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WO2008001110A2 - Compositions de manganèse, zinc et sélénium, leurs préparations et leurs utilisations - Google Patents

Compositions de manganèse, zinc et sélénium, leurs préparations et leurs utilisations Download PDF

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Publication number
WO2008001110A2
WO2008001110A2 PCT/GB2007/002442 GB2007002442W WO2008001110A2 WO 2008001110 A2 WO2008001110 A2 WO 2008001110A2 GB 2007002442 W GB2007002442 W GB 2007002442W WO 2008001110 A2 WO2008001110 A2 WO 2008001110A2
Authority
WO
WIPO (PCT)
Prior art keywords
composition
excess
ammonium
water
zinc
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/GB2007/002442
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English (en)
Other versions
WO2008001110A3 (fr
Inventor
Stephen Spaulding Hickok
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Remedy Research Ltd
Original Assignee
Remedy Research Ltd
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.)
Filing date
Publication date
Application filed by Remedy Research Ltd filed Critical Remedy Research Ltd
Publication of WO2008001110A2 publication Critical patent/WO2008001110A2/fr
Publication of WO2008001110A3 publication Critical patent/WO2008001110A3/fr
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
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K33/04—Sulfur, selenium or tellurium; Compounds thereof
    • 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
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/30—Zinc; Compounds thereof
    • 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
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/32—Manganese; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants

