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WO2012095459A1 - Composition contenant de l'acide acétique, de l'acide propanoïque, de l'acide butanoïque, de l'acide méthylpropanoïque et/ou de l'acide méthylbutanoïque - Google Patents

Composition contenant de l'acide acétique, de l'acide propanoïque, de l'acide butanoïque, de l'acide méthylpropanoïque et/ou de l'acide méthylbutanoïque Download PDF

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Publication number
WO2012095459A1
WO2012095459A1 PCT/EP2012/050378 EP2012050378W WO2012095459A1 WO 2012095459 A1 WO2012095459 A1 WO 2012095459A1 EP 2012050378 W EP2012050378 W EP 2012050378W WO 2012095459 A1 WO2012095459 A1 WO 2012095459A1
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WO
WIPO (PCT)
Prior art keywords
acid
active ingredients
composition according
composition
preparation
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/EP2012/050378
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German (de)
English (en)
Inventor
Albert Daxer
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Individual
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Individual
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Publication of WO2012095459A1 publication Critical patent/WO2012095459A1/fr
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115—Fatty acids or derivatives thereof; Fats or oils
    • A23L33/12—Fatty acids or derivatives thereof
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/30—Dietetic or nutritional methods, e.g. for losing weight
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/06—Contraceptive devices; Pessaries; Applicators therefor for use by females

