EP4175491A1 - Kit de coloration d'aliments pour alimentation par sonde - Google Patents

Kit de coloration d'aliments pour alimentation par sonde

Info

Publication number
EP4175491A1
EP4175491A1 EP21739062.4A EP21739062A EP4175491A1 EP 4175491 A1 EP4175491 A1 EP 4175491A1 EP 21739062 A EP21739062 A EP 21739062A EP 4175491 A1 EP4175491 A1 EP 4175491A1
Authority
EP
European Patent Office
Prior art keywords
compartment
colorant
tube feed
feed composition
comprised
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.)
Pending
Application number
EP21739062.4A
Other languages
German (de)
English (en)
Inventor
Julia HECKMANN
Nadja SIEGERT
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.)
Fresenius Kabi Deutschland GmbH
Original Assignee
Fresenius Kabi Deutschland GmbH
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 Fresenius Kabi Deutschland GmbH filed Critical Fresenius Kabi Deutschland GmbH
Publication of EP4175491A1 publication Critical patent/EP4175491A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/40—Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
    • A—HUMAN NECESSITIES
    • 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
    • A23L2/00—Non-alcoholic beverages; Dry compositions or concentrates therefor; Their preparation
    • A23L2/52—Adding ingredients
    • A23L2/58—Colouring agents
    • 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
    • A23L33/30—Dietetic or nutritional methods, e.g. for losing weight
    • 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
    • A23L5/00—Preparation or treatment of foods or foodstuffs, in general; Food or foodstuffs obtained thereby; Materials therefor
    • A23L5/40—Colouring or decolouring of foods
    • A23L5/42—Addition of dyes or pigments, e.g. in combination with optical brighteners
    • 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
    • A23L5/00—Preparation or treatment of foods or foodstuffs, in general; Food or foodstuffs obtained thereby; Materials therefor
    • A23L5/40—Colouring or decolouring of foods
    • A23L5/42—Addition of dyes or pigments, e.g. in combination with optical brighteners
    • A23L5/43—Addition of dyes or pigments, e.g. in combination with optical brighteners using naturally occurring organic dyes or pigments, their artificial duplicates or their derivatives
    • 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
    • A23L5/00—Preparation or treatment of foods or foodstuffs, in general; Food or foodstuffs obtained thereby; Materials therefor
    • A23L5/40—Colouring or decolouring of foods
    • A23L5/42—Addition of dyes or pigments, e.g. in combination with optical brighteners
    • A23L5/46—Addition of dyes or pigments, e.g. in combination with optical brighteners using dyes or pigments of microbial or algal origin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/002—Compounding apparatus specially for enteral or parenteral nutritive solutions
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2205/00—General identification or selection means
    • A61J2205/20—Colour codes

Definitions

  • the present invention relates to a kit for coloring tube feed compositions comprising a tube feed and a colorant, to a device for the administration of a colorant into a tube feed composition and to a method for preparing a colored tube feed composition.
  • Tube feeding is a well-established way of providing enteral nutrition to malnourished people, people with oral-food-intake difficulties due to e.g. swallowing difficulties or numerous other medical complications, which require nutritional support.
  • Nasogastric and nasojejenual tubes are examples for providing tube feed compositions to the stomach or intestine of people in need thereof.
  • colorants from the group consisting of copper complexes of chlorophyllins, copper complexes of chlorophylls, vegetable charcoal, anthocyanins, spirulina, and mixtures thereof are capable of coloring tube feed compositions and that the color of the resulting tube feed compositions is stable under the strongly acidic conditions of the stomach, i.e. at a pH- value of about 2.2. Furthermore, it has been found that these colorants are stable against secretions from the Gl tract such as gastric enzymes, bile, pancreatic enzymes and small intestine electrolyte solution (SIES).
  • All colorants according to the invention are selected in a way that the color of the colored tube feed can be distinguished from the color of the physiological secretions in the Gl tract.
  • the colorants of this invention are safe based on the fact that they are group II colorants, authorized "quantum satis" (i.e. without quantitative restriction) to be used in food for special medical purposes (FSMP), indicating their non-toxic properties. Consequently, they overcome the limitations of the colorants used for the coloring of tube feeds disclosed in the prior art.
