[go: up one dir, main page]

WO2014078544A1 - Compositions et procédés pour améliorer la sécurité à long terme des formules pour nourrissons en poudre - Google Patents

Compositions et procédés pour améliorer la sécurité à long terme des formules pour nourrissons en poudre Download PDF

Info

Publication number
WO2014078544A1
WO2014078544A1 PCT/US2013/070113 US2013070113W WO2014078544A1 WO 2014078544 A1 WO2014078544 A1 WO 2014078544A1 US 2013070113 W US2013070113 W US 2013070113W WO 2014078544 A1 WO2014078544 A1 WO 2014078544A1
Authority
WO
WIPO (PCT)
Prior art keywords
powdered
caprylic acid
enriched
coconut oil
nutritional
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2013/070113
Other languages
English (en)
Inventor
Mustafa Vurma
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Abbott Laboratories
Original Assignee
Abbott Laboratories
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 Abbott Laboratories filed Critical Abbott Laboratories
Publication of WO2014078544A1 publication Critical patent/WO2014078544A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23B—PRESERVATION OF FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES; CHEMICAL RIPENING OF FRUIT OR VEGETABLES
    • A23B2/00—Preservation of foods or foodstuffs, in general
    • A23B2/70—Preservation of foods or foodstuffs, in general by treatment with chemicals
    • A23B2/725—Preservation of foods or foodstuffs, in general by treatment with chemicals in the form of liquids or solids
    • A23B2/729—Organic compounds; Microorganisms; Enzymes
    • A23B2/742—Organic compounds containing oxygen
    • A23B2/754—Organic compounds containing oxygen containing carboxyl groups
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115—Fatty acids or derivatives thereof; Fats or oils
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115—Fatty acids or derivatives thereof; Fats or oils
    • A23L33/12—Fatty acids or derivatives thereof
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/40—Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/889—Arecaceae, Palmae or Palmaceae (Palm family), e.g. date or coconut palm or palmetto
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A40/00—Adaptation technologies in agriculture, forestry, livestock or agroalimentary production
    • Y02A40/90—Adaptation technologies in agriculture, forestry, livestock or agroalimentary production in food processing or handling, e.g. food conservation

