ZA200506794B - Multi-vitamin and mineral supplement for pregnant women - Google Patents
Multi-vitamin and mineral supplement for pregnant women Download PDFInfo
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- ZA200506794B ZA200506794B ZA200506794A ZA200506794A ZA200506794B ZA 200506794 B ZA200506794 B ZA 200506794B ZA 200506794 A ZA200506794 A ZA 200506794A ZA 200506794 A ZA200506794 A ZA 200506794A ZA 200506794 B ZA200506794 B ZA 200506794B
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- South Africa
- Prior art keywords
- vitamin
- pharmaceutical
- composition according
- dietary composition
- dietary
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- CPLXHLVBOLITMK-UHFFFAOYSA-N magnesium oxide Inorganic materials [Mg]=O CPLXHLVBOLITMK-UHFFFAOYSA-N 0.000 description 1
- 235000019359 magnesium stearate Nutrition 0.000 description 1
- 229940091250 magnesium supplement Drugs 0.000 description 1
- AXZKOIWUVFPNLO-UHFFFAOYSA-N magnesium;oxygen(2-) Chemical compound [O-2].[Mg+2] AXZKOIWUVFPNLO-UHFFFAOYSA-N 0.000 description 1
- 229910052748 manganese Inorganic materials 0.000 description 1
- 239000011572 manganese Substances 0.000 description 1
- 229940099596 manganese sulfate Drugs 0.000 description 1
- 239000011702 manganese sulphate Substances 0.000 description 1
- 235000007079 manganese sulphate Nutrition 0.000 description 1
- SQQMAOCOWKFBNP-UHFFFAOYSA-L manganese(II) sulfate Chemical compound [Mn+2].[O-]S([O-])(=O)=O SQQMAOCOWKFBNP-UHFFFAOYSA-L 0.000 description 1
- 235000021239 milk protein Nutrition 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 235000019426 modified starch Nutrition 0.000 description 1
- 210000000276 neural tube Anatomy 0.000 description 1
- 201000010193 neural tube defect Diseases 0.000 description 1
- 229960003512 nicotinic acid Drugs 0.000 description 1
- 235000001968 nicotinic acid Nutrition 0.000 description 1
- 239000011664 nicotinic acid Substances 0.000 description 1
- 235000015097 nutrients Nutrition 0.000 description 1
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 1
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 description 1
- 239000003605 opacifier Substances 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 239000011574 phosphorus Substances 0.000 description 1
- 229910052698 phosphorus Inorganic materials 0.000 description 1
- SHUZOJHMOBOZST-UHFFFAOYSA-N phylloquinone Natural products CC(C)CCCCC(C)CCC(C)CCCC(=CCC1=C(C)C(=O)c2ccccc2C1=O)C SHUZOJHMOBOZST-UHFFFAOYSA-N 0.000 description 1
- 239000000049 pigment Substances 0.000 description 1
- 229920005862 polyol Polymers 0.000 description 1
- 150000003077 polyols Chemical class 0.000 description 1
- 235000020777 polyunsaturated fatty acids Nutrition 0.000 description 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
- 239000011591 potassium Substances 0.000 description 1
- 229910052700 potassium Inorganic materials 0.000 description 1
- NLKNQRATVPKPDG-UHFFFAOYSA-M potassium iodide Chemical compound [K+].[I-] NLKNQRATVPKPDG-UHFFFAOYSA-M 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 235000018102 proteins Nutrition 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 238000004080 punching Methods 0.000 description 1
- RADKZDMFGJYCBB-UHFFFAOYSA-N pyridoxal hydrochloride Natural products CC1=NC=C(CO)C(C=O)=C1O RADKZDMFGJYCBB-UHFFFAOYSA-N 0.000 description 1
- 235000008160 pyridoxine Nutrition 0.000 description 1
- 239000011677 pyridoxine Substances 0.000 description 1
- 229960004172 pyridoxine hydrochloride Drugs 0.000 description 1
- 235000019171 pyridoxine hydrochloride Nutrition 0.000 description 1
- 239000011764 pyridoxine hydrochloride Substances 0.000 description 1
- 235000019192 riboflavin Nutrition 0.000 description 1
- 229960002477 riboflavin Drugs 0.000 description 1
- 239000002151 riboflavin Substances 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000011684 sodium molybdate Substances 0.000 description 1
- 235000015393 sodium molybdate Nutrition 0.000 description 1
- TVXXNOYZHKPKGW-UHFFFAOYSA-N sodium molybdate (anhydrous) Chemical compound [Na+].[Na+].[O-][Mo]([O-])(=O)=O TVXXNOYZHKPKGW-UHFFFAOYSA-N 0.000 description 1
- MHQOTKLEMKRJIR-UHFFFAOYSA-L sodium selenate Chemical compound [Na+].[Na+].[O-][Se]([O-])(=O)=O MHQOTKLEMKRJIR-UHFFFAOYSA-L 0.000 description 1
- 239000007901 soft capsule Substances 0.000 description 1
- 239000007905 soft elastic gelatin capsule Substances 0.000 description 1
- 239000007886 soft shell capsule Substances 0.000 description 1
- 239000007909 solid dosage form Substances 0.000 description 1
- 239000000600 sorbitol Substances 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 239000008117 stearic acid Substances 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 108010013480 succinylated gelatin Proteins 0.000 description 1
- 229940007079 succinylated gelatin Drugs 0.000 description 1
