WO1997003676A1 - Novel pharmaceutical formulation of dehydroepiandrosterone for percutaneous topical application - Google Patents

Novel pharmaceutical formulation of dehydroepiandrosterone for percutaneous topical application Download PDF

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Publication number
WO1997003676A1
WO1997003676A1 PCT/ES1996/000153 ES9600153W WO9703676A1 WO 1997003676 A1 WO1997003676 A1 WO 1997003676A1 ES 9600153 W ES9600153 W ES 9600153W WO 9703676 A1 WO9703676 A1 WO 9703676A1
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WIPO (PCT)
Prior art keywords
formulation
dehydroepiandrosterone
glycolic
dhea
ingredients
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Application number
PCT/ES1996/000153
Other languages
Spanish (es)
French (fr)
Inventor
José CABO SOLER
Jesús CALDERON GOMEZ
Santiago PALACIOS GIL-ANTUÑANO
Original Assignee
Cabo Soler Jose
Calderon Gomez Jesus
Palacios Gil Antunano Santiago
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Application filed by Cabo Soler Jose, Calderon Gomez Jesus, Palacios Gil Antunano Santiago filed Critical Cabo Soler Jose
Priority to AU64196/96A priority Critical patent/AU6419696A/en
Publication of WO1997003676A1 publication Critical patent/WO1997003676A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A61Q19/06—Preparations for care of the skin for countering cellulitis
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
    • A61K31/5685—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone having an oxo group in position 17, e.g. androsterone
    • 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
    • A61K36/02—Algae
    • A61K36/03—Phaeophycota or phaeophyta (brown algae), e.g. Fucus
    • 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
    • A61K36/16—Ginkgophyta, e.g. Ginkgoaceae (Ginkgo family)
    • 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)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • 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)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • 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)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • 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)
    • A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/06—Tripeptides
    • 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
    • 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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
    • A61K8/04—Dispersions; Emulsions
    • A61K8/042—Gels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/63—Steroids; Derivatives thereof
    • 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
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin

Definitions

  • the present invention falls within the technical field of hormonal therapy for the maintenance of certain vital functions that deteriorate with age or the treatment of various metabolic or degenerative diseases. More specifically, the present invention relates to a new form of presentation of dehydropediandrosterone (DHEA) intended for percutaneous topical application.
  • DHEA dehydropediandrosterone
  • DHEA Dehydroepiandrosterone
  • the present invention refers to a new pharmaceutical formulation of dehydroepiandrosterone intended for percutaneous topical application.
  • the applicant has been able to verify, after his investigations, that steroid hormones and, in particular, dehydroepiandrosterone are well absorbed topically, fundamentally, percutaneously. Therefore, as a result of this finding, the inventors propose a new form of pharmaceutical presentation of dehydroe ⁇ piandrosterone, as a gel, emulsion or solution intended for percutaneous application.
  • This type of application allows to reach, in blood, the most convenient levels for each problem (either replenish the physiological levels of other phases of life or raise them).
  • the formulation may comprise, in addition to ingredients (a) and (b) other hydrophilic gels, selected from glycolic, hydro-glycolic, hydroglycerolate, hydroalcoholic and hydropropylene glycol in similar proportions of 0.5-2% carbopol and other ingredients assets selected from 0.02-0.1% estradiol, 0.05-1% Vitamin E, 0.1-5% Vitamin C, 2-5% progesterone, 1-3% minoxidil, 0, 1-2% of tricosaccharides and tricopeptides, 0.1-5% of xanthic bases, 0.1-20% of iodinated products, 100-2000 U% of hyaluronidase, 0.1-12% of vasoprotective and capillary agents , 0.1-2% dinitrilesuccinic, 0.1-5% glycolic and hydroalcoholic extracts of capsicum and arnica, 0.1-0.75% camphor,
  • the formulation of the invention can be presented in any form suitable for percutaneous application, such as gel, emulsion, lotion, ointment, paste, dermal diffusion patch, etc.