  • kits for coloring tube feed compositions comprising at least a first and a second compartment, and, optionally, handling instructions; wherein the first compartment comprises a tube feed composition, the second compartment comprises at least one colorant selected from the group consisting of copper complexes of chlorophyllins, copper complexes of chlorophylls, vegetable charcoal, anthocyanins, spirulina, and mixtures thereof; and wherein the at least one colorant is transferable from the second compartment to the first compartment to allow a mixing of the at least one colorant with the tube feed composition.
  • the invention provides a device for the administration of at least one colorant into a tube feed composition, wherein the device is connectable to a compartment comprising a tube feed composition, optionally via a coupling link, the device comprises at least one colorant, and, wherein the at least one colorant is selected from the group consisting of copper complexes of chlorophyllins, copper complexes of chlorophylls, vegetable charcoal, anthocyanins, spirulina, and mixtures thereof.
  • the present invention also relates in a third aspect to a method for preparing a colored tube feed composition
  • a method for preparing a colored tube feed composition comprising the steps of a) providing a first compartment comprising a tube feed composition, b) providing a second compartment comprising at least one colorant selected from the group consisting of copper complexes of chlorophyllins, copper complexes of chlorophylls, vegetable charcoal, anthocyanins, spirulina, and mixtures thereof, c) transferring the at least one colorant from the second compartment to the first compartment, optionally by means of a third compartment, to allow a mixing of the at least one colorant with the tube feed composition to obtain a colored tube feed composition.
  • Colorant or colorants as used herein refers to one Group II colorant or a mixture of different Group II colorants as well as Group II colorant compositions suitable for tinting tube feed compositions, that comprise one or more ingredients other than the Group II colorants, which are required for instance for the stabilization of those compositions, such as additives or adjuvants.
  • Color IndexTM Number (C.l. No.) as used herein refers to the "The Color IndexTM https://colour- index.com published online by the Society of Dyers and Colourists and the American Association of Textile Chemists and Colorists”.
  • Copper Chlorophyllin refers to a colorant comprising copper complexes of chlorophyllin such as the sodium or potassium salts of Copper Chlorophyllin or mixtures thereof. Copper Chlorophyllin is commercially available for instance from Sensient Colors Europe GmbH, Geesthachter Str. 103, 21502 Geesthacht, Germany, Product number 503523. Copper Chlorophyllin refers to E141(ii) in the E-number codes for substances used as food additives for use within the European Union (EU) and European Free Trade Association (EFTA).
  • EU European Union
  • EFTA European Free Trade Association
  • An example of a Copper Chlorophyllin colorant for use in the present invention is the trisodium salt identified by the C.l. No. 75815 or CAS-No. 11006-34-1.
  • Carbon Black as used herein refers to a colorant comprising a dispersion of micronized vegetable carbon, C.l. No. 77266, CAS-No. 7440-44-0. Carbon Black is commercially available for instance from Sensient Colors Europe GmbH, Geesthachter Str. 103, 21502 Geesthacht, Germany, Product number 409208. Carbon Black refers to E153 in the E-number codes for substances used as food additives for use within the European Union (EU) and European Free Trade Association (EFTA).
  • EU European Union
  • EFTA European Free Trade Association
  • Anthocyanin as used herein refers to an Anthocyanin extract. Anthocyanin is commercially available for instance from Sensient Colors Europe GmbH, Geesthachter Str. 103, 21502 Geesthacht, Germany, Product number 409291. Anthocyanin refers to E163 in the E-number codes for substances used as food additives for use within the European Union (EU) and European Free Trade Association (EFTA).
  • Marine Blue as used herein refers to a water-soluble preparations of spirulina concentrate made from Spirulina Platensis. Marine blue is for instance commercially available from Sensient Colors Europe GmbH, Geesthachter Str. 103, 21502 Geesthacht, Germany, Product number 419174.
  • Group II colorants refers to food colors authorized at quantum satis (group II) pursuant to the regulation No. 1333/2008 of the European Parliament of 16. Dec 2008 to be used in food for special medical purposes defined in directive 1999/21/EC.
  • E-numbers refer to the E-number codes for substances used as food additives for use within the European Union (EU) and European Free Trade Association (EFTA).
