WO2021190988A1 - Prenatal confectionery - Google Patents

Prenatal confectionery Download PDF

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Publication number
WO2021190988A1
WO2021190988A1 PCT/EP2021/056596 EP2021056596W WO2021190988A1 WO 2021190988 A1 WO2021190988 A1 WO 2021190988A1 EP 2021056596 W EP2021056596 W EP 2021056596W WO 2021190988 A1 WO2021190988 A1 WO 2021190988A1
Authority
WO
WIPO (PCT)
Prior art keywords
vitamin
formulation
prenatal
soft chewable
formulation according
Prior art date
Application number
PCT/EP2021/056596
Other languages
French (fr)
Inventor
José BARBOSA
Zhenbo Ma
Conroy Clive SALMON
Sherry SITEMAN
Original Assignee
Dsm Ip Assets B.V.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Dsm Ip Assets B.V. filed Critical Dsm Ip Assets B.V.
Publication of WO2021190988A1 publication Critical patent/WO2021190988A1/en

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    • 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
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
    • A23G3/34—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof
    • A23G3/36—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds
    • A23G3/362—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds containing inorganic compounds
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
    • A23G3/34—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof
    • A23G3/36—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds
    • A23G3/364—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds containing microorganisms or enzymes; containing paramedical or dietetical agents, e.g. vitamins
    • A23G3/368—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds containing microorganisms or enzymes; containing paramedical or dietetical agents, e.g. vitamins containing vitamins, antibiotics
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
    • A23G3/34—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof
    • A23G3/36—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds
    • A23G3/46—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds containing dairy products
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
    • A23G3/34—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof
    • A23G3/50—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by shape, structure or physical form, e.g. products with supported structure
    • A23G3/54—Composite products, e.g. layered, coated, filled
    • 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
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/07—Retinol compounds, e.g. vitamin A
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    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A—HUMAN NECESSITIES
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    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • A61K31/355—Tocopherols, e.g. vitamin E
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4188—1,3-Diazoles condensed with other heterocyclic ring systems, e.g. biotin, sorbinil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4415—Pyridoxine, i.e. Vitamin B6
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/455—Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • A61K31/51—Thiamines, e.g. vitamin B1
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A—HUMAN NECESSITIES
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    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/525—Isoalloxazines, e.g. riboflavins, vitamin B2
    • 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
    • A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • A61K31/593—9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7135—Compounds containing heavy metals
    • A61K31/714—Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
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    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
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    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds

Definitions

  • the present invention relates to a new soft chewable prenatal formulation, which is a soft non-gummy and non-compression formulation.
  • the placenta is not yet formed and foetal circulation is not yet established. Therefore, during this period the foetus is nour ished via digested maternal uterine cells and the diffusion of blood exudates.
  • Vitamins and minerals can help a person prevent or recover from diseases, or maintain the body's normal healthy status. It is widely accepted knowledge that insufficiencies of a particular vitamin or mineral can cause certain human diseases. These insufficiencies most greatly affect a human during the stage of embryonic development. The embryonic stage is the most critical period in the formation and development of various tissues and organs of the human body. Con genital defects that occur in this period cannot be improved after birth. An example m is human brain tissue cell development, which determines the level of intelligence when the baby is born.
  • a foetus receives its entire nutritional intake from its mother, so the nutritional intake of the mother determines the level of foetus development Nutrition, good or bad, plays a critical role in foetal development in pregnant women. If certain nutrients, vitamins, and minerals are -deficient this may lead to disease in the mother and/or the foetus.
  • the formulation according to the present invention consists of a core and a coating.
  • the formulation is soft and easy to chew, but is not a gummy type kind of formulation.
  • the present invention relates to a chewable prenatal formulation (PF), which comprises a core and a coating.
  • PF chewable prenatal formulation
  • the chewable prenatal for mulation is a non-gummy and non-compression formulation.
  • the present invention relates to a soft chewable prenatal formulation (PF1), which the prenatal formulation (PF), wherein the formulation is a non-gummy and non compression formulation.
  • Soft chew confectioneries are an oral dosage form intended to be chewed and then swallowed by the patient rather than swallowed whole.
  • the core comprises the vitamins, the trace elements and the minerals, which are the es sential ingredients for the pregnant woman.
  • Soft chew confectioneries which are required to be broken and chewed in between the teeth before ingestion. These tablets are given to the children who have difficulty in swal lowing and to the adults who dislike swallowing.
  • the present invention relates to a soft chewable prenatal formulation (PF2), which the prenatal formulation (PF) and/or (PF1), wherein the core comprises the vita mins, the trace elements and the minerals, which are the essential for the pregnant woman.
  • the vitamins can include water-soluble as well as fat-soluble vitamins.
  • vitamin A vitamins from the vitamin B group (B1 , B2, B3, B5, B7, B9 and B12), vitamin C, vitamin D3 and vitamin E.
  • the dosage of the vitamins may vary.
  • the minerals, which are added to the formulation are Calcium, Iron, Zinc, and Magnesium.
  • a suitable trace element is for example Iodine.
  • the vitamins, the minerals and the trace elements can be added to the formulation and/or in preformulated form.
  • vitamin B1, B2 and B3 are added in a fat coated form.
  • Calcium is usually and preferably added in a micronized form.
  • the total amount of the vitamin, trace elements and minerals is at least 1000mg/unit.
  • the present invention relates to a soft chewable prenatal formulation (PF2’), which the prenatal formulation (PF2), wherein the vitamins are chosen from the group consisting of vitamin A, vitamins from the vitamin B group (B1 , B2, B3, B5, B7, B9, and B12), vitamin C, vitamin D3 and vitamin E. Therefore, the present invention relates to a soft chewable prenatal formulation (PF2”), which the prenatal formulation (PF2) of (PF2’), wherein the minerals are chosen from the group consisting of Calcium, Iron, Zinc, and Magnesium.
  • the present invention relates to a soft chewable prenatal formulation (PF2’”), which the prenatal formulation (PF2), (PF2’) or (PF2”), wherein the trace elements is Io dine
  • the present invention relates to a soft chewable prenatal formulation (PF3), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”) or (PF2’”), wherein the total amount of the vitamin, trace elements and minerals is at least 100 mg in the chewable prenatal formulation
  • the formulation according to the present invention comprises at least 3 different vitamins, preferably at least 8 different vitamins.
  • the formulation comprises 3 - 11 different vitamins, preferably 8 - 11 different vitamins.
  • the formulation comprises 3 - 11 different vitamins chosen from the group consisting of vitamin A, vitamins from the vitamin B group (B1 , B2, B3, B5, B7, B9, and B12), vitamin C, vitamin D3, and vitamin E, preferably 8 - 11 different vitamins chosen from the group consisting of vitamin A, vitamins from the vitamin B group (B1 , B2, B3, B5, B7, B9, and B12), vitamin C, vitamin D3, and vitamin E.
  • the present invention relates to a soft chewable prenatal formulation (PF4), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”) or (PF3), wherein the prenatal formulation comprises at least 3 different vitamins.