  • the formulation is applied in a predetermined amount by rubbing over an area of the skin with good circulation (preferably the arms, forearms, abdomen, etc.) 1 to 3 times a day.
  • the optional active ingredients depend on the type of final utility that is intended to be given to the formulation.
  • DHEA In controlling the disorders of the female menstrual cycle and as a preventive of breast and gynecological malignancies, DHEA will be associated, in any of the ways described above, with estrogens (mainly estradiol, estrone and its derivatives) with a concentration of estradiol or equivalent of 0.02-0.1%. This neutralizes some of the negative effects of estrogen itself.
  • estrogens mainly estradiol, estrone and its derivatives
  • these preparations will be associated with Vitamin E (between 0.05 and 1%) and / or Vitamin C (between 0, one and 5%).
  • DHEA can be associated with Progesterone (between 2-5%) and / or with Minoxidil (between 1 and 3%), as well as with Tricosaccharides and tricopeptides (0.1-2%) for hair maintenance.
  • DHEA is associated with vasoprotective and capillary agents, both synthetic and naturally occurring (flavonoids, biflavonoids, anthocyanosides, procyanidoles and steroidal saponosides), especially glycolic and hydroalcocholic citrides (citrides) ) between 0.1-12%, the glycolic and alcoholic extracts of Ginko Biloba, between 0.1-15%, the glycolic and alcoholic extracts of Black and Red Currant, of Black Mirtilo and Red Vine between 0 , 1-15%.
  • DHEA can be associated with vesicant and rubefacient substances for topical therapies derived from congestion, hyperemias, bruises and muscle aches glycolic and hydroalcoholic extracts of capsicum and arnica between 0.1-5%; Camphor between 0.1-0.75%) and that of these substances with antipruritic substances (menthol, 0.01-0.5%, and glycolic and hydro-glycolic extract of Centella Asiatica, between 0.1-5% ).
  • DHEA can be associated with the natural (1-15%) or synthetic (0.1-5%) antiandrogens indicated above.
  • DHEA could be associated with any combination of the substances described in the previous sections.
  • This formulation can also be applied by dermal diffusion patches.
  • EXAMPLE 1 This Example illustrates various formulations according to the present invention, indicating the amounts of active ingredients used and the application to which they were intended: Formulation 1 DHEA 3%
  • Tricopeptides 1% This formulation is useful for the maintenance of axillary hair and hair as well as the treatment of certain forms of alopecia.
  • This formulation is useful for the treatment of congestion, hyperemias, bruises and muscle aches.

Abstract

The disclosed formulation is comprised of: (a) 0.1-5 % by weight of dehydroepiandrosterone; (b) 0.5-3 % of acrylic gel, 1-3 % of guar gum or 1-3 % of a gel derived from cellulose; and optionally other ingredients such as hydrophilic gels, estradiol, vitamines, progesterone, minoxydil, xantic bases, hyaluronidase, vasoprotectors, plant extracts, etc. The formulation has various pharmacological applications, for example for treating troubles in the feminine menstruation, mammary and gynaecological neoplasia, lipodystrophy, paniculopathy and circulatory troubles, bruises, muscular pain, obesity, diabetes, osteoporosis, ageing, etc.

