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
• • 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
  • 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
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
  • 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 OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
  • 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 OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
  • 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 OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
  • 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 OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
  • 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 OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
  • 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

Definitions

• the invention relates to pharmaceutical or dietary unit dosage form, which can be swallowed easily, 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 carrier.
• 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, e.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).
• a multi-vitamin and mineral dietary supplement 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 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 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.
• 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.
• 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.
• 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, Iodine, 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.
• 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 (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.
• the invention relates to 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 such a pharmaceutical or dietary composition.
• 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.
• 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.
• 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.
• compositions of the present invention containing vitamin(s) (a), minerals (b), trace elements (c), and DHA(d) are preferably encapsulated in a soft gelatin including bovine, porcine, vegetable and succinylated gelatin shell.
• the soft gelatin shell is essentially transparent so as to enhance the aesthetic qualities of the 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.
• the soft gelatin shell of the capsules of the instant invention 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.
• the shell of the present invention 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 being 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.
• colorings including color coatings, flavorings, preservatives, anti-oxidants, essences, and other aesthetically pleasing components.
• 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) p ⁇ .409-449; F. S. Horn et at., "Capsules, Soft", Encyclopedia of
• the capsules have an oblong shape to facilitate swallowing.
• 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.
• 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
• suspending agents wetting agents, flavoring agents, bulking agents, adhesives, coloring agents, sweetening agents appropriate to their form.
• the composition when the composition is in a tablet form, the composition will further comprise a film coat, e. g. hydroxypropylmethylcellulose (HPMC).
• a film coat e. g. hydroxypropylmethylcellulose (HPMC).
• HPMC hydroxypropylmethylcellulose
• 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.
• 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.
• 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.
• 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.
• the tablets have an oblong shape to facilitate swallowing.
• an oblong tablet may be about 10-20 mm long and have a width of about 5 to 10 mm.
• the tablets according to the present invention contain lower amounts of DHA (d) than the capsules due to the oily nature of DHA.
• 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.
• vitamins, minerals and trace elements include, for example, Vitamin A or beta-carotene, Vitamin B i (as Thiamin or Thiamin mononitrate), Vitamin B 2 (as Riboflavin), Vitamin B 3 (as Niacin), Vitamin B 6 (as Pyridoxine or Pyridoxine hydrochlori.de), Vitamin B 9 (Folic Acid), Vitamin B 12 (cyanocobalamine), Vitamin H (Biotin), Vitamin C (Ascorbic Acid), Vitamin D, Vitamin E (as dl- Alpha Tocopherol Acetate), Vitamin K, Folacin, Niacinamide, Iron (as Ferrous Fumarate), Phosphorus, Pantothenic Acid (as Calcium Pantothenate), Iodine (as Potassium Iodide), Magnes, Vitamin
• the composition according to the invention contains at least one vitamin selected from the group consisting of ⁇ -carotene, Vitamin B 1; Vitamin B 2 , Vitamin B 6 , Vitamin B ⁇ 2 , Vitamin C, Vitamin D 3 , Vitamin E, Folic Acid, Biotin and Niacinamide, in particular such dosage forms, in which the multivitamin mixture consists of ⁇ -carotene, Vitamin B ls Vitamin B 2 , Vitamin B 6 , Vitamin B 12 , Vitamin C, Vitamin D 3 , Vitamin E, Folic Acid, Biotin and Niacinamide.
• 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 : 1 to 30,000 : 1.
• composition wherein the weight ratio of folic acid to Vitamin B6 is from 1 : 1 to 1 : 8, preferably 1 : 1.5 to 1 : 7.5, in particular about 1 : 3.
• composition wherein weight ratio of Iron to Magnesium is from 10 : 1 to 1 to 2, in particular from 5 : 1 to 1 : 1, most preferred about 2.7 : 1.
• 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, Iodine, 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.
• Pre-mixes containing vitamins and minerals recommended for pregnant women, lactating women and women having childbearing potential that are attempting to become pregnant may be employed to produce the unit dosage form of the present invention may be obtained from Watson Foods Co., Inc. under Watson Code WT-6061A.
