WO2006082596A2 - Preparations contraceptives a base d'herbes - Google Patents

Preparations contraceptives a base d'herbes Download PDF

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Publication number
WO2006082596A2
WO2006082596A2 PCT/IN2006/000016 IN2006000016W WO2006082596A2 WO 2006082596 A2 WO2006082596 A2 WO 2006082596A2 IN 2006000016 W IN2006000016 W IN 2006000016W WO 2006082596 A2 WO2006082596 A2 WO 2006082596A2
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WO
WIPO (PCT)
Prior art keywords
contraception
range
female subject
composition according
fertility
Prior art date
Application number
PCT/IN2006/000016
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English (en)
Other versions
WO2006082596A3 (fr
Inventor
Kamalinder Kaur Singh
Pratima Arun Tatke
Shruti Dhuru
Original Assignee
Kamalinder Kaur Singh
Pratima Arun Tatke
Shruti Dhuru
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Application filed by Kamalinder Kaur Singh, Pratima Arun Tatke, Shruti Dhuru filed Critical Kamalinder Kaur Singh
Publication of WO2006082596A2 publication Critical patent/WO2006082596A2/fr
Publication of WO2006082596A3 publication Critical patent/WO2006082596A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/58—Meliaceae (Chinaberry or Mahogany family), e.g. Azadirachta (neem)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/18—Feminine contraceptives