  • Vol.% (v/v) as used herein refers to volume percent (volume per volume) based on the volume of the colored tube feed composition.
  • Caloric density refers to the calorie content relative to its volume.
  • Dietary fiber as used herein refers to indigestible carbohydrates, such as fructooligosaccharides, fructanes, e.g. inulin, galactooligosaccharides, pectin, gums, such as guar gum, loctus bean gum and gum acacia, cocoa, xanthan, carrageenan, cellulose, such as microcristalline cellulose, dextrins, such as wheat dextrin, fruit purees, and mixtures thereof.
  • indigestible carbohydrates such as fructooligosaccharides, fructanes, e.g. inulin, galactooligosaccharides, pectin, gums, such as guar gum, loctus bean gum and gum acacia, cocoa, xanthan, carrageenan, cellulose, such as microcristalline cellulose, dextrins, such as wheat dextrin, fruit purees, and mixtures thereof.
  • Protein component as used herein refers to the entirety of ingredients of the nutritional composition declarable as protein, such as total milk protein, milk protein concentrate, milk protein isolate, casein, caseinate, such as sodium caseinate, potassium caseinate, calcium caseinate, whey protein, vegetable proteins, such as pea protein and soy protein, animal proteins, such as collagen, and mixtures thereof.
  • the protein component may comprise protein that is essentially non-hydrolyzed, partially hydrolyzed protein, or in amino acid form, as well as mixtures thereof.
  • the protein may be present in native or denatured form or mixtures of both.
  • Fat component refers to the entirety of ingredients of the nutritional composition declarable as fat, such as fish oil, rapeseed oil, safflower oil, sunflower oil, linseed oil, canola oil, tributyrin, medium chain triglycerides (MCT), and mixtures thereof.
  • fat such as fish oil, rapeseed oil, safflower oil, sunflower oil, linseed oil, canola oil, tributyrin, medium chain triglycerides (MCT), and mixtures thereof.
  • Carbohydrate component refers to the entirety of ingredients of the nutritional composition declarable as carbohydrate, such as starch, maltodextrin, glucose syrup, mono- and disaccharides, such as sucrose, maltose, isomaltulose, lactose, glucose, fructose, galactose, and mixtures thereof.
  • Amino acid as used herein includes the free amino acid, salts of the amino acid, chemically modified amino acids and metabolites of amino acids, such as alpha-ketoisocaproic acid (KIC), 3-Hydroxy- 3-methyl-butyric acid (HMB) and (R)-3-Hydroxybutyl-(R)-3-hydroxybutyrate, and mixtures thereof.
  • KIC alpha-ketoisocaproic acid
  • HMB 3-Hydroxy- 3-methyl-butyric acid
  • R -3-Hydroxybutyl-(R)-3-hydroxybutyrate
  • Nutritionally complete refers to nutritional compositions suitable as sole source of nutrition. To be nutritionally complete, it is required that a nutritional composition comprises - in addition to the fat, carbohydrate and protein components - minerals and vitamins. In order to be nutritionally complete, vitamins and minerals should be present in amounts in accordance with established nutritional guidelines. The recommended nutrient requirements, particularly with respect to minerals and vitamins, can be found in standard nutritional guidelines, such as EU commission directive 1999/21/EC (see table 1 herein below). Suitable nutritional compositions according to the present disclosure fulfil the requirements of / are listed in REGULATION (EU) No 609/2013.
  • Caseinate refers to caseinate salts with alkali and earth-alkali metals, e.g. sodium caseinate, potassium caseinates, calcium caseinate, acid casein, rennet casein, and mixtures thereof.
  • Tube feed or tube feeds refers to food, which is provided to the gastro-intestinal tract, e.g. stomach or small intestine, of a patient via a tube, e.g. a tube inserted through the nose or abdomen of the patient.
  • Co-polymers as used herein include random- and block-copolymers.
  • Transferable from the second compartment to the first compartment refers to a complete or partial transfer of the colorant from the second compartment to the first compartment comprising the tube feed composition or vice versa or a mixture of both.
