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WO2007108712A1 - Kit et procédé servant à traiter ou à prévenir une anémie provoquée par une carence en fer - Google Patents

Kit et procédé servant à traiter ou à prévenir une anémie provoquée par une carence en fer Download PDF

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Publication number
WO2007108712A1
WO2007108712A1 PCT/RU2006/000122 RU2006000122W WO2007108712A1 WO 2007108712 A1 WO2007108712 A1 WO 2007108712A1 RU 2006000122 W RU2006000122 W RU 2006000122W WO 2007108712 A1 WO2007108712 A1 WO 2007108712A1
Authority
WO
WIPO (PCT)
Prior art keywords
ferrous
iron
ferric
dosage form
kit
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/RU2006/000122
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English (en)
Inventor
Tatyana Vyacheslavovna Popkova
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.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Priority to PCT/RU2006/000122 priority Critical patent/WO2007108712A1/fr
Publication of WO2007108712A1 publication Critical patent/WO2007108712A1/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
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/26—Iron; Compounds 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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0007—Effervescent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06—Antianaemics

Definitions

  • the present invention relates to kits and methods for treating or preventing anemia caused by iron deficiency.
  • Iron deficiency is defined as decreased total iron body content. Iron deficiency is the most prevalent single deficiency state on a worldwide basis. The typical causes of iron deficiency are too little iron in the diet, poor absorption of iron by the body, and loss of blood (including from heavy menstrual bleeding).
  • Iron deficiency anemia is the most common form of anemia. Approximately 20% of women, 50% of pregnant women, and 3% of men are iron deficient. Iron deficiency anemia occurs when iron deficiency is sufficiently severe to diminish erythropoiesis and cause the development of anemia. Anemia caused by iron deficiency can be diagnosed by low blood iron level, hemoglobin, and red blood cell count.
  • Iron fortification of foods and oral iron supplements are typically used to restore normal total iron body content and, thus, to treat or prevent anemia caused by iron deficiency.
  • calcium amounts that can be delivered with drinking water are less than the calcium amounts that demonstrated above to be inhibitory for iron absorption. It is unknown whether usual calcium levels in drinking water can affect iron bioavailability if this water is used by a subject for improving swallowing solid iron supplements or dissolving an effervescent iron supplement prior to the oral administration.
  • the calcium levels in drinking water are not regulated now since this element does not destroy health.
  • the World Health Organization in the Guidelines for drinking water quality did not set any either minimum or maximum recommended calcium limits in drinking water.
  • the levels of calcium in drinking water prepared from natural water is not a constant and frequently vary from 0 to 120 mg/L depending on Earth region and method of preparation of drinking water.
  • It is an object of the present invention to provide a kit comprising a therapeutically effective amount of an iron compound and a pharmaceutically acceptable carrier in a first unit dosage form; an amount of aqueous liquid composition with concentration of calcium less than 10 mg/L in a second dosage form; container means for containing said first and second dosage forms; and an instruction describing the method of treating or preventing anemia caused by iron deficiency.
  • the present invention provides a kit comprising a therapeutically effective amount of an iron compound and a pharmaceutically acceptable carrier in a first unit dosage form; an amount of aqueous liquid composition with concentration of calcium less than 10 mg/L in a second dosage form; container means for containing said first and second dosage forms; and an instruction describing the method of treating or preventing anemia caused by iron deficiency which comprises administering orally to a subject in need thereof stepwise or in physical combination said first unit dosage form and said second dosage form.
  • the iron compound is selected from the group consisting of ferrous lactate, ferrous tartrate, ferrous fumarate, ferrous sulfate, ferrous folate, an iron dextran, ferric oxyhydroxide dextran, ferrous pyrophosphate, ferrous cholinisocitrate, a chitosan derivative of iron, an oligosaccharide derivative of iron, fei ⁇ ous acetyl salicylate, ferrous gluconate, ferrous diphosphate, carbonyl iron, ferric orthophosphate, ferrous glycine sulfate, ferrous chloride, ferrous ammonium citrate, ferric ammonium citrate, ferric ammonium tartrate, ferric phosphate, ferric potassium tartrate, ferric albuminate, ferric cacodylate, ferric hydroxide, ferric pyrophosphate, ferric quinine citrate, ferric valerate, ferrous fructate-ascorbate, saccharated iron oxide, iron oxide, ferric