Description

TITULO DE LA INVENCIÓN NUEVA FORMULACIÓN FARMACÉUTICA DE DEHIDROEPIANDROSTERONA PARA APLICACIÓN TÓPICA PERCUTANEA. CAMPO TÉCNICO DE LA INVENCIÓN La presente invención se encuadra dentro del campo técnico de la terapia hormonal destinada al manteni¬ miento de ciertas funciones vitales que se van deteriorando con la edad o al tratamiento de diversas enfermedades metabólicas o degenerativas. Más concretamente, la presente invención se refiere a una nueva forma de presentación de la dehidroe- piandrosterona (DHEA) destinada a su aplicación tópica percutánea. ESTADO DE LA TÉCNICA ANTERIOR A LA INVENCIÓN La Dehidroepiandrosterona (DHEA) es una hormona esteroidea de carácter androgénico, sintetizada por las glándulas suprarrenales y que se ha venido utilizando por via oral en el mantenimiento de determinadas funciones, que van deteriorándose con la edad, y en el tratamiento de diversas enfermedades metabólicas y degenerativas tales como la diabetes, la obesidad, la osteoporosis, ciertas neoplasias, artritis, artrosis y disminución de la activi¬ dad sexual, etc. TITLE OF THE INVENTION NEW PHARMACEUTICAL FORMULATION OF DEHYDROEPIANDROSTERONE FOR PERCUTANEOUS APPLICATION. TECHNICAL FIELD OF THE INVENTION The present invention falls within the technical field of hormonal therapy for the maintenance of certain vital functions that deteriorate with age or the treatment of various metabolic or degenerative diseases. More specifically, the present invention relates to a new form of presentation of dehydropediandrosterone (DHEA) intended for percutaneous topical application. STATE OF THE PRIOR ART OF THE INVENTION Dehydroepiandrosterone (DHEA) is an androgenic steroid hormone, synthesized by the adrenal glands and has been used orally in the maintenance of certain functions, which are deteriorating with age, and in the treatment of various metabolic and degenerative diseases such as diabetes, obesity, osteoporosis, certain neoplasms, arthritis, osteoarthritis and decreased sexual activity, etc.
Se han efectuado numerosos estudios con esta hormona y sus posibles aplicaciones. Burke, K.E. en Postgrad. Med., 85 (6), 52-58 y 67-73, expone un estudio sobre la pérdida del cabello y sus posibles causas, asi como su posible tratamiento con progesterona a la que se puede asociar DHEA. Ishihara y col. en Horm.Metab.Res. , 25 (1) , 34-36, 1993, publica un estudio acerca del papel de la dehidroepiandrosterona y del sulfato de dehidroepiandroste¬ rona para el mantenimiento del vello axilar en la mujer. Por su parte, Lufkin, E.G. y col. en Trends Endocrinol. Metab., 6, 50-54, 1995, hace un estudio acerca de la terapia postmenopáusica con estrógenos. Morales, A.J. y col. en J.Clin. Endocrinol . Metab., 78, 1360-1367, 1994 expone los efectos de las dosis de sustitución o reposición de dehidroepiandrosterona en hombres y mujeres de edad avanzada. Finalmente, puede mencionarse también un importante trabajo de Yamashita, A., acerca estudios farmacológicos de la aplicación intravaginal del sulfato de dehidroepiandrosterona, que se encuentra publicado en Nippon Yakurigaku.Zasshi, 98(1) .31-39, 1991. DESCRIPCIÓN DETALLADA DE LA INVENCIÓNThere have been numerous studies with this hormone and its possible applications. Burke, KE in Postgrad. Med., 85 (6), 52-58 and 67-73, presents a study on hair loss and its possible causes, as well as its possible treatment with progesterone with which DHEA can be associated. Ishihara et al. in Horm.Metab.Res. , 25 (1), 34-36, 1993, publishes a study about the role of dehydroepiandrosterone and dehydroepiandrosterone sulfate in maintaining axillary hair in women. On the other hand, Lufkin, EG et al. in Trends Endocrinol. Metab., 6, 50-54, 1995, makes a study about postmenopausal estrogen therapy. Morales, AJ et al. in J.Clin. Endocrinol Metab., 78, 1360-1367, 1994 exposes the effects of replacement or replacement doses of dehydroepiandrosterone in elderly men and women. Finally, an important work by Yamashita, A., on pharmacological studies of the intravaginal application of dehydroepiandrosterone sulfate, which is published in Nippon Yakurigaku.Zasshi, 98 (1) .31-39, 1991. DETAILED DESCRIPTION OF THE INVENTION
La presente invención, tal y como se expone en su enunciado, se refiere a una nueva formulación farmacéutica de dehidroepiandrosterona destinada a la aplicación tópica percutánea. El solicitante ha podido comprobar, después de sus investigaciones, que las hormonas esteroideas y, en particular, la dehidroepiandrosterona se absorben bien por via tópica, fundamentalmente, percutánea. Por tanto, como consecuencia de este hallazgo, los inventores proponen una nueva forma de presentación farmacéutica de la dehidroe¬ piandrosterona, como gel, emulsión o solución destinada a la aplicación percutánea. Este tipo de aplicación permite poder alcanzar, en sangre, los niveles más convenientes para cada problemática (bien sea reponer los niveles fisiológicos de otras fases de la vida o elevarlos) .The present invention, as set forth in its statement, refers to a new pharmaceutical formulation of dehydroepiandrosterone intended for percutaneous topical application. The applicant has been able to verify, after his investigations, that steroid hormones and, in particular, dehydroepiandrosterone are well absorbed topically, fundamentally, percutaneously. Therefore, as a result of this finding, the inventors propose a new form of pharmaceutical presentation of dehydroe¬ piandrosterone, as a gel, emulsion or solution intended for percutaneous application. This type of application allows to reach, in blood, the most convenient levels for each problem (either replenish the physiological levels of other phases of life or raise them).