Definitions

  • the present disclosure relates to compositions and methods for creating an effective antimicrobial barrier in powdered nutritional compositions, and particularly, powdered infant formulas, to reduce the risk of microbial contaminants in the powdered nutritional compositions that can further be amplified once reconstituted with an aqueous liquid. More particularly, powdered nutritional compositions are prepared by incorporating caprylic acid-enriched coconut oil prior to reconstitution to inhibit the growth of pathogenic bacteria, such as Cronobacter sakazakii (C. sakazakii), in the compositions.
  • pathogenic bacteria such as Cronobacter sakazakii (C. sakazakii)
  • Nutritional compositions comprising a targeted selection of nutritional ingredients are well known and widely available, some of which may provide a sole source of nutrition, while others may provide a supplemental source.
  • These nutritional compositions include nutritional powders that can be reconstituted with water or other aqueous liquid.
  • These nutritional powders may be dryblended nutritional powders that include dry ingredients blended together or spray dried nutritional powders that may optionally include one or more dryblended components.
  • Powdered infant formulas are especially popular for providing nutrition early in life and their use continues to increase around the world. These powdered infant formulas are particularly convenient as the powdered formulas can be easily stored and transported, later to be reconstituted to provide liquid formula.
  • Cronobacter which contains at least 16 biogroups of the emerging opportunistic pathogen, C sakazakii, primarily affects infants, and occasionally immunocompromised and/or elderly patients. These microorganisms are part of the normal flora in any type of processing environment, including food factories and homes. For example, C. sakazakii is known to survive for at least two years in powdered infant formulas. It is not currently possible to completely eliminate this group of microorganisms from the environment, and various previous attempts to reduce levels of Cronobacter spp. have not been successful.
  • powdered formulas and in particular powdered infant formulas, are typically not commercially prepared as sterile products. Further, improper handling during preparation (e.g., reconstitution) and feeding of the formulas allows for the amplification of any bacteria present in the formulas.
  • the present disclosure is directed to powdered nutritional compositions and methods of preparing powdered nutritional compositions having improved safety and reduced risk of microbial contaminants. More particularly, the methods inhibit the growth of opportunistic pathogenic bacteria, and specifically the growth of Cronobacter sakazakii, in powdered nutritional compositions. To improve the safety and reduce the risk of microbial contaminants, a caprylic acid-enriched coconut oil is utilized in the compositions.
  • One embodiment of the present disclosure is directed to a method of inhibiting the growth of pathogenic bacteria in a powdered nutritional composition.
  • the method comprises incorporating caprylic acid-enriched coconut oil into the powdered nutritional composition.
  • Another embodiment of the present disclosure is directed to a method of inhibiting the growth of Cronobacter sakazakii in a powdered nutritional composition.
  • the method comprises incorporating caprylic acid-enriched coconut oil into the powdered nutritional composition.
  • Another embodiment of the present disclosure is directed to a powdered nutritional composition comprising caprylic acid-enriched coconut oil.
  • Another embodiment of the present disclosure is directed to a powdered infant formula comprising caprylic acid-enriched coconut oil.
  • caprylic acid enriched coconut oil can be introduced into powdered nutritional compositions prior to reconstitution to inhibit the growth of pathogenic bacteria.
  • the presence of caprylic acid in powdered nutritional compositions inhibits the growth of C. sakazakii, thereby creating an effective antimicrobial barrier to reduce the risk of microbial contaminants and improve the safety of the powdered nutritional compositions.
  • this antimicrobial barrier approach can have broad applicability in various powdered nutritional products.
  • the powdered nutritional compositions and methods of the present disclosure utilize a caprylic acid-enriched coconut oil to inhibit the growth of pathogenic bacteria, and particularly, the growth of C. sakazakii.
  • the methods described in the present disclosure address and overcome the longstanding problem of controlling microbial contamination in powdered nutritional compositions.
  • prior methods of reducing microbial infection in nutritional compositions, and particularly, in powdered infant formulas have been available, these methods have had limited success as powdered formulas are typically improperly handled during preparation, reconstitution and feeding, thus requiring reconstitution of the formulas with relatively hot ( ⁇ 70°C) water to avoid growth and amplification of the bacteria present in the powdered formulas.
  • By creating an effective antimicrobial barrier in the powdered nutritional composition that is, prior to reconstitution, presence of bacteria is reduced such to reduce the risk of microbial contamination created during subsequent reconstitution.
  • the methods described herein offer a new alternative means for reducing the microbial load of powdered nutritional compositions by incorporating caprylic acid-enriched coconut oil into the powdered nutritional composition prior to reconstitution.
  • the methods of the present disclosure can easily be utilized with a variety of powdered nutritional products.
  • the present disclosure provides for an easy and cost effective means of improving the safety of powdered nutritional compositions, and particularly, of powdered infant formulas.
  • the terms "nutritional formulation” or “nutritional composition” as used herein, are used interchangeably and, unless otherwise specified, refer to nutritional liquids, nutritional powders, nutritional bars, nutritional supplements, and any other nutritional food product as known in the art.
  • the nutritional powders may be reconstituted to form a nutritional liquid.
  • the nutritional formulation or nutritional composition may include at least one of fat, protein and carbohydrate, and is suitable for oral consumption by a human.
  • nutritional liquid refers to nutritional products in ready-to-drink liquid form, concentrated form, and nutritional liquids made by reconstituting the nutritional powders described herein prior to use.
  • pillered nutritional or “nutritional powder” as used herein, are used interchangeably and, unless otherwise specified, refer to nutritional formulations in flowable or scoopable form that can be reconstituted with water or another aqueous liquid prior to consumption and include both spray dried and dry mixed/dryblended powders.
  • infant formula refers to solid infant formulas and toddler formulas, wherein infant formulas are intended for infants up to 1 year of age and toddler formulas are intended for children from about 1 year of age to about 10 years of age.
  • the formulas include components that are of semi-purified or purified origin.
  • semi-purified or purified refer to a material that has been prepared by purification of a natural material or by synthesis.
  • infant formula does not include human breast milk.
  • preterm infant formula refers to solid nutritional compositions suitable for consumption by a preterm infant.