Definitions

  • the invention relates to a composition
  • a composition comprising one or more of the active ingredients acetic acid, propanoic acid, butanoic acid, methylpropanoic acid,
  • Methylbutanoic acid Some of these acids are known as feminine attractants.
  • a disadvantage of hormonal or oral contraceptives is that the mid-cycle vaginal mucus no longer reaches the secretory composition that exists in a mid-cycle fertile woman. This disorder can cause a significant restriction in the perception of women, even on a psychological level. Thus, the subjective attractiveness of the woman in the sense of a male counterpart is not increased, as is the case with a woman in the middle of the cycle who is conceivable. Due to the lack of these substances in the vaginal secretions, the vaginal flora can also be changed secondarily, which can lead to unfavorable germ colonization in the vagina, both bacterial and mycotic. Also, the beneficial concentration of other substances in the
  • Vaginal secretions may be disturbed, especially the pH value.
  • the described invention compensates for this disadvantage of oral contraceptives or restores or improves the normal physiological function.
  • FR 2124399 A describes a combination of fatty acids which exert a sexually stimulating effect in women who take oral contraceptives, mainly on the skin or superficially (topically) by their scent effect (evaporation) on the olfactory organ of the man and thus the deficiencies described above oral contraceptives.
  • This approach has, among other things, the following significant disadvantages:
  • the fatty acids described, or combinations thereof have such an unpleasant odor that a useful application as "more pleasant Even if they were a pleasant odorant, the evaporation does not occur evenly for each of the fatty acids, so the relative concentration constantly changes, which makes the specific effect unpredictable and predictable
  • the fatty acids at the physiological site of action (vaginal mucous membrane, vaginal secretions) occur in a specific, preferably cycle-dependent, concentration and there interact with certain substances of the physiological site of action - such as the physiological vaginal flora ( Lactobacillus acidophilus, L. iners, L. crispatus, L. delbruekii, L. jensenii, L. buchneri, L. gasseri and Bifidobacterium spp., Döderlein sticks, for example, also according to the Nugent score), the prevailing pH value ( eg between 3 and 5 or between 3.8 and 4.5), sugar
  • An object of the invention is the physiological concentration of fatty acids in the vagina of the woman, in particular with simultaneous administration of
  • contraceptive hormones e.g., progestogens, estrogens, testosterones.
  • the invention solves the problem with a composition comprising one or more of the active ingredients acetic acid, propanoic acid, butanoic acid, methylpropanoic acid, methyl butanoic acid for producing a physiological concentration thereof
  • compositions in the vaginal secretion of the woman (according to that of a fertile woman on her fertile days in the middle of her cycle), said composition being formulated for oral, rectal or vaginal administration.
  • the composition may in particular be solid (tablet, capsule, suppository) or gelatinous.
  • the composition may additionally contain contraceptive substances.
  • a contraceptive containing one or more hormones may be used for systemic administration as a tablet, capsule, drink, drinking juice,
  • Vaginalzäpfchen, rectal suppository, vaginal capsule or vaginal gel may be provided which contains one or more active substances according to the invention, which lead to a physiological concentration of fatty acids in the vagina.
  • active substances are e.g. Fatty acids such as acetic acid, propionic acid, butanoic acid,
  • Methylpropanoic acid methylbutanoic acid.
  • Tablet, capsule, drink, drinking juice, vaginal suppositories, rectal suppository or vaginal gel Depending on the nature of the systemic delivery and thus depending on the selective absorption, body-internal distribution and secretion behavior to each other, in the various dosage forms such. Tablet, capsule, drink, drinking juice, vaginal suppositories, rectal suppository or vaginal gel.
  • an oral contraceptive with hormonal action is meant.
  • Estrogens and progestins can be administered alone (each alone and without the other and independently) or together.
  • the effect is preferably at the systemic or central nervous level by influencing the hypothalamo-pituitary control loop.
  • the increased estrogen and / or gestagen concentration in the plasma leads to a decrease in gonadotropin release from the pituitary gland and to an inhibition of ovulation.
  • there are also other mechanisms of action For example, when administering low dose gestagens, the viscosity of the cervical mucus may be altered, thereby inhibiting sperm penetration. Ovulation is i.a. not inhibited.
  • chemical contraceptives such as spermicidal gels or creams may be included, which are applied in the vagina, such as applied. It would be advantageous to enable the relative distribution of the fatty acids at the physiological site of action of the recipient woman on a cycle-dependent basis, since a cycle-independent composition of the fatty acids may be counterproductive. It is therefore particularly effective if the concentration of the active ingredients occur cycle-dependent in the different dosage forms in different concentrations and / or concentration ratios, the
  • Composition so for different days of the cycle of the woman
  • the woman essentially takes a contraceptive dosage form (such as a pill) every day.