  • the present invention relates to a soft chewable prenatal formulation (PF4’), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”) or (PF3), wherein the prenatal formulation comprises at least 8 different vitamins. Therefore, the present invention relates to a soft chewable prenatal formulation (PF4”), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”) or (PF3), wherein the prenatal formulation comprises 3 - 11 different vitamins.
  • the present invention relates to a soft chewable prenatal formulation (PF4’”), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”) or (PF3), wherein the prenatal formulation comprises 8 - 11 different vitamins.
  • the present invention relates to a soft chewable prenatal formulation (PF5), which the prenatal formulation (PF4”), wherein the 3 - 11 different vitamins are chosen from the group consisting of vitamin A, vitamins from the vitamin B group (B1, B2, B3, B5, B7, B9, and B12), vitamin C, vitamin D3, and vitamin E.
  • the present invention relates to a soft chewable prenatal formulation (PF5’), which the prenatal formulation (PF4;”), wherein the 8 - 11 different vitamins are chosen from the group consisting of vitamin A, vitamins from the vitamin B group (B1, B2, B3, B5, B7, B9, and B12), vitamin C, vitamin D3, and vitamin E.
  • the amount of the different vitamins can vary.
  • the dosage of each vitamin should be high enough that the one serving (one unit) of the chewable formulation fulfils the need for the pregnant woman.
  • the formulation comprises at least different minerals, preferably at least 2 different min erals.
  • the formulation comprises 1 - 7 different minerals.
  • the formulation comprises 1 - 7, preferably 2 - 5, more preferably 3 - 5, of different minerals chosen from the group consisting of Calcium, Copper, Iron, Zinc, and Magne sium.
  • the present invention relates to a soft chewable prenatal formulation (PF6), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”), (PF3), (PF4), (PF4’), (PF4”), (PF4’”), (PF5) or (PF5’), wherein the prenatal formulation comprises at least 2 different minerals.
  • PF6 soft chewable prenatal formulation
  • the present invention relates to a soft chewable prenatal formulation (PF6’), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”), (PF3), (PF4), (PF4’), (PF4”), (PF4’”), (PF5) or (PF5’), wherein the prenatal formulation comprises 1 - 7 different minerals.
  • PF6 soft chewable prenatal formulation
  • the present invention relates to a soft chewable prenatal formulation (PF6”), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”), (PF3), (PF4), (PF4’), (PF4”), (PF4’”), (PF5) or (PF5’), wherein the prenatal formulation comprises 2 - 5 different minerals.
  • PF6 soft chewable prenatal formulation
  • the present invention relates to a soft chewable prenatal formulation (PF6’”), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”), (PF3), (PF4), (PF4’), (PF4”), (PF4’”), (PF5) or (PF5’), wherein the prenatal formulation comprises 3 - 5 different minerals.
  • PF6 soft chewable prenatal formulation
  • the present invention relates to a soft chewable prenatal formulation (PF7), which the prenatal formulation (PF6), (PF6’), (PF6”) or (PF6’”), wherein the minerals are chosen from the group consisting of Calcium, Copper, Iron, Zinc, and Magnesium.
  • the amount of the different minerals can vary.
  • the dosage of each mineral should be high enough that the one serving (one unit) of the soft chewable formulation fulfils the need for the pregnant woman.
  • the formulation comprises at least one trace element.
  • the formulation comprises iodine.
  • the present invention relates to a soft chewable prenatal formulation (PF8), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”), (PF3), (PF4), (PF4’), (PF4”), (PF4’”), (PF5), (PF5’), (PF6), (PF6’), (PF6”), (PF6’”) or (PF7), wherein the prenatal formulation comprising iodine as trace element.
  • the amount of the different trace elements can vary.
  • the dosage of each trace element should be high enough that the one serving (one unit) of the soft chewable for mulation fulfils the need for the pregnant woman.
  • the total amount of the vitamin, trace elements and minerals in the formulation is at least 500mg/unit. Preferably, 1000mg/unit to 1800 mg/unit, more preferably 1000 to 1500 mg/unit.
  • the present invention relates to a soft chewable prenatal formulation (PF9), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”), (PF3), (PF4), (PF4’), (PF4”), (PF4’”), (PF5), (PF5’), (PF6), (PF6’), (PF6”), (PF6’”), (PF7) or (PF8), wherein the total amount of the vitamin, trace elements and minerals in the chewable prenatal formulation is 500mg to 1800 mg.
  • the present invention relates to a soft chewable prenatal formulation (PF9’), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”), (PF3), (PF4), (PF4’), (PF4”), (PF4’”), (PF5), (PF5’), (PF6), (PF6’), (PF6”), (PF6’”), (PF7) or (PF8), wherein the total amount of the vitamin, trace elements and minerals in the chewable prenatal formulation is 1000mg to 1500 mg.
  • vitamin A 3 - 11 different vitamins chosen form the group consisting of vitamin A, vita mins from the vitamin B group (B1, B2, B3, B5, B7, B9, and B12), vitamin C, vitamin D3, and vitamin E, preferably 8- 11 different vitamins chosen form the group consisting of vitamin A, vitamins from the vitamin B group (B1, B2, B3, B5, B7, B9, and B12), vitamin C, vitamin D3, and vitamin E.
  • the present invention relates to a soft chewable prenatal formulation (PF10), wherein the core comprises
  • vitamin A 3 - 11 different vitamins chosen form the group consisting of vitamin A, vita mins from the vitamin B group (B1, B2, B3, B5, B7, B9, and B12), vitamin C, vitamin D3, and vitamin E, preferably 8- 11 different vitamins chosen form the group consisting of vitamin A, vitamins from the vitamin B group (B1, B2, B3, B5, B7, B9, and B12), vitamin C, vitamin D3, and vitamin E.
  • a suitable amount (per unit, which is the soft chewable formulation according to the pre sent invention) of the several vitamins in the core are vitamin A : 400 mg - 870 mg vitamin B1: 1 - 4 mg vitamin B2 : 1 - 4 mg vitamin B3 : 10 - 25 mg vitamin B5 : 3 - 15 mg vitamin B7: 15 mg - 50 mg vitamin B9: 300 mg - 500 mg vitamin B12 : 0 mg - 5 mg vitamin C : 60 mg - 250 mg vitamin D3 : 5 mg - 30 mg vitamin E: 10 mg- 30 mg.
  • a suitable amount (per unit, which is the soft chewable formulation according to the pre sent invention) of the iodine in the core is 220 mg - 290 mg.
  • the total amount of the vitamins, of the minerals and of the trace elements is 1000mg/unit to 1800 mg/unit, preferably from 1000 to 1500 mg/unit.