  • preterm infant refers to a person born prior to 36 weeks of gestation.
  • adult formula and “adult nutritional product” as used herein, are used interchangeably to refer to formulas for generally maintaining or improving the health of an adult, and includes those formulas designed for adults who have, are susceptible to, or are at risk of specific diseases and conditions.
  • fat and “oil” as used herein, unless otherwise specified, are used interchangeably to refer to lipid materials derived or processed from plants or animals.
  • inhibitor growth refers to preventing the growth and amplification of, inactivating, and/or even killing microbes present in the powdered nutritional compositions.
  • activate or “inactivating” as used herein, refer to altering microbes such to put the microbes in a non-viable state; that is, a state in which the microbial cells are non-culturable and are metabolically inactive.
  • microbe or “microorganism” as used herein, are used herein interchangeably to refer to organisms having a single cell, cell clusters or no cell at all, and include, for example, bacteria, fungi, archaea, and protists, which can cause disease.
  • the various embodiments of the powdered nutritional compositions prepared using the methods of the present disclosure may also be substantially free of any optional or selected essential ingredient or feature described herein, provided that the remaining powdered nutritional composition still contains all of the required ingredients or features as described herein.
  • substantially free means that the selected powdered nutritional compositions contain less than a functional amount of the optional ingredient, typically less than 0.1% by weight, and also including zero percent by weight of such optional or selected essential ingredient.
  • the powdered nutritional compositions and corresponding methods of the present disclosure can comprise, consist of, or consist essentially of the essential elements of the disclosure as described herein, as well as any additional or optional element described herein or otherwise useful in powdered nutritional composition applications.
  • the powdered nutritional compositions of the present disclosure including the caprylic acid-enriched coconut oil may be formulated and administered in any known or otherwise suitable powdered product form.
  • Any powdered product form is suitable for use herein, provided that such form allows for safe and effective oral delivery to the individual of the essential ingredients and any optional ingredients, as also defined herein.
  • the powdered nutritional compositions of the present disclosure are preferably formulated as dietary powdered product forms, which are defined herein as those embodiments comprising the essential ingredients of the present disclosure in a powdered form that then contains at least one of fat, protein, and carbohydrate, and preferably also contains vitamins, minerals, or combinations thereof.
  • the nutritional compositions will comprise caprylic acid-enriched coconut oil, desirably in combination with at least one of protein, carbohydrate, vitamins, and minerals, to produce a nutritional combination.
  • the powdered nutritional composition may be formulated with sufficient kinds and amounts of nutrients to provide a sole, primary, or supplemental source of nutrition, or to provide a specialized nutritional composition for use in individuals afflicted with specific diseases, disorders, or conditions or with a targeted nutritional benefit as described below.
  • the powdered nutritional compositions are typically in the form of flowable or substantially flowable particulate compositions, or at least particulate compositions.
  • Particularly suitable nutritional solid product forms include spray dried, agglomerated and/or dryblended powder compositions.
  • the compositions can easily be scooped and measured with a spoon or similar other device, and can easily be reconstituted by the intended user with a suitable aqueous liquid, typically water, to form a nutritional composition for immediate oral or enteral use.
  • "immediate" use generally means within about 48 hours, most typically within about 24 hours, preferably right after reconstitution.
  • product forms prepared using the methods as disclosed herein include, for example, powdered human milk fortifiers, powdered preterm infant formulas, powdered infant formulas, powdered elemental and semi-elemental formulas, powdered pediatric formulas, powdered toddler formulas, powdered adult formulas, and powdered medicinal formulas.
  • the nutritional powders may be reconstituted with water prior to use to a caloric density tailored to the nutritional needs of the ultimate user, although in most instances the powders are reconstituted with water to form compositions comprising at least 19 kcal/fl oz (660 kcal/liter), more typically from about 20 kcal/fl oz (675-680 kcal/liter) to about 25 kcal/fl oz (820 kcal/liter), even more typically from about 20 kcal/fl oz (675-680 kcal/liter) to about 24 kcal/fl oz (800-810 kcal/liter).
  • the 22-24 kcal/fl oz formulas are more commonly used in preterm or low birth weight infants, and the 20-21 kcal/fl oz (675-680 to 700 kcal/liter) formulas are more often used in term infants.
  • the reconstituted powder may have a caloric density of from about 50-100 kcal/liter to about 2000 kcal/liter, including from about 150 kcal/liter to about 500 kcal/liter.
  • the emulsion may have a caloric density of 25, or 50, or 75, or 100 kcal/liter.
  • the powdered nutritional compositions of the present disclosure include caprylic acid, typically through incorporation into the composition of a caprylic acid-enriched coconut oil.
  • Caprylic acid is an eight-carbon saturated fatty acid known by the systematic name octanoic acid, and has the formula
  • Caprylic acid As well as its monoglyceride, monocaprylin, is used in the treatment of some bacterial infections. Due to its relatively short chain length, it has no difficulty in penetrating fatty cell wall membranes, and thus, is effective in combating certain bacteria.
  • coconut oil is an edible oil extracted from the kernel or meat of matured coconuts harvested from the coconut palm (Cocos nucifera).
  • coconut oil includes caprylic acid in an amount of about 8% by weight.
  • the caprylic acid-enriched coconut oil for use in the powdered nutritional compositions of the present disclosure includes at least 9% by weight caprylic acid, including at least 15% by weight caprylic acid, including at least 20% by weight caprylic acid, including at least 25% by weight caprylic acid, and including at least 30% by weight caprylic acid.
  • the caprylic acid- enriched coconut oil comprises from 10% to about 99% by weight caprylic acid, including from about 20% to about 25% by weight caprylic acid, and including from about 28% to about 33% by weight caprylic acid.
  • the caprylic acid-enriched coconut oil includes about 30% by weight caprylic acid.
  • the powdered nutritional composition includes from about 1% to about 15% by weight caprylic acid-enriched coconut oil, including from about 3% to about 11% by weight, including from about 4% to about 9% by weight, and including from about 5% to about 8% by weight caprylic acid-enriched coconut oil.
  • the powdered nutritional composition provide an individual with from about 0.9 grams to about 11 grams caprylic acid in one liter, including from about 2 grams to about 9 grams, and including from about 4 grams to about 7 grams caprylic acid in one liter.