  • a contraceptive dosage form such as a pill
  • a particularly favorable effect is then achieved in that, for example, the pill (or another form of administration) for a particular cycle day has a different relative mixing ratio of the active substances to one another or a different concentration (in relation to the others
  • Constituents of the dosage form in the dosage form e.g., pill, tablet, etc.
  • Cycle day x is different from that which is determined for the day y, where x and y is selected from 0 to 31.
  • the concentration of the active ingredients can be adapted to the physiological course of the concentration of the active ingredients in the vaginal secretion without contraceptives and thus simulate a cycle-dependent behavior despite the use of contraceptives and so the physiology and
  • the product would then be eg a set of tablets or vaginal suppositories (eg 21) with different
  • compositions which may be present in the composition and which can exert a particularly favorable action alone or with one or more other active ingredients are magnesium or magnesium stearate, cellulose or microcrystalline cellulose, corn starch, calcium hydrogen phosphate, sodium starch glycolate, talc , Glycerin, lactose, polyethylene glycol, mannitol, lactic acid, calcium lactate, hypromellose, silica, macrogol stearate, hard fat, water, physiological saline, lactic acid, glycogen, levulinic acid
  • Methylcellulose Na Lactate, Na Hydroxide, Sodium, Potassium, Calcium, Aqua distillate, BSS (Balanced Salt Solution), Ringer's solution, Propylene, Hydroxypropyl, Gelatine or compounds in liquid, solid or gel form.
  • BSS Battery Salt Solution
  • Ringer's solution Propylene, Hydroxypropyl, Gelatine or compounds in liquid, solid or gel form.
  • each active ingredient or ingredient can be combined with any other ingredient and each dosage form.
  • Particularly advantageous are the combination of one or more substances of magnesium or magnesium stearate, cellulose or microcrystalline cellulose, corn starch, calcium hydrogen phosphate, sodium starch glycolate, talc, glycerol, lactose, polyethylene glycol, mannitol with one or more active ingredients of acetic acid, propionic acid, Butanoic acid, methylpropanoic acid, methylbutanoic acid.
  • magnesium or magnesium stearate cellulose or microcrystalline cellulose
  • corn starch calcium hydrogen phosphate
  • sodium starch glycolate sodium starch glycolate
  • talc talc
  • glycerol glycerol
  • lactose polyethylene glycol
  • mannitol with one or more active ingredients of acetic acid, propionic acid, Butanoic acid, methylpropanoic acid, methylbutanoic acid.
  • microcrystalline cellulose materials corn starch, lactose, lactic acid, calcium lactate, hypromellose, silicon dioxide,
  • Additional substances should preferably be used individually or in combination with one or more active substances of acetic acid, propionic acid, butanoic acid,
  • Methylpropanoic acid, methyl butyric acid are present together in a dosage form. These other additives are said to be odoriferous
  • Fatty acid does not directly on the olfactory organ of third parties come into effect, and lead to the best possible systemic absorption and distribution in the body.
  • the transport or unfolding of the active ingredients acetic acid, propionic acid,
  • Acetic acid, propionic acid, butyric acid, methylpropanoic acid, methyl butanoic acid and the above-mentioned active ingredients in the described dosage forms may also be mixed with flavoring agents or other friendlier odors.
  • flavorings may be eucalyptus, raspberry, strawberry, apple or other fruit, herbs or leaves or extracts.
  • each of these dosage forms (preparations) of the composition according to the invention one or more of the above
  • contraceptive agents are preferably hormones such as estrogens (e.g., ethinyl estradiol, estradiol, estrone, estriol, mestranol, etc.) or their analogs or their derivatives and / or
  • Norgestrel, etc. or their analogues or their derivatives or, under certain conditions, also testosterone or its analogues or their derivatives.
  • one or more active substances may also be administered separately from the contraceptive substances or even be administered without contraceptive substances - that is to say in the case of the recipient woman.
  • contraceptive substances may also be administered separately from the contraceptive substances or even be administered without contraceptive substances - that is to say in the case of the recipient woman.
  • contraceptive substances only about 60-70% of women in the population produce these substances in the vaginal mucosa or vaginal secretions in a suitable composition. Therefore, the combination of the active ingredients is also particularly advantageous
  • Contraceptives with barrier effect either by application to or incorporation into the barrier (e.g., cervical cap or
  • Vaginal diaphragm or spiral or pessary Vaginal diaphragm or spiral or pessary.
  • the described active ingredients are in any combination, preferably common ingredients with contraceptive substances, in various dosage forms, preparations or preparations such as tablet, capsule, drink, drinking juice, vaginal suppositories, rectal suppository,
  • Vaginal capsule or vaginal gel formulated.
  • the relative composition of the active ingredients in volume or weight percent at the site of action when administering the preparation and / or in the dosage form (preparation) is preferably: Acetic acid 50% to 100%
  • Composition be as follows:
  • administered preparation vary.