  • the term "therapeutically effective amount” means an amount of the iron compound in the first unit dosage form sufficient to achieve a significant increase in iron levels, hematocrit, hemoglobin, and/or blood erythrocyte counts when said amount is administered to a subject in need thereof. Depending on the iron compound used the amount used may be different. Preferably, the therapeutically effective amount of the iron compound is 10 to 250 mg per the first unit dosage form.
  • the first unit dosage form is an effervescent or non- effervescent anhydrous powder, granulate, tablet or micro-encapsulated product.
  • anhydrous powder, granulate, tablet or micro-encapsulated product is manufactured by methods well-known from the art.
  • the first unit dosage form is an effervescent tablet comprising a pharmaceutically acceptable effervescent system comprising an alkaline carbonate and an organic acid.
  • Nonexclusive examples of the alkaline carbonates which can be used in practicing the present invention are sodium bicarbonate, potassium bicarbonate, carboxylysine, sodium carbonate, potassium carbonate and mixture of these compounds.
  • the organic acids which can be used in practicing the present invention are compounds capable of reacting with alkaline carbonates to release carbon dioxide when they are brought to contact with a sufficient amount of water.
  • suitable acids are citric acid, fumaric acid, adipic acid, succinic acid, tartaric acid and mixture of these compounds.
  • the effervescent tablet further comprises an effective amount 5 of ascorbic acid or a pharmaceutically acceptable salt thereof.
  • the ascorbic acid can be used as L-ascorbic acid, D,L-ascorbic acid or pharmaceutically acceptable salts thereof.
  • the effective amount of ascorbic acid or a pharmaceutically acceptable salt thereof is 10 to 1000 mg per the tablet.
  • the ascorbic acid or a pharmaceutically acceptable salt thereof will i o be used in a molar ratio to the iron compound from 2 : 1 to 8 : 1.
  • the effervescent tablet of the invention may be prepared by methods well-known from the art.
  • the process for the manufacture of the effervescent tablet comprises the steps of: treating the iron compound by spraying it with a solution or emulsion containing a hydrophilic polymer (e.g. is polyvinylpirrolidon) to form coated granulate of the iron compound; premixing the constituents forming the effervescent system preferably in form of granules; premixing the other constituents in the form of powders (e.g. ascorbic acid, sweeteners, and flavors); mixing the products resulting from the previous steps; and forming the effervescent tablet.
  • a hydrophilic polymer e.g. is polyvinylpirrolidon
  • the aqueous liquid composition of the invention is any water-based liquid composition with concentration of calcium less than 10 mg/L suitable for the human use.
  • the aqueous liquid composition with concentration of calcium less than 10 mg/L is selected from the group consisting of beverage, drinking water, distilled water, and purified water. More preferably, the 5 concentration of calcium in said aqueous liquid composition is less than 1 mg/L.
  • the beverage of the invention can be prepared by adding to the water with concentration of calcium less than 10 mg/L any sweeteners or additives such as flavors, extracts, essences, nutrients, or minerals.
  • the drinking water of the invention can be prepared by ion-exchange treatment or reverse osmosis of natural water. These processes are widely used in industry and provide drinking water with desired concentration of calcium ⁇ 10 mg/L and even less than 1 mg/1.
  • the distilled water of the invention can be prepared from natural water by two-step process comprising water evaporation and condensation which process provides desired water with concentration of calcium even less than 1 mg/L.
  • the amount of the aqueous liquid composition in the second unit dosage form is from 25 to 10000 ml, more preferably, from 100 to 150 ml.
  • the container means of the invention is any means suitable for containing the separate first dosage forms (e.g. an effervescent or non-effervescent anhydrous powder, granulate, tablet or micro-encapsulated product) and second dosage forms (e.g. bottle).
  • first dosage forms e.g. an effervescent or non-effervescent anhydrous powder, granulate, tablet or micro-encapsulated product
  • second dosage forms e.g. bottle
  • Nonexclusive examples of such container means include package, box, bottle, and tube.
  • the instruction of the invention describes the method to be used by a subject to treat or prevent anemia caused by iron deficiency which method comprises administering orally to a subject in need thereof stepwise or in physical combination said first unit dosage form and said second dosage form.
  • the method comprises administering orally to a subject the aqueous solution of the therapeutically effective amount of an iron compound wherein said aqueous solution is formed by mixing an effervescent tablet as the first unit dosage form with distilled water as the second dosage form.