La nueva formulación de la invención se caracteriza porque comprende como ingredientes esenciales:The new formulation of the invention is characterized in that it comprises as essential ingredients:
(a) 0,1 a 5% de dehidroepiandrosterona;(a) 0.1 to 5% dehydroepiandrosterone;
(b) 0,5 -3% de un gel acrilico (carbopol), goma-guar (1-3%) o un gel derivado de celulosa (1-3%); pudiendo comprender la formulación además de los ingredien¬ tes (a) y (b) otros geles de tipo hidrófilo, seleccionados entre glicólicos, hidroglicólicos, hidroglicerolatos, hidroalcohólicos e hidropropilenglicólicos en proporciones semejantes del 0,5-2% de carbopol y otros ingredientes activos seleccionados entre 0,02-0,1% de estradiol, 0,05-1% de Vitamina E, 0,1-5% de Vitamina C, 2-5% de progesterona, 1-3% de minoxidil, 0,1-2% de tricosacáridos y tricopép¬ tidos, 0,1-5% de bases xánticas, 0,1-20% de productos yodados, 100-2000 U% de hialuronidasa, 0,1-12% de agentes vasoprotectores y capilarotropos, 0,1-2% de dinitrilosucci- nico, 0,1-5% de extractos glicólicos e hidroalcohólicos de capsico y árnica, 0,1-0,75% de alcanfor, 0,01-0,5% de mentol y 0,1-5% de extractos de Centella Asiática y entre 1-15% de antiendrógenos naturales (Sabal. Serrulata y lúpulo) ó del 0,1-5% de antiandrógenos sintéticos como el acetato de ciproterona.(b) 0.5-3% of an acrylic gel (carbopol), guar gum (1-3%) or a cellulose derived gel (1-3%); The formulation may comprise, in addition to ingredients (a) and (b) other hydrophilic gels, selected from glycolic, hydro-glycolic, hydroglycerolate, hydroalcoholic and hydropropylene glycol in similar proportions of 0.5-2% carbopol and other ingredients assets selected from 0.02-0.1% estradiol, 0.05-1% Vitamin E, 0.1-5% Vitamin C, 2-5% progesterone, 1-3% minoxidil, 0, 1-2% of tricosaccharides and tricopeptides, 0.1-5% of xanthic bases, 0.1-20% of iodinated products, 100-2000 U% of hyaluronidase, 0.1-12% of vasoprotective and capillary agents , 0.1-2% dinitrilesuccinic, 0.1-5% glycolic and hydroalcoholic extracts of capsicum and arnica, 0.1-0.75% camphor, 0.01-0.5% menthol and 0.1-5% of Centella Asiatica extracts and between 1-15% of natural antiendrogens (Sabal. Serrulata and hops) or 0.1-5% of synthetic antiandrogens such as cyproterone acetate.