  • the present invention relates to a soft chewable prenatal formulation (PF 11), which the prenatal formulation (PF10), wherein the core comprises vitamin A : 400 mg - 870 mg, and vitamin B1 : 1 - 4 mg, and vitamin B2 : 1 - 4 mg, and vitamin B3 : 10 - 25 mg, and vitamin B5 : 3 - 15 mg, and vitamin B7: 15 mg - 50 mg, and vitamin B9: 300 mg - 500 mg, and vitamin B12 : 0 mg - 5 mg, and vitamin C : 60 mg - 250 mg, and vitamin D3 : 5 mg - 30 mg, and vitamin E: 10 mg- 30 mg, and
  • the amount could be lowered, when the pregnant women consumes more than one unit to get the desired amount of the vitamins, minerals and trace elements.
  • the vitamins, the minerals and the trace elements can be added to the formulation and/or in preformulated form.
  • vitamin B1, B2 and B3 are added in a fat coated form.
  • Calcium is usually and preferably added in a micronized form.
  • the core is chewable and soft (but no gummy type), therefore the core can usually comprise one or more the following ingredients to achieve these properties: Texturizer (such as tapioca syrup), fillers (such as tapioca starch), wetting agents (such as lecithin), sweeteners (such as Stevia Reb M), taste improvers (such as malic acid and any flavor), binders (such as powder sugar), humectant (such as glycerin), and any other ingredients, which could be useful for the production of the core.
  • Texturizer such as tapioca syrup
  • fillers such as tapioca starch
  • wetting agents such as lecithin
  • sweeteners such as Stevia Reb M
  • taste improvers such as malic acid and any flavor
  • binders such as powder sugar
  • humectant such as glycerin
  • the core comprises (next to the amount of the vitamins , minerals and trace elements)
  • At least one texturizer such as tapioca syrup
  • At least one filler such as tapioca starch
  • At least one sweetener such as Reb M
  • At least one taste improver such as malic acid
  • At least one softener such as glycerin
  • the present invention relates to a soft chewable prenatal formulation (PF12), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”), (PF3), (PF4), (PF4’), (PF4”), (PF4’”), (PF5), (PF5’), (PF6), (PF6’), (PF6”), (PF6’”), (PF7), (PF8), (PF9), (PF9’), (PF10) or (PF11), wherein the core comprises (next to the amount of the vitamins, minerals and trace elements)
  • At least one texturizer such as tapioca syrup
  • at least one filler such as tapioca starch
  • at least one wetting agent such as lecithin
  • at least one sweetener such as Reb M
  • at least one taste improver such as malic acid
  • 800 - 1600mg of at least one binder such as sugar
  • at least one softener such as glycerin
  • the present invention relates to a soft chewable prenatal formulation (PF13), wherein the core comprises vitamin A : 400 mg - 870 mg, and vitamin B1 : 1 - 4 mg, and vitamin B2 : 1 - 4 mg, and vitamin B3 : 10 - 25 mg, and vitamin B5 : 3 - 15 mg, and vitamin B7: 15 mg - 50 mg, and vitamin B9: 300 mg - 500 mg, and vitamin B12 : 0 mg - 5 mg, and vitamin C : 60 mg - 250 mg, and vitamin D3 : 5 mg - 30 mg, and vitamin E: 10 mg- 30 mg, and
  • Iodine 220 mg - 290 mg, and 1000 - 1700 mg of at least one texturizer (such as tapioca syrup), and 180 - 400 g of at least one filler (such as tapioca starch), and 15 mg of at least one wetting agent (such as lecithin), and 0 - 5 mg of at least one sweetener, (such as Reb M), and 0 - 5 mg of at least one taste improver, (such as malic acid), and 800 - 1600mg of at least one binder (such as sugar)
  • At least one softener such as glycerin
  • the present invention relates to a soft chewable prenatal formulation (PF14), wherein the core consists of vitamin A : 400 mg - 870 mg, and vitamin B1 : 1 - 4 mg, and vitamin B2 : 1 - 4 mg, and vitamin B3 : 10 - 25 mg, and vitamin B5 : 3 - 15 mg, and vitamin B7: 15 mg - 50 mg, and vitamin B9: 300 mg - 500 mg, and vitamin B12 : 0 mg - 5 mg, and vitamin C : 60 mg - 250 mg, and vitamin D3 : 5 mg - 30 mg, and vitamin E: 10 mg- 30 mg, and
  • PF14 soft chewable prenatal formulation
  • At least one texturizer such as tapioca syrup
  • at least one filler such as tapioca starch
  • at least one wetting agent such as lecithin
  • at least one sweetener such as Reb M
  • at least one taste improver such as malic acid
  • 800 - 1600mg of at least one binder such as sugar
  • At least one softener such as glycerin
  • any other ingredient such as oil(s)
  • the total amount of the vitamins, of the minerals and of the trace elements is 1000mg 1800 mg (preferably from 1000 to 1500 mg).
  • the total weight of the soft chewable formulation (core and coating) according to present invention is usually between 4 and 7 g.
  • the present invention relates to a soft chewable prenatal formulation (PF15), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”), (PF3), (PF4), (PF4’), (PF4”), (PF4’”), (PF5), (PF5’), (PF6), (PF6’), (PF6”), (PF6’”), (PF7), (PF8), (PF9), (PF9’), (PF10), (PF11), (PF12), (PF13) or (PF14), wherein the total weight of the chewable prenatal formulation (core and coating) is between 4 and 7 g.
  • the formulation according to the present invention is also coated. Such a coating is used that the formulation is still easy to chew. This means that the coating is not hard (shell coating).
  • a suitable coating material is chocolate, or a similar compound, which allows to provide a soft coating.
  • a suitable coating material are gum Arabic (or similar material) as well as chocolate as well as mixtures of such compounds.
  • the present invention relates to a soft chewable prenatal formulation (PF16), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”), (PF3), (PF4), (PF4’), (PF4”), (PF4’”), (PF5), (PF5’), (PF6), (PF6’), (PF6”), (PF6’”), (PF7), (PF8), (PF9), (PF9’), (PF10), (PF11), (PF12), (PF13), (PF14) or (PF15), wherein the coating material of the coating of the chewable prenatal formulation is chosen form the group consisting of chocolate (or similar material), gum Arabic (or similar material) as well as chocolate as well as mixtures of such compounds.
  • the core of the soft chewable prenatal formulation according to the present invention is dominant. This means that the weight of the core is much higher than that of the coating.
  • An usual ratio (based on the total weight of the soft chewable prenatal formulation accord ing to the present invention) of core to coating is about 60 : 40 up to 90 : 10.
  • the coating covers the whole surface of the core.
  • the present invention relates to a soft chewable prenatal formulation (PF17), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”), (PF3), (PF4), (PF4’), (PF4”), (PF4’”), (PF5), (PF5’), (PF6), (PF6’), (PF6”), (PF6’”), (PF7), (PF8), (PF9), (PF9’), (PF10), (PF11), (PF12), (PF13), (PF14), (PF15) or (PF16), wherein the weight ratio (based on the total weight of the chewable prenatal formulation according to the present invention) of core to coating is about 60 : 40 up to 90 : 10.
  • the coating layers covers the whole surface of the core.