Definitions

  • the present invention relates to stable herbal, non-synthetic, Neem based intravaginal contraceptive formulations having high spermicidal activity. More particularly the present invention relates to Neem based contraceptive gel formulations (nano emulgels) and fast disintegrating and dispersible vaginal contraceptive tablets, which is free from any synthetic hormonal agents. The present invention further relates to process for preparation of said formulations and to a method of contraception in a female subject to prevent pregnancy.
  • the synthetic contraceptive agents available today for fertility control produces severe side effects such as hormonal imbalance, hypertension, increased risk of cancer, weight gain etc. Hence there is a need to replace these agents by safe and effective non synthetic agents such as plant based contraceptive agents.
  • Neem, Azadirachta indica, Family Meliaceae is a plant that has a long history of use. AU parts of the tree have medicinal uses. In India, Neem is sometimes called the 'village pharmacy' and has many traditional applications. The seed kernels yield a greenish yellow to brown, acrid; bitter fixed oil, known as oil of Margosa, having a strong and disagreeable odor resembling garlic. The oil has many therapeutic uses such as antiinflammatory, anti-bacterial, anti-pyretic, hypoglycemic and as anti-fertility properties and is used in various pharmaceutical products. Medicinal properties of the oil are attributed to the presence of bitter principles and odorous compounds.
  • Neem oil used as contraceptive is well known in the art. Intrauterine administration of Neem oil has been reported to produce antifertility effect in rodents and monkeys. Earlier experimental studies have also shown the contraceptive effect of intravaginal administration of Neem oil (Sinha et al 1984).
  • EP0472791 discloses compositions containing Neem oil for fertility control and prevention of pregnancy in females. Another modality is the use of these components in association with reetha extract as a vaginal cream applied locally to vagina. As a formulation, Neem has not been used alone but has been used in combination with reetha.
  • US5501855 discloses an alternative approach to vasectomy for long term male contraception following a single intra-vas. application of a traditional plant Azadirachta Indica product having immuno modulatory properties.
  • a male antifertility agent comprises Neem oil can be administered into the vas deferens to block the fertility in mammals was disclosed in GB2281511.
  • Neem seed extract in combination with reetha and quinine as cream formulation has also been reported as vaginal contraceptive (Garg et al 1993).
  • the degree of efficacy, a weak point in barrier methods is improved by the composition as compared to the Neem oil alone.
  • Neem formulations have also experienced acceptability problems in women as a result of the unpleasant odor of the oil. Fortunately, these problems are taken care of by the inventive formulations.
  • Nano emul gels have the advantage of being water miscible, water washable, easily spreadable, compatible with the aqueous vaginal environment and miscible with the vaginal fluid and non- irritant.
  • the sub-micronic particle size offers better stability than ordinary creams or emulgels and faster release of the active ingredients. So, the present invention provides intravaginal nano emulgel contraceptive formulations with better stability.
  • the method employs applying effective amount of Neem oil, in composition into the vagina to prevent conception.
  • Vaginal tablets are solid dosage forms for vaginal administration. They offer easy placement in the vagina by means of a plastic inserter, less messy and are easy to handle. Conventional vaginal tablets disintegrate slowly in the vagina and would not be suitable for incorporation of spermicidal agents, which require faster action. However, our present invention deals with fast disintegrating, non-messy, vaginal tablets for spermicidal activity. The method employs inserting fast disintegrating tablets comprising effective amount of Neem oil to prevent conception.
  • the present invention provides contraceptive emulgel formulation and intravaginal fast disintegrating tablet formulations which comprises effective amount of Neem oil, along with other suitable pharmaceutically acceptable excipients.
  • Another objective of the present invention is to provide fast disintegrating, non- messy vaginal tablets for spermicidal activity.
  • Still another objective of the invention is to provide a method for contraception in female subjects to prevent pregnancy.
  • the present invention discloses a stable non-synthetic Neem based contraceptive formulations having high spermicidal activity in the form of intravaginal nanoemulgel and fast disintegrating contraceptive vaginal tablets being free from hormones.
  • the present invention also discloses the process for preparation of said formulations.
  • the present invention also discloses a method of contraception in a female subject to prevent pregnancy
  • the present invention describes Neem based anti-fertility intravaginal nanoemulgel formulations having high spermicidal activity with better stability and fast disintegrating contraceptive vaginal tablets and process for preparation of said formulations. Further, the present invention describes a method of contraception in a female subject to prevent pregnancy.
  • an intravaginal nanoemulgel formulation with better stability Nanoemulgels have the advantage of being non- irritant, water miscible, and water washable, mucoadhesive, easily spreadable, compatible with the aqueous vaginal environment and miscible with the vaginal fluid.
  • the sub-micronic particle size offers better stability than ordinary creams or emulgels and faster release of the active ingredients. So, the present invention provides intravaginal nanoemulgel formulations for easy and non-messy application into the vagina.
  • the gel compositions of the present invention can also be used as lubricant in male and female condoms. Process for the formulation of nano emulgels:
  • Emulsion was prepared using Neem oil, SLS (sodium lauryl sulphate) and water. It was stirred for 2 hrs on an overhead stirrer and then homogenized on APV Lab High Pressure Homogenizer at 500 bars pressure for 2 to 4 cycles. Emulsion having a particle size in the range of 250-600 nm was obtained. The emulsion was then added to the already soaked gelling agents. The nano emulgel containing Carbopol Polycarbophil was then neutralized using 10% NaOH.
  • compositions are selected from thickeners, gelling agents and surfactants etc and more specifically from Carbopol940, Carbopol 971, Carbopol934P, polycarbophil, xanthan gum, HPMC, sodium CMC, Lutrol, carragenan, pectin, Pemulen and sodium lauryl sulphate.
