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WO2018014100A1 - Ingestible magnesium chloride dosage form - Google Patents

Ingestible magnesium chloride dosage form Download PDF

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Publication number
WO2018014100A1
WO2018014100A1 PCT/BR2017/050193 BR2017050193W WO2018014100A1 WO 2018014100 A1 WO2018014100 A1 WO 2018014100A1 BR 2017050193 W BR2017050193 W BR 2017050193W WO 2018014100 A1 WO2018014100 A1 WO 2018014100A1
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WO
WIPO (PCT)
Prior art keywords
magnesium chloride
oil
ingestible
presentation according
presentation
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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/BR2017/050193
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French (fr)
Portuguese (pt)
Inventor
Luiz Francisco Pianowski
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Individual
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Individual
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Publication of WO2018014100A1 publication Critical patent/WO2018014100A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/10—Laxatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/02—Nutrients, e.g. vitamins, minerals

Definitions

  • This invention relates to an ingestible magnesium chloride presentation, characterized in that it comprises a mixture of magnesium chloride and an oil, and said mixture is contained in a soft capsule.
  • Magnesium chloride is a compound typically used as a laxative, like other magnesium salts, however the benefits disclosed in the prior art extend to several other aspects by the administration of magnesium ions: immunostimulant, toning, blood pressure stabilizer, treatment of external injuries, etc.
  • magnesium chloride is considered to be the only one that is fully ionizable and therefore most accessible to body.
  • magnesium chloride is one of several osmotic purgatives, which act by increasing intestinal osmotic pressure by promoting fluid retention in the intestine. Its effect on intestinal motility and stool consistency or hardness is amplified with the amount ingested in a single dose.
  • magnesium chloride has some drawbacks.
  • magnesium chloride is a very hygroscopic compound. To allow its proper compression, it is necessary to use other salts, which are not as efficient as laxatives, and are less ionizable.
  • the present invention proposes the presentation of magnesium chloride as a mixture of magnesium chloride with an oil, such mixture contained in a capsule, preferably soft capsule.
  • Magnesium chloride suitable for the invention may be anhydrous or hydrated.
  • soft capsule means a single body capsule, also known as a softgel.
  • soft and hard capsules are both gelatinous, the soft capsule is more readily soluble in biological fluids at room temperature, and is best suited for the delivery of liquids such as oils, suspensions, emulsions, and semisolids, while hard capsules are retained. solids, granules or powders.
  • oils of mineral, vegetable or animal nature which may be associated with magnesium chloride in any acceptable form, for example dispersion or emulsion are used. Mixtures of these oils in any proportion are also covered by the invention.
  • vegetable oils for example, but not limited to soybean, coconut, corn, sunflower seed, cottonseed, olive, palm oil. , peanut, almond, Brazil nuts, cashews, macadamia nuts, hazelnuts, pecans, pistachios, walnuts, acai, flax, etc. and their mixtures.
  • Animal oils are also suitable for use in the invention, provided they are pharmaceutically acceptable, such as fish oil, cod liver oil, salmon, trout oil, etc., and mixtures thereof.
  • the mixture of magnesium chloride and oil according to the invention may contain excipients known to the person skilled in the art and may contain other actives, for example, without excluding any others, one or more antibiotic, hormone, antioxidant, antihypertensive, muscle relaxant, vitamin, analgesic, antihyperlipidemic, etc.
  • the soft capsule of the invention may contain dyes, and have surface impression.
  • the amount of magnesium chloride ranges from 5 to 5000 mg.

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  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The present invention relates to an ingestible magnesium chloride dosage form characterised in that it comprises a mixture of magnesium chloride and an oil, and in that the mixture is contained in a soft capsule.

Description

APRESENTAÇÃO DE CLORETO DE MAGNÉSIO INGERÍVEL A presente invenção refere-se a uma apresentação de cloreto de magnésio ingerivel, caracterizada por compreender uma mistura de cloreto de magnésio e um óleo, e dita mistura estar contida em cápsula mole.  Ingestable Magnesium Chloride Presentation This invention relates to an ingestible magnesium chloride presentation, characterized in that it comprises a mixture of magnesium chloride and an oil, and said mixture is contained in a soft capsule.

Antecedentes da invenção Background of the invention

Cloreto de magnésio é um composto tipicamente utilizado como laxante, como outros sais de magnésio, entretanto os benefícios divulgados no estado da técnica estendem-se a vários outros aspectos, pela administração de íons magnésio: imunoestimulante, tonificante, estabilizante de pressão arterial, tratamento de ferimentos externos, etc .  Magnesium chloride is a compound typically used as a laxative, like other magnesium salts, however the benefits disclosed in the prior art extend to several other aspects by the administration of magnesium ions: immunostimulant, toning, blood pressure stabilizer, treatment of external injuries, etc.

