eISSN: 1897-4309
ISSN: 1428-2526
Contemporary Oncology/Współczesna Onkologia
Current issue Archive Manuscripts accepted About the journal Supplements Addendum Special Issues Abstracting and indexing Subscription Contact Instructions for authors
SCImago Journal & Country Rank
5/2012
vol. 16
 
Share:
Share:
more
 
 
abstract:
Original paper

The physical and chemical stability of cisplatin (Teva) in concentrate and diluted in sodium chloride 0.9%

Agnieszka Karbownik, Edyta Szałek, Hanna Urjasz, Aleksandra Głęboka, Emilia Mierzwa, Edmund Grześkowiak

Wspolczesna Onkol 2012; 16 (5): 435–439
Online publish date: 2012/11/20
View full text
Get citation
ENW
EndNote
BIB
JabRef, Mendeley
RIS
Papers, Reference Manager, RefWorks, Zotero
AMA
APA
Chicago
Harvard
MLA
Vancouver
 
Aim of the study: The subject of study was the stability of cisplatin in concentrate in glass vials and diluted in polyethylene (PE) bags stored at 15–25°C for up to 30 days.

Material and methods: Original vials of cisplatin injection (1 mg/ml, Teva) were stored at room temperature and subjected to re-piercing after 1, 2, 3, 7, 14, 21, 28 and 30 days following the initial piercing. Cisplatin infusions at nominal concentrations of 0.1 mg/ml were prepared in 0.9% sodium chloride (1000 ml) in PE bags. Chemical stability was measured by means of a stability-indicating high-performance liquid chromatography (HPLC) assay. Physical stability was assessed by visual inspection in normal light.

Results: The concentration of cisplatin at each sampling time in the analysed solutions remained within 92.0–100.7% of initial concentration, regardless of the container. No changes in colour or turbidity were observed in any of the vials or prepared solutions.

Conclusions: Cisplatin, both undiluted in glass containers and diluted with NaCl 0.9% in PE bags, remains stable (< 10% degradation) for at least 30 days at room temperature when protected from light.
keywords:

cisplatin, stability, concentrate, infusion

references:

Hanigan MH, Devarajan P. Cisplatin nephrotoxicity: molecular mechanisms. Cancer Ther 2003; 1: 47-61.
  
Piulats JM, Jiménez L, García del Muro X, Villanueva A, Vin~als F, Germa`-Lluch JR. Molecular mechanism behind the resistance of cisplatin in germ cell tumours. Clin Transl Oncol 2009; 11: 780-6.
  
Miller RP, Tadagavadi RK, Ramesh G, Reeves WB. Mechanisms of Cisplatin nephrotoxicity. Toxins (Basel) 2010; 2: 2490-518.
  
Baskerville-Abraham IM, Boysen G, Troutman JM, et al. Development of an ultraperformance liquid chromatography/mass spectrometry method to quantify cisplatin 1,2 intrastrand guanine-guanine adducts. Chem Res Toxicol 2009; 22: 905-12.
  
Cepeda V, Fuertes MA, Castilla J, Alonso C, Quevedo C, Pérez JM. Biochemical mechanisms of cisplatin cytotoxicity. Anticancer Agents Med Chem 2007; 7: 3-18.

Gonzalez VM, Fuertes MA, Alonso C, Perez JM. Is cisplatin-induced cell death always produced by apoptosis? Mol Pharmacol 2001; 59: 657-63.
  
Sewell G. Physical and chemical stability of cisplatin infusions in PVC containers. EJOP 2010; 4: 11-3.
  
Pujol Cubells M, Prat Aixela J, Girona Brumos V, Duran Pou S, Villaronga Flaque M. Stability of cisplatin in sodium chloride 0.9% intravenous solution related to the container’s material. Pharm World Sci 1993; 15: 34-6.

Allwood M, Stanley A, Wright P. The cytotoxics handbook. Radcliffe Publishing, Abingdon 2002; 286-9, 414-6, 426-7.

Zieske PA, Koberda M, Hines JL, Knight CC, Sriram R, Raghavan NV, Rabinow BE. Characterization of cisplatin degradation as affected by pH and light. Am J Hosp Pharm 1991; 48: 1500-6.

Hrubisko M, Mc Gown AT, Prendiville JA, Radford JA, Thatcher N, Fox BW. Suitability of cisplatin solutions for 14-day continuous infusion by ambulatory pump. Cancer Chemother Pharmacol 1992; 29: 252-5.

Mittner A, Vincze Z, Jemnitz K. Stability of cisplatin containing infusion. Pharmazie 1998; 53: 490-2.

Pujol Cubells M, Prat Aixela J, Girona Brumos V, Duran Pou S, Villaronga Flaque M. Stability of cisplatin in sodium chloride 0.9% intravenous solution related to the container’s material. Pharm World Sci 1993; 15: 34-6.

Rochard E, Barthes D, Courtois P. Stability of cisplatin in ethylene vinylacetate portable infusion-pump reservoirs. J Clin Pharm Ther 1992; 17: 315-8.

Lecompte D, Bousselet M, Gayrard D, Poitou P. Stability study of reconstituted and diluted solutions of calcium folinate. Pharm Ind 1991; 53: 90-4.

Astier A, Pinguet F, Vigneron J. The practical stability of anticancer drugs: SFPO and ESOP recommendations. EJOP 2010; 4: 4-6.

Bardin C, Astier A, Vulto A, et al. Guidelines for the practical stability studies of anticancer drugs: a European consensus conference. Ann Pharm Fr 2011; 69: 221-31
Quick links
© 2018 Termedia Sp. z o.o. All rights reserved.
Developed by Bentus.
PayU - płatności internetowe