  • concentration of active ingredients at the site of action in the preparation at the beginning of the cycle e.g. in the case of preparations 1 to 9 (days 1 to 9 of the real or simulated cycle) between 90 and 100% and in the middle of the cycle (for example preparations 10 to 20) between 70 and 85% for the acetic acid.
  • this variation in propanoic acid is said to be between 0 and 10% for the beginning and 10 to 20% for the middle, for butanoic acid between 0 and 3% for the beginning and 3 to 6 and 8% for the middle, respectively
  • Methylpropanoic acid between 0 and 0.5% for the beginning and 0.5 to 1% for the middle and for the methyl butanoic acid between 0 and 1, 5% at the beginning and 1 to 3% in the middle amount.
  • any period between Day 1 and Day 10 may be selected as the beginning.
  • Day 1 to Day 8 or 9 is particularly advantageous.
  • the middle can be any period between day 10 and 25. Particularly advantageous is day 10 to 18 or 19 or 20 or 21.
  • There is therefore a set of a number of daily single doses of the preparation e.g., 21
  • the active ingredients in constant or variable concentration from single dose to single dose (single dosage form, e.g., tablet or vaginal suppository). This can be done together or without additional contraceptive substances in the preparation.
  • the volume or weight fraction of the sum of the active ingredients in the contraceptive or in a dosage form without contraceptive substances such as for
  • the volume or weight fraction of the active ingredients should not exceed 5%. It is preferably less than 1% and ideally less than 0.1% or, depending on the other ingredients, less than 0.01%.
  • the volume or weight content of the active ingredients in the mixture with the liquid base substance can be between 1% and 5%, between 0.1% and 1% or between 0.01% and 0.1%, depending on the application. About 0.08%, 0.04% or even 0.005% or less.
  • active ingredients, additives or contraceptive substances are incorporated into the preparation so that the active ingredients, additives or Contraceptive substances mutually influence each other as far as possible, not negatively or positively.
  • the direct odor effects of the active ingredients should be eliminated or at least greatly reduced insofar as active substance molecules or at least a relevant number of them can not escape from the preparation into the environment during or before administration. This can be achieved, inter alia, by binding them to one or more of the additives which change the vapor pressure of these compounds so strongly (for example, to lower them) in order to prevent them from diffusing out of the preparation.
  • additives can be attached to the drug molecules so that they lose their direct odor effect.
  • the active ingredients in the preparation can be arranged so that they preferably do not come to rest in or near the surface of the preparation.
  • an additive barrier against the diffusion of the active ingredients through the surface can be achieved. It can therefore be achieved by additives a barrier against the diffusion of active ingredient molecules from the preparation, if, for example, the active ingredients are arranged inside the preparation (active ingredient core) and the (blocking) additives in the outer or surface area.
  • the active ingredients can be both homogeneous, and inhomogeneous in the interior
  • a layered or layered arrangement of various active ingredients and additives may also be advantageous, so that a stepwise or selective release of the active ingredients is achieved during manipulations of the preparation degradable or deformable when the temperature is increased (thermi changeable or degradable), if a certain pH prevails (eg between 3.8 and 4.5), certain bacteria are present (eg vaginal, oral or intestinal flora), certain other substances are present (eg hormones - progestogens, estrogens, tesosterone,
  • Preparation be incorporated.
  • the amount of active ingredient per application depending on the dosage form (tablet, suppository, etc.), e.g. between 0.5 g to 4 g, less than 500 mg, ideally less than 100 mg.
  • Composition of the invention between 0.1 mg and 0.2 mg, between 0.1 and 2 mg and between 1 mg and 40 mg.
  • composition according to the invention is intended for non-therapeutic use, namely the active ingredients acetic acid, propanoic acid, butanoic acid, methylpropanoic acid, and / or methyl butanoic acid in
  • composition according to the invention as
  • Medicaments for therapeutic purposes to use namely the active ingredients acetic acid, propionic acid, butyric acid, methylpropanoic acid, and / or
  • Methylbutanoic acid in the vaginal secretion of the woman to increase, and thus the
  • the vaginal flora predominantly consists of various types of lactic acid bacteria, the so-called Döderlein bacteria, as already explained above. However, if their number decreases, this also leads to a lower acidity, ie a higher pH value. This means a considerable reduction of the natural protection, which makes it much easier to overgrow the physiological germs that are desired with non-physiological germs (pathogenic germs such as bacteria or bacteria) Mushrooms) can come. The number of physiological germs can be reduced, for example due to taking birth control pills or antibiotics.
  • Physiological is used here in the sense of "normal, occurring in healthy people, not pathological". Accordingly, “non-physiological” or “pathological” refers to a departure from the normal, or desirable, state in a healthy person.
  • composition according to the invention is not only the restoration of the physiological conditions in the vaginal environment of the woman, but also secondarily the correction of the psychological consequences up to the cancellation of depressive moods, improvement of the mental