- 230000009469 supplementation Effects 0.000 description 1
- 208000035581 susceptibility to neural tube defects Diseases 0.000 description 1
- 239000000375 suspending agent Substances 0.000 description 1
- 239000003765 sweetening agent Substances 0.000 description 1
- 150000003892 tartrate salts Chemical class 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 235000019157 thiamine Nutrition 0.000 description 1
- 239000011721 thiamine Substances 0.000 description 1
- UIERGBJEBXXIGO-UHFFFAOYSA-N thiamine mononitrate Chemical compound [O-][N+]([O-])=O.CC1=C(CCO)SC=[N+]1CC1=CN=C(C)N=C1N UIERGBJEBXXIGO-UHFFFAOYSA-N 0.000 description 1
- 239000004408 titanium dioxide Substances 0.000 description 1
- 229960000984 tocofersolan Drugs 0.000 description 1
- 235000013311 vegetables Nutrition 0.000 description 1
- 235000019155 vitamin A Nutrition 0.000 description 1
- 239000011719 vitamin A Substances 0.000 description 1
- 235000019158 vitamin B6 Nutrition 0.000 description 1
- 239000011726 vitamin B6 Substances 0.000 description 1
- 235000011912 vitamin B7 Nutrition 0.000 description 1
- 239000011735 vitamin B7 Substances 0.000 description 1
- 235000019166 vitamin D Nutrition 0.000 description 1
- 239000011710 vitamin D Substances 0.000 description 1
- 150000003710 vitamin D derivatives Chemical class 0.000 description 1
- 235000019168 vitamin K Nutrition 0.000 description 1
- 239000011712 vitamin K Substances 0.000 description 1
- 150000003721 vitamin K derivatives Chemical class 0.000 description 1
- 229940045997 vitamin a Drugs 0.000 description 1
- 229940046008 vitamin d Drugs 0.000 description 1
- 229940046010 vitamin k Drugs 0.000 description 1
- 235000019195 vitamin supplement Nutrition 0.000 description 1
- 239000000080 wetting agent Substances 0.000 description 1
- RNWHGQJWIACOKP-UHFFFAOYSA-N zinc;oxygen(2-) Chemical compound [O-2].[Zn+2] RNWHGQJWIACOKP-UHFFFAOYSA-N 0.000 description 1
- 235000004835 α-tocopherol Nutrition 0.000 description 1
- 239000002076 α-tocopherol Substances 0.000 description 1
- OENHQHLEOONYIE-JLTXGRSLSA-N β-Carotene Chemical compound CC=1CCCC(C)(C)C=1\C=C\C(\C)=C\C=C\C(\C)=C\C=C\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C OENHQHLEOONYIE-JLTXGRSLSA-N 0.000 description 1
Classifications
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- 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
- A61K33/24—Heavy metals; 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
- A61K33/04—Sulfur, selenium or tellurium; Compounds thereof
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/115—Fatty acids or derivatives thereof; Fats or oils
- A23L33/12—Fatty acids or derivatives thereof
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/15—Vitamins
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/15—Vitamins
- A23L33/155—Vitamins A or D
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/16—Inorganic salts, minerals or trace elements
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/40—Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
-
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/24—Heavy metals; Compounds thereof
- A61K33/34—Copper; Compounds thereof
-
- 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
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Nutrition Science (AREA)
- Mycology (AREA)
- Animal Behavior & Ethology (AREA)
- Polymers & Plastics (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Food Science & Technology (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Inorganic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Pediatric Medicine (AREA)
- Diabetes (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Coloring Foods And Improving Nutritive Qualities (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Description
® MULTI-VITAMIN AND MINERAL SUPPLEMENT FOR PREGNANT WOMEN
. 5 1. TECHNICAL FIELD ~The invention relates to pharmaceutical or dietary unit dosage form, which can be swallowed casily, consisting essentially of vitamins and minerals recommended for consumption by pregnant women, lactating women or women of childbearing potential that are attempting to become pregnant, DHA and a pharmaceutically or dietetically suitable camer. 2. BACKGROUND INFORMATION
Vitamin and mineral preparations are commonly administered to treat specific medical conditions or as general nutritional supplements. Recent studies have elucidated the important physiological roles played by vitamins and minerals, and established a correlation between deficiencies or excesses of these nutrients and the etiologies of certain disease states in humans. See, €.g., Diplock, "Antioxidant Nutrients and Disease
Prevention: An Overview," Am. J. Clin. Nutr., 53:189-193 (1991); Documenta Geigy
Scientific Tables, 457-497, (Diem and Cemtuer eds., 7th ed, 1975).
