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
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23D—EDIBLE OILS OR FATS, e.g. MARGARINES, SHORTENINGS OR COOKING OILS
  • A23D9/00—Other edible oils or fats, e.g. shortenings or cooking oils
• • 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
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/28—Compounds containing heavy metals
  • A61K31/295—Iron group metal compounds
• • 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
  • A61K9/0012—Galenical forms characterised by the site of application
  • A61K9/0041—Mammary glands, e.g. breasts, udder; Intramammary administration
• • 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
  • A61K9/10—Dispersions; Emulsions
• • 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
  • 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
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
  • B65D47/00—Closures with filling and discharging, or with discharging, devices
  • B65D47/04—Closures with discharging devices other than pumps
  • B65D47/06—Closures with discharging devices other than pumps with pouring spouts or tubes; with discharge nozzles or passages
  • B65D47/18—Closures with discharging devices other than pumps with pouring spouts or tubes; with discharge nozzles or passages for discharging drops; Droppers
• • 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 present invention relates to a composition particularly useful as a dietery supplement, more particularly as dietery iron (Fe) supplement.
• the present invention relates to use of the composition as a dietery supplement, for example to prevent or treat iron deficiency in a human.
• Iron is a known and necessary nutrient that is involved in the proper function of enzymes involved in energy transfer. Iron is also a component of hemoglobin and myoglobin - i.e., components of blood that are used to transport oxygen.
• Iron deficiency anemia is the most common nutrient deficiency in the world. The condition is readily treatable with an iron supplement. Iron deficiency even without the manifestation of anemia can harm infants because iron deficiency can impair neurodevelopment and behavior, some of which may be irreversible.
• iron supplement products are known. Typically, these are products that, when available for use with infants, are in in the form of drops comprised, for example, of iron sulfate solution in a water base with glycerine or alcohol, together with optional colors or flavorings.
• An example of such a commercially available supplement is FER-IN- SOLTM.
• the iron may be in a different form.
• iron fumarate is available as water- based suspension, under the brand name PLAFERTM
• ferrous sulfate is available as a water- based suspension, under the brand name MYKIDZTM.
• chewable iron tablets are available, for example, FEOSOLTM.
• iron is a component of many multivitamin pills.
• Iron sprinkles a powder containing micro-encapsulated ferrous fumarate is also known in the prior art.
• United States patent 6,830,761 teaches a composition useful in the prevention of iron deficiency anemia.
• the composition comprises micro-encapsulated iron granules in combination with a lipid-based excipient.
• the composition may additionally contain other micronutrients including ascorbic acid, zinc, vitamin A and iodine.
• Zlotkin teaches that the composition is particularly useful for the prevention of iron deficiency anemia in infants between the ages of 6 and 24 months of age since it can readily be admixed with the semi-solid foods this age group consumes.
• micro-encapsulated iron i.e., versus non- encapsulated iron
• Examples 1 and 2 of Zlotkin The importance of using micro-encapsulated iron (i.e., versus non- encapsulated iron) is illustrated in Examples 1 and 2 of Zlotkin. Specifically, it is reported in Example 2 of Zlotkin that there is no significant difference in the hemoglobin response between rats fed similar amounts of iron as the reference compound (i.e., non-encapsulated ferrous sulfate) versus rats fed micro-encapsulated ferrous fumarate. Thus, the use of microencapsulated iron is central to the teaching of Zlotkin.
• United States patent 6,352,730 [Zimmerman et al. (Zimmerman)] teaches a method of adding food-additive ingredients to a food product, particularly a reduced fat fried snack product, and an ingredient suspension containing a flowable edible, preferably a nondigestible fat, and food-additive ingredients.
• the method consists of suspending the encapsulated or powdered ingredients in the flowable edible fat, and applying the suspension in a controlled amount to the surface of a food product.
• the preferred food product is a fabricated reduced fat or fat-free potato chip which is a fried snack made by frying a dough in a nondigestible fat to a moisture content of less than 5%.
• the ingredient suspension is applied to the surface of the fried snack soon after emerging from the fryer.
• Zimmerman states that the food product has a light, crispy, improved crunchy texture, improved flavor and a fat content of from about 20% to about 38% nondigestible fat and is fortified with food-additive ingredients.
• the process taught by Zimmerman is for food production, primarily with vitamins, and there is a focus on the fact that "the edible fat is a non-digestible fat” such as olestra; the purpose of these fats is that they are a fat substitute used for a cholesterol-lowering diet.
• the suspension taught by Zimmerman is not suitable for use a nutrient supplement, let alone an iron nutrient supplement.