  • the present invention relates to a soft chewable prenatal formulation (PF18), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”), (PF3), (PF4), (PF4’), (PF4”), (PF4’”), (PF5), (PF5’), (PF6), (PF6’), (PF6”), (PF6’”), (PF7), (PF8), (PF9), (PF9’), (PF10), (PF11), (PF12), (PF13), (PF14), (PF15), (PF16) or (PF17), wherein the coating layer covers the whole surface of the core.
  • PF18 soft chewable prenatal formulation
  • the shape of the chewable prenatal formulation according to the present invention can be any commonly known form (suitable for the total weight of about 4 - 7 g).
  • the shape is sphere-like (or like an egg). But it could also be like a cube or any suitable geo metrical form.
  • the present invention relates to a soft chewable prenatal formulation (PF19), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”), (PF3), (PF4), (PF4’), (PF4”), (PF4’”), (PF5), (PF5’), (PF6), (PF6’), (PF6”), (PF6’”), (PF7), (PF8), (PF9), (PF9’), (PF10), (PF11), (PF12), (PF13), (PF14), (PF15), (PF16), (PF17) or (PF18), wherein the shape of the chewable prenatal formulation can have any commonly known form (suitable for the total weight of about 4 - 7 g).
  • the shape is sphere-like (or like an egg). But it could also be like a cube or any suitable geometrical form (hearts, animal-shape, etc).
  • the present invention relates to a soft chewable prenatal formulation (PF19’), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”), (PF3), (PF4), (PF4’), (PF4”), (PF4’”), (PF5), (PF5’), (PF6), (PF6’), (PF6”), (PF6’”), (PF7), (PF8), (PF9), (PF9’), (PF10), (PF11), (PF12), (PF13), (PF14), (PF15), (PF16), (PF17) or (PF18), wherein the shape of the chewable prenatal formulation is sphere-like (or like an egg).
  • Very mild production conditions for the core can be applied, which means that the ingredients, (especially the vitamins) are not harmed (destroyed) during the production.
  • an oil mix including i.e. coconut oil and the wetting agents (i.e. lecithin) by melting the oil and mixing with the wetting agent (i.e. lecithin).
  • the wetting agents i.e. lecithin
  • the process to produce the core is usually and preferably done at low temperature. Therefore the present invention relates to a process (P) to produce the soft chewable prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”), (PF3), (PF4), (PF4’), (PF4”), (PF4’”), (PF5), (PF5’), (PF6), (PF6’), (PF6”), (PF6’”), (PF7, (PF8), (PF9), (PF9’), (PF10), (PF11), (PF12), (PF13), (PF14), (PF15), (PF16), (PF17), (PF18), (PF19) or (PF19’), comprising the following steps
  • step (iv) applying the coating layer, wherein the process of producing the core (steps (i) to (iii)) is carried out at low tempera ture (between 20 - 30 °C, more preferred room temperature).

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Abstract

The present invention relates to a new soft chewable prenatal formulation, which is a non-gummy and non-compression formulation.

Description

Prenatal Confectionery
The present invention relates to a new soft chewable prenatal formulation, which is a soft non-gummy and non-compression formulation.
It is well established that pregnant women have heightened nutritional requirements. A mother's body provides the environment in which development of the embryo and foetus occur. See Understanding Nutrition, 479-480 (Whitney and Rolfes Eds. 6 th Ed., 1993). Accordingly, the mother's nutritional status during pregnancy directly impacts the devel opment of the foetus and embryo and is therefore implicated with regard to the occurrence of birth defects.
In particular, during the first 20-25 days of pregnancy, the placenta is not yet formed and foetal circulation is not yet established. Therefore, during this period the foetus is nour ished via digested maternal uterine cells and the diffusion of blood exudates.
It is believed that a good nutrient supply during the first 20-25 days of pregnancy is nec essary to provide optimal concentrations of essential micronutrients to the endometrium.
There are many varieties of vitamins and minerals to treat specific diseases or to play the important physiological role of nutritional supplements. Vitamins and minerals can help a person prevent or recover from diseases, or maintain the body's normal healthy status. It is widely accepted knowledge that insufficiencies of a particular vitamin or mineral can cause certain human diseases. These insufficiencies most greatly affect a human during the stage of embryonic development. The embryonic stage is the most critical period in the formation and development of various tissues and organs of the human body. Con genital defects that occur in this period cannot be improved after birth. An example m is human brain tissue cell development, which determines the level of intelligence when the baby is born. A foetus receives its entire nutritional intake from its mother, so the nutritional intake of the mother determines the level of foetus development Nutrition, good or bad, plays a critical role in foetal development in pregnant women. If certain nutrients, vitamins, and minerals are -deficient this may lead to disease in the mother and/or the foetus.
Due to the special nutritional needs, pregnant women should take-in more nutrients than non-pregnant woman. There are many available dosage forms for prenatal supplementation on the market, in cluding liquid, gel-like or solid dose.
Delivery of essential vitamins and minerals in a traditional tablet often requires a relatively large tablet which is difficult for pregnant women to swallow.
An alternative format is gummy with good taste; however, the preparation of gummies is known to expose vitamins to high temperature during the process, often causing degra dation of vitamins. This means that the vitamins have to be significantly overdosed during production to achieve the desired amount in the final product.
Due to the importance of prenatal formulation, there is always a need to provide new and improved formulations.
It was found that a specific soft chew format is an ideal form to deliver vitamins and min erals in one chew. This formulation does not have the aforementioned disadvantages as the prior art formulations have.
The formulation according to the present invention consists of a core and a coating. The formulation is soft and easy to chew, but is not a gummy type kind of formulation.
Therefore the present invention relates to a chewable prenatal formulation (PF), which comprises a core and a coating.
Furthermore the formulation according to the present invention the chewable prenatal for mulation is a non-gummy and non-compression formulation.
Therefore, the present invention relates to a soft chewable prenatal formulation (PF1), which the prenatal formulation (PF), wherein the formulation is a non-gummy and non compression formulation.
Soft chew confectioneries (= soft chews) are an oral dosage form intended to be chewed and then swallowed by the patient rather than swallowed whole.
The core comprises the vitamins, the trace elements and the minerals, which are the es sential ingredients for the pregnant woman. Soft chew confectioneries which are required to be broken and chewed in between the teeth before ingestion. These tablets are given to the children who have difficulty in swal lowing and to the adults who dislike swallowing.
Therefore, the present invention relates to a soft chewable prenatal formulation (PF2), which the prenatal formulation (PF) and/or (PF1), wherein the core comprises the vita mins, the trace elements and the minerals, which are the essential for the pregnant woman.
The vitamins can include water-soluble as well as fat-soluble vitamins.
Preferred are such as vitamin A, vitamins from the vitamin B group (B1 , B2, B3, B5, B7, B9 and B12), vitamin C, vitamin D3 and vitamin E.
The dosage of the vitamins may vary.
The minerals, which are added to the formulation are Calcium, Iron, Zinc, and Magnesium. A suitable trace element is for example Iodine.
The vitamins, the minerals and the trace elements can be added to the formulation and/or in preformulated form.
Usually and preferably vitamin B1, B2 and B3 are added in a fat coated form. Calcium is usually and preferably added in a micronized form.