It has further become recognized that various, groups of the human population require different quantities and types of vitamins and minerals to prevent or alleviate diseases, as well as to maintain general good health. For example, it is known that pregnant women commonly require iron therapy to prevent or treat iron-deficiency anemia. Various prior patents have been directed to improving the efficacy of iron supplements for use during pregnancy. U.S. Pat. No. 4,994,283, for example, discloses nutritional mineral supplements which include iron and calcium compounds in combination with citrates or tartrates, ) ascorbates, and fructose. The tendency of calcium to inhibit the bioavailability of iron is said to be reduced in such compositions, so that the conjoint bioavailability of these two . 30 minerals is enhanced.
® U.S. Pat. No. 4,431,634 maximizes the bioavailability of iron in prenatal iron supplements by maintaining the amount of calcium compounds in the supplement at 300 mg or less and the amount of magnesium compounds at 75 mg or less per dosage unit. } 5 Another approach to the same problem is found in U.S. Pat. No. 4,752,479, wherein a multi-vitamin and mineral dietary supplement is provided which includes (a) one or more divalent dietary mineral components such as calcium or magnesium; and (b) a bioavailable iron component, present in a controlled release form and adapted to be released in a controlled manner in the gastrointestinal tract.
U.S. Pat. No. 4,710,387 discloses a nutritional supplement preparation for pregnant and breast-feeding women which contains 10-20% by weight of protein, 16-28% by weight of fat, 43-65% by weight carbohydrates, and at most 3.5% by weight of moisture, minerals, trace elements and vitamins. There is no hint to DHA nor to easily swalloble capsules or tablets.
The International Patent Application WO 99/53777 discloses a nutritional composition in form of water based drinks or cereal bars for pregnant and lactating women comprising a non-milk protein source, a dietary fiber, a source of polyunsaturated fatty acids including
DHA, minerals and vitamins. There is no hint to of a capsules or tablets, beads or lozenges.
The International Patent Application WO 00/66133 discloses a nutritional composition for administration before and during pregnancy comprising certain amounts of Vitamin B6, folic acid, magnesium and optionally calcium and DHA. Moreover, all the compositions os disclosed therein contain additionally high amounts of calcium, resulting in a comparable voluminous dosage form, which is hard to swallow. . The International Patent Application WO 01/87070 discloses a nutritional supplement comprising vitamins minerals and a fish oil granulate in pulverized form comprising . 30 eicosapentenoic acid (EPA) and DHA. Moreover, all the compositions disclosed therein contain high amounts of calcium, resulting in comparable voluminous dosage form of 1000 mg or more containing about 20 mg DHA, which is hard to swallow and contains about 2 % by weight of DHA only.
®
The US Patent Application US 20020102330 Al provides food bars for consumption by pregnant women containing one or more vitamins and/or minerals, and one or more anti- ) constipation and regularity-maintaining agents, which in addition may contain DHA.
The US Patent Application US 20030050341 Al suggests a composition for supplementing the diet comprising more than 100 mg of DHA. However, there is no hint to the trace elements Chromium, Copper, Molybdenum and Selenium. Moreover, all the compositions disclosed therein contain additionally high amounts of calcium, resulting in a comparable voluminous dosage form, which is hard to swallow.
Despite the foregoing efforts to improve vitamin and mineral supplementation for pregnant women, conventional prenatal supplements exhibit several deficiencies. One notable problem is that due to the high amount of calcium and the comparably high amount of vitamins the dosage form becomes very voluminous and hard to swallow especially for pregnant women.
Morning sickness generally causes a loss of appetite and a feeling of nausea, and is experienced by a significant number of pregnant women. Because they experience morning sickness, and because the pills and/or food bars that contain a high dose of recommended prenatal vitamins and minerals generally are very large in size, many pregnant women are often reluctant to take their prenatal vitamin and mineral pills or food bars. Further, when they do take these pills or food bars, these pregnant women often experience difficulty swallowing and retaining them. Problems, thus, arise concerning patient compliance (the daily consumption of vitamin and mineral supplements), maintaining or enhancing the health of pregnant woman, and the absorption of the quantity of vitamins and minerals that are associated with proper fetal development.
Moreover, during morning sickness pregnant women prefer to swallow capsules, pills or ) 30 tablets than eating a food bar. The intake of a food bar requires that the bar is chewed by the woman; chewing the bar women feel the taste and this will usually have a negative impact on the nausea originated by the morning sickness.
® Morning sickness generally occurs most frequently during the first trimester of pregnancy.
Defects in the neural tube of a developing fetus (spina bifida) can also occur during the first trimester of pregnancy, for example, during the first month of gestation, before a woman may have become aware of her pregnancy. These defects are known to be linked to an inadequate intake of folic acid. It is well known that folic acid prevents neural tube defects. Thus, folic acid should be consumed in sufficient quantities by women of child- bearing ages. Folic acid has also been shown to have beneficial cardiac effects, and to decrease the risk of cervical dysplasia.
Moreover, the vitamin and mineral preparations available up to now for pregnant women do not provide any active ingredient to improve foetus’ healthy brain development and eye sight.