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  • Health & Medical Sciences (AREA)
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  • Polymers & Plastics (AREA)
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  • Animal Behavior & Ethology (AREA)
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  • Heart & Thoracic Surgery (AREA)
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  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

L'invention concerne une composition comprenant un ou plusieurs des principes actifs parmi lesquels figurent l'acide acétique, l'acide propanoïque, l'acide butanoïque, l'acide méthylpropanoïque et l'acide méthylbutanoïque pour générer une concentration physiologique de ces principes actifs dans les sécrétions vaginales de la femme. Cette invention est caractérisée en ce que la composition est formulée pour une administration par voie orale, rectale ou vaginale. La concentration physiologique d'acides gras peut ainsi être reconstituée dans le vagin de la femme, en particulier lors de l'administration concomitante d'hormones à effet contraceptif (telles que gestagènes, oestrogènes, testostérones).
PCT/EP2012/050378 2011-01-12 2012-01-11 Composition contenant de l'acide acétique, de l'acide propanoïque, de l'acide butanoïque, de l'acide méthylpropanoïque et/ou de l'acide méthylbutanoïque Ceased WO2012095459A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ATA38/2011 2011-01-12
AT382011 2011-01-12

Publications (1)

Publication Number Publication Date
WO2012095459A1 true WO2012095459A1 (fr) 2012-07-19

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PCT/EP2012/050378 Ceased WO2012095459A1 (fr) 2011-01-12 2012-01-11 Composition contenant de l'acide acétique, de l'acide propanoïque, de l'acide butanoïque, de l'acide méthylpropanoïque et/ou de l'acide méthylbutanoïque

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2124399A1 (fr) 1971-02-02 1972-09-22 Nat Res Dev
EP2008691A1 (fr) * 2007-06-29 2008-12-31 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Odorisants vaginaux

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2124399A1 (fr) 1971-02-02 1972-09-22 Nat Res Dev
EP2008691A1 (fr) * 2007-06-29 2008-12-31 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Odorisants vaginaux

Non-Patent Citations (5)

* Cited by examiner, † Cited by third party
Title
CURTIS R F ET AL: "Identification of primate sexual pheromones and the properties of synthetic attractants.", 6 August 1971, NATURE 6 AUG 1971 LNKD- PUBMED:4999879, VOL. 232, NR. 5310, PAGE(S) 396 - 398, ISSN: 0028-0836, XP002674200 *
GOLDFOOT D A ET AL: "LACK OF EFFECT OF VAGINAL LAVAGES AND ALIPHATIC ACIDS ON EJACULATORY RESPONSES IN RHESUS MONKEYS BEHAVIORAL AND CHEMICAL ANALYSES", 1976, HORMONES AND BEHAVIOR, VOL. 7, NR. 1, PAGE(S) 1-27, ISSN: 0018-506X, XP002674199 *
MICHAEL R P ET AL: "BEHAVIORAL EFFECTS OF A SYNTHETIC MIXTURE OF ALIPHATIC ACIDS IN RHESUS MONKEYS MACACA-MULATTA", 1977, HORMONES AND BEHAVIOR, VOL. 9, NR. 3, PAGE(S) 296-308, ISSN: 0018-506X, XP002674201 *
MICHAEL R P ET AL: "Differential effects on behaviour of the subcutaneous and intravaginal administration of oestrogen in the rhesus monkey (Macaca mulatta)", JOURNAL OF ENDOCRINOLOGY, SOCIETY FOR ENDOCRINOLOGY, GB, vol. 41, no. 2, 1 June 1968 (1968-06-01), pages 231 - 246, XP008150997, ISSN: 0022-0795, DOI: 10.1677/JOE.0.0410231 *
MICHAEL R P ET AL: "Influence of olfactory signals on the reproductive behaviour of social groups of rhesus monkeys (Macaca mulatta)", JOURNAL OF ENDOCRINOLOGY, SOCIETY FOR ENDOCRINOLOGY, GB, vol. 95, no. 2, 1 November 1982 (1982-11-01), pages 189 - 205, XP008150983, ISSN: 0022-0795 *

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