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THE PHARMA REVIEW (MAR 2010)

“Formulation and Evaluation of Herbal Gel Containing Stevia Leaves Extract”

Kuntal Das, Raman Dang, Manjunath U Machale, Santosh Fatepuri

Abstract
The aim of this study was to formulate and evaluate the noble herbal moisturise gel containing Stevia extract. The cosmetic gel formulation was designed by using aqueous extract of Stevia rebaudiana leaves in varied concentrations (2.5%, 5.0% and 10.0%) and evaluated using physiological measurements. The gel was prepared by using various polymer bases (HPMC, Sodium CMC and Carbopol 934). Among them Carbopol 934 (Polymer grade) has given better gel formation at particular (1.0%) concentration. The gel was prepared by utilizing Carbopol 934, Stevia extract, Propylene glycol 400 (5%), Methyl paraben (0.5%), and required amount of distilled water. Finally skin pH (6.8-7.0) was maintained by drop wise addition of tri-ethanolamine solution. The physicochemical parameters of formulations SF-I to SF-III, i.e. pH, viscosity, spreadability, extrudability were found to be in the range of 6.89  0.20 – 6.98 0.12, 7853- 24580 cps (at different RPM using spindle # 7, 250C), 27.32- 30.03 % and 89.21- 91.73% respectively. Stability study have carried out as per ICH guideline for 3 months at different temperatures and results revealed formulation containing 2.5% Stevia extract showed comparatively better stability than other formulations and control sample. Further all the formulations have studied for toxicity and skin irritancy on animal model (Rabbit) before application to the human volunteers. Results show there were no toxicity and no skin irritation to the animals by evaluated various parameters (PDI scores of eythema/edema, behavioral observations, body weight determination, hematological & biochemical parameters and histopathological analysis)
when compared with control formulation.
 
Introduction
Herbals are the oldest form of primary healthcare which had been used by all cultures throughout history. It was an integral part of the development of modern civilization. Oflate Stevia is a plant which was originated from South America (Paraguay and Brazil), belongs to the family Compositae (Bertoni, 1905). The Asian markets consume over 85% of the global supply of the fluffy white crystalline Stevia extracts. The current extract market is 1.5 million kg, processed from 12 million kg of Stevia leaf and use for various preparations. Stevioside is one of the important active constituents which is abundantly available in the leaf of Stevia (5-10% of dry weight basis). The focus of the study is not only to substantiate Stevia’s effect as calorie substitute and sweetener but also to justify the multiple uses of stevioside in particular. Stevia acts as flavor enhancer and in medicinal field it has hypoglycemic, oral contraceptive, cardiovascular, antimicrobial activity. It is also used to weight loss, digestive and skin problems (Mourey, 1992; Ghosh et al., 2008 and Kuntal et al, 2009). There are scanty reports on Stevia as herbal gel preparation. A report on gel formulation containing 5, 10, 15 % crude Stevia extract and 5 and 10% of pure stevioside were prepared and their physical stability were established (Manosroi et al., 1999). Literature survey revealed that stevioside (active constituent of Stevia plant) is a useful potent drug (Shawn, 1949). Looking at that, in a part of Ph. D study, successful attempts have been made for the first time in India to establish only the role of Stevia as skin tonner. Hence various formulations were prepared from the cultivated Stevia in South India (Ripponpet, Shimoga Dist, Karnataka) and tested for pH, stability, viscosity, tonicity, spreadibility and other parameters. Further preclinical study was carried out and investigated toxicity and irritancy for safely study of gel formulations that will cover all the aspects of improving healthy skin.

 

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