Definitions

  • Minerals i.e. traces of certain specific metal or semi-metal elements are required as part of the human diet for good health. Mineral deficiencies can lead to poor health and specific disorders. Amongst the minerals that the body requires, there are for example, the metals manganese and zinc and the semi-metal selenium. The human body requires traces of such minerals in soluble form whereby the corresponding metallic or semi-metallic (herein collectively "metallo") ions become bio-available within the bloodstream for cellular uptake.
  • metallic or semi-metallic herein collectively "metallo"
  • This invention is particularly concerned with manganese, zinc and selenium mineral compositions, their preparation and uses in treating selective medical indications in humans or animals.
  • Simple mineral compounds such as inorganic mineral salts, e.g. zinc sulphate, manganese sulphate and the like will dissociate in aqueous solution to form the corresponding metallo-ions e.g. Zn 2+ and Mn 2+ and dissolved sulphate ions, SO 4 2' .
  • metallo-ions e.g. Zn 2+ and Mn 2+ and dissolved sulphate ions, SO 4 2' .
  • Mineral binder systems are known which seek to improve bio-availability of at least zinc ions.
  • One such mineral supplement composition is based upon inorganic chelate binders, where the required mineral element, e.g. zinc, is chemically bonded to a chelate. Bio-availability of such chelated zinc still has room for improvement. The digestive system has difficulty in leaching chelated zinc away from the chelate binder for cellular uptake and retention. This still limits their bio-availability. Chelate-based zinc supplements apparently limit the body's absorption of soluble zinc.
  • Remaining zinc content is apparently not absorbed but passed in faeces.
  • Iron chelated mineral supplements in particular can cause constipation as the chelate can act as a flocculent in the large intestine. It is desirable that these disadvantages are reduced or preferably minimised by providing an alternative mineral delivery system for one or more of: manganese, zinc and/or selenium with enhanced bioavailability of the dissolved mineral metallo-ions.
  • Another mineral supplement is based upon a mineral salt combined with an organic gluconate binder.
  • One product based upon the gluconate bound mineral delivery system is a lozenge containing zinc for oral ingestion.
  • the gluconate delivery system restrict mineral element/ion bio-availability similarly to chelated minerals described above, but zinc gluconate lozenges in particular can be unpalatable and leave undesirable coloured stains in the mouth. Accordingly it is also desirable to reduce or minimise this disadvantage by providing an alternative mineral delivery system yielding better mineral element bio-availability for ions of at least one of manganese, zinc and selenium.
  • the present inventor has considered existing zinc chelate and gluconate delivery systems and their disadvantages.
  • the present invention provides inter alia, improved mineral delivery compositions based on components which appear to have the capacity to enhance and prolong (gastrointestinal) absorption of ionic zinc, manganese and selenium compositions.
  • the present inventor provides several aspects to his invention, arising from novel mineral element - containing compositions per se, methods for preparing such compositions and therapeutic uses of such compositions which encompass their use in treating and/or preventing specific medical conditions and diseases.
  • an ionic manganese- containing composition which comprises:
  • composition having: (vii) an acidic pH; and (viii) an electrolytic potential in excess of 50 millivolts and/or
  • a zinc containing composition which comprises:
  • composition having (vii) an acidic pH and (viii) an electrolytic potential of at least 50 millivolts; and/or (ix) an electrolytic conductivity in excess of 50 mS/cm.
  • a selenium containing composition which comprises (b) as defined above according to the first aspect together with (a) as defined above according to the first aspect and/or one or more water soluble manganese compounds able to form manganese-containing ions when dissolved in water and (iv), (v) and (vi) all as defined above according to the first aspect, the composition having (vii) an acidic pH and (viii) an electrolytic potential of at least 50 millivolts and/or (ix) an electrolytic conductivity in excess of 50 mS/cm.
  • compositions preferably essentially consist of the specified components with any optional but preferred additives (if required) and more preferably consist of such specified components optional additives and the balance (if any) being any inevitable impurities.
  • a method of making a composition as defined in the first aspect comprising dissolving (i) (with (a) and/or (b) if required) in pure distilled water (vi), adding agent(s) (iv) and mixing or allowing to dissolve, then adding acid(s) (v) whilst simultaneously monitoring the pH and electrolytic potential and/or conductivity of the composition until a required value of each measurement is obtained.
  • a third aspect of this invention provides an antimicrobial and/or antiviral, and/or antiinflammatory formulation as defined herein.
  • the present compositions can have useful benefits in medicine, for example the compositions can be for use in enhancing immune system function, in the treatment or prevention of inflammation and as an antioxidant in the scavenging of potentially harmful free radicals circulating within the bloodstream.
  • compositions as defined in the first, second and third aspects may be useful in the preparation of a medicament for use in the prevention and/or treatment of immune disorders and/or inflammation.
  • Manganese compositions alone or with either or both of zinc and selenium mineral components can be useful as immunomodulators such as immunostimulants and immunoboosters, pre-vaccination response enhancers, immunoenhancers and immunoactivators.
  • the zinc composition with or without either or both of selenium and manganese components, or the selenium compositions alone may show the same activity and practical medical applications. IfTaTO ⁇ rth " aspect the " present invention provides " the use of a composition as defined in the first, second or third aspects as an immunomodulatory and/or anti inflammatory preparation and/or anti-oxidant preparation.
  • ammonium agent acts as an ammonium ion donor into the aqueous compositions and may assist transport of metallo-ions containing the required ionic mineral through the digestive (or mucous membrane) system into the bloodstream. It is preferred to use ammonium agents which are water-soluble inorganic ammonium compounds such as for example ammonium hydroxide aqueous solution or one or more of the following ammonium salts: e.g. one or more of ammonium chloride, sulphate, phosphate, nitrate, citrate or tartrate.
  • ammonium agents which are water-soluble inorganic ammonium compounds such as for example ammonium hydroxide aqueous solution or one or more of the following ammonium salts: e.g. one or more of ammonium chloride, sulphate, phosphate, nitrate, citrate or tartrate.
  • ammonium agents appear to assist effectiveness of the aqueous mineral compositions of (or containing) manganese, zinc and/or selenium, which compositions preferably demonstrate beneficial high levels of electrolytic potential and/or conductivity in the prepared aqueous compositions containing dissolved metallo-ions.
  • the aqueous compositions formed appear to behave as acidic aqueous electrolytic solutions with preferably high electrolyte potential and/or conductivity.
  • An improved metallic (or semi-metallic) mineral delivery system in the form of aqueous compositions for ingestion can surprisingly be formulated from a selection of but a few highly specific metals and/or semi-metals, and even more specific metallo- ionic combinations thereof (in acidic aqueous media), which compositions demonstrate significant maintained electrolytic potential and/or conductivity which properties can be stable for a surprisingly long period of time - months or even years.
  • Such compositions have surprisingly been found, inter alia, when ingested from oral dosage form or absorbed through e.g. the buccal or sublingual mucosa to make the beneficial mineral ions bio-available with apparently enhanced cellular retention but without significant adverse affect upon surrounding human tissue.
  • the metailo-ions (in aqueous solution) which are or which comprise the metallic mineral element appear to be more effective in treatments than comparable mineral compositions in which ammonium agents are excluded. Accordingly, within the present compositions, the metallic and/or semi-metallic element effects (depending which of the three mineral species are present) of manganese, with or without zinc and/or selenium, appear to be synergistically improved by the presence of at least one ammonium agent. In particular this appears to be the case with manganese-only, zinc-only and selenium-only metal or semi-metal compositions, as well as acidic aqueous electrolytic solutions that contain combinations of at least two of manganese, zinc and selenium.
  • the compositions are derived from manganese with or without zinc and selenium, or are derived from selenium with at least one of zinc and manganese or are derived from zinc with at least one of manganese and selenium.
  • These compositions can act if required through the buccal/sublingual mucosa, i.e. mucous membrane, for rapid absorption into the bloodstream.
  • compositions in the form of acidic aqueous (optionally mixed) metallo-ion electrolyte solutions for medical uses can provide for rapid mineral element ion delivery to the body for cellular uptake, with less wastage of the desirable mineral(s).
  • preferred compositions which contain at least one of manganese, zinc and selenium as the mineral element it is possible to reduce the disadvantages of chelated zinc gluconate mentioned above, whilst simultaneously providing soluble and effective manganese, zinc and/or selenium, in an improved ionic form.
  • compositions for human (or animal) medical use are based upon the presence of water soluble manganese, zinc and/or selenium compound(s) such as a readily available salt thereof in aqueous acidic solution, which further contains components [as defined in the above aspects] and appearing in the US Pharmacopoeia designated GRAS (generally regarded as safe) food additives or other chemicals by the US-FDA regulatory authority.
  • GRAS generally regarded as safe
  • the required metal and/or semi-metal such as a mineral element or elements, e.g. zinc, manganese and/or selenium is included as a water soluble mineral salt such as zinc sulphate or semi-metal compound.
  • a water soluble mineral salt such as zinc sulphate or semi-metal compound.
  • At least one ammonium agent is added such as ammonium hydroxide or one or more soluble ammonium salts is added for example one or more of: ammonium sulphate, ammonium chloride, ammonium citrate, and ammonium phosphate, which is mixed into the solution obtained in step (a) to dissolve therein.
  • step (c) To the aqueous mixture, obtained after step (b), at least one acid component, (e.g. sulphuric and/or citric acid and/or hydrochloric acid) is added carefully and slowly, preferably by measured metering, to create an acidic pH and then further lower the pH of the mixture to a preferred level preferably below 2 and to simultaneously exhibit a measurable electrolytic potential and/or conductivity until a preferred level thereof is also reached.
  • the value of electrolytic potential is conveniently measured and monitored throughout this stage by milli-voltmeter.
  • Several commercially available instantaneous readout pH meters can function as a milli-voltmeter by simple adjustment.
  • Sufficient acid should be added to control the values of pH and electrolytic potential and/or electrolytic conductivity.
  • This process for completing preparation of the aqueous metal- and/or semi-metal containing ionic compositions can be likened to a form of electrometric titration.
  • Commercially available conductivity meters can be utilised to measure, monitor and control the obtained valves of conductivity.
  • stage (c) in the general procedure the addition of one or more acids, preferably one or more acids designated 'GRAS' generally regarded as safe by the US-FDA as noted above, an exothermic reaction can be observed which may simply represent the heat of diluting strong acids.
  • 'GRAS' generally regarded as safe by the US-FDA as noted above
  • an exothermic reaction can be observed which may simply represent the heat of diluting strong acids.
  • the formulations can be administered orally, e.g. in the range of about 1 to 100, preferably 1 to 50, more preferably 1 to 30, such as 1 drop to 15 drops, dissolved in more water or aqueous beverage other than milk, once, twice or three times daily, depending upon the severity of the condition.
  • the most preferred embodiments are those wherein there is an ionic consistency amongst the selected components.
  • the mineral compound present is a sulphate
  • the ammonium agent is preferably also a sulphate and the acid preferably is sulphuric.
  • Ammonium hydroxide may also work well in view of the presence of hydroxyl ions in the water.
  • the ammonium agent is preferably also ammonium chloride and the acid is preferably hydrochloric.
  • the ammonium agent is a phosphate, it is preferred to use phosphoric acid as the acid, whatever mineral salt is used as the source of metallic ions.
  • NB variable denotes amount adjusted to obtain required specific pH, mV, and mScrrV 1 values, low pH with high mV and mScrr ⁇ 1 and being preferred.
  • compositions may include one or more other additional components, besides the metal compound such as a preferred mineral compound, ammonium agent, acid and water.
  • Zinc mineral compositions may optionally contain one or more of the following or other stimulants: caffeine, nicotine and ginseng.
  • compositions have application as immunostimulants, immunoboosters, immunomodulators, anti-oxidants and/or pre-vaccination enhancers.
  • Manganese- containing compositions in particular appear to have application as anti-inflammatory agents, although anti-inflammatory effects may be observed in the zinc and/or selenium compositions in the presence or absence of a manganese component.
  • compositions may be formulated as aqueous solutions and presented for use and/or sale within dropper bottles for convenient dilution in more water or other aqueous beverages other than milk for oral ingestion.
  • the compositions can be applied directly to the buccal and/or sublingual mucosa for even more rapid ionic mineral absorption into the bloodstream.
  • composition may be formulated as capsules containing a unit dose.
  • the present compositions may alternatively or additionally function as effective antiviral agents.
  • the present compositions may be useful in preventing and/or treating for example humans or animals affected by or likely to encounter: common cold, SARS, West Nile virus, Influenza, Influenza, (e.g. H5W, H5N1 , H7N2, H7N7) Papillomavins, Herpes simplex, Cytomegalovirus MCMV and human CMV, respiratory syncytial virus, Parainfluenza, human meta pneumovirus, measles, yellow fever, western equine encephalitis, Venezuelan equine encephalitis, HIV.
  • zinc, selenium or copper formulations specifically set out in the example of our US Patent 7,060,302 may be useful as antiviral formulations in the treatment and/or prevention of the specifically identified virus diseases set out above.
  • the known antiviral pharmaceutical preparations there are anti-influenza inhibitors oseltamivir, ramantidine and ribavirin.
  • anti-HIV and anti-Herpes drugs There are also known anti-HIV and anti-Herpes drugs.
  • the compositions provided herein or the aforementioned compositions exemplified in our US Patent 7,060,302 may be used in conjunction with these known antiviral preparations or the known anti-HIV and anti-Herpes drugs so as to limit the dose thereof. This may especially be the case for the presently disclosed zinc-based compositions.
  • Preferred embodiments of antiviral compositions are based on a combination of metal-ion components.
  • the zinc component with either the selenium or manganese components or both, or to incorporate the manganese component with either the selenium or zinc component or both, or to incorporate the selenium component with either the manganese component or the zinc component or both.
  • compositions comprising a combination of two (or more) different metallo-ion components are referred to herein as 'combination' compositions.
  • Other preferred compositions for use as antiviral agents within the scope of the invention are based on a combination of active agents for example - a 'combination' composition as herein defined in admixture with at least one known other antiviral preparation such as one or more of: osteltamivir, ramantidine and ribavirin..
  • Such combination therapies against the selected viruses may lead to enhancement of activity of at least one active component, may allow the use of lower dosages and potentially lessen the development of drug-resistant viruses.