• the dosage forms of the invention may be formulated using any pharmaceutically- acceptable forms of the vitamins and/or minerals described above, including their salts, which are known by those of skill in the art.
• useful pharmaceutically- acceptable magnesium compounds include Magnesium Stearate, Magnesium Carbonate, Magnesium Oxide, Magnesium Hydroxide and Magnesium Sulfate.
• iron compounds include any of the well-known Iron II (ferrous) or Iron III (ferric) supplements, such as Ferrous Sulfate, Ferric Chloride, Ferrous Gluconate, Ferrous Lactate, Ferrous Tartrate, Iron-Sugar-Carboxylate complexes, Ferrous Fumarate, Ferrous Succinate, Ferrous Glutamate, Ferrous Citrate, Ferrous Pyrophosphate, Ferrous Cholinisocitrate, Ferrous Carbonate, and the like.
• Iron II ferrous
• Ferric Chloride Ferrous Gluconate
• Ferrous Lactate Ferrous Tartrate
• Iron-Sugar-Carboxylate complexes Ferrous Fumarate
• Ferrous Succinate Ferrous Glutamate
• Ferrous Citrate Ferrous Citrate
• Ferrous Pyrophosphate Ferrous Cholinisocitrate
• Ferrous Carbonate and the like.
• the vitamins and/or minerals used to prepare the dosage forms of the invention may be microencapsulated in a coating of fat, microcrystalline cellulose or similar material in order to prevent their degradation under various conditions.
• the vitamins and/or minerals that are employed in the dosage form of the invention are those that are recommended for consumption by pregnant women, lactating women or women having childbearing potential that are attempting to become pregnant. These vitamins and minerals are employed in an amount that is effective for enhancing the nutrition of pregnant women, lactating women or women having childbearing potential that are attempting to become pregnant, or of their developing fetuses or babies. This quantity will vary depending upon the particular vitamins and/or minerals chosen for use, but generally ranges from about 25 to about 95 weight percent of the total weight of the dosage form, and preferably ranges from about 30 to about 90 weight percent, with about 80 weight percent being most preferred.
• Each dosage form may contain one or more of the above vitamins, minerals and/or trace elements in any quantity that is safe for consumption by pregnant women, lactating women or women having childbearing potential that are attempting to become pregnant (i.e., a quantity that would not cause harm to the woman consuming the food bar, or to her developing fetus or breast-feeding baby).
• lactating women or women having childbearing potential that are attempting to become pregnant (i.e., a quantity that would not cause harm to the woman consuming the food bar, or to her developing fetus or breast-feeding baby).
• Set forth hereinbelow are the approximate preferred ranges of the daily quantities of the various vitamins and minerals that may generally be used in one dosage form(or divided between more than one dosage form for consumption during a one-day period) for pregnant women, lactating women or women having childbearing potential that are attempting to become pregnant (from about one quantity to about another quantity), as well as more preferred ranges, and the most preferred quantities.
• each dosage form according to the present invention contains one or more of the above vitamins, minerals and/or trace elements in an amount which corresponds to about 100 % of the recommended daily dose for pregnant women.
• DHA docosahexaenoic acid
• DHA is a long-chain fatty acid that is necessary for brain and eye development in children, and is included as an ingredient of the dosage form of the invention in an amount ranging from about 10 to about 300 mg, with about 100 to 200 mg being preferred, and about 150 mg being most preferred for pregnant women, lactating women, and women having childbearing potential that are attempting to become pregnant.
• fats and oils can be employed as carriers of DHA (d).
• These fats or oils include, for example, olive oil, canola oil, palm oil, coconut oil, sunflower oil, peanut oil, vegetable oil, lecithin, fish oil, cotton seed oil, soybean oil, lard, monoglycerides, diglycerides, butter, margarine, and other animal, vegetable, and marine fats, and milk fats, waxes such as beeswax, which are commercially available from sources known by those of skill in the art, and mixtures thereof.
• Vegetable oil is the preferred fat for use in the food bars of the invention.
• dosage forms according to the invention consisting essentially of (a) a multi- vitamin mixture consisting of ⁇ -carotene, Vitamin Bi, Vitamin B 2 ,
• Vitamin B 6 Vitamin B ⁇ 2 , Vitamin C, Vitamin D 3 , Vitamin E, Folic Acid, Biotin and Niacinamide;
• a dosage form according to the invention consisting essentially of
• a dosage form according to the invention consisting essentially of
• a multi-vitamin mixture consisting of 1.5 to 2.5 mg of ⁇ -carotene, 1.0 to 1.8 of mg Vitamin Bi, 1.0 to 1.8 mg of Vitamin B 2 , 1.5 to 2.5 mg of Vitamin B 6 , 1.0 to 5.0 ⁇ g of Vitamin B ⁇ 2 , 60 to 110 mg of Vitamin C, 2.0 to 200 ⁇ g, in particular 2.5 to 10 ⁇ g of Vitamin D 3 , 15 to 30 mg of Vitamin E, 200 to 1000 ⁇ g of Folic Acid, 10 to 100 ⁇ g of Biotin and 10 to 40 mg of Niacinamide;
• the weight of the active ingredients (a) to (d) in the unit dosage form of the composition according to the invention is from 150 to 700 mg, in particular from 200 to 600 mg, most preferably from about 300 to 400 mg.
• One unit dosage form of the composition according to the invention is preferably administered per day.
• Soft gelatine capsules are prepared containing the following active ingredients:
• the ingredients are mixed and encapsulated into gelatine, water and a plasticifier to form oblong soft gelatine capsules having the following dimensions: Diameter: 7 to 11, preferably 8 to 9 mm; Length: 21 to 26, preferably about 25 mm

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