  • Various gel formulations are prepared comprising Neem oil varying from 1% to 50%; sodium lauryl sulphate varying from 0.5% to 1.5%; and Carbopol 940NF 0.5% to 5% , Carbopol 934 P 0.5-5% Polycarbophil 0.5-5% Lutrol5 to 30%; HPMC varying from 1 to 5%; and xanthan gum 0.5 to 5%,Pemulen 0.5 to5% and combinations thereof to evaluate the efficacy; illustrating the invention are as follows.
  • pH The pH of the gels was found to be in the range of 4.5-5.5 compatible with the vaginal pH.
  • Mucoadhesion The mucoadhesive force was 4.97-8.70 gms.
  • Semen samples of healthy male volunteers were used for the study. The samples of motility more than 80% were used for the study. lO ⁇ l of sperm suspension and lO ⁇ l of the gels (1:1) were placed on a glass slide. Then it was mixed uniformly and examined under binocular microscope at a magnification of 1OX. With the help of stopwatch, the time for the cessation of motility of spermatozoa was studied. The motility of the sperms was observed at different time intervals.
  • the estrus cycle of the female rats was monitored for at least for two cycles before including the animal in the test group by obtaining daily vaginal smears.
  • the female rats were weighed and the vaginal smears were taken early in the morning, seven days a week. Few drops of saline in a dropper were inserted into the vagina, taking care not to touch the cervix. The saline was expelled into the vagina and withdrawn two or three times. The contents of the dropper were placed on a microscope slide. The cells (epithelial, cornified, leukocyte) of the smear were observed using a microscope and determine the estrous cycle of the female rat.
  • the nanoemulgels were administered intravaginally on the evening between the proestrous stage and the estrous stage, the female rats were kept for mating with the male rats since mating normally occurs on the night between the days of proestrous and estrous. The females were then isolated the next morning.
  • the female rats were then observed for pregnancy and number of litters after 21 days.
  • vaginal gels were administered intravaginally to the female rabbits and the female rabbits were allowed to mate with the male in the ratio of 1 : 1.They were then isolated and the number of pregnancies after a period of one month were recorded.
  • Vaginal tablets are solid dosage forms for vaginal administration. They offer easy placement in the vagina by means of a plastic inserter. They are less messy and easy to handle. Conventional vaginal tablets disintegrate slowly in the vagina and would not be suitable for incorporation of spermicidal agents, which require faster action.
  • Neem oil based vaginal tablets are prepared using Neem oil in the range of 1-50% and pharmaceutically acceptable excipients such as binders, fillers, lubricants, disintegrants, and diluents used in the range of 50-99%.
  • the pharmaceutically acceptable excipients are selected from lactose, aerosil, starch, micro crystalline cellulose, mannitol, dicalcium phosphate, dextrose, hydrolysed starch, cellulose derivatives, gelatin, polyvinyl pyrrolidone, starch paste, pregelatinized starch, sodium alginate, sorbitol, clays, cross liked PVP, stearic acid, talc, polyethelene glycol, surfactants, waxes and silica derivatives.
  • the fillers are selected from the group of lactose, microcrystalline cellulose, dextrose, mannitol, dicalcium phosphate, sorbitol calcium carbonate, magnesium oxide, magnesium carbonate, Aerosil, and the like in the range of 20-99%.
  • the binders are selected from the group of starch, polyvinyl pyrrolidone, sodium alginate,ethyl cellulose, pregelatinized starch, gelatin and the like.
  • the lubricants are selected from the group of stearic acid, talc, Magnesium stearate,
  • Aerosil polyethylene glycol and the like in the range 0.5-5%.
  • the disinitegrants are selected from the group of crosspovidone, crosscarmellose sodium, sodium starch glycolate, microcrystalline cellulose, starch, cross linked PVP and the likel-20%.
  • Process for the formulation of fast disintegrating contraceptive vaginal tablets The tablets are prepared in such a way that Neem oil is adsorbed onto Aerosil. Lactose and super disintegrant are added to it and mixed thoroughly. Granulation is done using PVP in alcohol till dough was obtained. The dough was passed through sieve number 10. The granules were then dried at 100°C for 3 hours. The dried granules were then passed through sieve number 16. To these granules, weighed amount of magnesium stearate was added. Talc was incorporated, mixed thoroughly and the blend was punched on a single punch machine.
  • the granules were evaluated for their bulk density; tapped density, angle of repose and the tablets were evaluated for uniformity of weight, hardness, disintegration time, friability and spermicidal activity.
  • Tap density was found to be 0.4166-0.420 g/cm 3 after 3 tappings and 0.4651-0.4657 g/cm 3 after 500 tappings.
  • Angle of repose was found to be in the range of 30-32°.
  • the tablets complied with test for uniformity.
  • the hardness of the tablets was found to be in the range of 2.5-3.5 kg/cm 2 when tested using the Monsanto hardness tester.
  • the Disintegration time of the tablets ranged from 7 seconds to 45 sees.
  • Spermicidal activity of the fast disintegrating vaginal tablets was carried out using the in vitro, Sander Crammer Immobilization test for determining the spermicidal activity. Semen samples of healthy male volunteers were used for the study. The samples of motility more than 80% were used for the study. lO ⁇ l of sperm suspension and lO ⁇ l of the suspension obtained from the tablet after disintegration (1:1) were placed on a glass slide. Then it was mixed uniformly and examined under binocular microscope at a magnification of 1OX. With the help of stopwatch, the time for the cessation of motility of spermatozoa was studied. The motility of the sperms was observed at different time intervals.
  • the partial immobilization began 1 minute after mixing the suspension of dispersible tablet with semen and spermicidal effect was found in 5 to 10 minutes depending on the vitality of the sperm.
  • the selected vaginal tablets were administered intravaginally to the female rabbits and the female rabbits were allowed to mate with the male in the ratio of 1 : 1.They were then isolated and the number of pregnancies after a period of one month were recorded.
  • the formulations showed anti-fertility effect in vivo in rabbits.
  • the formulations containing neem oil showed anti-fertility effect in vivo in rabbits as compared to the placebo formulations which delivered pups at the end of one month.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
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  • Gynecology & Obstetrics (AREA)
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Abstract