• United States patent 3,992,556 [Kovacs et al. (Kovacs)] teaches a particulate food supplement composition comprising a nutrient such as assimilable iron compounds, vitamins, minerals or mixtures thereof which nutrient is uniformly dispersed in a carrier consisting essentially of particles or beads of an edible metabolizable fat.
• the edible fat is solid at room temperature, with a preferred softening or melting point between about 100° and 250°F., whereby the assimilable iron compounds, vitamins, minerals or mixtures thereof can be conveniently added or applied to a variety of foods, such as breakfast food cereals, crackers, cookies, potato chips and similar snack foods, flour and pasta during their productions.
• the particulate food supplement taught by Kovacs is not suitable for use a liquid (room temperature) nutrient supplement, let alone a liquid (room temperature) iron nutrient supplement.
• the present invention provides a composition comprising: (i) a non-encapsulated iron salt, and (ii) a carrier comprising digestible edible oil that is a liquid at 20°C.
• the present invention relates to use of the above-mentioned composition as a dietery supplement.
• the present invention relates to a delivery system for dispensing the above-mentioned composition.
• the present invention relates to use of the above-mentioned delivery system to dispense the above-mentioned composition as a dietery supplement.
• this is provided a composition comprising finely powdered salts of iron in a suspension in edible oil.
• This is provided in a vial that is capped with a vertical-dropper dispenser plug, also known as a Eurodropper, as illustrated Figure 1.
• the dose of iron can be dispensed by counting out fewer than 30 drops, ideally about 1-5 drops.
• a method for preventing iron deficiency anemia in a mammal comprising the steps of providing a therapeutically effective amount of the iron suspension in a pharmaceutically acceptable liquid lipid based excipient to the mammal.
• an article of manufacture comprising packaging material, preferably a glass vial, and a pharmaceutical composition contained therein, wherein said pharmaceutical composition is therapeutically effective to prevent or treat iron deficiency anemia.
• the packaging material comprises a vial into the opening of which is inserted a Eurodropper fitting to dispense individual drops, a screw cap to completely enclose the contents.
• the contents comprise one or more finely powdered iron salts in an edible oil.
• the present composition advantageously provides iron in a form that is easily administered to an infant or adult.
• the composition When taken directly by mouth or added to food or infant formula, the composition has a desirably bland flavor and is easy to consume.
• the high density of iron per unit volume of the composition results in a minimal volume of liquid to be administered. This makes the composition relatively innocuous and easy for infants to consume.
• an article of manufacture comprising packaging material, preferably a glass or squeezable plastic vial, and a pharmaceutical composition contained therein, wherein said pharmaceutical composition is therapeutically effective to prevent or treat iron deficiency anemia.
• the packaging material comprises capped vial that is first shaken, and then from which suspension is drawn up using a calibrated eyedropper or a syringe.
• the packaging material is a plastic vial capped with a dropper nozzle, whereby after shaking, the vial can be inverted and drops counted as they are squeezed from the vial.
• the present inventor has discovered a composition which is particularly suitable for administration of iron to infants, but also suitable for children and adults.
• One aspect of the present invention is a liquid suspension of iron salts in edible oil in a composition that makes it suitable for a product that drips properly from a vial that has a vertical, so-called Eurodropper dispenser dropper affixed to it - see Figure 1.
• the present composition may be drawn up into a syringe or an eyedropper for administration, for example, to a human.
• suspensions of non-encapsulated salts of iron in oil can be manufactured to provide milligram amounts of elemental iron per drop.
• the present composition has a desirably bland taste and behaves in a manner suitable for delivery with a convenient, reliable and safe, inverted-dropper (e.g., Eurodropper or plastic squeeze-bottle) format.
• the present composition is in the form of a concentrated iron suspension in oil, more preferably having one or more of the following features:
• the suspension is dense enough so that no more than 30 drops deliver the dose of iron for a day. i.e. about 60 mg elemental iron per mL.
• Figure 1 illustrates a preferred delivery system for dispense the present composition.
• the present invention relates to a composition
• a composition comprising: (i) a non-encapsulated iron salt, and (ii) a carrier comprising digestible edible oil that is a liquid at 20°C.
