Investigation of the physical, chemical and microbiological stability of hydrogels, creams and ointments of DAB and DAC

Thoma, K.; Holzmann, C.; Oberkoetter, E.

Pharmazie 53(6): 413-417


ISSN/ISBN: 0031-7144
Accession: 008913463

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There are no data about the physical, chemical and microbiological stability of the bases of hydrogels, creams, and ointments of the German Pharmacopoea (DAB 1997) and German Drug Codex (DAC), which would enable the assessment of their durability. Therefore the objective of this work was the investigation of the physical and chemical stability of 19 preparations after storage of 0, 3, 6, 9 and 12 months, in tubes and plastic jars without opening or working up. The microbiological stability was tested after 0, 3 and 9 months. The physical stability of most of the bases showed no or only little deviations with the exception of Glycerol Gel DAC in plastic jars and Cold Cream in tubes and plastic jars. Preparations preserved with sorbic acid/potassium sorbate showed partly high losses of sorbic acid, especially in plastic jars. The allowed peroxide value of the lipophilic ingredients was only exceeded in case of the Cold Cream without antioxidans before the expiration of 3 months. For none of the 19 investigated preparations a microbiological contamination could be detected under the chosen storage conditions, apart from insignificant exceptions. The results very significantly show the stabilizing effect of tube storing in many cases.