PHARMACEUTICAL DEVELOPMENT AND COMPATIBILITY STUDIES ON CYTARABINE INJECTION

Authors

  • Noveen Konda
  • Prashanth P
  • Arvind G
  • Sumit Shah

Abstract

The aim of present work was to develop a stable Cytarabine injectable formulation for the treatment of various cancers. Cytarabine is freely soluble and stable in water. Different compatibility studies of Cytarabine formulation was carried out. The fluororesin coated chlorobutyl rubber stopper was given least % impurities as compare to bromobutyl and teflon coated rubber stoppers. The platinum cured silicon tubing of Masterflex was observed the best suitable tubing in terms of % impurities. The filter made of the Polyethersulfone (PES) was compatible with Cytarabine formulation in terms of % impurities and loss of drug during filtration. Thermal cycling was performed at 40°C for 4 days and there was found that there was no significant decrease in assay and related substances. Filter validation was carried out with PES capsule filter and it was found to be compatible with Cytarabine formulation. Chemical stability of Cytarabine formulation with infusion solutions was performed and (0.9% NaCl, 5% Dextrose & Water) it was observed that the final solution for injection was stable after 5 days. Osmolality of the Cytarabine injection with 0.9% sodium chloride & 5% dextrose was performed and it was found to be optimum for injectable formulation.

 

Key words: Cytarabine, Compatibility, Container closure, Filter validation.

References

Wang WS, Tzeng CH, Chiou TJ, et al. High-dose cytarabine and mitoxantrone as salvage therapy for refractory non-Hodgkin's lymphoma. Jpn. J. Clin. Oncol. 1997; 27 Suppl 3: 154–57.

Perry, Michael J. The Chemotherapy source book, Philadelphia; 2008. p. 80 - 90.

Lemke, Thomas L, Williams, David H, Foye, William O. Foye's principles of medicinal chemistry. Hagerstwon; 2002. p. 963 - 75.

The prescribing information provided by Pfizer Labs, http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1315f89d-f530-4dff-98e5-27d51617d4a1, Accessed April 2012.

The prescribing information provided by Bedford Laboratories, http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8bfe6bb4-b240-440e-83b4-64b03d62e073, Accessed August 2009.

Kostecka D, Duncan MR and Wagenknecht D. Formulation of a stable parenteral product; Clonidine Hydrochloride Injection, PDA J Pharm Sci Technol. 1998; 52 Suppl 6 : 320-25.

Selina Hines and Steve Pleasance. Compatibility of injectable hydromorphone formulations with typical diluents, components of giving sets and drugs for potential co-administration, EJHP Praticel. 2011; 17 Suppl 3: 47-53.

Xiaolin (Charlie) Tang and Michael J.Pikal. Design of freeze-drying processes for pharmaceuticals, practical advice, Pharmaceutical Research.2004, (21, Suppl 2):191-200.

Sunil kumar panda, Subas Chandra Dinda. Formulation and in-vitro evaluation of Clopidogrel bisulphate in parenteral dosage form using Lyophilization technique. IJPRBS 2012; 1 Suppl 5: 436-55.

Gopal Krishna, William F. Hodnick, Wengsheng Lang. Pharmaceutical Development and Manufacturing of a Parenteral Formulation of a Novel Antitumor agent, VNP4010M. AAPS Pharm sci Tech, 2001; 14 (2, Suppl 3): 1-9.

Sunitha S, Amareshwar P, Santhosh kumar M. a study on the effect of different cellulose polymers on release rate from tramadol loaded microspheres prepared by emulsion solvent evaporation method, Asian Journal of Pharmaceutical and clinical research; 2010 3 Suppl 4: 35-39.

John Bennan, Frank Bing, Heather Boone, Jim Fernandez. Evaluation of Extractables from Product-Contact Surfaces, Bio Pharm International; 2002. p. 22-34.

http://wine.appstate.edu/sites/wine.appstate.edu/files/Bubble%20Point%20Test.pdf, Accessed 2010.

Meor Mohd Affandi, T Julianto, ABA Majeed. Development and stability evaluation of Astaxanthin Nanoemulsion, Asian Journal of Pharmaceutical and clinical research; 2011 4 Suppl 1: 142-48.

Published

2013-07-01

How to Cite

Konda, N., P. P, A. G, and S. Shah. “PHARMACEUTICAL DEVELOPMENT AND COMPATIBILITY STUDIES ON CYTARABINE INJECTION”. Asian Journal of Pharmaceutical and Clinical Research, vol. 6, no. 3, July 2013, pp. 142-5, https://innovareacademics.in/journals/index.php/ajpcr/article/view/136.

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