It would therefore be desirable to provide a prenatal multi-vitamin and mineral supplement which overcomes the aforementioned deficiencies of the prior art.
It has now surprisingly been found that a pharmaceutical or dietary composition in form of a capsule or tablet, bead or lozenge, which can be swallowed easily, consisting essentially of (a) one or more vitamins, (b) one or more minerals selected from the group consisting of
Iron, Zinc and Magnesium, (c) one or more trace elements selected from the group consisting of Chromium, Copper, ladine, Molybdenum and Selenium, (d) DHA, and (e) a pharmaceutically or dietetically suitable carrier does overcome the above mentioned disadvantages of the known multi-vitamin and mineral supplements for pregnant women.
Accordingly the invention relates to a pharmaceutical or dietary composition in form of a . capsule or tablet, bead or lozenge, which can be swallowed easily, consisting essentially of (2) one or more vitamins, (b) one or more minerals selected from the group consisting of . 30 Iron, Zinc and Magnesium, (c) one or more trace elements selected from the group consisting of Chromium, Copper, Iodine, Molybdenum and Selenium, (d) DHA, and (¢) a pharmaceutically or dietetically suitable carrier. :
@® Furthermore, the invention relates to a method of supplementing the dictary needs of a pregnant woman, a lactating woman or a woman of childbearing potential who is attempting to become pregnant, said method comprising administering to the woman a dietary supplementing amount of such a pharmaceutical or dietary composition.
Moreover, the invention relates to use of such a pharmaceutical or dietary composition, for the preparation of a pharmaceutical or dietary composition for supplementing the dietary needs of a pregnant woman, a lactating woman or a woman of childbearing potential who is attempting to become pregnant.
The present invention may be understood more readily by reference to the following detailed description of the preferred embodiments of the invention, and to the example included therein.
The term “pharmaceutical composition” means a composition, which is suitable for prescription and OTC medicaments, and which are available from doctors, in chemist’s shop or in drugstores, only.
The term “dietary composition ” means a composition, which is for supplementing the regular food intake with additional nutritional elements to enhance quality of life, and which are freely available without prescription in groceries or super market, but not only in drugstores.
The pharmaceutical or dietary composition is formulated in the form of capsules, tablets, beads or lozenges, preferably as soft shell capsules or tablets.
Pre-selected amounts of the composition of the present invention containing vitamins) (a), : 30 minerals (b), trace elements (c), and DHA(d) are preferably encapsulated in a soft gelatin including bovine, porcine, vegetable and succinylated gelatin shell. Optionally, the soft gelatin shell is essentially transparent so as to enhance the aesthetic qualities of the
Co WO 2004091317 PCT/EP2004/003913 ® capsule. The soft gelatin shells as a rule comprise the following essential, as well as optional, components.
Gelatin is an essential component of the soft gelatin shells of the instant invention. The starting gelatin material used in the manufacture of soft capsules is obtained by the partial hydrolysis of collagenous material, such as the skin, white connective tissues, or bones of animals. Gelatin material can be classified as Type A gelatin, which is obtained from the acid-processing of porcine skins and exhibits an iso-electric point between pH 7 and pH 9; and Type B gelatin, which is obtained from the alkaline-processing of bone and animal (bovine) skins and exhibits an isoelectric point between pH 4.7 and pH 5.2. Blends of Type
A and Type B gelatins can be used to obtain a gelatin with the requisite viscosity and bloom strength characteristics for capsule manufacture. Gelatin suitable for capsule manufacture is commercially available from the Sigma Chemical Company, St. Louis, Mo.
For a general description of gelatin and gelatin-based capsules, see Remington's
Pharmaceutical Sciences, 16th ed., Mack Publishing Company, Easton, Pa. (1980), page 1245 and pages 1576-1582; and U.S. Pat. No. 4,935,243, to Borkan et at, issued Jun. 19, 1990; these two references being incorporated herein by reference in their entirety.
The soft gelatin shell of the capsules of the instant invention, as initially prepared, comprises from about 20% to about 60% gelatin, more preferably from about 25% to about 50% gelatin, and most preferably from about 40% to about 50% gelatin. The gelatin can be of Type & Type B, or a mixture thereof with bloom numbers ranging from about 60 to about 300.
A plasticizer is another component of the soft gelatin shells of the instant invention. One or more plasticizers is incorporated to produce a soft gelatin shell. The soft gelatin thus obtained has the required flexibility characteristics for use as an encapsulation agent.
Useful plasticizers of the present invention include glycerin, sorbitan, sorbitol, or similar low molecular weight polyols, and mixtures thereof. . 30
The shell of the present invention, as initially prepared, generally comprises from about 10% to about 35% plasticizer, preferably from about 10% to about 25% plasticizer, and
® most preferably from about 10% to about 20% plasticizer. A preferred plasticizer useful in the present invention is glycerin. ’ The soft gelatin shells of the instant invention also comprise water. Without bein g limited by theory, the water is believed to aid in the rapid dissolution or rupture of the soft gelatin shell upon contact with the gastrointestinal fluids encountered in the body.