  • Mixing of the at least one colorant with the tube feed composition as used herein refers to a complete or partial mixing of the at least one colorant and the tube feed composition in the first compartment. Depending on the means by which the transfer of colorant into the tube feed composition is accomplished, mixing of partial amounts of the at least one colorant and the tube feed composition may also take place in other compartments of the kit as well as in the coupling links or the connectors comprised in the kit.
  • Secondary packaging refers to a packaging, which is neither in contact with the tube feed composition comprised in the first compartment, nor with the at least one colorant comprised in the second compartment.
  • ENPlus system refers to a connecting system for tube feed containers and administration systems for tube feeds comprising a plus (+) shaped connector on the feed containers as well as a plus (+) shaped spike on the administration system.
  • the ENPlus connection system ensures that only enteral nutrition feed containers can be attached to enteral feed administration systems and that enteral nutrition administration sets cannot be connected to IV solution containers.
  • ENPlus connection systems are routinely used in commercially available tube feed products and are described in the ISO Norm 18250.
  • One example of a tube feed container comprising an ENplus connecting system is the EasyBag ® system by Fresenius Kabi.
  • the kit of the present invention comprises at least a first and a second compartment, wherein the first compartment comprises a tube feed composition, the second compartment comprises at least one colorant selected from the group consisting of copper complexes of chlorophyllins, copper complexes of chlorophylls, vegetable charcoal, anthocyanins, spirulina, and mixtures thereof; and wherein the at least one colorant is transferable from the second compartment to the first compartment to allow a mixing of the at least one colorant with the tube feed composition.
  • the colorant is selected from the group consisting of Copper Chlorophyllin (E141(ii)), Carbon Black (E153), Anthocyanin (E163), Marine Blue, and mixtures thereof, more preferably from Copper Chlorophyllin (E141(ii)), Carbon Black (E153), Anthocyanin (E163), and mixtures thereof. Most preferably, the colorant is Copper Chlorophyllin (E141(ii)).
  • Substances to enhance the storage stability of the at least one colorant may also be comprised in the second compartment of the kit.
  • the kit of the present invention comprises handling instructions. Handling instructions allow for a safe and convenient handling of the kit of the present invention as well as a safe and convenient preparation of colored tube feed compositions by mixing the at least one colorant comprised in the second compartment and the tube feed composition comprised in the first compartment.
  • the kit of the present invention may comprise a secondary packaging.
  • the second packaging encloses at least the first and the second compartment, and, optionally the handling instructions and auxiliary means comprised in the kit.
  • the secondary packaging may be selected from the group consisting of bags, blisters, and flow-packs.
  • the secondary packaging may be impermeable for oxygen. It may further be partially or fully transparent for light. Additionally, it may protect the kit of the present invention from contamination, e.g. dust.
  • the kit may comprise auxiliary means for the administration of the at least one colorant from the second compartment to the tube feed composition comprised in the first compartment, such as coupling links, syringes or needles.
  • the needle is packaged prior to the administration of the colorant from the second compartment to the tube feed composition comprised in the first compartment in order to keep it sterile.
  • the needle is included in a protecting cap. The use of packaged, protected needles allows for a safe and convenient handling of the kit as well as for a sterile administration of the colorant from the second compartment to the tube feed in the first compartment.
  • the first compartment is a container, for example a bottle, a bag or a pouch, such as a stand-up pouch.
  • the, first compartment is a plastic container.
  • the plastic container comprises polymers selected form the group consisting of polyethylene, polypropylene, polybutylene, polyisoprene, polystyrene, polyamide, polyvinylchloride, and mixtures thereof, more preferably polyethylene, polypropylene, polyamide, and mixtures thereof.
  • the polymers may be present in the form of homo polymers or co-polymers.
  • the plastic container may comprise one or more layers, preferably 1 to 4 layers, more preferably 3 to 4 layers.
  • the layers may be identical of different regarding their polymer composition.
  • the one or more layer may be coated independently from each other. Preferred coatings comprise ceramics. Coating leads to improved properties of the container, e.g. improved mechanical properties.
  • a plastic container according to the present invention is a container as disclosed in W02015/052209.
  • the first compartment comprises a connector.
  • the connector may comprise a break-up part and/or a septum.
  • the connector comprises a break-up part and a septum and is connectable to an administration system comprising a spike by injection of the spike through the septum comprised in the connector.