Em comparação com outros sais de magnésio, por exemplo, citrato, lactato, gluconato, glutamato, malato, glicinato, aspartato, e mesmo óxido de magnésio, o cloreto de magnésio é tido como o único que é totalmente ionizável, portanto o mais acessível ao organismo.  Compared to other magnesium salts, for example citrate, lactate, gluconate, glutamate, malate, glycinate, aspartate, and even magnesium oxide, magnesium chloride is considered to be the only one that is fully ionizable and therefore most accessible to body.

Como laxativo o cloreto de magnésio é um dentre vários purgativos osmóticos, que atuam pelo aumento da pressão osmótica intestinal promovendo retenção de fluido no intestino. Seu efeito sobre motilidade intestinal e consistência ou dureza das fezes é amplificado com a quantidade ingerida em uma única dose.  As a laxative, magnesium chloride is one of several osmotic purgatives, which act by increasing intestinal osmotic pressure by promoting fluid retention in the intestine. Its effect on intestinal motility and stool consistency or hardness is amplified with the amount ingested in a single dose.

Entretanto, dentro da apresentação como comprimido, o cloreto de magnésio apresenta alguns inconvenientes .  However, within the tablet form, magnesium chloride has some drawbacks.

Por um lado o cloreto de magnésio é um composto muito higroscópico . Para permitir sua compressão adequada, é necessário utilizar outros sais, que não são tão eficientes como laxantes, e são menos ionizáveis.  On the one hand, magnesium chloride is a very hygroscopic compound. To allow its proper compression, it is necessary to use other salts, which are not as efficient as laxatives, and are less ionizable.

Por outro lado, para utilizar quantidades maiores de cloreto de magnésio, o comprimido resultante é muito volumoso, inadequado à ingestão para a maioria das pessoas.On the other hand, to use larger amounts of magnesium chloride, the resulting tablet is very bulky, unsuitable for most people.

Em vista de tais problemas, a presente invenção propõe a apresentação de cloreto de magnésio sob forma de uma mistura de cloreto de magnésio com um óleo, tal mistura contida em uma cápsula, preferencialmente cápsula mole. In view of such problems, the present invention proposes the presentation of magnesium chloride as a mixture of magnesium chloride with an oil, such mixture contained in a capsule, preferably soft capsule.

Cloreto de magnésio adequado à invenção pode ser anidro ou hidratado.  Magnesium chloride suitable for the invention may be anhydrous or hydrated.

Conforme entendimento da invenção, entende-se por cápsula mole aquela constituída de corpo único, conhecida também como softgel.  According to the invention, "soft capsule" means a single body capsule, also known as a softgel.

Embora cápsulas mole e dura sejam ambas gelatinosas, a cápsula mole é mais facilmente solúvel nos fluidos biológicos a temperatura ambiente, sendo mais adequada à veiculação de líquidos, como óleos, suspensões, emulsões, e semissólidos , enquanto que as cápsulas duras são voltadas a conter sólidos, grânulos ou pós.  Although soft and hard capsules are both gelatinous, the soft capsule is more readily soluble in biological fluids at room temperature, and is best suited for the delivery of liquids such as oils, suspensions, emulsions, and semisolids, while hard capsules are retained. solids, granules or powders.

Dentro da utilização da apresentação da invenção, são utilizados óleos farmaceuticamente aceitáveis, de natureza mineral, vegetal ou animal, e que possam ser associados com cloreto de magnésio, sob qualquer forma aceitável, por exemplo, dispersão ou emulsão. São também cobertos pela invenção misturas desses óleos em quaisquer proporções .  Within the use of the presentation of the invention, pharmaceutically acceptable oils of mineral, vegetable or animal nature which may be associated with magnesium chloride in any acceptable form, for example dispersion or emulsion are used. Mixtures of these oils in any proportion are also covered by the invention.

A utilização de óleo na apresentação da invenção, além de permitir maior teor de cloreto de magnésio em relação a comprimidos, também tem efeito laxativo per se, de forma que há sinergia voltada àquele fim.  The use of oil in the presentation of the invention, in addition to allowing higher magnesium chloride content over tablets, also has a laxative effect per se, so that there is synergy towards that end.

Não há limitações à utilização de óleos vegetais farmaceuticamente aceitáveis na invenção, sendo adequados, por exemplo, sem exclusão de qualquer outro, óleos de soja, de coco, de milho, de semente de girassol, de semente de algodão, de oliva, de palma, de amendoim, de amêndoa, de castanha do Pará, castanha de caju, de macadâmia, de avelã, de noz pecã, de pistache, de noz, de açaí, de linho, etc. e suas misturas. There are no limitations to the use of pharmaceutically acceptable vegetable oils in the invention, for example, but not limited to soybean, coconut, corn, sunflower seed, cottonseed, olive, palm oil. , peanut, almond, Brazil nuts, cashews, macadamia nuts, hazelnuts, pecans, pistachios, walnuts, acai, flax, etc. and their mixtures.

