および日本の後発品セフトリアキソン製品におけるセルトリアキソン-カルシウム塩析出に関連する不溶性微粒子形成に対するチオトリアジノン夾雑物の影響

Author (6)： OHTA Shinako (Division of Pharmacokinetics and Pharmacodynamics, Department of Pharmacotherapeutic Sciences, Showa University School of Pharmacy) ,  SUGIYAMA Erika (Division of Pharmacokinetics and Pharmacodynamics, Department of Pharmacotherapeutic Sciences, Showa University School of Pharmacy) ,  SAITO Kiyomi (Division of Pharmacokinetics and Pharmacodynamics, Department of Pharmacotherapeutic Sciences, Showa University School of Pharmacy) ,  NAGAFUJI Kohei (Division of Pharmacokinetics and Pharmacodynamics, Department of Pharmacotherapeutic Sciences, Showa University School of Pharmacy) ,  SATO Vilasinee Hirunpanich (Department of Pharmacology, Faculty of Pharmacy, Mahidol University) ,  SATO Hitoshi (Division of Pharmacokinetics and Pharmacodynamics, Department of Pharmacotherapeutic Sciences, Showa University School of Pharmacy)
Material： Showa University Journal of Medical Sciences  (Showa Univ J Med Sci)
Volume： 28  Issue： 1  Page： 1-8(J-STAGE)  Publication year： 2016 
JST Material Number： L1154A  ISSN： 0915-6380  CODEN： SUMSEG  Document type： Article
Article type： 原著論文  Country of issue： Japan (JPN)  Language： ENGLISH (EN)

Thesaurus term： *Cephalosporins ,...
Semi thesaurus term： advanced drugs

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Author keywords (5)： ceftriaxone ,  calcium ,  insoluble microparticles ,  light obscuration particle counter ,  generic products

JST classification (2)： Analysis of drugs  (GV01040Q) ,  Interactions of drugs  (GV01070X)

Substance index (2)： Ceftriaxone ,  Ro11-8390

Reference (10)：

• 1) Ceftriaxone sodium［‘Rocephin’］for injection: FDA MedWatch, FDA ALERT (Healthcare Professional Sheet) (Internet). 2007. (accessed 2015 Jul 27) Available from: http://www.nihs.go.jp/dig/sireport/weekly5/19070920.pdf
• 2) Food and Drug Administration. Information for healthcare professionals: ceftriaxone (marketed as Rocephin and generics) (Internet). 2009. (accessed 2015 Jul 27) Available from: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm084263.htm
• 3) Schmutz HR, Detampel P, Buhler T, et al. In vitro assessment of the formation of ceftriaxone-calcium precipitates in human plasma. J Pharm Sci. 2011;100:2300-2310.
• 4) Tange M, Yoshida M, Nakai Y, et al. Comparison between original and generic versions of ceftriaxone sodium preparation for injection: compatibility with calcium-containing product. Chem Pharm Bull. 2012;60:429-434.
• 5) Lambert PA, Conway BR. Pharmaceutical quality of ceftriaxone generic drug products compared with Rocephin^®. J Chemother. 2003;15:357-368.

Terms in the title (9)： 先発品 ,  セフトリアキソン ,  ロセフィン ,  日本 ,  後発品 ,  カルシウム塩 ,  析出 ,  不溶性微粒子 ,  夾雑物