The total amount of the vitamin, trace elements and minerals is at least 1000mg/unit.
Therefore, the present invention relates to a soft chewable prenatal formulation (PF2’), which the prenatal formulation (PF2), wherein the vitamins are chosen from the group consisting of vitamin A, vitamins from the vitamin B group (B1 , B2, B3, B5, B7, B9, and B12), vitamin C, vitamin D3 and vitamin E. Therefore, the present invention relates to a soft chewable prenatal formulation (PF2”), which the prenatal formulation (PF2) of (PF2’), wherein the minerals are chosen from the group consisting of Calcium, Iron, Zinc, and Magnesium.
Therefore, the present invention relates to a soft chewable prenatal formulation (PF2’”), which the prenatal formulation (PF2), (PF2’) or (PF2”), wherein the trace elements is Io dine
Therefore, the present invention relates to a soft chewable prenatal formulation (PF3), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”) or (PF2’”), wherein the total amount of the vitamin, trace elements and minerals is at least 100 mg in the chewable prenatal formulation
The formulation according to the present invention comprises at least 3 different vitamins, preferably at least 8 different vitamins.
The formulation comprises 3 - 11 different vitamins, preferably 8 - 11 different vitamins.
The formulation comprises 3 - 11 different vitamins chosen from the group consisting of vitamin A, vitamins from the vitamin B group (B1 , B2, B3, B5, B7, B9, and B12), vitamin C, vitamin D3, and vitamin E, preferably 8 - 11 different vitamins chosen from the group consisting of vitamin A, vitamins from the vitamin B group (B1 , B2, B3, B5, B7, B9, and B12), vitamin C, vitamin D3, and vitamin E.
Therefore, the present invention relates to a soft chewable prenatal formulation (PF4), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”) or (PF3), wherein the prenatal formulation comprises at least 3 different vitamins.
Therefore, the present invention relates to a soft chewable prenatal formulation (PF4’), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”) or (PF3), wherein the prenatal formulation comprises at least 8 different vitamins. Therefore, the present invention relates to a soft chewable prenatal formulation (PF4”), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”) or (PF3), wherein the prenatal formulation comprises 3 - 11 different vitamins.
Therefore, the present invention relates to a soft chewable prenatal formulation (PF4’”), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”) or (PF3), wherein the prenatal formulation comprises 8 - 11 different vitamins.
Therefore, the present invention relates to a soft chewable prenatal formulation (PF5), which the prenatal formulation (PF4”), wherein the 3 - 11 different vitamins are chosen from the group consisting of vitamin A, vitamins from the vitamin B group (B1, B2, B3, B5, B7, B9, and B12), vitamin C, vitamin D3, and vitamin E.
Therefore, the present invention relates to a soft chewable prenatal formulation (PF5’), which the prenatal formulation (PF4;”), wherein the 8 - 11 different vitamins are chosen from the group consisting of vitamin A, vitamins from the vitamin B group (B1, B2, B3, B5, B7, B9, and B12), vitamin C, vitamin D3, and vitamin E.
The amount of the different vitamins can vary. Preferably, the dosage of each vitamin should be high enough that the one serving (one unit) of the chewable formulation fulfils the need for the pregnant woman.
The formulation comprises at least different minerals, preferably at least 2 different min erals.
The formulation comprises 1 - 7 different minerals.
The formulation comprises 1 - 7, preferably 2 - 5, more preferably 3 - 5, of different minerals chosen from the group consisting of Calcium, Copper, Iron, Zinc, and Magne sium.
Therefore, the present invention relates to a soft chewable prenatal formulation (PF6), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”), (PF3), (PF4), (PF4’), (PF4”), (PF4’”), (PF5) or (PF5’), wherein the prenatal formulation comprises at least 2 different minerals.
Therefore, the present invention relates to a soft chewable prenatal formulation (PF6’), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”), (PF3), (PF4), (PF4’), (PF4”), (PF4’”), (PF5) or (PF5’), wherein the prenatal formulation comprises 1 - 7 different minerals.
Therefore, the present invention relates to a soft chewable prenatal formulation (PF6”), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”), (PF3), (PF4), (PF4’), (PF4”), (PF4’”), (PF5) or (PF5’), wherein the prenatal formulation comprises 2 - 5 different minerals.
Therefore, the present invention relates to a soft chewable prenatal formulation (PF6’”), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”), (PF3), (PF4), (PF4’), (PF4”), (PF4’”), (PF5) or (PF5’), wherein the prenatal formulation comprises 3 - 5 different minerals.
Therefore, the present invention relates to a soft chewable prenatal formulation (PF7), which the prenatal formulation (PF6), (PF6’), (PF6”) or (PF6’”), wherein the minerals are chosen from the group consisting of Calcium, Copper, Iron, Zinc, and Magnesium.
The amount of the different minerals can vary. Preferably, the dosage of each mineral should be high enough that the one serving (one unit) of the soft chewable formulation fulfils the need for the pregnant woman.
The formulation comprises at least one trace element.
Preferably, the formulation comprises iodine.
Therefore, the present invention relates to a soft chewable prenatal formulation (PF8), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”), (PF3), (PF4), (PF4’), (PF4”), (PF4’”), (PF5), (PF5’), (PF6), (PF6’), (PF6”), (PF6’”) or (PF7), wherein the prenatal formulation comprising iodine as trace element. The amount of the different trace elements can vary. Preferably, the dosage of each trace element should be high enough that the one serving (one unit) of the soft chewable for mulation fulfils the need for the pregnant woman.
The total amount of the vitamin, trace elements and minerals in the formulation is at least 500mg/unit. Preferably, 1000mg/unit to 1800 mg/unit, more preferably 1000 to 1500 mg/unit.
Therefore, the present invention relates to a soft chewable prenatal formulation (PF9), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”), (PF3), (PF4), (PF4’), (PF4”), (PF4’”), (PF5), (PF5’), (PF6), (PF6’), (PF6”), (PF6’”), (PF7) or (PF8), wherein the total amount of the vitamin, trace elements and minerals in the chewable prenatal formulation is 500mg to 1800 mg.
Therefore, the present invention relates to a soft chewable prenatal formulation (PF9’), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”), (PF3), (PF4), (PF4’), (PF4”), (PF4’”), (PF5), (PF5’), (PF6), (PF6’), (PF6”), (PF6’”), (PF7) or (PF8), wherein the total amount of the vitamin, trace elements and minerals in the chewable prenatal formulation is 1000mg to 1500 mg.
A very preferred embodiment of the present invention is a soft chewable prenatal formu lation wherein the core comprises
(i) 3 - 11 different vitamins chosen form the group consisting of vitamin A, vita mins from the vitamin B group (B1, B2, B3, B5, B7, B9, and B12), vitamin C, vitamin D3, and vitamin E, preferably 8- 11 different vitamins chosen form the group consisting of vitamin A, vitamins from the vitamin B group (B1, B2, B3, B5, B7, B9, and B12), vitamin C, vitamin D3, and vitamin E.
