Čes. slov. farm. 2013, 62(2):95-98
Evaluation of the influence of sterilization method on the stability of carboxymethyl cellulose wound dressing
- 1 Veterinární a farmaceutická univerzita Brno, Farmaceutická fakulta, Ústav technologie léků, Brno
- 2 Lékárna Sfinx, Brno
- 3 Holzbecher spol. s r. o. barevna a bělidlo Zlíč, divize Holzbecher Medical
Carboxymethyl cellulose, especially its sodium salt, is a versatile pharmaceutical excipient. From a therapeutic point of view, sodium salt of carboxymethyl cellulose is used in the production of modern wound dressings to allow moist wound healing. Wound dressings must be sterile and stable throughout their shelf life and have to be able to withstand different temperature conditions. At the present time, a number of sterilization methods are available. In the case of polymeric materials, the selected sterilization process must not induce any changes in the polymer structure, such as polymer chains cleavage, changes in cross-linking, etc. This paper evaluates the influence of different sterilization methods (γ-radiation, β-radiation, ethylene oxide) on the stability of carboxymethyl cellulose and the results of long-term and accelerated stability testing. Evaluation of samples was performed using size-exclusion chromatography. The obtained results showed that ethylene oxide sterilization was the least aggressive variant of the sterilization methods tested. When the γ-radiation sterilization was used, the changes in the size of the carboxymethyl cellulose molecule occurred. In the course of accelerated and long term stability studies, no further degradation changes were observed, and thus sterilized samples are suitable for long term storage.
Keywords: carboxymethyl cellulose; sterilization; stability testing; size exclusion chromatography
Grants and funding:
Výsledky práce byly získány za finančního přispění TA ČR v rámci řešení projektu programu ALFA č. TA01010244.
Received: February 20, 2013; Accepted: March 7, 2013; Published: February 1, 2013 Show citation
References
- Wiegand C., Abel M., Ruth P., Wilhelms T., Schulze D., Norgauer J., Hipler U.-C. Effect of the sterilization method on the performance of collagen Type I on chronic wound parameters in vitro. Biomed. Mater. Res. Part B 2009; 90B, 710-719.
Go to original source... 
Go to PubMed... - Labarre D., Ponchel G., Vauthier C. Biomedical and Pharmaceutical Polymers. 1st ed. London: Pharmaceutical Press 2010.
- Bushell J. A., Claybourn M., Williams H. E., Murphy D. M. An EPR and ENDOR study of γγ- and ββ-radiation sterilization in poly(lactide-co-glycolide) polymers and microspheres. J. Control. Release 2005; 110, 49-57. Go to original source... Go to PubMed...
- Choi J. I., Lee H. S., Kim J. H., Lee K. W., Lee J. W. Seo S. J., Kang K. W., Byun M. W. Controlling the radiation degradation of carboxymethylcellulose solution. Polym. Degrad. Stabil. 2008; 93, 310-315. Go to original source...
- Fei B., Wach R. A., Mitomo H., Yoshi, F., Kume T. Hydrogel of biodegradable cellulose derivatives. I. Radiation-induced crosslinking of CMC. J. Appl. Polym. Sci. 2000; 78, 278-283. Go to original source...
- Liu P., Zhai M., Li J., Peng J., Wu J. Radiation preparation and swelling behavior of sodium carboxymethyl cellulose hydrogels. Rad. Phys. Chem. 2002; 63, 525-528. Go to original source...
- Lee H. S., Choi J. I., Kim J. H., Lee K. W., Chung Y. J., Shin M. H., Byun M. W., Shin M. G., Lee J. W. Investigation on radiation degradation of carboxymethylcellulose by ionizing irradiation. Appl. Radiat. Isotopes 2009; 67, 1513-1515. Go to original source... Go to PubMed...
- Choi J. I., Lee H. S., Kim J. H., Lee K. W., Chung Y. J., Byun M. W., Lee J. W. Effect of electron beam irradiation on the viscosity of carboxymethylcellulose solution. Nucl. Instrum. Meth. B 2008; 266, 5068-5071. Go to original source...
- Vetchý D., Frýbortová K., Rabišková M., Häring A. Testování stability léčivých přípravků. Chem. Listy. 2006; 100, 24-29.