  • Suitable caprylic acid-enriched coconut oils for use in the powdered nutritional compositions are commercially available from Peter Cremer North America, LP (Cincinnati, Ohio) and Twin Rivers Technologies, Inc. (Quincy, Massachusetts).
  • the powdered nutritional compositions including the caprylic acid- enriched coconut oil may be formulated to additionally include at least one of fat (in addition to the coconut oil), protein and carbohydrate.
  • the powdered nutritional compositions will include the caprylic acid-enriched coconut oil in combination with protein, carbohydrate and additional fat.
  • the protein component is present in an amount of from about 5% to about 35%, including from about 8% to about 12%, and including from about 10% to about 12% by weight of the preterm or term infant formula;
  • the fat component (including both the caprylic acid- enriched coconut oil and any other fat sources) is present in an amount of from about 10% to about 35% , including from about 25% to about 30%, and including from about 26% to about 28% by weight of the preterm or term infant formula;
  • the carbohydrate component is present in an amount of from about 30% to about 85%, including from about 45% to about 60%, including from about 50% to about 55% by weight of the preterm or term infant formula.
  • the protein component is present in an amount of from about 1% to about 55%, including from about 10% to about 50%, and including from about 10% to about 30% by weight of the human milk fortifier;
  • the fat component (including both the caprylic acid-enriched coconut oil and any other fat sources) is present in an amount of from about 1% to about 30%, including from about 1% to about 25%, and including from about 1% to about 20% by weight of the human milk fortifier;
  • the carbohydrate component is present in an amount of from about 15% to about 75%, including from about 15% to about 60%, including from about 20% to about 50% by weight of the human milk fortifier.
  • the protein component is present in an amount of from about 10% to about 90%, including from about 30% to about 80%, and including from about 40% to about 75% by weight of the adult nutritional;
  • the fat component (including both the caprylic acid-enriched coconut oil and any other fat sources) is present in an amount of from about 0.5% to about 20%, including from about 1% to about 10%, and including from about 2% to about 5% by weight of the adult nutritional;
  • the carbohydrate component is present in an amount of from about 5% to about 40%, including from about 7% to about 30%, including from about 10% to about 25% by weight of the adult nutritional.
  • the total amount or concentration of fat, carbohydrate, and protein, in the powdered nutritional compositions of the present disclosure can vary
  • the total amount or concentration refers to all fat, carbohydrate, and protein sources in the powdered composition.
  • the total amounts or concentrations are most typically and preferably formulated within any of the embodied ranges described in the following table (each numerical value is preceded by the term "about').
  • the powdered nutritional compositions of the present disclosure may optionally comprise any source or sources of fat (in addition to the caprylic acid- enriched coconut oil).
  • Suitable additional sources of fat for use herein include any fat or fat source that is suitable for use in an oral nutritional composition and is compatible with the essential elements and features of such composition.
  • the fat is derived from long chain
  • LCPUFAs polyunsaturated fatty acids
  • Exemplary LCPUFAs for use in the nutritional compositions include, for example, ⁇ -3 LCPUFAs and ⁇ -6 LCPUFAs.
  • Specific LCPUFAs include docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), arachidonic acid (ARA), linoleic acid, linolenic acid (alpha linolenic acid) and gamma-linolenic acid derived from oil sources such as plant oils, marine plankton, fungal oils, and fish oils.
  • DHA docosahexaenoic acid
  • EPA eicosapentaenoic acid
  • ARA arachidonic acid
  • linoleic acid linolenic acid (alpha linolenic acid)
  • gamma-linolenic acid derived from oil sources such as plant oils, marine plankton, fungal oils, and fish oils.
  • the LCPUFAs are derived from fish oils such as menhaden, salmon, anchovy, cod, halibut, tuna, or herring oil.
  • Particularly preferred LCPUFAs for use in the nutritional compositions with the caprylic acid-enriched coconut oil include DHA, ARA, EPA, and combinations thereof.
  • the content of LCPUFAs preferably does not exceed 3% by weight of the total fat content, including below 2% by weight of the total fat content, and including below 1% by weight of the total fat content in the nutritional composition.
  • the LCPUFA may be provided as free fatty acids, in triglyceride form, in diglyceride form, in monoglyceride form, in phospholipid form, or as a mixture of one or more of the above, preferably in triglyceride form.
  • the fat is derived from short chain fatty acids.
  • suitable fats or sources thereof for use in the nutritional compositions described herein include fractionated coconut oil, soybean oil, corn oil, olive oil, safflower oil, high oleic safflower oil, oleic acids (EMERSOL 6313 OLEIC ACID, Cognis Oleochemicals, Malaysia), MCT oil (medium chain triglycerides), sunflower oil, high oleic sunflower oil, palm and palm kernel oils, palm olein, canola oil, marine oils, fish oils, fungal oils, algae oils, cottonseed oils, and combinations thereof.
  • EMERSOL 6313 OLEIC ACID Cognis Oleochemicals, Malaysia
  • MCT oil medium chain triglycerides
  • sunflower oil high oleic sunflower oil, palm and palm kernel oils, palm olein
  • canola oil marine oils, fish oils, fungal oils, algae oils, cottonseed oils, and combinations thereof.
  • the powdered nutritional compositions of the present disclosure may optionally further comprise proteins.
  • Any protein source that is suitable for use in oral nutritional compositions and is compatible with the essential elements and features of such compositions is suitable for use in the nutritional compositions.
  • Non-limiting examples of suitable proteins or sources thereof for use in the nutritional compositions include hydrolyzed, partially hydrolyzed or non- hydrolyzed proteins or protein sources, which may be derived from any known or otherwise suitable source such as milk (e.g., casein, whey), animal (e.g., meat, fish), cereal (e.g., rice, corn), vegetable (e.g., soy) or combinations thereof.
  • suitable proteins include milk protein isolates, milk protein concentrates, casein protein isolates, extensively hydrolyzed casein, whey protein, sodium or calcium caseinates, whole cow milk, partially or completely defatted milk, soy protein isolates, soy protein concentrates, and so forth.
  • the protein source is a hydrolyzed protein hydrolysate.
  • hydrolyzed protein or “protein hydrolysates” are used interchangeably herein and include extensively hydrolyzed proteins, wherein the degree of hydrolysis is most often at least 20%, including from 20% to about 80%, and also including from about 30% to about 80%, even more preferably from about 40% to about 60%.
  • the degree of hydrolysis is the extent to which peptide bonds are broken by a hydrolysis method.
  • the degree of protein hydrolysis for purposes of characterizing the extensively hydrolyzed protein component of these embodiments is easily determined by one of ordinary skill in the formulation arts by quantifying the amino nitrogen to total nitrogen ratio (AN/TN) of the protein component of the selected liquid formulation.
  • the amino nitrogen component is quantified by USP titration methods for determining amino nitrogen content, while the total nitrogen component is determined by the Tecator Kjeldahl method, all of which are well known methods to one of ordinary skill in the analytical chemistry art.