  • the administration system is connected to the connector by an ENPlus system.
  • the first compartment may comprise a suspension arrangement, such as a hanger, an aperture or an orifice.
  • a suspension arrangement such as a hanger, an aperture or an orifice.
  • the suspension arrangement is placed at the opposite side to the connector comprised in the first compartment. This arrangement allows for a flow out of the contents through the connector comprised in the first compartment by means of gravity, i.e. without the need to apply additional force.
  • the tube feed composition comprised in the first compartment may be sterilized.
  • the colorant comprised in the second compartment as well as at least one of the additional parts, optionally comprised in the kit, such as coupling links, auxiliary means or the secondary packaging, may be sterilized as well. In one embodiment all parts of the kit are sterilized.
  • the second compartment may be a container, wherein the container is selected from the group consisting of syringes, bottles, ampules, bags, pouches, such as stand-up pouches, vials, tubes and capsules, preferably from syringes, bottles, bags, and pouches, such a stand-up pouches, more preferably the second compartment is a syringe.
  • the plastic container comprises polymers selected form the group consisting of polyethylene, polypropylene, polybutylene, polyisoprene, polystyrene, polyamide, polyvinylchloride, and mixtures thereof, more preferably polyethylene, polypropylene, polyamide, and mixtures thereof.
  • the polymers may be present in the form of homo polymers or co-polymers.
  • the plastic container may comprise one or more layers, preferably 1 to 4 layers, more preferably 3 to 4 layers. In the case the plastic container comprises more layers the layers may be identical of different regarding their polymer composition.
  • the one or more layer may be coated independently from each other. Preferred coatings comprise ceramics. Coating leads to improved properties of the container, e.g. improved mechanical properties.
  • the second compartment is a device for the administration of the at least one colorant into the tube feed composition comprised in the first compartment, optionally via a coupling link.
  • a device for the administration of the at least one colorant into the tube feed composition comprised in the first compartment is a syringe.
  • the second compartment can alternatively be connected to the first compartment to administer the colorant to the tube feed composition in the first compartment, optionally via a coupling link.
  • the coupling link comprises a least a first and a second connector, wherein the first connector fits to a connector comprised in the first compartment and wherein the second connector fits to a connector comprised in the second compartment.
  • the first and/or the second connector comprised in the coupling link may comprise a spike that are connectable to the first and/or the second compartment by injecting the spike through the septum comprised in the connector comprised in the first and/or the second compartment.
  • the connectors comprised in the coupling link are connected to the connectors in the first and/or the second compartment by an ENPlus system.
  • the coupling link may comprise at least one branching point, such as a Y-conjunction or a T- conjunction, for the simultaneous addition of at least the at least one colorant comprised in the second compartment and the tube feed composition comprised in the first compartment to a patient.
  • branching point such as a Y-conjunction or a T- conjunction
  • the colorant and the tube feed composition may be mixed in a third compartment prior to the administration to a patient.
  • the coupling link comprises more than one branching point.
  • additional substances other than the at least one colorant and the tube feed composition can be added.
  • the coupling link comprises a shut-off device, preferably a stopcock, such as a two-way stopcock or a three-way stopcock.
  • a stopcock such as a two-way stopcock or a three-way stopcock.
  • the coupling link is a tube, more preferably a plastic tube
  • the plastic tube comprises polymers selected form the group consisting of polyethylene, polypropylene, polybutylene, polyisoprene, polystyrene, polyamide, polyvinylchloride, and mixtures thereof.
  • the plastic tube may be coated in an alternative embodiment.
  • the second compartment comprises a connector that fits to a connector comprised in the first compartment. This allows for the mixing of the at least one colorant and the tube feed composition comprised in the first compartment without the need to use a coupling link under sterile conditions and avoids the contamination of the colored tube feed composition prior to its administration to the patient.
  • the at least one colorant may be transferred from the second compartment to the tube feed composition comprised in the first compartment by the application of force.
  • the force is applied to the piston of the syringe to transfer the at least one colorant comprised in the syringe to the first compartment comprising the tube feed composition, preferably through a needle.
  • the force is applied to the first compartment, the second compartment or to both, to break the seal and allow for a mixing of the colorant comprised in the second compartment and the tube feed composition comprised in the first compartment.