La formulación de la invención se puede presentar en cualquier forma adecuada para la aplicación percutánea, como por ejemplo gel, emulsión, loción, pomada, pasta, parche de difusión dérmica, etc.The formulation of the invention can be presented in any form suitable for percutaneous application, such as gel, emulsion, lotion, ointment, paste, dermal diffusion patch, etc.
Normalmente, la formulación se aplica en una cantidad predeterminada friccionando sobre una zona de la piel con buena circulación (preferentemente los brazos, antebrazos, abdomen, etc.) de 1 a 3 veces al dia.Normally, the formulation is applied in a predetermined amount by rubbing over an area of the skin with good circulation (preferably the arms, forearms, abdomen, etc.) 1 to 3 times a day.
Los ingredientes activos opcionales dependen del tipo de utilidad final que se pretenda dar a la formulación.The optional active ingredients depend on the type of final utility that is intended to be given to the formulation.
En el control de los desarreglos del ciclo menstrual femenino y como preventivo de neoplasias de mama y ginecológicas se asociará la DHEA, en cualquiera de las formas descritas anteriormente, con estrógenos (fundamen¬ talmente estradiol, estrona y sus derivados) con una concentración de estradiol o equivalente de 0,02-0,1% . Asi se neutralizan algunos de los efectos negativos de los propios estrógenos.In controlling the disorders of the female menstrual cycle and as a preventive of breast and gynecological malignancies, DHEA will be associated, in any of the ways described above, with estrogens (mainly estradiol, estrone and its derivatives) with a concentration of estradiol or equivalent of 0.02-0.1%. This neutralizes some of the negative effects of estrogen itself.
En los tratamientos que requieran una larga estabilidad de los preparados y/o una acción antirradicalar del producto, a estos preparados se les asociará Vitamina E (entre el 0,05 y el 1%) y/o la Vitamina C (entre el 0,1 y el 5%) .In treatments that require a long stability of the preparations and / or an anti-radical action of the product, these preparations will be associated with Vitamin E (between 0.05 and 1%) and / or Vitamin C (between 0, one and 5%).
En los tratamientos para mantener el vello axilar (especialmente en mujeres) y ciertas formas de alopecias la DHEA se puede asociar a la Progesterona (entre el 2-5%) y/o con Minoxidil (entre el 1 y el 3%), asi como con Tricosacáridos y tricopéptidos (del 0,1-2%) para el mantenimiento del cabello.In treatments to maintain axillary hair (especially in women) and certain forms of alopecia, DHEA can be associated with Progesterone (between 2-5%) and / or with Minoxidil (between 1 and 3%), as well as with Tricosaccharides and tricopeptides (0.1-2%) for hair maintenance.
Por esta via percutánea es igualmente útil asociar a los geles, emulsiones y soluciones de DHEA, ciertos productos que ayudan a controlar, a corregir y eliminar ciertas lipodistrofias, ya que la DHEA estimula la colagenasa, por lo que es conveniente asociarla a bases xánticas (entre 0,1-5%), productos yodados, que facilitan los intercambios osmóticos y la oxidación de ácidos grasos, tanto inorgánicos como orgánicos (extractos glicólicos e hidroalcohólicos de Fucus y Laminaria y de algas pardas fundamentalmente, entre el 0,1 y el 20%) .By this percutaneous route it is equally useful to associate DHEA gels, emulsions and solutions, certain products that help control, correct and eliminate certain lipodystrophies, since DHEA stimulates collagenase, so it is convenient to associate it with xanthic bases ( between 0.1-5%), iodized products, which facilitate osmotic exchanges and the oxidation of fatty acids, both inorganic and organic (glycolic and hydroalcoholic extracts of Fucus and Laminaria and mainly brown algae, between 0.1 and twenty%) .
Es también útil asociar la DHEA a la Hialuro- nidasa (entre 100 y 2000 U%) o enzimas semejantes para estas lipodistrofias.It is also useful to associate DHEA with Hyaluridase (between 100 and 2000 U%) or similar enzymes for these lipodystrophies.