(ii) 1 - 7 (preferably 2-5) different minerals chosen form the group consisting of Calcium, Copper, Iron, Zinc, and Magnesium.
(iii) at least one trace element, preferably only one trace element, which is iodine, wherein the total amount of the vitamin, trace elements and minerals goes from 500mg/unit to 1800 mg/unit, preferably from 1000 to 1500 mg/unit.
Therefore, the present invention relates to a soft chewable prenatal formulation (PF10), wherein the core comprises
(i) 3 - 11 different vitamins chosen form the group consisting of vitamin A, vita mins from the vitamin B group (B1, B2, B3, B5, B7, B9, and B12), vitamin C, vitamin D3, and vitamin E, preferably 8- 11 different vitamins chosen form the group consisting of vitamin A, vitamins from the vitamin B group (B1, B2, B3, B5, B7, B9, and B12), vitamin C, vitamin D3, and vitamin E.
(ii) 1 - 7 (preferably 2-5) different minerals chosen form the group consisting of Calcium, Copper, Iron, Zinc, and Magnesium.
(iii) at least one trace element, preferably only one trace element, which is iodine, wherein the total amount of the vitamin, trace elements and minerals goes from 500mg to 1800 mg in the soft chewable prenatal formulation (preferably from 1000 to 1500 mg).
A suitable amount (per unit, which is the soft chewable formulation according to the pre sent invention) of the several vitamins in the core are vitamin A : 400 mg - 870 mg vitamin B1: 1 - 4 mg vitamin B2 : 1 - 4 mg vitamin B3 : 10 - 25 mg vitamin B5 : 3 - 15 mg vitamin B7: 15 mg - 50 mg vitamin B9: 300 mg - 500 mg vitamin B12 : 0 mg - 5 mg vitamin C : 60 mg - 250 mg vitamin D3 : 5 mg - 30 mg vitamin E: 10 mg- 30 mg. A suitable amount (per unit, which is the soft chewable formulation according to the pre sent invention) of the several minerals in the core are Calcium : 150 mg - 500 mg Magnesium : 20 mg - 60 mg Iron : 0 mg - 50 mg Zinc : 3 mg - 10 mg Copper: 0 mg - 60 mg
A suitable amount (per unit, which is the soft chewable formulation according to the pre sent invention) of the iodine in the core is 220 mg - 290 mg.
As stated above the total amount of the vitamins, of the minerals and of the trace elements is 1000mg/unit to 1800 mg/unit, preferably from 1000 to 1500 mg/unit.
Therefore, the present invention relates to a soft chewable prenatal formulation (PF 11), which the prenatal formulation (PF10), wherein the core comprises vitamin A : 400 mg - 870 mg, and vitamin B1 : 1 - 4 mg, and vitamin B2 : 1 - 4 mg, and vitamin B3 : 10 - 25 mg, and vitamin B5 : 3 - 15 mg, and vitamin B7: 15 mg - 50 mg, and vitamin B9: 300 mg - 500 mg, and vitamin B12 : 0 mg - 5 mg, and vitamin C : 60 mg - 250 mg, and vitamin D3 : 5 mg - 30 mg, and vitamin E: 10 mg- 30 mg, and
Calcium : 150 mg - 500 mg, and
Magnesium : 20 mg - 60 mg, and
Iron : 0 mg - 50 mg, and
Zinc : 3 mg - 10 mg, and
Copper: 0 mg - 60 mg, and Iodine : 220 mV - 290 mV, wherein the total amount of the vitamins, of the minerals and of the trace elements is 500mg 1800 mg (preferably from 1000 to 1500 mg).
In principle the amount could be lowered, when the pregnant women consumes more than one unit to get the desired amount of the vitamins, minerals and trace elements.
The vitamins, the minerals and the trace elements can be added to the formulation and/or in preformulated form.
Usually and preferably vitamin B1, B2 and B3 are added in a fat coated form. Calcium is usually and preferably added in a micronized form.
As stated above the core is chewable and soft (but no gummy type), therefore the core can usually comprise one or more the following ingredients to achieve these properties: Texturizer (such as tapioca syrup), fillers (such as tapioca starch), wetting agents (such as lecithin), sweeteners (such as Stevia Reb M), taste improvers (such as malic acid and any flavor), binders (such as powder sugar), humectant (such as glycerin), and any other ingredients, which could be useful for the production of the core.
The core comprises (next to the amount of the vitamins , minerals and trace elements)
1000 - 1700 mg of at least one texturizer (such as tapioca syrup), and
180 - 400 mg of at least one filler (such as tapioca starch), and
15 mg of at least one wetting agent (such as lecithin), and
0 - 5 mg of at least one sweetener, (such as Reb M), and
0 - 5 mg of at least one taste improver, (such as malic acid), and
800 - 1600mg of at least one binder (such as sugar), and
45 mg of at least one softener (such as glycerin), and
400 - 600 mg of milk powder (improves the creaminess of the formulation), and 0 - 500 mg of any other ingredient which could be useful for the production of the core.
Therefore, the present invention relates to a soft chewable prenatal formulation (PF12), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”), (PF3), (PF4), (PF4’), (PF4”), (PF4’”), (PF5), (PF5’), (PF6), (PF6’), (PF6”), (PF6’”), (PF7), (PF8), (PF9), (PF9’), (PF10) or (PF11), wherein the core comprises (next to the amount of the vitamins, minerals and trace elements)
1000 - 1700 mg of at least one texturizer (such as tapioca syrup), and 180 - 400 mg of at least one filler (such as tapioca starch), and 15 mg of at least one wetting agent (such as lecithin), and 0 - 5 mg of at least one sweetener, (such as Reb M), and 0 - 5 mg of at least one taste improver, (such as malic acid), and 800 - 1600mg of at least one binder (such as sugar), and 45 mg of at least one softener (such as glycerin), and 400 - 600 mg of milk powder, and 0 - 500 mg of any other ingredient.
Therefore, the present invention relates to a soft chewable prenatal formulation (PF13), wherein the core comprises vitamin A : 400 mg - 870 mg, and vitamin B1 : 1 - 4 mg, and vitamin B2 : 1 - 4 mg, and vitamin B3 : 10 - 25 mg, and vitamin B5 : 3 - 15 mg, and vitamin B7: 15 mg - 50 mg, and vitamin B9: 300 mg - 500 mg, and vitamin B12 : 0 mg - 5 mg, and vitamin C : 60 mg - 250 mg, and vitamin D3 : 5 mg - 30 mg, and vitamin E: 10 mg- 30 mg, and
Calcium : 150 mg - 500 mg, and
Magnesium : 20 mg - 60 mg, and
Iron : 0 mg - 50 mg, and
Zinc : 3 mg - 10 mg, and
Copper: 0 mg - 60 mg, and
Iodine : 220 mg - 290 mg, and 1000 - 1700 mg of at least one texturizer (such as tapioca syrup), and 180 - 400 g of at least one filler (such as tapioca starch), and 15 mg of at least one wetting agent (such as lecithin), and 0 - 5 mg of at least one sweetener, (such as Reb M), and 0 - 5 mg of at least one taste improver, (such as malic acid), and 800 - 1600mg of at least one binder (such as sugar)
45 mg of at least one softener (such as glycerin)
400 - 600 mg of milk powder (improves the creaminess of the formulation, and 0 - 500 mg of any other ingredient, wherein the total amount of the vitamins, of the minerals and of the trace elements is 1000mg 1800 mg (preferably from 1000 to 1500 mg).