• Preferred embodiments of the composition may include any one or a combination of any two or more of any of the following features:
• the non-encapsulated iron salt is selected from the group consisting of ferrous fumarate, ferrous succinate, ferrous gluconate, ferric pyrophosphate, ferric saccharate, ferric orthophosphate, ferrous sulfate and mixtures of two or more of these;
• the non-encapsulated iron salt is ferrous fumarate
• the digestible edible oil is a naturally occurring oil
• the digestible edible oil is a vegatable oil
• the digestible edible oil is selected from from the group consisting of fractionated palm oil, coconut oil, olive oil, sesame oil, borage oil, canola oil, corn oil, almond oil, peanut oil, castor oil, cottonseed oil, rapeseed oil, sesame seed oil, fractionated components of any of these and mixtures of two or more of these;
• the digestible edible oil is a triglyceride oil
• the digestible edible oil is a medium chain triglyceride oil
• the digestible edible oil is a medium chain triglyceride oil have at least 90% by weight C -C 12 triglycerides
• the digestible edible oil is a medium chain triglyceride oil have at least 95% by weight C 6 -C 12 triglycerides; • the digestible edible oil is a medium chain triglyceride oil have at least 90% by weight C 8 -C] 0 triglycerides;
• the digestible edible oil is a medium chain triglyceride oil have at least 95% by weight Cg-C 10 triglycerides
• the carrier comprises a mixture of the medium chain triglyceride oil and non-fractionated edible oil
• the medium chain triglyceride oil is present in an amount of from about 10% to about 90% by weight and the non-fractionated edible oil makes up the balance of the mixture;
• the non-encapsulated iron salt is present in an amount to provide at least about 25 mg elemental iron/mL digestible edible oil
• the non-encapsulated iron salt is present in an amount to provide from about 25 mg elemental iron/mL digestible edible oil to about 150 mg elemental iron/mL digestible edible oil;
• the non-encapsulated iron salt is present in an amount to provide from about 40 mg elemental iron/mL digestible edible oil to about 120 mg elemental iron/mL digestible edible oil;
• the non-encapsulated iron salt is present in an amount to provide from about 40 mg elemental iron mL digestible edible oil to about 100 mg elemental iron/mL digestible edible oil;
• the non-encapsulated iron salt is present in an amount to provide from about 60 mg elemental iron/mL digestible edible oil to about 70 mg elemental iron mL digestible edible oil; • the composition further comprises at least one supplemental nutrient;
• the supplemental nutrient is a vitamin
• the supplemental nutrient is a fat-soluble vitamin
• the supplemental nutrient is selected from the group consisting of vitamin D, vitamin E, vitamin K and mixtures of two or more of these; and/or
• the present invention relates to use of the above-described composition a dietery supplement.
• Preferred embodiments of this use may include any one or a combination of any two or more of any of the following features:
• the physical surface is a foodstuff; • the physical surface is a solid foodstuff; and/or
• the physical surface is human skin, such as a clean finger used to wipe the iron suspension into the mouth of an infant
• the physical surface is human skin, such as the back of a hand from which the iron suspension is licked into the mouth
• the present invention relates to a delivery system comprising a housing containing the above-described composition, the housing configured to dispense the composition.
• Preferred embodiments of this delivery system may include any one or a combination of any two or more of any of the following features:
• the housing comprises a nozzle that is configured to dispense at least one drop of the composition
• the housing comprises a nozzle that is configured to dispense multiple drops of the composition
• the housing comprises a nozzle that is configured to dispense only a single drop of the composition
• the housing comprises a nozzle that is configured to dispense at least one drop of the composition when the housing is inverted;
• the housing comprises a nozzle that is configured to dispense multiple drops of the composition when the housing is inverted;
• the housing comprises a nozzle that is configured to dispense only a single drop of the composition when the housing is inverted;
• the delivery system is in the form of a dropper bottle; • the delivery system is in the form of an eye-dropper;
• the delivery system is in the form of a syringe
• the delivery system is in the form of a squeeze bottle.
• the present invention relates to use of the above-described delivery system to dispense the above-mentioned composition as a dietery supplement.
• Preferred embodiments of this use may include any one or a combination of any two or more of any of the following features:
• the physical surface is a solid foodstuff; and/or • the physical surface is a liquid foodstuff.
• the present invention provides a composition and delivery system useful to the prevention and treatment of iron deficiency anemia.
• the composition is in the form of a suspension of iron in an edible, digestible oil contained within a vial to the opening of which is inserted Eurodropper plug.
• the term "prevent” is used to describe the capacity of the composition to lessen the risk of iron deficiency anemia, and may also refer to the therapy to prevent or treat one or more of the adverse effects associated with iron deficiency.
• the term "edible oil” is used to refer to edible and digestible oil, which is liquid at room temperature (20°C).
• the edible oil will suspend granules of one or more salts of iron that are not encapsulated, but that may or may not be microencapsulated.
• the oil serves as an excipient.