The shell of the present invention, as initially prepared, generally comprises from about 15% to about 50% water, more preferably from about 25% to about 40% water, and most preferably from about 30% to about 40% water.
Other optional components which can be incorporated into the soft gelatin shells include colorings including color coatings, flavorings, preservatives, anti-oxidants, essences, and other aesthetically pleasing components. 15 .
The compositions of the present invention can be encapsulated within any conventional soft gelatin shell that is capable of substantially containing the composition for a reasonable period of time. The soft gelatin shells of the instant invention can be prepared by combining appropriate amounts of gelatin, water, plasticizer, and any optional : components in a suitable vessel and agitating and/or stirring while heating to about 65 °C, until a uniform solution is obtained. This soft gelatin shell preparation can then be used for encapsulating the desired quantity of the fill composition employing standard encapsulation methodology to produce one-piece, hermetically-sealed, soft gelatin capsules. The gelatin capsules are formed into the desired shape and size so that they can be readily swallowed. The soft gelatin capsules of the instant invention are of a suitable size for easy swallowing and typically contain from about 100 mg to about 2000 mg of the active composition. Soft gelatin capsules and encapsulation methods are described in P. K.
Wilkinson et at., "Softgels: Manufacturing Considerations", Drugs and the Pharmaceutical
Sciences, 41 (Specialized Drug Delivery Systems), P. Tyle, Ed. (Marcel Dekker, Inc., New
York, 1990) pp.409-449; F. S. Horn et at., "Capsules, Soft", Encyclopedia of
Pharmaceutical Technology, vol. 2, J. Swarbrick and J. C. Boylan, eds. (Marcel Dekker,
Inc., New York, 1990) pp. 269-284; M. S. Patel et at., "Advances in Softgel Formulation
Technology", Manufacturing Chemist, vol. 60, no. 7, pp. 26-28 (July 1989); M. S. Pate] et
® al., "Softgel Technology”, Manufacturing Chemist, vol. 60, no. 8, pp. 47-49 (August 1989); R. F. Jimerson, "Softgel (Soft Gelatin Capsule) Update", Drug Development and
Industrial Pharmacy (Interphex '86 Conference), vol. 12, no. 8 & 9, pp. 1133-1144 (1986); ) and W. R. Ebert, "Soft Elastic Gelatin Capsules: A Unique Dosage Form", Pharmaceutical
Technology, vol. 1, no. 5, pp. 44-50 (1977); these references are incorporated by reference herein in their entirety. The resulting soft gelatin capsule is soluble in water and in gatrointestinal fluids. Upon swallowing the capsule, the gelatin shell rapidly dissolves or ruptures in the gastrointestinal tract thereby introducing the pharmaceutical actives from the liquid core into the physiological system.
Preferably the capsules have an oblong shape to facilitate swallowing. In the case of a capsule containing 300 to 700 mg of the combined active ingredients an oblong capsule may be about 10-28 mm, preferably 20-26 mm, in particular about 25 mm long and have a diameter of about 5 to 11 mm, preferably 6-10 mm, in particular 8-9 mm.
Tablets of the invention will generally contain at least one pharmaceutically or dietary acceptable excipient conventionally used in the art of solid dosage form formulation.
Suitable excipients which may be incorporated include lubricants, for example magnesium stearate and stearic acid; disintegrants, for example cellulose derivatives; starches; binders, for example modified starches, polyvinylpyrrolidones and cellulose derivatives; glidants, for example colloidal silicas; compression aids, for example cellulose derivatives; as well as preservatives, suspending agents, wetting agents, flavoring agents, bulking agents, adhesives, coloring agents, sweetening agents appropriate to their form.
Suitably when the composition is in a tablet form, the composition will further comprise a film coat, e. g. hydroxypropylmethylcellulose (HPMC). Suitably the film coat is a transparent film coat, although an opaque film coat e. g. as obtained when using a film coat material in combination with an opacifier or a pigment such as titanium dioxide, a lake or a dye, may also be used. Advantageously it has been found that the inclusion of an opaque film coat minimizes tablet discoloration, which may occur on long-term storage of the tablet. Discoloration may also be avoided by incorporating a coloring agent into the tablet
® core. Suitably such tablets may also be film-coated, e. g. if desired for aesthetic purposes and/or to aid swallowing.
The combined active ingredients are mixed with the excipients of the tablet core and compressed on a suitable tablet press.
The compression forces which are needed to produce tablets of suitable breaking resistance and hence with the required breakdown times are dependent on the shapes and sizes of the punching tools used. Compression forces in the range from 2 - 20 kN are preferred. Higher compression forces may lead to tablets with a delayed released of the active substances (i) to (iv). Lower compression forces may produce mechanically unstable tablets. The tablet cores may have different shapes; the preferred shapes are round biplanar or biconvex and oval or oblong forms.
The coating solution is prepared by mixing the film-forming agent with the colouring materials and a plasticizer in water. Using a suitable coating pan the film-coating solution is applied on to the tablet cores.