  • Suitable hydrolyzed proteins may include soy protein hydrolysate, casein protein hydrolysate, whey protein hydrolysate, rice protein hydrolysate, potato protein hydrolysate, fish protein hydrolysate, egg albumen hydrolysate, gelatin protein hydrolysate, combinations of animal and vegetable protein hydrolysates, and combinations thereof.
  • Particularly preferred protein hydrolysates include whey protein hydrolysate and hydrolyzed sodium caseinate.
  • the protein source may include at least 20% (by weight total protein) protein hydrolysate, including from about 30% to 100% (by weight total protein) protein hydrolysate, and including from about 40% to about 80% (by weight total protein) protein hydrolysate, and including about 50% (by weight total protein) protein hydrolysate.
  • the nutritional composition includes 100% (by weight total protein) protein hydrolysate.
  • the powdered nutritional compositions of the present disclosure may further optionally comprise carbohydrates that are suitable for use in an oral powdered nutritional composition and are compatible with the essential elements and features of such compositions.
  • Non-limiting examples of suitable carbohydrates or sources thereof for use in the powdered nutritional compositions described herein may include maltodextrin, hydrolyzed or modified starch or cornstarch, glucose polymers, corn syrup, corn syrup solids, rice-derived carbohydrates, pea-derived carbohydrates, potato-derived carbohydrates, tapioca, sucrose, glucose, fructose, lactose, high fructose corn syrup, honey, sugar alcohols (e.g., maltitol, erythritol, sorbitol), artificial sweeteners (e.g., sucralose, acesulfame potassium, stevia) and combinations thereof.
  • a particularly desirable carbohydrate is a low dextrose equivalent (DE) maltodextrin.
  • suitable carbohydrates include any dietary fiber suitable for use in a powdered nutritional composition, including soluble and insoluble fiber, especially fructooligosaccharides and/or galactooligosaccharides.
  • the powdered nutritional compositions of the present disclosure may further comprise other optional components that may modify the physical, chemical, aesthetic or processing characteristics of the compositions or serve as pharmaceutical or additional nutritional components when used in the targeted population.
  • Many such optional ingredients are known or otherwise suitable for use in medical food or other nutritional products or pharmaceutical dosage forms and may also be used in the compositions herein, provided that such optional ingredients are safe for oral administration and are compatible with the essential and other ingredients in the selected product form.
  • Non-limiting examples of such optional ingredients include preservatives, emulsifying agents, buffers, pharmaceutical actives, anti-inflammatory agents, additional nutrients as described herein, colorants, flavors, thickening agents and stabilizers, emulsifying agents, lubricants, and so forth.
  • a flowing agent or anti -caking agent may be included in the powdered nutritional compositions as described herein to retard clumping or caking of the powder over time and to make a powder embodiment flow easily from its container. Any known flowing or anti-caking agents that are known or otherwise suitable for use in a nutritional powder or product form are suitable for use herein, non-limiting examples of which include tricalcium phosphate, silicates, and combinations thereof.
  • the concentration of the flowing agent or anti-caking agent in the powdered nutritional composition varies depending upon the product form, the other selected ingredients, the desired flow properties, and so forth, but most typically range from about 0.1% to about 4%, including from about 0.5% to about 2%, by weight of the powdered nutritional composition.
  • a stabilizer may also be included in the powdered nutritional compositions. Any stabilizer that is known or otherwise suitable for use in a nutritional composition is also suitable for use herein, some non-limiting examples of which include gums such as xanthan gum.
  • the stabilizer may represent from about 0.1% to about 5.0%, including from about 0.5% to about 3%, including from about 0.7% to about 1.5%, by weight of the powdered nutritional composition.
  • the powdered nutritional compositions may comprise one or more antioxidants to provide nutritional support, as well as to reduce oxidative stress.
  • Any antioxidants suitable for oral administration may be included for use in the powdered nutritional compositions of the present disclosure, including, for example, vitamin A, vitamin E, vitamin C, retinol, tocopherol, and carotenoids.
  • the antioxidants for use in the powdered nutritional compositions include carotenoids such as lutein, zeaxanthin, lycopene, beta-carotene, and combinations thereof, and particularly, combinations of the carotenoids lutein, lycopene, and beta-carotene.
  • Nutritional compositions containing these combinations, as selected and defined herein, can be used to modulate inflammation and/or levels of C-reactive protein in preterm and term infants.
  • the powdered nutritional compositions may further comprise any of a variety of other vitamins or related nutrients, non-limiting examples of which include vitamin D, vitamin K, thiamine, riboflavin, pyridoxine, vitamin B 12, niacin, folic acid, pantothenic acid, biotin, choline, inositol, salts and derivatives thereof, and combinations thereof.
  • vitamins or related nutrients include vitamin D, vitamin K, thiamine, riboflavin, pyridoxine, vitamin B 12, niacin, folic acid, pantothenic acid, biotin, choline, inositol, salts and derivatives thereof, and combinations thereof.
  • the powdered nutritional compositions may further comprise any of a variety of other additional minerals, non-limiting examples of which include calcium, phosphorus, magnesium, iron, zinc, manganese, copper, sodium, potassium, molybdenum, chromium, chloride, and combinations thereof.
  • the powdered nutritional compositions of the present disclosure may additionally comprise nucleotides and/or nucleotide precursors selected from the group consisting of nucleoside, purine base, pyrimidine base, ribose and deoxyribose to improve intestinal barrier integrity and/or maturation. This is particularly desirable when the powdered nutritional composition is a powdered infant formula.
  • the nucleotide may be in monophosphate, diphosphate, or triphosphate form.
  • the nucleotide may be a ribonucleotide or a deoxyribonucleotide.
  • the nucleotides may be monomeric, dimeric, or polymeric (including RNA and DNA).
  • the nucleotide may be present in the powdered nutritional composition as a free acid or in the form of a salt, preferably a monosodium salt.
  • Suitable nucleotides and/or nucleosides for use in the powdered nutritional compositions include one or more of cytidine 5'-monophosphate, uridine 5'-monophosphate, adenosine 5 '-monophosphate, guanosine 5 '-1 -monophosphate, and/or inosine 5'-monophosphate, more preferably cytidine 5'-monophosphate, uridine 5'-monophosphate, adenosine 5 '-monophosphate, guanosine 5 '-monophosphate, and inosine 5 '-monophosphate.
  • the powdered nutritional compositions of the present disclosure may be prepared by any known or otherwise effective manufacturing technique for preparing nutritional powders and can easily be applied by one of ordinary skill in the art to the powdered nutritional compositions described herein.
