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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
inhuman 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.
Keywords
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References
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- Synergistic spermicidal activity of Neem seed extract, Reetha saponins and quinine hydrochloride.Contraception. 1993; (Submitted)
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- Dermal toxicity.in: Appraisal of the safety of chemicals in foods, drugs and cosmetics Editorial Committee of the Association of Food and Drug Officials of the United States. 1959: 3425 (York: PA, 17402)
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Article info
Publication history
Accepted:
September 29,
1993
Received:
August 24,
1993
Identification
Copyright
© 1993 Published by Elsevier Inc.