Preferably the tablets have an oblong shape to facilitate swallowing. In the case of a film- coated tablet containing 300 to 700 mg of the combined active ingredients an oblong tablet may be about 10-20 mm long and have a width of about 5 to 10 mm.
As a rule the tablets according to the present invention contain lower amounts of DHA (d) than the capsules due to the oily nature of DHA.
A wide variety of vitamins, minerals and trace elements that are safe for consumption by pregnant women, lactating women or women having childbearing potential that are attempting to become pregnant may be used in the dosage form of the invention in varying quantities. These vitamins, minerals and trace elements include, for example, Vitamin A or beta-carotene, Vitamin B, (as Thiamin or Thiamin mononitrate), Vitamin B; (as
Riboflavin), Vitamin Bj (as Niacin), Vitamin Bg (as Pyridoxine or Pyridoxine hydrochloride), Vitamin By (Folic Acid), Vitamin B,, (cyanocobalamine), Vitamin H (Biotin), Vitamin C (Ascorbic Acid), Vitamin D, Vitamin E (as dI- Alpha Tocopherol
CWO 2004091317 PCT/EP2004/003913 ® Acetate), Vitamin K, Folacin, Niacinamide, Iron (as Ferrous Fumarate), Phosphorus,
Pantothenic Acid (as Calcium Pantothenate), Iodine (as Potassium Iodide), Magnesium (as
Magnesium Oxide), Zinc (as Zinc Oxide), Selenium (as Sodium Selenate), Copper (as
Cupric Oxide), Manganese (as Manganese Sulfate), Chromium (as Chromium Chloride),
Molybdenum (as Sodium Molybdate), Choline, Fluoride, Chloride, Potassium, Sodium, and mixtures thereof. Such vitamins, minerals and trace elements are commercially available from sources known by those of skill in the art, such as Hoffmann-LaRoche Inc. (Nutley, N.J.).
Preferably the composition according to the invention contains at least one vitamin selected from the group consisting of f3-carotene, Vitamin B,, Vitamin B;, Vitamin By,
Vitamin B),, Vitamin C, Vitamin Ds, Vitamin E, Folic Acid, Biotin and Niacinamide, in particular such dosage forms, in which the multivitamin mixture consists of 3-carotene,
Vitamin B;, Vitamin B,, Vitamin Bg, Vitamin B,, Vitamin C, Vitamin Ds, Vitamin E,
Folic Acid, Biotin and Niacinamide.
Preferably, the weight ratio of DHA (d) to at least one of the vitamins (a) selected from the group consisting of Vitamin D3 and Biotin is from 500 : 1 to 100,000 : 1, preferably 3,000 :11t030,000: 1.
Furthermore preferred is a composition, wherein the weight ratio of folic acid to Vitamin
B6isfrom1:1to1:8, preferably 1:1.5to 1 :7.5, in particular about 1 : 3.
Furthermore preferred is a composition, wherein weight ratio of Iron to Magnesium is from 25s 10: 1to 1to 2, in particular from 5: 1 to 1 : 1, most preferred about 2.7 : 1.
The composition according to the invention contains at least two minerals selected from the group consisting of Iron, Zinc and Magnesium, and at least two trace elements selected from Chromium, Copper, lodine, Molybdenum and Selenium, preferred are composition comprising at least Molybdenum and/or Selenium, in particular such compositions, in which the mixture of minerals and trace elements consists of Iron, Zinc, Magnesium,
Chromium, Copper, Iodine, Molybdenum and Selenium.
Claims (18)
- k WO 2004/091317 PCT/EP2004/003913 ® CLAIMS:I. A pharmaceutical or dietary composition in form of a capsule or tablet, bead or lozenge, which can be swallowed easily, consisting of (a) one or more vitamins, (b) one or more minerals selected from the group consisting of Iron, Zinc and Magnesium, (c) one or more trace elements selected from the group consisting of Chromium, Copper, Iodine Molybdenum and Selenium, (d) DHA, and (e) a pharmaceutically or dietetically suitable carrier.
- 2. A pharmaceutical or dietary composition according to claim 1, wherein the vitamins (a) are selected from the group consisting of B-carotene, Vitamin B;, Vitamin B,, Vitamin Bg, Vitamin B,, Vitamin C, Vitamin D3, Vitamin E, Folic Acid, Biotin and Niacinamide.
- 3. A pharmaceutical or dietary composition according to claim 1 or 2, wherein the weight ratio of DHA (d) to at least one of the vitamins (a) selected from the group consisting of Vitamin D3 and Biotin is from 500 : 1 to 100,000 : 1.
- 4. A pharmaceutical or dietary composition according to any one of the preceding claims, wherein the weight ratio of folic acid to Vitamin B6is from1:1to 1:8.
- 5. A pharmaceutical or dietary composition according to any one of the preceding claims, wherein the weight ratio of Iron to Magnesium is from 10: 1 to 1 to 2.