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  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Oncology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Communicable Diseases (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention concerne une composition ionique contenant du manganèse qui comprend : (i) un ou plusieurs composés de manganèse solubles dans l'eau capables de former des ions contenant du manganèse lorsqu'on le ou les dissous dans l'eau; éventuellement avec : (ii) un ou plusieurs composés de zinc solubles dans l'eau capables de former des ions contenant du zinc lorsqu'on le ou les dissout dans l'eau, et/ou éventuellement avec; (iii) un ou plusieurs composés de sélénium solubles dans l'eau capables de former des ions contenant du sélénium lorsqu'on le ou les dissout dans l'eau; (iv) un ou plusieurs agents d'ammonium capables de former des ions d'ammonium lorsqu'on le ou les dissout dans l'eau; (v) un ou plusieurs acides; et (vi) de l'eau; ladite composition présentant : (vii) un pH acide;et (viii) un potentiel électrolytique excédentaire de 50 millivolts et/ou (ix) une conductivité électrolytique excédentaire de 50 millisiemens cm-1(mS/cm).
PCT/GB2007/002442 2006-06-29 2007-06-29 Compositions de manganèse, zinc et sélénium, leurs préparations et leurs utilisations Ceased WO2008001110A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0612917.5 2006-06-29
GBGB0612917.5A GB0612917D0 (en) 2006-06-29 2006-06-29 Metallic compositions,preparations and uses