  • the components of the kit are administered for 1 day or longer, more preferably, for 30 to 90 days to achieve desired therapeutic effect in treating or preventing anemia caused by iron deficiency.
  • the components of the kit are administered to a subject fasted overnight.
  • the subject of the invention is human. More preferably, the subject of the invention is women or pregnant women.
  • the present invention provides a method of treating or preventing anemia caused by iron deficiency which comprises administering orally to a subject in need thereof stepwise or in physical combination a therapeutically effective amount of an iron compound and an amount of water with concentration of calcium less than 10 mg/L; wherein said water is selected from the group consisting of drinking water, distilled water, and purified water.
  • concentration of calcium in said water is less than 1 mg/L.
  • the therapeutically effective amount of an iron compound may be different depending on the iron compound used.
  • the iron compound will be used in a unit dosage forms such as anhydrous powder, granulate, tablet and micro-encapsulated product.
  • the therapeutically effective amount of the iron compound is 10 to 250 mg per the unit dosage form.
  • the amount of water for the use in the method of the invention is from 25 to 500 ml, preferably, from 100 to 150 ml.
  • the method can further comprises the step of administering orally to said subject a nutritional supplement comprising an effective amount of calcium at time of 1 to 12 hours after administering the iron compound.
  • This step is directed to eliminating possible side effects on bone and tooth metabolism which effects may result from administering water with concentration of calcium ⁇ 10 mg/L.
  • the first unit dosage form effervescent tablet.
  • the effervescent tablet is manufactured by a process comprising the steps of: treating the ferrous (II) sulfate by spraying it with a solution or emulsion containing polyvinylpirrolidon (Povidon K-30) to form coated granulate; premixing the constituents forming the effervescent system comprising sodium bicarbonate and citric acid preferably in form of granules; premixing the other constituents in the form of powders (ascorbic acid, sweeteners, and flavors); mixing the products resulting from the previous steps; and forming the effervescent tablet.
  • the tablets are packaged in the container by 30 tablets per container.
  • the second unit dosage form distilled water.
  • Distilled water is prepared by distillation of natural water. Water with concentration of calcium ⁇ 1 mg/L is bottled into bottles with volume 100 ml. The bottles are packaged in the container by 30 bottles per container.
  • the container means the effervescent tablets and the bottles are packaged in the container by 30 tablets and bottles per container.
  • the instruction for the kit use is enclosed: mixing the first unit dosage form with the second unit dosage form of the kit to provide an aqueous composition comprising a therapeutically effective amount of an iron compound; and administering orally said aqueous composition to a subject in need thereof singly a day for 30 days.
  • Example 2
  • the first unit dosage form effervescent tablet.
  • the effervescent tablet is manufactured by a process as described in the example 1.
  • the tablets are packaged in the package by 30 tablets per package.
  • the second unit dosage form distilled water.
  • Distilled water is prepared by reverse osmosis of natural water.
  • Water with concentration of calcium ⁇ 1 mg/L is bottled into bottles with volume 100 ml.
  • the bottles are packaged in the container by 30 bottles per container.
  • the container means the effervescent tablets and the bottles are packaged in the container by 30 tablets and bottles per container.
  • 3AMEIMIOmHH JIHCT ( ⁇ PABHJIO 26)
  • the instruction for the kit use is enclosed: mixing the first unit dosage form with the second unit dosage form of the kit to provide an aqueous composition comprising a therapeutically effective amount of an iron compound; and administering orally said aqueous composition to a subject in need thereof singly a day for 30 days.
  • This example demonstrates the method for treating or preventing anemia caused by iron deficiency.
  • This example demonstrates the method of treating or preventing anemia caused by iron deficiency.
  • Three women with chronic iron deficiency anemia received daily for 28 days singly a day a solution prepared by mixing effervescent iron supplement comprising 100 mg ferrous (II) sulfate and 500 mg ascorbic acid with 100 ml of drinking water with concentration of calcium about 120 mg/1 (control) or, one month later, a solution prepared by mixing the same amount of ferrous (II) sulfate and ascorbic acid with 100 ml of distilled water with concentration of calcium ⁇ 1 mg/1.
  • Mean rate of hemoglobin rise was 0. 45 g/1 per day vs. 0.05 g/1 per day in the control.