  • the force may be applied to both compartments stepwise or simultaneously.
  • the at least one colorant is transferred from the second compartment to the tube feed composition comprised in the first compartment through a needle, preferably through a septum comprised in the first compartment.
  • the septum is preferably comprised in a connector comprised in the first compartment.
  • the second compartment is a syringe and the at least one colorant is transferred from the second compartment to the tube feed composition comprised in the first compartment through a needle, preferably through a septum comprised in the first compartment.
  • the septum is preferably comprised in a connector comprised in the first compartment.
  • the first compartment is a pouch, such as a stand-up pouch, or a bottle
  • the second compartment is a syringe and the at least one colorant is transferred from the syringe to the pouch through a needle by injecting the needle through the septum comprised in a connector comprised in the first compartment.
  • the kit comprises a third compartment for transferring the at least one colorant from the second compartment to the tube feed composition comprised in the first compartment.
  • the third compartment is comprised in a syringe and the at least one colorant is transferred in a first step from the second compartment to the third compartment comprised in the syringe through a needle by injecting the needle through a septum comprised in a connector comprised in in the second compartment.
  • the at least one colorant is transferred from the third compartment comprised in the syringe to the tube feed composition comprised in the first compartment through the needle by injecting the needle through a septum comprised in the first compartment.
  • the first and the second compartment may be placed inside one container.
  • the container is equal to the fist compartment.
  • the second compartment placed inside the first compartment is a capsule or a small bag, wherein the capsule or the small bag releases the colorant after the application of force.
  • the second compartment is a capsule or a small bag placed in the first compartment and the first compartment comprises a connector comprising a septum, the connector is connectable to an administration system comprising a spike by injecting the spike through the septum comprised in the connector, and a suspension arrangement placed at the opposite side to the connector in the second compartment.
  • the administration system is connected to the connector by an ENPlus system.
  • the first and the second compartment placed in one container are separated by a peelable seal or a permanent seal having a frangible valve.
  • the container comprising the first and the second compartment separated by a peelable seal or a permanent seal having a frangible valve is a multi-chamber bag, such as at two- or a three-chamber bag. Multi-chamber bags according to this invention are for example disclosed in EP1773277B1.
  • the container is a two-chamber bag, wherein the two chamber bag comprises a first chamber comprising the first compartment and a second chamber comprising the second compartment, wherein the first and the second compartment are separated by a seal, and wherein the at least one colorant comprised in the second compartment is transferred to the tube feed composition comprised in the first compartment by the application of force, and wherein the first compartment comprises a connector comprising a septum, the connector is connectable to an administration system comprising a spike by injecting the spike through the septum comprised in the connector, and a suspension arrangement placed at the opposite side to the connector comprised in the first compartment.
  • the administration system is connected to the connector by an ENPlus system.
  • the tube feed composition of the present invention may have a caloric density of at least 0.3 kcal/ml, preferably of at least 0.8 kcal/ml, more preferably of at least 1.0 kcal/ml, such as 1.0 kcal/ml, 2.0 kcal/ml, 2.4 kcal/ml, 3.2 kcal/ml or 5.0 kcal ml.
  • the tube feed composition of the present invention comprises a protein component.
  • the protein component may comprise at least one protein selected from non-hydrolyzed protein, partially hydrolyzed protein, or amino acids, and mixtures thereof.
  • the protein component may comprise one or more proteins selected from milk proteins, such as total milk protein, milk protein concentrate, milk protein isolate, casein, caseinate, such as sodium caseinate, potassium caseinate, calcium caseinate, whey protein, vegetable proteins, such as pea protein and soy protein, animal proteins, such as collagen, and mixtures thereof.
  • the proteins in the protein component may be essentially non- hydrolyzed protein or partially hydrolyzed protein, such as casein hydrolysate, hydrolyzed caseinate, whey hydrolysate, pea protein hydrolysate and collagen hydrolysate, and mixtures thereof.
  • the protein component may comprise amino acids.
  • the protein component comprises one or more proteins selected from casein, caseinate, whey protein, and mixtures thereof.