Também são adequadas frações especificas de óleos vegetais, ricas em determinados compostos, por exemplo, sem excluir qualquer outro, ômega 3, ômega 6, ômega 9, gama-linoleico, lecitina, etc, e suas misturas.  Specific fractions of vegetable oils rich in certain compounds are also suitable, for example, without excluding any other, omega 3, omega 6, omega 9, gamma linoleic, lecithin, etc., and mixtures thereof.

Óleos animais também são adequados ao uso na invenção, desde que farmaceuticamente aceitáveis, como óleo de peixe, óleo de fígado de bacalhau, óleo de salmão, de truta, etc, e suas misturas.  Animal oils are also suitable for use in the invention, provided they are pharmaceutically acceptable, such as fish oil, cod liver oil, salmon, trout oil, etc., and mixtures thereof.

A mistura de cloreto de magnésio e óleo, conforme a invenção, podem conter excipientes conhecidos do técnico no assunto, podendo ainda conter outros ativos, por exemplo, sem excluir quaisquer outros, um ou mais dentre antibiótico, hormônio, antioxidante, anti-hipertensivo, relaxante muscular, vitamina, analgésico, anti- hiperlipidêmico, etc.  The mixture of magnesium chloride and oil according to the invention may contain excipients known to the person skilled in the art and may contain other actives, for example, without excluding any others, one or more antibiotic, hormone, antioxidant, antihypertensive, muscle relaxant, vitamin, analgesic, antihyperlipidemic, etc.

A cápsula mole da invenção pode conter corantes, e ter impressão superficial.  The soft capsule of the invention may contain dyes, and have surface impression.

Dentro de realizações particulares da invenção, sem excluir qualquer outra, a quantidade de cloreto de magnésio varia entre 5 e 5000 mg.  Within particular embodiments of the invention, without excluding any other, the amount of magnesium chloride ranges from 5 to 5000 mg.

Um técnico no assunto poderá, a partir das informações aqui fornecidas, realizar a invenção de formas equivalentes não expressamente descritas, mas com a mesma ou substancialmente a mesma função, e os mesmos ou substancialmente os mesmos resultados, estando mesmo assim dentro do escopo de proteção das reivindicações anexas.  One skilled in the art may, from the information provided herein, carry out the invention in equivalent ways not expressly described, but having the same or substantially the same function, and the same or substantially the same results, yet be within the scope of protection. of the attached claims.