En paniculopatias e insuficiencias venosas y vasculares, en general, se asocia la DHEA con agentes vasoprotectores y capilarotropos, tanto sintéticos como de origen natural (flavonoides, biflavonoides, antocianósidos, procianidoles y saponósidos esteroidicos) especialmente a los extractos glicólicos e hidroalcohólicos de citricos (citroflavonoides) entre el 0,1-12%, los extractos glicóli¬ cos y alcohólicos de Ginko Biloba, entre el 0,1-15%, los extractos glicólicos y alcohólicos de Grosellero negro y rojo, de Mirtilo negro y Viña roja entre el 0,1-15%.In paniculopathies and venous and vascular insufficiencies, in general, DHEA is associated with vasoprotective and capillary agents, both synthetic and naturally occurring (flavonoids, biflavonoids, anthocyanosides, procyanidoles and steroidal saponosides), especially glycolic and hydroalcocholic citrides (citrides) ) between 0.1-12%, the glycolic and alcoholic extracts of Ginko Biloba, between 0.1-15%, the glycolic and alcoholic extracts of Black and Red Currant, of Black Mirtilo and Red Vine between 0 , 1-15%.
También se pueden asociar estos preparados para via percutánea con dinitrilosuccinico (0,1-2 %) y otros vasodilatadores derivados de la nitroglicerina para tratar los problemas vasculares. Asimismo, la DHEA se puede asociar con sustancias vesicantes y rubefacientes para terapias tópicas derivativas de las congestiones, hiperemias, contusiones y dolores musculares extractos glicólicos e hidroalcohólicos de capsico y árnica entre el 0,1-5 %; alcanfor entre 0,1- 0,75 %) y la de estas sustancias con antipruriginosos (mentol, de 0,01-0,5 %, y extracto glicólico e hidroglicó- lico de Centella Asiática, entre el 0,1-5 %) .These preparations can also be associated percutaneously with dinitrilosuccinic (0.1-2%) and other vasodilators derived from nitroglycerin to treat vascular problems. Also, DHEA can be associated with vesicant and rubefacient substances for topical therapies derived from congestion, hyperemias, bruises and muscle aches glycolic and hydroalcoholic extracts of capsicum and arnica between 0.1-5%; Camphor between 0.1-0.75%) and that of these substances with antipruritic substances (menthol, 0.01-0.5%, and glycolic and hydro-glycolic extract of Centella Asiatica, between 0.1-5% ).
Ante problemas de hiperplasia prostética se puede asociar la DHEA con los antiandrógenos naturales (1-15%) ó sintéticos (0,1-5%) señalados anteriormente.Faced with prostatic hyperplasia, DHEA can be associated with the natural (1-15%) or synthetic (0.1-5%) antiandrogens indicated above.