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

Abstract

Cette invention concerne des kits et des procédés servant à traiter ou à prévenir une anémie provoquée par une carence en fer chez un sujet qui en a besoin. L'invention concerne un kit comprenant une quantité efficace du point de vue thérapeutique d'un composé du fer et un véhicule acceptable du point de vue pharmaceutique dans une première forme de dosage unitaire ; une certaine quantité d'une composition liquide aqueuse ayant une concentration en calcium inférieure à 10 mg/l dans une seconde forme de dosage ; des emballages servant à contenir ladite première forme de dosage et ladite seconde forme de dosage ; et une notice décrivant le procédé de traitement ou de prévention d'une anémie provoquée par une carence en fer lequel consiste à administrer oralement à un sujet qui en a besoin l'une après l'autre ou sous forme d'une association physique de celles-ci ladite première forme de dosage unitaire et ladite seconde forme de dosage. De préférence, la première forme de dosage unitaire du kit est un comprimé effervescent. En outre, l'invention concerne un procédé de traitement ou de prévention d'une anémie provoquée par une carence en fer lequel consiste à administrer oralement à un sujet qui en a besoin l'une après l'autre ou sous forme d'une association physique de celles-ci une quantité efficace du point de vue thérapeutique d'un composé du fer et une certaine quantité d'eau ayant une concentration en calcium inférieure à 10 mg/l ; ladite eau étant sélectionnée dans le groupe constitué de l'eau potable, de l'eau distillée et de l'eau purifiée.
PCT/RU2006/000122 2006-03-17 2006-03-17 Kit et procédé servant à traiter ou à prévenir une anémie provoquée par une carence en fer Ceased WO2007108712A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/RU2006/000122 WO2007108712A1 (fr) 2006-03-17 2006-03-17 Kit et procédé servant à traiter ou à prévenir une anémie provoquée par une carence en fer

Applications Claiming Priority (1)

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PCT/RU2006/000122 WO2007108712A1 (fr) 2006-03-17 2006-03-17 Kit et procédé servant à traiter ou à prévenir une anémie provoquée par une carence en fer

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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2928269A1 (fr) * 2008-03-05 2009-09-11 Innothera Chouzy Sarl Formulation pharmaceutique orale sous forme unitaire de comprime soluble ou dispersible, notamment effervescent, appropriee a une fabrication par compression
US20120177700A1 (en) * 2010-12-27 2012-07-12 Imran Mir A Nanonized Iron Compositions and Methods of Use Thereof
EP2574669A4 (fr) * 2011-06-29 2013-09-04 Dnaform Kk Procédé de prétraitement d'un échantillon biologique, procédé de détection d'arn et kit de prétraitement
CN103432165A (zh) * 2013-08-27 2013-12-11 江苏轩驿生物科技有限公司 缓释多功能兽用补铁注射剂及其生产工艺
AU2013202190A1 (en) * 2012-06-20 2014-01-16 Massey University Micronutrient Fortification Process and its Uses
GR1008167B (el) * 2013-03-12 2014-04-08 GLOBAL DEVELOPMENT ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΠΕ με δ.τ. "SOIN DE SANTE", Φαρμακευτικη συνθεση που περιεχει γλυκονικο σιδηρο και μεθοδος για την παρασκευη της
CN104887696A (zh) * 2014-03-04 2015-09-09 天津怀仁制药有限公司 右旋糖酐铁和维生素c的复方制剂
CN105192318A (zh) * 2015-10-27 2015-12-30 南宁市泽威尔饲料有限责任公司 复合有机铁补铁剂
US9248148B2 (en) 2008-05-15 2016-02-02 Iron Therapeutics Holdings Ag Mono (iron hydroxypyrone) and combination (iron hydroxypyrone and GI inflammation inhibiting agents) compositions for anaemia or H. pylori infections