- 6. A pharmaceutical or dietary composition according to any one of the preceding claims, wherein the weight ratio of DHA (d) to at least one of the trace elements (c) selected from the group consisting of Chromium, Molybdenum, Selenium is from 500 : 1 to 20,000 : 1. : 30
- 7. A pharmaceutical or dietary composition according to any one of the preceding claims consisting essentially ofCWO 2004091317 PCT/EP2004/003913 ® (a) a multi-vitamin mixture consisting of $-carotene, Vitamin B;, Vitamin Ba, Vitamin Bg, Vitamin B,,, Vitamin C, Vitamin Ds, Vitamin E, Folic Acid, Biotin and Niacinamide; (b) a mineral mixture consisting of Iron, Zinc and Magnesium ; (©) a mixture of trace elements consisting of Chromium, Copper, Iodine, - Molybdenum and Selenium; (d) DHA; and (e) a pharmaceutically or dietetically suitable carrier.
- 8. A pharmaceutical or dietary composition according to any one of the preceding claims wherein the weight of the active ingredients (a) to (d) in the unit dosage form is from 150 to 700 mg
- 9. A pharmaceutical or dietary composition according to any one of the preceding claims consisting essentially of (a) 100 to 160 mg of a multi-vitamin mixture consisting of 3-carotene, Vitamin Bi, Vitamin B,, Vitamin Bg, Vitamin By, Vitamin C, Vitamin D3, Vitamin E, Folic Acid, Biotin and Niacinamide; (b) 60 to 120 mg of a mineral mixture consisting of Iron, Zinc and Magnesium; ©) 100 to 5000 pg of a mixture of trace elements consisting of Chromium, Copper, Iodine, Selenium and Molybdenum; (d) 100 to 200 mg of DHA; and (e) a pharmaceutically or dietetically suitable carrier.
- 10. A pharmaceutical or dietary composition according to any one of the preceding claims consisting essentially of (a) a multi-vitamin mixture consisting of 15 to 3.5 mg of B-carotene, 1.0 to 1.8 of mg Vitamin By, 1.0 to 1.8 mg of Vitamin Ba, 1.5 to 2.5 mg of Vitamin Bg, 1.0 to 5.0 ug of Vitamin Bj, 60 to 150 mg of Vitamin C, 2.0 to 200 pg of Vitamin Ds, 15 to 30 mg of } 30 Vitamin E, 200 to 1000 ug of Folic Acid, 10 to 100 ug of Biotin and 10 to 40 mg of Niacinamide; (b) a mineral mixture consisting of 10 to 50 mg of Iron, 5 to 20 mg of Zinc and 1 to 100 mg of Magnesium;®) a mineral mixture consisting of 10 to 50 pg of Chromium, 0.5 to 1.5 mg of Copper, 50 to 500 pg of Iodine, 10 to 100 pg of Molybdenum and 10 to 100 ug of Selenium; (d 100 to 200 mg of DHA; and (e) a pharmaceutically or dietetically suitable carrier.
- 11. A pharmaceutical or dietary composition according to any one of the preceding claims in the form of an oblong gelatine capsule having the following dimensions: diameter: 7 to 11 mm; and length: 21 to 26 mm.
- 12. A method of supplementing the dietary needs of a pregnant woman, a lactating woman or a woman of childbearing potential who is attempting to become pregnant, said method comprising administering to the woman a dietary supplementing amount of a pharmaceutical or dietary composition according to any one of the preceding claims.
- 13. The method according to claim 12, wherein one unit dosage form of the pharmaceutical or dietary composition according to claims 1 to 11 is administered to a woman in need thereof per day.
- 14. Use of a pharmaceutical or dietary composition according to any one of claims 1 to 11, for the preparation of a pharmaceutical or dietary unit dosage form for supplementing the dietary needs of a pregnant woman, a lactating woman or 2 woman of childbearing potential who is attempting to become pregnant.
- 15. The use according to claim 14, for the preparation of a single pharmaceutical or dietary unit dosage form, which can be administered once a day.\ -18a-
- 16. A pharmaceutical or dietary composition according to claim 1, substantially as herein described and exemplified.
- 17. The method according to claim 12, substantially as herein described and exemplified.
