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Pharm World Sci. 1997 Aug;19(4):197-201.

Stability of nystatin in mouthrinses; effect of pH temperature, concentration and colloidal silver addition, studied using an in vitro antifungal activity.

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Pharmacy Service, Jean Verdier Hospital AP-HP, Bondy, France.


Alkaline low concentration nystatin mouthrinses extemporanely prepared can be used to treat oropharyngeal candidiasis in immunodeficient patients. However, their expiration dates are not distinctly determined. The stability of nystatin, added (as Mycostatine) at a concentration of 14,400 U/ml in 10-4N hydrochloric acid, purified water and 1.4% injectable sodium hydrogen carbonate with or without 0.002% colloidal silver (an antiseptic agent added because of its known antifungal potency) was studied after storage in tinted glass bottles at 5 degrees C and 22 degrees C over 11 days, and compared with reconstituted 100,000 U/ml aqueous Mycostatine oral suspension. At 2, 4, 7, 9, and 11 days after preparation. Samples were tested for pH, microbial contamination, and assayed by an in vitro microbiological test. Neither significant variation of pH nor microbial contamination were in evidence. Nystatin 14400 U/ml maintained at least 90% of its initial concentration for 4 days in acid at both temperatures, for 7 days (5 degrees C) and 4 days (22 degrees C) in aqueous and alkaline environments, for 9 days (5 degrees C) and 7 days (22 degrees C) in 1.4% injectable sodium hydrogen carbonate containing colloidal silver which showed an antifungal potency. The 100,000 U/ml aqueous Mycostatine oral suspension was stable for 9 days and 4 days at 5 degrees C and 22 degrees C respectively. An ambulant patient can keep a low concentration alkaline antifungal mouthrinse at home for a week at 5 degrees C.

[Indexed for MEDLINE]

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