Claims

REIVINDICAÇÕES 1. Apresentação de cloreto de magnésio ingerivel caracterizada por compreender uma mistura de cloreto de magnésio com um óleo, e dita mistura estar contida dentro de uma cápsula mole.  An ingestible magnesium chloride presentation comprising a mixture of magnesium chloride with an oil, said mixture being contained within a soft capsule. 2. Apresentação de cloreto de magnésio ingerigel de acordo com a reivindicação 1, caracterizada pelo fato da dita mistura ser uma dispersão, suspensão ou emulsão .  Ingestible magnesium chloride presentation according to claim 1, characterized in that said mixture is a dispersion, suspension or emulsion. 3. Apresentação de cloreto de magnésio ingerigel de acordo com a reivindicação 1, caracterizada pelo fato do dito óleo ser óleo mineral.  Ingestible magnesium chloride presentation according to claim 1, characterized in that said oil is mineral oil. 4. Apresentação de cloreto de magnésio ingerigel de acordo com a reivindicação 1, caracterizada pelo fato do dito óleo ser óleo vegetal, particularmente um ou mais dentre os óleos de soja, de coco, de milho, de semente de girassol, de semente de algodão, de oliva, de palma, de amendoim, de amêndoa, de castanha do Pará, castanha de caju, de macadâmia, de avelã, de noz pecã, de pistache, de noz, de açaí, de linho.  Ingestible magnesium chloride presentation according to claim 1, characterized in that said oil is vegetable oil, particularly one or more of soybean, coconut, corn, sunflower seed, cottonseed oils , olive, palm, peanut, almond, Brazil nuts, cashews, macadamia nuts, hazelnuts, pecans, pistachios, walnuts, acai, flax. 5. Apresentação de cloreto de magnésio ingerigel de acordo com a reivindicação 1, caracterizada pelo fato do dito óleo ser uma fração de óleo ou fração enriquecida de óleo, particularmente um ou mais dentre ômega 3, ômega 6, ômega 9, gama-linoleico, lecitina.  An ingerigel magnesium chloride presentation according to claim 1, characterized in that said oil is an oil fraction or oil enriched fraction, particularly one or more of omega 3, omega 6, omega 9, gamma linoleic, lecithin. 6. Apresentação de cloreto de magnésio ingerigel de acordo com a reivindicação 1, caracterizada pelo fato do dito óleo ser um óleo animal, particularmente um ou mais dentre óleo de peixe, óleo de fígado de bacalhau, óleo de salmão, de truta.  Ingestible magnesium chloride presentation according to claim 1, characterized in that said oil is an animal oil, particularly one or more of fish oil, cod liver oil, salmon oil, trout oil. 7. Apresentação de cloreto de magnésio ingerigel de acordo com a reivindicação 1, caracterizada por compreender um ou mais excipientes. Presentation of ingestible magnesium chloride according to Claim 1, characterized in that comprise one or more excipients. 8. Apresentação de cloreto de magnésio ingerigel de acordo com a reivindicação 1, caracterizada por compreender outros ativos, particularmente um ou mais dentre antibiótico, hormônio, antioxidante, anti- hipertensivo, relaxante muscular, vitamina, analgésico, anti-hiperlipidêmico .  Ingestible magnesium chloride presentation according to claim 1, characterized in that it comprises other actives, particularly one or more of antibiotic, hormone, antioxidant, antihypertensive, muscle relaxant, vitamin, analgesic, antihyperlipidemic. 9. Apresentação de cloreto de magnésio ingerigel de acordo com a reivindicação 1, caracterizada pelo fato da dita cápsula mole conter corantes ou ter impressão superficial .  Ingestible magnesium chloride presentation according to Claim 1, characterized in that said soft capsule contains dyes or has a surface impression. 10. Apresentação de cloreto de magnésio ingerigel de acordo com a reivindicação 1, caracterizada pelo fato da quantidade de cloreto de magnésio variar entre 5 mg e 5000 mg.  Ingestible magnesium chloride presentation according to Claim 1, characterized in that the amount of magnesium chloride ranges from 5 mg to 5000 mg. 11. Apresentação de cloreto de magnésio ingerigel de acordo com a reivindicação 1, caracterizada pelo fato do cloreto de magnésio ser anidro ou hidratado.  Ingestible magnesium chloride presentation according to Claim 1, characterized in that the magnesium chloride is anhydrous or hydrated.
PCT/BR2017/050193 2016-07-18 2017-07-17 Ingestible magnesium chloride dosage form Ceased WO2018014100A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
BR102016016559-8A BR102016016559A2 (en) 2016-07-18 2016-07-18 Presentation of Ingestible Magnesium Chloride
BRBR1020160165598 2016-07-18

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030104078A1 (en) * 2001-03-30 2003-06-05 Bridget Barrett-Reis Method of improving the antioxidant status of an infant
US20050054724A1 (en) * 2003-09-05 2005-03-10 Mustad Vikkie A. Lipid system and methods of use
US8168611B1 (en) * 2011-09-29 2012-05-01 Chemo S.A. France Compositions, kits and methods for nutrition supplementation
US20130022673A1 (en) * 2003-08-15 2013-01-24 Russell Jaffe Enhancement of magnesium uptake in mammals
US20140271908A1 (en) * 2013-03-15 2014-09-18 Melaleuca, Inc. Dietary supplements and methods for preventing and treating migraines
US20160022594A1 (en) * 2013-03-15 2016-01-28 Russell Jaffe Soft gel encapsulation

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030104078A1 (en) * 2001-03-30 2003-06-05 Bridget Barrett-Reis Method of improving the antioxidant status of an infant
US20130022673A1 (en) * 2003-08-15 2013-01-24 Russell Jaffe Enhancement of magnesium uptake in mammals
US20050054724A1 (en) * 2003-09-05 2005-03-10 Mustad Vikkie A. Lipid system and methods of use
US8168611B1 (en) * 2011-09-29 2012-05-01 Chemo S.A. France Compositions, kits and methods for nutrition supplementation
US20140271908A1 (en) * 2013-03-15 2014-09-18 Melaleuca, Inc. Dietary supplements and methods for preventing and treating migraines
US20160022594A1 (en) * 2013-03-15 2016-01-28 Russell Jaffe Soft gel encapsulation

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
KHAJEHALI, E. ET AL.: "Effects of chronic administration of calcium- magnesium soft gels on morphine tolerance and dependence in mice", MAGNESIUM RESEARCH, vol. 22, no. 2, 1 June 2009 (2009-06-01), pages 81 - 88, XP055454874 *
PICKERING, G. ET AL.: "Oral magnesium treatment in patients with neuropathic pain: a randomized clinical trial.", MAGNESIUM RESEARCH, vol. 24, no. 2, 2011, pages 28 - 35, XP055454869 *

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