  • the powdered nutritional compositions of the present disclosure can therefore be prepared by any of a variety of known or otherwise effective formulation or manufacturing methods.
  • at least three separate slurries are prepared, including a protein-in-fat (PIF) slurry, a carbohydrate-mineral (CHO-MIN) slurry, a protein-in-water (PIW) slurry.
  • the PIF slurry is formed by heating and mixing the oil (e.g., caprylic acid-enriched coconut oil, etc.) and then adding an emulsifier (e.g., lecithin), fat soluble vitamins, and a portion of the total protein (e.g., milk protein concentrate, etc.) with continued heat and agitation.
  • the CHO-MIN slurry is formed by adding with heated agitation to water: minerals (e.g., potassium citrate, dipotassium phosphate, sodium citrate, etc.), trace and ultra trace minerals (TM/UTM premix), thickening or suspending agents (e.g. avicel, gellan, carrageenan).
  • minerals e.g., potassium citrate, dipotassium phosphate, sodium citrate, etc.
  • trace and ultra trace minerals e.g. avicel, gellan, carrageenan
  • thickening or suspending agents e.g. avicel, gellan, carrageenan
  • additional minerals e.g., potassium chloride, magnesium carbonate, potassium iodide, etc.
  • carbohydrates e.g., GOS, HMOs, fructooligosaccharide, sucrose, corn syrup, etc.
  • the PIW slurry is then formed by mixing with heat and agitation the remaining protein, if any.
  • the resulting slurries are then blended together with heated agitation and the pH adjusted to 6.6-7.0, after which the composition is subjected to high- temperature short-time (HTST) processing during which the composition is heat treated, emulsified and homogenized, and then allowed to cool.
  • HTST high- temperature short-time
  • Water soluble vitamins and ascorbic acid are added, the pH is adjusted to the desired range if necessary, flavors are added, and water is added to achieve the desired total solid level.
  • the composition is then heat-treated and subsequently processed and packaged as a reconstitutable powder, e.g., spray dried, drymixed, agglomerated.
  • the spray drying step may likewise include any spray drying technique that is known for or otherwise suitable for use in the production of nutritional powders. Many different spray drying methods and techniques are known for use in the nutrition field, all of which are suitable for use in the manufacture of the spray dried nutritional powders herein.
  • One method of preparing the spray dried nutritional powder comprises forming and homogenizing the slurries comprising fat (including the caprylic acid-enriched coconut oil), and optionally protein, carbohydrate, and other sources of fat as described above, and then spray drying the slurries to produce a spray dried nutritional powder.
  • the method may further comprise the step of spray drying, drymixing, or otherwise adding additional nutritional ingredients, including any one or more of the ingredients described herein, to the spray dried nutritional powder.
  • compositions are described, for example, in U.S. Pat. No. 6,365,218 (Borschel, et al.), U.S. Patent No. 6,589,576 (Borschel, et al.), U.S. Pat. No. 6,306,908 (Carlson, et al.), U.S. Patent Application No. 20030118703 Al (Nguyen, et al.), which descriptions are incorporated herein by reference to the extent that they are consistent herewith.
  • Cronobacter is a gram-negative, rod-shaped, pathogenic bacterium. Cronobacter has been associated with the use of powdered infant formula and is a cause of invasive infection in infants with historically high case fatality rates (40-80%). Particularly, in infants, it can cause bacteraemia, meningitis and necrotizing enterocolitis. All Cronobacter species have been linked retrospectively to clinical cases of infection in either adults or infants and therefore all species should be considered as opportunistic pathogens.
  • the methods of the present disclosure are directed to inhibiting the growth of opportunistic pathogen, and particularly, of C. sakazakii in powdered nutritional compositions, and in particular embodiments, in powdered infant formulas.
  • the powdered nutritional compositions including caprylic acid- enriched coconut oil may be administered to a subset of individuals in need of powdered nutritional compositions with improved safety.
  • Some individuals that are in specific need of safer powdered nutritional compositions having reduced risk of microbial contamination may include immunocompromised preterm infants, infants, pediatrics, teens, adults or older adults (adults age 50 and over), preterm infants, infants, pediatrics, teens, adults or older adults who experience, are susceptible to, or at an elevated risk of diseases and conditions, associated with a suppression in immunity (e.g., cancer, HIV, AIDS, diabetes, etc.), preterm infants and infants who experience, are susceptible to, or at an elevated risk of necrotizing enterocolitis, and the like.
  • a suppression in immunity e.g., cancer, HIV, AIDS, diabetes, etc.
  • Preterm infants, infants, pediatrics, teens, adults, and older adults may be susceptible to or at elevated risk for experiencing these diseases and conditions due to family history, age, environment, and/or lifestyle. Based on the foregoing, because some of the method embodiments of the present disclosure are directed to specific subsets or subclasses of identified individuals (that is, the subset or subclass of individuals "in need" of assistance in addressing one or more specific conditions noted herein), not all individuals will fall within the subset or subclass of individuals as described herein for certain diseases or conditions.
  • the individual desirably consumes at least one serving of the powdered nutritional composition daily, and in some embodiments, may consume two, three, or even more servings per day.
  • Each serving is desirably administered as a single, undivided dose, although the serving may also be divided into two or more partial or divided servings to be taken at two or more times during the day.
  • the methods of the present disclosure include continuous day after day administration, as well as periodic or limited administration, although continuous day after day administration is generally desirable.
  • the methods of the present disclosure are preferably applied on a daily basis, wherein the daily administration is maintained continuously for at least 3 days, including at least 5 days, including at least 1 month, including at least 4 weeks, including at least 8 weeks, including at least 2 months, including at least 6 months, desirably for at least 18-24 months, desirably as a long term, continuous, daily, dietary supplement.
  • the exemplified compositions are powdered nutritional compositions that may be prepared in accordance with the manufacturing methods described herein, such that each exemplified powdered nutritional composition has a reduced risk of microbial contamination.
  • Examples 1-5 illustrate powdered infant formulas of the present disclosure, the ingredients of which are listed in the table below. All ingredient amounts are listed as kg per 1000 kg batch, unless otherwise specified.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Mycology (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Polymers & Plastics (AREA)
  • Food Science & Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nutrition Science (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Pediatric Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oncology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Biotechnology (AREA)
  • Botany (AREA)
  • Medical Informatics (AREA)
  • Microbiology (AREA)
  • Communicable Diseases (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