Non-Patent Citations (5)

* Cited by examiner, † Cited by third party
Title
BARTON J C ET AL: "CALCIUM INHIBITION OF INORGANIC IRON ABSORPTION IN RATS", GASTROENTEROLOGY, ELSEVIER, PHILADELPHIA, PA, US, vol. 84, no. 1, 1983, pages 90 - 101, XP009077040, ISSN: 0016-5085 *
HALLBERG ET AL: "Calcium;effect on different amiunts on non hem and heme iron absorption in humans", AM.J.CLIN.NUTR., vol. 1, no. 52, 1991 - 1991, pages 112 - 119, XP002414946 *
HALLBERG ET AL: "Prediction of dietary iron absorption: an algorithm for calculating absorption and bioavalability of dietary iron", AM.J.CLIN.NUTR, vol. 71, 2000 - 2000, pages 1147 - 1160, XP002414947 *
KALTWASSER J P ET AL: "ORALE EISENTHERAPIE BIOVERFUEGBARKEIT UND THERAPEUTISCHE WIRKSAMKEIT VON FERRO-EISEN ALS BRAUSETABLETTEN BEI POSTHAEMORRHAGISCHER EISENMANGELANAEMIE ORAL IRON TREATMENT: BIO-AVAILABILITY AND THERAPEUTIC EFFICACY OF FERROUS IRON AS EFFERVESCENT TABLETS IN POSTHAEMORRHAGIC IRON-DEFICIENCY ANAEMIA", DEUTSCHE MEDIZINISCHE WOCHENSCHRIFT, GEORG THIEME, STUTTGART,, DE, vol. 114, no. 31/32, 1989, pages 1188 - 1195, XP000990013, ISSN: 0012-0472 *
SELIGMAN P A ET AL: "MEASUREMENTS OF IRON ABSORPTION FROM PRENATAL MULTIVITAMIN-MINERAL SUPPLEMENTS", OBSTETRICS AND GYNECOLOGY, NEW YORK, NY, US, vol. 61, no. 3, 1983, pages 356 - 362, XP009077041, ISSN: 0029-7844 *

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2928269A1 (fr) * 2008-03-05 2009-09-11 Innothera Chouzy Sarl Formulation pharmaceutique orale sous forme unitaire de comprime soluble ou dispersible, notamment effervescent, appropriee a une fabrication par compression
WO2009118465A1 (fr) * 2008-03-05 2009-10-01 Innothera Chouzy Formulation pharmaceutique orale sous forme unitaire de comprime soluble ou dispersible, notamment effervescent
US9248148B2 (en) 2008-05-15 2016-02-02 Iron Therapeutics Holdings Ag Mono (iron hydroxypyrone) and combination (iron hydroxypyrone and GI inflammation inhibiting agents) compositions for anaemia or H. pylori infections
US20120177700A1 (en) * 2010-12-27 2012-07-12 Imran Mir A Nanonized Iron Compositions and Methods of Use Thereof
EP2574669A4 (fr) * 2011-06-29 2013-09-04 Dnaform Kk Procédé de prétraitement d'un échantillon biologique, procédé de détection d'arn et kit de prétraitement
US9518901B2 (en) 2011-06-29 2016-12-13 Kabushiki Kaisha Dnaform Pretreatment method of biological sample, detection method of RNA, and pretreatment kit
AU2013202190A1 (en) * 2012-06-20 2014-01-16 Massey University Micronutrient Fortification Process and its Uses
GR1008167B (el) * 2013-03-12 2014-04-08 GLOBAL DEVELOPMENT ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΠΕ με δ.τ. "SOIN DE SANTE", Φαρμακευτικη συνθεση που περιεχει γλυκονικο σιδηρο και μεθοδος για την παρασκευη της
CN103432165A (zh) * 2013-08-27 2013-12-11 江苏轩驿生物科技有限公司 缓释多功能兽用补铁注射剂及其生产工艺
CN104887696A (zh) * 2014-03-04 2015-09-09 天津怀仁制药有限公司 右旋糖酐铁和维生素c的复方制剂
CN105192318A (zh) * 2015-10-27 2015-12-30 南宁市泽威尔饲料有限责任公司 复合有机铁补铁剂

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