Volume 4

January-March 2012

Evaluation for safety assessment of formulated vanishing cream containing aqueous stevia extract for topical application

Kuntal Das, Raman Dang, Manjunath U Machale, Ugandar R E, Lalitha B R

Abstract:
In the present work, herbal vanishing cream based drug formulations (2.5% and 5.0%) were designed and prepared for the skin moisturizer with Stevia white extract. The creams were O/W emulsion based formulations containing suitable combination of oil phase and aqueous phase along with preservatives. Both the creams were non greasy, coolant and pearl like appearance. They were subjected to various physicochemical parameters i.e. pH, viscosity, spreadability, tube extrudability and drug content studies. Stability studies of creams were also done at different temperature for the period of 3 months as per ICH guideline and results revealed both the formulations showed good stability over control preparation. Amount of active constituent present, pH, spreadability, tube extrudability of the formulation were found to be 7.47 mg and 3.64 mg; 6.70-6.80, 16.11- 16.12 gm.cm/sec; 92.38% – 92.40 % for 5% and 2.5% Stevia cream respectively. Furthermore, both the formulations were studied for primary skin irritation test in rabbit and 30 numbers of healthy human volunteers for 48 hours and observed for skin rashes, inflammation, itching or redness on applied portions. Results revealed no adverse skin reactions with all the formulations. It was proved that vanishing cream containing Stevia extract is pleasant, effective, easily washable and completely safe for human use.

Keywords: Physicochemical Parameters, Patch Test, Stevia Extract, Skin Irritation.