Therefore, the present invention relates to a soft chewable prenatal formulation (PF14), wherein the core consists of vitamin A : 400 mg - 870 mg, and vitamin B1 : 1 - 4 mg, and vitamin B2 : 1 - 4 mg, and vitamin B3 : 10 - 25 mg, and vitamin B5 : 3 - 15 mg, and vitamin B7: 15 mg - 50 mg, and vitamin B9: 300 mg - 500 mg, and vitamin B12 : 0 mg - 5 mg, and vitamin C : 60 mg - 250 mg, and vitamin D3 : 5 mg - 30 mg, and vitamin E: 10 mg- 30 mg, and
Calcium : 150 mg - 500 mg, and
Magnesium : 20 mg - 60 mg, and
Iron : 0 mg - 50 mg, and
Zinc : 3 mg - 10 mg, and
Copper: 0 mg - 60 mg, and
Iodine : 220 mg - 290 mg, and
1000 - 1700 mg of at least one texturizer (such as tapioca syrup), and 180 - 400 mg of at least one filler (such as tapioca starch), and 15 g of at least one wetting agent (such as lecithin), and 0 - 5 mg of at least one sweetener, (such as Reb M), and 0 - 5 mg of at least one taste improver, (such as malic acid), and 800 - 1600mg of at least one binder (such as sugar)
45 mg of at least one softener (such as glycerin)
400 - 600 mg of milk powder (improves the creaminess of the formulation) and 0 - 500 mg of any other ingredient (such as oil(s)), wherein the total amount of the vitamins, of the minerals and of the trace elements is 1000mg 1800 mg (preferably from 1000 to 1500 mg).
The total weight of the soft chewable formulation (core and coating) according to present invention is usually between 4 and 7 g.
Therefore, the present invention relates to a soft chewable prenatal formulation (PF15), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”), (PF3), (PF4), (PF4’), (PF4”), (PF4’”), (PF5), (PF5’), (PF6), (PF6’), (PF6”), (PF6’”), (PF7), (PF8), (PF9), (PF9’), (PF10), (PF11), (PF12), (PF13) or (PF14), wherein the total weight of the chewable prenatal formulation (core and coating) is between 4 and 7 g.
All the amounts given above could also be defined in weight percentage in relation to the total weight of the chewable formulation according to the present invention.
The formulation according to the present invention is also coated. Such a coating is used that the formulation is still easy to chew. This means that the coating is not hard (shell coating).
A suitable coating material is chocolate, or a similar compound, which allows to provide a soft coating. A suitable coating material are gum Arabic (or similar material) as well as chocolate as well as mixtures of such compounds.
Therefore, the present invention relates to a soft chewable prenatal formulation (PF16), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”), (PF3), (PF4), (PF4’), (PF4”), (PF4’”), (PF5), (PF5’), (PF6), (PF6’), (PF6”), (PF6’”), (PF7), (PF8), (PF9), (PF9’), (PF10), (PF11), (PF12), (PF13), (PF14) or (PF15), wherein the coating material of the coating of the chewable prenatal formulation is chosen form the group consisting of chocolate (or similar material), gum Arabic (or similar material) as well as chocolate as well as mixtures of such compounds.
It is clear that the core of the soft chewable prenatal formulation according to the present invention is dominant. This means that the weight of the core is much higher than that of the coating.
An usual ratio (based on the total weight of the soft chewable prenatal formulation accord ing to the present invention) of core to coating is about 60 : 40 up to 90 : 10.
Usually the coating covers the whole surface of the core.
Therefore, the present invention relates to a soft chewable prenatal formulation (PF17), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”), (PF3), (PF4), (PF4’), (PF4”), (PF4’”), (PF5), (PF5’), (PF6), (PF6’), (PF6”), (PF6’”), (PF7), (PF8), (PF9), (PF9’), (PF10), (PF11), (PF12), (PF13), (PF14), (PF15) or (PF16), wherein the weight ratio (based on the total weight of the chewable prenatal formulation according to the present invention) of core to coating is about 60 : 40 up to 90 : 10.
Usually the coating layers covers the whole surface of the core.
Therefore, the present invention relates to a soft chewable prenatal formulation (PF18), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”), (PF3), (PF4), (PF4’), (PF4”), (PF4’”), (PF5), (PF5’), (PF6), (PF6’), (PF6”), (PF6’”), (PF7), (PF8), (PF9), (PF9’), (PF10), (PF11), (PF12), (PF13), (PF14), (PF15), (PF16) or (PF17), wherein the coating layer covers the whole surface of the core.
The shape of the chewable prenatal formulation according to the present invention can be any commonly known form (suitable for the total weight of about 4 - 7 g). Preferably the shape is sphere-like (or like an egg). But it could also be like a cube or any suitable geo metrical form. Therefore, the present invention relates to a soft chewable prenatal formulation (PF19), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”), (PF3), (PF4), (PF4’), (PF4”), (PF4’”), (PF5), (PF5’), (PF6), (PF6’), (PF6”), (PF6’”), (PF7), (PF8), (PF9), (PF9’), (PF10), (PF11), (PF12), (PF13), (PF14), (PF15), (PF16), (PF17) or (PF18), wherein the shape of the chewable prenatal formulation can have any commonly known form (suitable for the total weight of about 4 - 7 g). Preferably the shape is sphere-like (or like an egg). But it could also be like a cube or any suitable geometrical form (hearts, animal-shape, etc).
Therefore, the present invention relates to a soft chewable prenatal formulation (PF19’), which the prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”), (PF3), (PF4), (PF4’), (PF4”), (PF4’”), (PF5), (PF5’), (PF6), (PF6’), (PF6”), (PF6’”), (PF7), (PF8), (PF9), (PF9’), (PF10), (PF11), (PF12), (PF13), (PF14), (PF15), (PF16), (PF17) or (PF18), wherein the shape of the chewable prenatal formulation is sphere-like (or like an egg).
As stated above one of the advantages of the new formulation according to the present invention lies in the production of the formulation.
Very mild production conditions (low temperatures, pressures) for the core can be applied, which means that the ingredients, (especially the vitamins) are not harmed (destroyed) during the production.
A general way to produce the formulation according to the present invention is the follow ing:
First prepare an oil mix including i.e. coconut oil and the wetting agents (i.e. lecithin) by melting the oil and mixing with the wetting agent (i.e. lecithin).
Mix all dry ingredients in a mixer then add the oil mix, glycerine, and flavors while mixing at room temperature (or similar low temperature). Furthermore no high pressure needs to be applied.
Knead the mix until uniform then form into soft chews to the desired weight and form. Then apply chocolate coating by a panning process.