L'invention concerne des compositions anti-fertilité à base d'herbes non synthétiques, stables, présentant une activité spermicide élevée, destinées à l'administration intra-vaginale, comprenant de l'huile de neem ainsi que des excipients pharmaceutiquement acceptables sous forme posologique préparée de manière appropriée pour l'administration vaginale. L'invention concerne également une méthode de contraception chez une patiente destinée à empêcher la grossesse.
PCT/IN2006/000016 2005-01-19 2006-01-19 Preparations contraceptives a base d'herbes WO2006082596A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN57/MUM/2005 2005-01-19
IN57MU2005 2005-01-19

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WO2006082596A2 true WO2006082596A2 (fr) 2006-08-10
WO2006082596A3 WO2006082596A3 (fr) 2007-09-20

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007074478A1 (fr) * 2005-12-28 2007-07-05 Panacea Biotec Ltd Spermicide et dispositif contraceptif anti-infectieux innovants
CN102696696A (zh) * 2012-06-11 2012-10-03 四川农业大学 一种防治草原鼠害的草粉颗粒剂及制备方法和应用
WO2012151237A1 (fr) 2011-05-02 2012-11-08 Aptalis Pharmatech, Inc. Compositions de comprimés à dissolution rapide pour administration vaginale
CN104472515A (zh) * 2014-12-22 2015-04-01 成都绿金生物科技有限责任公司 家庭园艺用印楝素泡腾片及生产工艺
CN107343882A (zh) * 2016-05-06 2017-11-14 山西海清医疗器械有限公司 一种超大载药量水凝胶贴剂及其制备方法
US20200121589A1 (en) * 2017-06-22 2020-04-23 Viramal Limited Compositions for drug delivery and methods of use thereof
US12016953B2 (en) 2018-11-30 2024-06-25 Viramal Limited Method of preparing a gelling agent, the gelling agent obtained thereby, and the use of said gelling agent

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0472791A1 (fr) * 1990-08-29 1992-03-04 National Institute Of Immunology Compositions contenant de l'huile de margousier pour la régulation de la fertilité et la prévention de la grossesse
EP0930073A1 (fr) * 1998-01-14 1999-07-21 National Research Development Corporation of India Procédé de préparation d'un agent spermicide

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0472791A1 (fr) * 1990-08-29 1992-03-04 National Institute Of Immunology Compositions contenant de l'huile de margousier pour la régulation de la fertilité et la prévention de la grossesse
EP0930073A1 (fr) * 1998-01-14 1999-07-21 National Research Development Corporation of India Procédé de préparation d'un agent spermicide

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
GARG S ET AL: "Studies on the contraceptive efficacy of Praneem polyherbal cream" CONTRACEPTION, vol. 48, no. 6, 1993, pages 591-596, XP002389157 ISSN: 0010-7824 *
JOSHI SMITA N ET AL: "Phase I safety study of Praneem polyherbal vaginal tablet use among HIV-uninfected women in Pune, India." TRANSACTIONS OF THE ROYAL SOCIETY OF TROPICAL MEDICINE AND HYGIENE. OCT 2005, vol. 99, no. 10, October 2005 (2005-10), pages 769-774, XP002389158 ISSN: 0035-9203 *
RIAR S S ET AL: "ANTIFERTILITY ACTIVITY OF VOLATILE FRACTION OF NEEM OIL" CONTRACEPTION, vol. 44, no. 3, 1991, pages 319-326, XP002389156 ISSN: 0010-7824 *

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007074478A1 (fr) * 2005-12-28 2007-07-05 Panacea Biotec Ltd Spermicide et dispositif contraceptif anti-infectieux innovants
WO2012151237A1 (fr) 2011-05-02 2012-11-08 Aptalis Pharmatech, Inc. Compositions de comprimés à dissolution rapide pour administration vaginale
EP2704694A1 (fr) * 2011-05-02 2014-03-12 Aptalis Pharmatech, Inc. Compositions de comprimés à dissolution rapide pour administration vaginale
EP2704694A4 (fr) * 2011-05-02 2014-11-19 Aptalis Pharmatech Inc Compositions de comprimés à dissolution rapide pour administration vaginale
CN102696696A (zh) * 2012-06-11 2012-10-03 四川农业大学 一种防治草原鼠害的草粉颗粒剂及制备方法和应用
CN104472515A (zh) * 2014-12-22 2015-04-01 成都绿金生物科技有限责任公司 家庭园艺用印楝素泡腾片及生产工艺
CN107343882A (zh) * 2016-05-06 2017-11-14 山西海清医疗器械有限公司 一种超大载药量水凝胶贴剂及其制备方法
US20200121589A1 (en) * 2017-06-22 2020-04-23 Viramal Limited Compositions for drug delivery and methods of use thereof
US12016953B2 (en) 2018-11-30 2024-06-25 Viramal Limited Method of preparing a gelling agent, the gelling agent obtained thereby, and the use of said gelling agent

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