- 18. The use according to claim 14, substantially as herein described and exemplified. AMENDED SHEET
Applications Claiming Priority (1)
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EP03008985 | 2003-04-17 |
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ZA200506794A ZA200506794B (en) | 2003-04-17 | 2005-08-24 | Multi-vitamin and mineral supplement for pregnant women |
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EP (1) | EP1617734A1 (en) |
JP (1) | JP2006523642A (en) |
KR (1) | KR20060004939A (en) |
CN (1) | CN1774179A (en) |
AR (1) | AR047483A1 (en) |
AU (1) | AU2004229165A1 (en) |
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CA (1) | CA2522462A1 (en) |
CL (1) | CL2004000813A1 (en) |
EC (1) | ECSP056108A (en) |
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RU (1) | RU2005135565A (en) |
TW (1) | TW200507877A (en) |
WO (1) | WO2004091317A1 (en) |
ZA (1) | ZA200506794B (en) |
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GB0403247D0 (en) † | 2004-02-13 | 2004-03-17 | Tillotts Pharma Ag | A pharmaceutical composition |
BRPI0608293A2 (en) * | 2005-03-10 | 2012-05-02 | Sciele Pharma Inc | nutritional preparations |
FR2902659A1 (en) | 2006-06-23 | 2007-12-28 | Pierre Fabre Medicament Sa | DHA ESTER AND ITS USE IN THE TREATMENT AND PREVENTION OF CARDIOVASCULAR DISEASES |
ES2362292B1 (en) * | 2009-12-11 | 2012-02-23 | Farmalider, S.A. | ORAL COMPOSITION SOLID PHARMACEUTICAL OR DIETARY SPECIFICALLY INDICATED FOR WOMEN MANAGER. |
JP5717092B2 (en) * | 2011-03-03 | 2015-05-13 | 株式会社 メドレックス | External patch |
WO2015167434A1 (en) * | 2014-04-28 | 2015-11-05 | Eduardo Fernandez | Compositions for nutritional supplementation |
CN104970372A (en) * | 2014-10-27 | 2015-10-14 | 上海妈咪宝贝生物科技有限公司 | Vitamin and mineral tablets for pregnant woman and wet nurse |
CA3013795A1 (en) * | 2016-02-17 | 2017-08-24 | Corr-Jensen Inc. | Time release vitamins and minerals in edible oils |
NL2017219B1 (en) * | 2016-07-22 | 2018-01-30 | Rousselot B V | Low cross-linking gelatine |
US11083738B2 (en) | 2017-09-28 | 2021-08-10 | Natals, Inc. | Dietary nutrient compositions |
CN108310010B (en) * | 2018-04-03 | 2021-01-12 | 中国科学院上海硅酸盐研究所 | Ion reagent for treating myocardial infarction and preparation method and application thereof |
WO2021190988A1 (en) * | 2020-03-27 | 2021-09-30 | Dsm Ip Assets B.V. | Prenatal confectionery |
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NL8403433A (en) * | 1984-11-09 | 1986-06-02 | Holland Melkunie | FOOD SUPPLY PREPARATION BASED ON MILK COMPONENTS. |
GB9608719D0 (en) * | 1996-04-26 | 1996-07-03 | Scherer Ltd R P | Pharmaceutical compositions |
EP0891719A1 (en) * | 1997-07-14 | 1999-01-20 | N.V. Nutricia | Nutritional composition containing methionine |
GB9808579D0 (en) * | 1998-04-22 | 1998-06-24 | Novartis Nutrition Ag | Improvements in or relating to organic compounds |
US6569857B1 (en) * | 1999-05-03 | 2003-05-27 | Drugtech Corporation | Dietary supplement |
US7226916B1 (en) * | 2000-05-08 | 2007-06-05 | N.V. Nutricia | Preparation for the prevention and/or treatment of vascular disorders |
DK1155620T3 (en) * | 2000-05-18 | 2005-12-05 | Mega Healthcare As Q | Dietary supplement with vitamins, minerals and polyunsaturated fatty acids |
US6436431B1 (en) * | 2001-07-02 | 2002-08-20 | Diane Wright Hoffpauer | Fortified rice bran food product and method for promoting cardiovascular health |
US7704542B2 (en) * | 2001-09-12 | 2010-04-27 | Xanodyne Pharmaceuticals, Inc. | Vitamin/mineral compositions with DHA |
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- 2004-04-14 MX MXPA05010930A patent/MXPA05010930A/en not_active Application Discontinuation
- 2004-04-14 CN CNA2004800101967A patent/CN1774179A/en active Pending
- 2004-04-14 KR KR1020057019535A patent/KR20060004939A/en not_active Application Discontinuation
- 2004-04-14 JP JP2006505117A patent/JP2006523642A/en active Pending
- 2004-04-14 AU AU2004229165A patent/AU2004229165A1/en not_active Abandoned
- 2004-04-14 WO PCT/EP2004/003913 patent/WO2004091317A1/en active Application Filing
- 2004-04-14 BR BRPI0409585-5A patent/BRPI0409585A/en not_active IP Right Cessation
- 2004-04-14 RU RU2005135565/13A patent/RU2005135565A/en not_active Application Discontinuation
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EP1617734A1 (en) | 2006-01-25 |
PE20040963A1 (en) | 2005-01-05 |
JP2006523642A (en) | 2006-10-19 |
ECSP056108A (en) | 2006-03-01 |
BRPI0409585A (en) | 2006-04-18 |
WO2004091317A1 (en) | 2004-10-28 |
MXPA05010930A (en) | 2005-11-25 |
TW200507877A (en) | 2005-03-01 |
CL2004000813A1 (en) | 2005-03-04 |
AU2004229165A1 (en) | 2004-10-28 |
AR047483A1 (en) | 2006-01-25 |
KR20060004939A (en) | 2006-01-16 |
CN1774179A (en) | 2006-05-17 |
RU2005135565A (en) | 2006-07-27 |
CA2522462A1 (en) | 2004-10-28 |
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