The process to produce the core is usually and preferably done at low temperature. Therefore the present invention relates to a process (P) to produce the soft chewable prenatal formulation (PF), (PF1), (PF2), (PF2’), (PF2”), (PF2’”), (PF3), (PF4), (PF4’), (PF4”), (PF4’”), (PF5), (PF5’), (PF6), (PF6’), (PF6”), (PF6’”), (PF7), (PF8), (PF9), (PF9’), (PF10), (PF11), (PF12), (PF13), (PF14), (PF15), (PF16), (PF17), (PF18), (PF19) or (PF19’), comprising the following steps
(i) preparing an oil mix including mixing with wetting agent(s) (such as lecithin), and.
(ii) mixing all dry ingredients for the core in a mixer then adding the oil mix, glyc erine, and flavors while mixing at room temperature (or similar low tempera ture), and
(iii) kneading the mix until uniform then form into soft chews to the desired weight and form, and
(iv) applying the coating layer, wherein the process of producing the core (steps (i) to (iii)) is carried out at low tempera ture (between 20 - 30 °C, more preferred room temperature).
The following examples serve to illustrate the invention.
Examples Example 1
• Weigh all ingredients into appropriate containers
Preparation of Oil Mix
• Weigh out the following ingredients
• Hydrogenated Coconut Oil
• Lecithin
Preparation
• Place beaker on hot plate to melt the coconut oil. Set the hot plate temperature to 70°C
• Prepare gum Arabic solution 20% solids with water
• After coconut oil melts then add lecithin and manually stir for uniformity using a spatula
Lab Preparation
• Add all the powdered ingredients into Hobart Mixer, along with 10X sugar first · Start mixing powders at 2 rpm, then slowly adjust speed to 4 rpm. Mix for 5 min · After 5 min reduce speed to 1 rpm, then add oil mix, glycerine, tapioca syrup 42 DE, and flavors, adjust mixer speed to 4 rpm, mix for 10 min
• After 10 min remove product from mixer, place product onto confectionery sheets then manually knead until uniform
• Cut pieces of soft chews to the desire weights
White Chocolate Coating Preparation Procedures
• Prepare chocolate for coating: use a double boiler to dissolve chocolate
• Set hot plate to 110°C, then place the double boiler with water on hot plate
• Place the chocolate in the double boiler for melting, using a wooden spoon to manually mix the chocolate to uniform. After melting, set the hot plate temperature to 90°C to maintain the correct temperature and viscosity of the chocolate Coating Process for Soft Chews
• Place soft chews in the bench top coating pan, turn the power on and set the speed to 50 rpm
• Weigh 5 g of the 20% gum Arabic solution, then slowly add to the chews.
Make sure that all chews are coated with gum Arabic solution
• Turn the cold air on for the drying process to begin. After drying add 7 g of yogurt and sugar 50/50 blend
• Add powder blend 4 to 5 additional times then turn on the cold air to dry the product at each additional dosage
• Use a wooden spoon to transfer the melted chocolate, then add slowly to coat the chews entirely
• Turn on the cold air to dry the chews at each dosage point. Repeat until all the chews are uniform
• Remove chews and place into a clean tray, set to air dry. Place product into poly bags after the drying process completes
Figure imgf000019_0001
Figure imgf000020_0001

Claims

Claims
1. Soft chewable prenatal formulation, which comprises a core and a coating, wherein the core comprises vitamins, trace elements, and minerals, and wherein the total amount of the vitamin, trace elements, and minerals in the prenatal formulation is at least 500mg, preferably 1000mg to 1800 mg, more preferably from 1000 to 1500 mg.
2. Soft prenatal chewable formulation according to claim 1, wherein the total weight of the formulation is 4g - 7g.
3. Soft chewable prenatal formulation according to claim 1 or 2, wherein the vitamins are chosen from the group consisting of vitamin A, vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B7, vitamin B9, vitamin B12, vitamin C, vitamin D3, and vitamin E.
4. Soft chewable prenatal formulation according to anyone of the preceding claims, wherein the formulation comprises 3 - 11 different vitamins.
5. Soft chewable prenatal formulation according to anyone of the preceding claims wherein the formulation comprises vitamin A : 400 mg - 870 mg vitamin B1: 1 - 4 mg vitamin B2 : 1 - 4 mg vitamin B3 : 10 - 25 mg vitamin B5 : 3 - 15 mg vitamin B7: 15 mg - 50 mg vitamin B9: 300 mg - 500 mg vitamin B12 : 0 mg - 5 mg vitamin C : 60 mg - 250 mg vitamin D3 : 5 mg - 30 mg vitamin E: 10 mg- 30 mg.
6. Soft chewable prenatal formulation according to anyone of the preceding claims, wherein the minerals are chosen from the group consisting of Calcium, Iron, Zinc, Copper, and Magnesium.
7. Soft chewable prenatal formulation according to anyone of the preceding claim, wherein the formulation comprises 1 - 7, preferably 2 - 5, of different minerals.
8. Soft chewable prenatal formulation according to anyone of the preceding claim, wherein the formulation comprises
Calcium : 150 mg - 500 mg Magnesium : 20 mg - 60 mg Iron : 0 mg - 50 mg Zinc : 3 mg - 10 mg Copper: 0 mg - 60 mg
9. Soft chewable prenatal formulation according to anyone of the preceding claims, wherein the trace element is iodine (preferably in an amount of 220 mg - 290 mg).
10. Soft chewable prenatal formulation according to anyone of the preceding claims, wherein the core also comprises texturizer (such as tapioca syrup), fillers (such as tapioca starch), wetting agents (such as lecithin), sweeteners (such as Reb M), taste improvers (such as malic acid and flavors), binders (such as powder sugar), humectant (such as glcerin), and any other ingredients, which could be useful for the production of the core
11. Soft chewable prenatal formulation according to anyone of the preceding claims, wherein the coating material is chosen form the group consisting of gum Arabic (or similar material) and chocolate (as well as mixtures of such compounds).
12. Soft chewable prenatal formulation according to anyone of the preceding claims, wherein weight ratio (based on the total weight of the chewable formulation according to the present invention) of core to coating is about 60 : 40 up to 90 : 10.
13. Soft chewable prenatal formulation according to anyone of the preceding claims, wherein the shape of the chewable formulation is sphere-like (or like an egg).
14. Process for the production of the soft chewable prenatal formulation according to claims 1 - 13, comprising the following steps
(i) preparing an oil mix including mixing with wetting agent(s) (such as lecithin), and.
(ii) mixing all dry ingredients for the core in a mixer then adding the oil mix, glyc erine, and flavors while mixing at room temperature (or similar low tempera ture), and
(iii) kneading the mix until uniform then form into soft chews to the desired weight and form, and
(iv) applying the coating layer, wherein the process of producing the core (steps (i) to (iii)) is carried out at low tempera ture (between 20 - 30 °C, more preferred room temperature).
PCT/EP2021/056596 2020-03-27 2021-03-16 Prenatal confectionery WO2021190988A1 (en)

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