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  • Title: Studies on the contraceptive efficacy of Praneem polyherbal cream.
    Author: Garg S, Taluja V, Upadhyay SN, Talwar GP.
    Journal: Contraception; 1993 Dec; 48(6):591-6. PubMed ID: 8131399.
    Abstract:
    Praneem polyherbal cream, a spermicidal formulation, has been developed at the National Institute of Immunology, which makes use of Praneem, a purified extract from the dried seeds of an ancient Indian plant Azadirachta indica (Neem), extract from the pericarp of fruits of Sapindus species and quinine hydrochloride. These ingredients have a synergistic spermicidal activity and an optimised formula was derived. The components were made into a water-soluble cream base prepared by using pharmaceutically acceptable base and stabilised by addition of IP grade antioxidant and preservatives. The cream is devoid of irritation and sensitization potential, as seen with standard Draize test on normal and abraded skin of rabbits and by 21-day cumulative skin sensitivity in human volunteers. The formulation was found to be safe under subacute toxicity studies in monkeys. The formulation has shown high contraceptive efficacy in rabbits and in monkeys after intravaginal application. The shelf-life of the cream at room temperature is estimated to be 18 months by accelerated stability studies. In India, the National Institute of Immunology has developed Praneem polyherbal cream as a vaginal spermicide. Scientists combined a purified extract from the dried seeds of an ancient Indian plant Azadirachta indica (Neem), extract from the pericarp of fruits of Sapindus species, and quinine hydrochloride with a pharmaceutically acceptable base to make a water-soluble cream base. They added IP grade antioxidant and preservatives to stabilize the cream base. They applied the cream on a shaved or abraded part of the skin of human volunteers and rabbits and inserted it into the vagina of Bonnet monkeys to test for sensitivity and irritation. They studied the dissolution characteristics of the cream after intravaginal application in the rabbits and monkeys. They compared pregnancy rates of monkeys who received intravaginal application of 2 ml cream every day with those of control monkeys. Praneem polyherbal cream did not irritate the skin of the rabbits or the human volunteers. The accelerated stability studies found the shelf-life of the cream at room temperature to be 18 months. The cream dissolves entirely within 30 minutes in the vaginal secretions of the rabbits and 40 minutes in those of the monkeys. Precoital application of the cream provided complete protection against pregnancy in rabbits in the 1st 30 minutes after application. The conception rate was acceptable at 60 minutes (7%), but thereafter it climbed to unacceptable levels (28.6% at 90 minutes and 75% at 12 hours). The conception rate of monkeys who received precoital application of Praneem polyherbal cream was only 2.27%. These results suggest that Praneem polyherbal cream can protect against pregnancy without causing irritation. Its antimicrobial properties provide another advantage.
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