En algunos preparados se podria asociar la DHEA a cualquier combinación de la sustancias descritas en los apartados anteriores. Esta formulación puede aplicarse también mediante parches de difusión dérmica. MODOS DE REALIZACIÓN DE LA INVENCIÓNIn some preparations, DHEA could be associated with any combination of the substances described in the previous sections. This formulation can also be applied by dermal diffusion patches. EMBODIMENTS OF THE INVENTION
La presente invención se ilustra adicionalmente mediante los siguientes Ejemplos no limita¬ tivos de su alcance. EJEMPLO 1 En este Ejemplo se ilustran diversas formula¬ ciones de acuerdo con la presente invención, indicando las cantidades de ingredientes activos empleados y la aplica¬ ción a la que iban destinadas: Formulación 1 DHEA 3 %The present invention is further illustrated by the following non-limiting examples of its scope. EXAMPLE 1 This Example illustrates various formulations according to the present invention, indicating the amounts of active ingredients used and the application to which they were intended: Formulation 1 DHEA 3%
Estradiol 0,06 %Estradiol 0.06%
Esta formulación es útil en el tratamiento de los transtornos del ciclo menstrual. Formulación 2 DHEA 0,9 %This formulation is useful in the treatment of menstrual cycle disorders. Formulation 2 DHEA 0.9%
Vitamina E 0,5 %Vitamin E 0.5%
Vitamina C 2 %Vitamin C 2%
Esta formulación es útil por su larga estabi¬ lidad y su acción antirradicalar. Formulación 3 DHEA 2 %This formulation is useful for its long stability and its anti-radical action. Formulation 3 DHEA 2%
Progesterona 3 %Progesterone 3%
Minoxidil 2 %Minoxidil 2%
Tricopéptidos 1 % Esta formulación es útil para el mantenimien¬ to del vello axilar y el cabello asi como el tratamiento de ciertas formas de alopecia. Formulación 4Tricopeptides 1% This formulation is useful for the maintenance of axillary hair and hair as well as the treatment of certain forms of alopecia. Formulation 4
DHEA 4,2 % Base xántica 2 %DHEA 4.2% Xanthic base 2%
Extracto de Fucus...5 %Fucus Extract ... 5%
Esta formulación es útil para controlar, corregir y eliminar ciertas lipodistrofias. Formulación 5 DHEA 2,6 %This formulation is useful for controlling, correcting and eliminating certain lipodystrophies. Formulation 5 DHEA 2.6%
Citroflavonoides 3 %Citroflavonoids 3%
Extracto de Gingko Biloba 5 %Gingko Biloba Extract 5%
Extracto de grosellero rojo y negro... 5 % Esta formulación es útil para el tratamiento de las paniculopatias y de las insuficiencias venosas y vasculares. Formulación 6Red and black currant extract ... 5% This formulation is useful for the treatment of panniculopathies and venous and vascular insufficiencies. Formulation 6
DHEA 3,5 %DHEA 3.5%
Extracto de capsico y árnica 2 % Alcanfor 0,3 %Capsic and Arnica extract 2% Camphor 0.3%
Mentol 0,1 %Menthol 0.1%
Extracto de Centella Asiática 3 %Centella Asiatic Extract 3%
Esta formulación es útil para el tratamiento de congestiones, hiperemias, contusiones y dolores muscula- res.This formulation is useful for the treatment of congestion, hyperemias, bruises and muscle aches.
EJEMPLO 2EXAMPLE 2
En este Ejemplo se exponen los resultados de estudios que demuestran que con dosis semejantes a las utilizadas por via oral, se alcanzan niveles séricos más elevados y en menos tiempo, que cuando se emplean las formulaciones tópicas.This Example shows the results of studies that demonstrate that with doses similar to those used orally, higher serum levels are reached and in less time, than when using the topical formulations
Dichos resultados se exponen en la tabla siguiente:These results are shown in the following table:
50 mg/d por 25 mg/d en gel 50 mg/d en gel boca (3 meses) (15 d.) (15 d.)50 mg / d for 25 mg / d gel 50 mg / d gel mouth (3 months) (15 d.) (15 d.)
ANTES 8 ± 0.5 7.5 ± 0.6 7.2 ± 0.8 nmol/L nmol/L nmol/L DESPUÉS 14 ± 1 ,2 21.5 ± 3.5 32.4 ± 3.8 nmol/L nmol/L nmol/LBEFORE 8 ± 0.5 7.5 ± 0.6 7.2 ± 0.8 nmol / L nmol / L nmol / L AFTER 14 ± 1, 2 21.5 ± 3.5 32.4 ± 3.8 nmol / L nmol / L nmol / L
Los estudios se han desarrollado con grupos de 10 personas a las que, tras una extracción de sangre previa para medir niveles de DHEA, se les ha tratado con 50 mg/dia de DHEA por via oral (grupo A) , 25 mg/dia de DHEA por via percutánea (gel acrilico) y 50 mg/dia de esta misma sustancia por via percutánea.Studies have been carried out with groups of 10 people who, after a previous blood draw to measure DHEA levels, have been treated with 50 mg / day of DHEA orally (group A), 25 mg / day of DHEA percutaneously (acrylic gel) and 50 mg / day of this same substance percutaneously.