• oils include mono-, di-and triglycerides, especially extracted edible oils in hydrogenated form such as vegetable oil, castor oil, cotton seed oil, corn oil, canola oil, rape seed oil, peanut oil, sesame seed oil, coconut oil and mixtures thereof, as well as fractionated components isolated from such oils, particularly medium-chain triglycerides.
• the iron of the present composition may comprise any bioavailable solid form of iron including such salts of iron as ferrous fumarate, ferrous sulfate, ferrous gluconate, ferrous succinate, ferric pyrophosphate, serric saccharate, ferric ortho phosphate or any other compound capable of providing bioavailable iron preferably without encapsulation, but also including microencapsulated forms of the compounds listed here.
• the present composition may be supplemented with additional micronutrients, which may function independently of iron to serve the nutritional needs of mammals.
• additional micronutrients which may function independently of iron to serve the nutritional needs of mammals.
• vitamin D would be included as a component.
• a method for use of the present composition to prevent or to treat iron deficiency in a mammal involves the steps of adding a therapeutically effective amount of the composition to a food, or directly into the mouth of a mammal or on to an exterior surface to be licked or sucked off.
• This method starts by having the liquid composition within a Eurodropper stoppered vial, sealed with a screw top cap.
• the vial is shaken vigorously by holding the vial by its cap and swinging it back and forth like an old- fashioned fever thermometer, the screw top is removed, the vial is held upside down to permit one or more drops of the iron suspension to be released from the nozzle portion of the Eurodropper.
• the vial is placed upright and the cap closure is reapplied to the vial.
• the one or more drops released contain the desired amount of elemental iron and can be taken directly into the mouth, or applied to an exterior surface and sucked, or added to food, infant formula or a beverage, or applied to a finger and wiped into the mouth (for example, wiped inside the cheek of an infant).
• the carrier comprises a medium chain triglyceride oil - e.g., medium chain triglyceride oil substantially comprising C 6 - Ci2 triglycerides (see above).
• Medium-chain triglyceride oils are conventionally obtained from the oil extracted from the hard, dried fraction of the endosperm of Cocos nucifera L. or from the dried endosperm of Elaeis guineensis Jacq. They consist of a mixture of triglycerides of saturated fatty acids, mainly of caprylic acid They contain not less than 95 percent of saturated fatty acids having 8 to 10 carbon atoms. The oil is a clear solution.
• the fatty acid fraction of medium-chain triglyceride has the following composition:
• Iron salt in the form of ferrous sulfate (dried) and ferrous fumarate were investigated for dispersibility and settling behavior in a range of carrier liquids. Sufficient iron salt was added to test tubes to achieve concentrations of elemental iron equivalent to 66 mg/mL suspension (i.e., 2 mg/drop, a commercially-viable concentration for infant supplementation). Each iron salt species was tested in liquids of differing viscosity - the results are provided in Table 1.
• a balance of rapid dispersion with slow settling is preferred for the present composition. Settling is inevitable for such a product given a shelf life in the range of months to years. Maintenance of an iron salt dispersion over this time period would require a prohibitively-thick carrier liquid (with viscosity in excess of 2,000 cp). As such, rapid dispersibility is also a preferred feature to ensure even distribution of iron salt throughout the carrier immediately prior to drop-wise dispensation.
• Ferrous fumarate has shown to be a particularly suitable iron salt in terms of consistent performance in the Eurodropper regardless of carrier liquid.
• the viscosity carrier liquid edible oil can also be adjusted to optimize the quality of the product by combining one or more other edible oils, such as bees wax as a thickener

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• Health & Medical Sciences (AREA)
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• Life Sciences & Earth Sciences (AREA)
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• Veterinary Medicine (AREA)
• Pharmacology & Pharmacy (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Medicinal Chemistry (AREA)
• Animal Behavior & Ethology (AREA)
• Epidemiology (AREA)
• Food Science & Technology (AREA)
• Polymers & Plastics (AREA)
• Nutrition Science (AREA)
• Mycology (AREA)
• Inorganic Chemistry (AREA)
• Dispersion Chemistry (AREA)
• Oil, Petroleum & Natural Gas (AREA)
• Diabetes (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Bioinformatics & Cheminformatics (AREA)
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• Organic Chemistry (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• General Chemical & Material Sciences (AREA)
• Mechanical Engineering (AREA)
• Obesity (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
• Coloring Foods And Improving Nutritive Qualities (AREA)
• Medicinal Preparation (AREA)
• Edible Oils And Fats (AREA)
• Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
• Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
• Fodder In General (AREA)

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• 2011
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• 2012
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