L'invention concerne des procédés pour préparer des compositions nutritionnelles en poudre comprenant de l'huile de noix de coco enrichie en acide caprylique. L'huile de noix de coco enrichie en acide caprylique forme une barrière antimicrobienne dans la composition nutritionnelle en poudre, en inhibant le développement des pathogènes opportunistes, et en particulier celui de Cronobacter sakazakii.
PCT/US2013/070113 2012-11-14 2013-11-14 Compositions et procédés pour améliorer la sécurité à long terme des formules pour nourrissons en poudre Ceased WO2014078544A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201261726275P 2012-11-14 2012-11-14
US61/726,275 2012-11-14

Publications (1)

Publication Number Publication Date
WO2014078544A1 true WO2014078544A1 (fr) 2014-05-22

Family

ID=49674397

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2013/070113 Ceased WO2014078544A1 (fr) 2012-11-14 2013-11-14 Compositions et procédés pour améliorer la sécurité à long terme des formules pour nourrissons en poudre

Country Status (1)

Country Link
WO (1) WO2014078544A1 (fr)

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5234703A (en) * 1992-10-31 1993-08-10 Guthery B Eugene Disinfecting product and process
US5892072A (en) * 1996-01-19 1999-04-06 Twin Rivers Technologies, Lp C 12-16-90% fatty acids and a process of making the same
US6080787A (en) * 1997-02-21 2000-06-27 Abbott Laboratories Methods for reducing the incidence of necrotizing enterocolitis
US6306908B1 (en) 1997-02-21 2001-10-23 Abbott Laboratories Methods for reducing the incidence of necrotizing enterocolitis
US6365218B1 (en) 2000-02-04 2002-04-02 Abbott Laboratories Pediatric formula and methods for providing nutrition and improving tolerance
US20030118703A1 (en) 2001-12-12 2003-06-26 Nguyen Minhthy Le Methods and compositions for brightening the color of thermally processed nutritionals
KR20100101377A (ko) * 2009-03-09 2010-09-17 고려대학교 산학협력단 액상분유 및 분유조성물의 제조방법
KR20120106135A (ko) * 2011-03-17 2012-09-26 고려대학교 산학협력단 천연 항미생물제를 이용한 조제분유 제조방법