Publications (2)

Publication Number Publication Date
WO2008001110A2 true WO2008001110A2 (fr) 2008-01-03
WO2008001110A3 WO2008001110A3 (fr) 2008-03-27

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WO (1) WO2008001110A2 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021245365A1 (fr) * 2020-06-04 2021-12-09 Remedy Research Limited Compositions d'immunomodulateur améliorées et traitements de pathogènes viraux

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2012162B (en) * 1977-11-24 1982-08-11 Mccollester Duncan Lee Composition for use in the immunotherapy of neoplastic disease
CA2382449A1 (fr) * 1999-08-31 2001-03-08 Remedy Research Limited Compositions contenant du metal, preparations et utilisations
US6576267B2 (en) * 2000-02-23 2003-06-10 Bioselect Innovations, Inc. Composition and method for treating the effects of diseases and maladies
GB2374008B (en) * 2001-04-04 2005-03-16 John Carter Pharmaceutical compositions comprising copper and zinc
PT1677628E (pt) * 2003-10-01 2010-04-15 Pharmaton Sa Composição para activação do sistema imunitário
US20050281888A1 (en) * 2004-06-16 2005-12-22 Chandra Ranjit K Nutritional supplement for infants
GB0515112D0 (en) * 2005-07-25 2005-08-31 Remedy Res Ltd Compositions for treating psychiatric conditions
GB0602325D0 (en) * 2006-02-06 2006-03-15 Remedy Res Ltd Virucidal compositions and uses

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021245365A1 (fr) * 2020-06-04 2021-12-09 Remedy Research Limited Compositions d'immunomodulateur améliorées et traitements de pathogènes viraux

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Publication number Publication date
GB0612917D0 (en) 2006-08-09
WO2008001110A3 (fr) 2008-03-27

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