A los 15 dias se ha analizado nuevamente la sangre y se han determinado los niveles de DHEA. En el grupo A se han tomado los niveles publicados en la biblio¬ grafía por Morales y Col. a los 3 meses. After 15 days the blood has been analyzed again and DHEA levels have been determined. In group A, the levels published in the literature by Morales and Col. at 3 months have been taken.

Claims

REIVINDICACIONES
1.- Nueva formulación farmacéutica de dehi¬ droepiandrosterona para aplicación tópica percutánea, caracterizada porque comprende como ingredientes esencia- les:1.- New pharmaceutical formulation of dehi¬ droepiandrosterone for percutaneous topical application, characterized in that it comprises as essential ingredients:
(a) 0,1 a 5 % en peso de dehidroepiandrosterona;(a) 0.1 to 5% by weight of dehydroepiandrosterone;
(b) 0,5 -3% de un gel acrilico (carbopol), goma-guar (1-3%) o un gel derivado de celulosa (1-3%); pudiendo comprender la formulación además de los ingredien¬ tes (a) y (b) otros geles de tipo hidrófilo, seleccionados entre glicólicos, hidroglicólicos, hidroglicerolatos, hidroalcohólicos e hidropropilenglicólicos en proporciones semejantes del 0,5-2% de carbopol y otros ingredientes activos seleccionados entre 0,02-0,1% de estradiol, 0,05-1% de Vitamina E, 0,1-5% de Vitamina C, 2-5% de progesterona, 1-3% de minoxidil, 0,1-2% de tricosacáridos y tricopép¬ tidos, 0,1-5% de bases xánticas, 0,1-20% de productos yodados, 100-2000 U% de hialuronidasa, 0,1-12% de agentes vasoprotectores y capilarotropos, 0,1-2% de dinitrilosucci- nico, 0,1-5% de extractos glicólicos e hidroalcohólicos de capsico y árnica, 0,1-0,75% de alcanfor, 0,01-0,5% de mentol y 0,1-5% de extractos de Centella Asiática y entre 1-15% de antiendrógenos naturales (Sabal. Serrulata y lúpulo) ó del 0,1-5% de antiandrógenos sintéticos como el acetato de ciproterona. (b) 0.5-3% of an acrylic gel (carbopol), guar gum (1-3%) or a cellulose derived gel (1-3%); the formulation may comprise, in addition to ingredients (a) and (b) other hydrophilic gels, selected from glycolic, hydro-glycolic, hydroglycerolate, hydroalcoholic and hydropropylene glycol in similar proportions of 0.5-2% carbopol and other active ingredients selected from 0.02-0.1% estradiol, 0.05-1% Vitamin E, 0.1-5% Vitamin C, 2-5% progesterone, 1-3% minoxidil, 0.1 -2% tricosaccharides and tricopeptides, 0.1-5% xanthic bases, 0.1-20% iodinated products, 100-2000 U% hyaluronidase, 0.1-12% vasoprotective and capillary agents, 0.1-2% dinitrile succinic, 0.1-5% glycolic and hydroalcoholic extracts of capsicum and arnica, 0.1-0.75% camphor, 0.01-0.5% menthol and 0 , 1-5% of extracts of Centella Asiatica and between 1-15% of natural antiendrogens (Sabal. Serrulata and hops) or 0.1-5% of synthetic antiandrogens such as cyproterone acetate.
PCT/ES1996/000153 1995-07-21 1996-07-19 Novel pharmaceutical formulation of dehydroepiandrosterone for percutaneous topical application WO1997003676A1 (en)

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US9320744B2 (en) 2011-10-19 2016-04-26 Dhea Llc DHEA bioadhesive controlled release gel
US11324690B2 (en) 2019-02-12 2022-05-10 Dawn Marie Cutillo Composition for restorative vaginal lubrication and a method of use thereof

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