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5234703A (en) * 1992-10-31 1993-08-10 Guthery B Eugene Disinfecting product and process
US5892072A (en) * 1996-01-19 1999-04-06 Twin Rivers Technologies, Lp C 12-16-90% fatty acids and a process of making the same
US6080787A (en) * 1997-02-21 2000-06-27 Abbott Laboratories Methods for reducing the incidence of necrotizing enterocolitis
US6306908B1 (en) 1997-02-21 2001-10-23 Abbott Laboratories Methods for reducing the incidence of necrotizing enterocolitis
US6365218B1 (en) 2000-02-04 2002-04-02 Abbott Laboratories Pediatric formula and methods for providing nutrition and improving tolerance
US6589576B2 (en) 2000-02-04 2003-07-08 Abbott Laboratories Pediatric formula and methods for providing nutrition and improving tolerance
US20030118703A1 (en) 2001-12-12 2003-06-26 Nguyen Minhthy Le Methods and compositions for brightening the color of thermally processed nutritionals
KR20100101377A (ko) * 2009-03-09 2010-09-17 고려대학교 산학협력단 액상분유 및 분유조성물의 제조방법
KR20120106135A (ko) * 2011-03-17 2012-09-26 고려대학교 산학협력단 천연 항미생물제를 이용한 조제분유 제조방법

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
JANG H I ET AL: "Inhibitory effect of caprylic acid and mild heat on Cronobacter spp. (Enterobacter sakazakii) in reconstituted infant formula and determination of injury by flow cytometry", INTERNATIONAL JOURNAL OF FOOD MICROBIOLOGY, ELSEVIER BV, NL, vol. 133, no. 1-2, 31 July 2009 (2009-07-31), pages 113 - 120, XP026223509, ISSN: 0168-1605, [retrieved on 20090513], DOI: 10.1016/J.IJFOODMICRO.2009.05.009 *
M.J. CHOI ET AL: "New decontamination method based on caprylic acid in combination with citric acid or vanillin for eliminating Cronobacter sakazakii and Salmonella enterica serovar Typhimurium in reconstituted infant formula", INTERNATIONAL JOURNAL OF FOOD MICROBIOLOGY, vol. 166, no. 3, 1 September 2013 (2013-09-01), pages 499 - 507, XP055098312, ISSN: 0168-1605, DOI: 10.1016/j.ijfoodmicro.2013.08.016 *
NAIR M, ET AL: "Inactivation of Enterobactersakazakii in reconstituted infant formula by monocaprylin", JOURNAL OF FOOD PROTECTION, INTERNATIONAL ASSOCIATION FOR FOOD PROTECTION, US, vol. 67, no. 12, 1 December 2004 (2004-12-01), pages 2815 - 2819, XP009175736, ISSN: 0362-028X *

Similar Documents

Publication Publication Date Title
US10779550B2 (en) Human milk oligosaccharides to ameliorate symptoms of stress
EP2658399B2 (fr) Compositions nutritionnelles contenant des oligosaccharides et des nucléotides de lait humain pour utilisation pour le traitement et/ou la prévention d'une infection à rotavirus entérique
US11160817B2 (en) Nutritional compositions comprising neuroprotective dietary oligosaccharides
TWI639387B (zh) 用於預防胃腸道受傷及／或促進胃腸道治癒之半乳寡糖
RU2706963C2 (ru) Молочная смесь, содержащая олигосахариды грудного молока, полиненасыщенные жирные кислоты, нуклеотиды и лютеин
MX2014011694A (es) Metodos para modular la inmunidad celular usando oligosacaridos de leche humana.
WO2014100225A1 (fr) Utilisation nutritionnelle d'oligosaccharides de lait humain
CA2825338C (fr) Produits a finalite nutritionnelle comportant du beta-hydroxy-beta-methylbutyrate
CA2904370C (fr) Procedes de stimulation de la maturation intestinale et pulmonaire chez le nourrisson
WO2014078544A1 (fr) Compositions et procédés pour améliorer la sécurité à long terme des formules pour nourrissons en poudre
WO2022177965A1 (fr) Compositions nutritionnelles comprenant des oligosaccharides du lait humain et de l'immunoglobuline bovine
EP4132560A1 (fr) Formulations nutritionnelles pour la modulation de cytokines induites par la respiration
HK40014955A (en) Methods for modulating cell-mediated immunity using human milk oligosaccharides
HK1198873A1 (en) Nutritional use of human milk oligosaccharides
HK1217082B (en) Human milk oligosaccharides to ameliorate symptoms of stress
HK1191186A (en) Nutritional products comprising beta-hydroxy-beta-methylbutyrate
HK1191186B (en) Nutritional products comprising beta-hydroxy-beta-methylbutyrate

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 13796208

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 13796208

Country of ref document: EP

Kind code of ref document: A1