Evaluation of the influence of sterilization method on the stability of carboxymethyl cellulose wound dressing

Česká verzia

Authors: Jan Muselík; Lenka Wojnarová; Ruta Masteiková; Tomáš Sopuch
Authors place of work: Veterinární a farmaceutická univerzita Brno, Farmaceutická fakulta, Ústav technologie léků ¹; Lékárna Sfinx, Brno ²; Holzbecher spol. s r. o. barevna a bělidlo Zlíč, divize Holzbecher Medical ³
Published in the journal: Čes. slov. Farm., 2013; 62, 95-98
Category: Původní práce

Summary

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

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