  • the protein component comprises one or more protein hydrolysates, such as casein hydrolysate, hydrolyzed caseinate, whey hydrolysate, pea protein hydrolysate, collagen hydrolysate or mixtures thereof.
  • the tube feed composition of the present invention may comprise a carbohydrate component.
  • the carbohydrate component may comprise at least one carbohydrate selected from digestible polysaccharides, mono- and disaccharides, and mixtures thereof.
  • the carbohydrate component may comprise one or more digestible polysaccharides, such as starch, maltodextrin, or glucose syrup, and mixtures thereof.
  • the carbohydrate component may comprise one or more mono- and disaccharides, such as sucrose, maltose, isomaltulose, lactose, glucose, fructose, or galactose, and mixtures thereof.
  • the carbohydrate component comprises one or more carbohydrates selected from starch, maltodextrin, glucose syrup, fructose, isomaltulose, or sucrose, and mixtures thereof.
  • the tube feed composition of the present invention comprises a fat component.
  • the fat component may comprise one or more oils selected from the group consisting of fish oil, rapeseed oil, safflower oil, sunflower oil, linseed oil, canola oil, tributyrin, or medium chain triglycerides (MCT), and mixtures thereof.
  • the tube feed of the present invention comprises a protein component, preferably at least one protein selected from casein, caseinate, or whey protein, and mixtures thereof, a carbohydrate component, preferably at least one carbohydrate selected from starch, maltodextrin, glucose syrup, fructose, isomaltulose, or sucrose, and mixtures thereof, and a fat component, preferably at least one oil selected from fish oil, rapeseed oil, safflower oil, sunflower oil, linseed oil, canola oil, tributyrin, or medium chain triglycerides (MCT), and mixtures thereof.
  • a protein component preferably at least one protein selected from casein, caseinate, or whey protein, and mixtures thereof
  • a carbohydrate component preferably at least one carbohydrate selected from starch, maltodextrin, glucose syrup, fructose, isomaltulose, or sucrose, and mixtures thereof
  • a fat component preferably at least one oil selected
  • the tube feed composition of the present invention comprises at least one dietary fiber, selected from fructooligosaccharides or fructanes, e.g. inulin, galactooligosaccharides, pectin, gums, such as guar gum, loctus bean gum and gum acacia, cocoa, xanthan, carrageenan, cellulose, such as microcristalline cellulose, wheat dextrin fibre, soyapolysaccharide, and mixtures thereof.
  • fructooligosaccharides or fructanes e.g. inulin, galactooligosaccharides, pectin, gums, such as guar gum, loctus bean gum and gum acacia, cocoa, xanthan, carrageenan, cellulose, such as microcristalline cellulose, wheat dextrin fibre, soyapolysaccharide, and mixtures thereof.
  • the tube feed composition of the present invention may comprise additional ingredients, such as, vitamins, minerals, and mixtures thereof, required to adapt the nutritional profile of the tube feed composition to address the nutritional requirements of the patients in need thereof.
  • the tube feed composition of the present invention is a food for special medical purposes (FSMP).
  • FSMP food for special medical purposes
  • the food for special medical purposes may be nutritionally complete or in the form of a nutritional supplement.
  • the tube feed composition of the present invention is nutritionally complete.
  • Substances to enhance the storage stability of the compositions, such as emulsifiers and / or antioxidants may also be comprised in the tube feed composition of the present invention.
  • the tube feed composition of the present invention may preferably comprise a protein component, a carbohydrate component, a fat component, dietary fibers, vitamins, minerals and substances to enhance the storage stability of the composition such as emulsifier and / or antioxidants and mixtures thereof.
  • the present invention also relates to a device for the administration of at least one colorant into a tube feed composition (the device), wherein the device is connectable to a compartment comprising a tube feed composition, the device comprises at least one colorant, and, wherein the at least one colorant is selected from the group consisting of copper complexes of chlorophyllins, copper complexes of chlorophylls, vegetable charcoal, anthocyanins, spirulina, and mixtures thereof.
  • the at least one colorant is selected from the group consisting of Copper Chlorophyllin (E141(ii)), Carbon Black (E153), Anthocyanin (E163), Marine Blue, and mixtures thereof, more preferably from Copper Chlorophyllin (E141(ii)), Carbon Black (E153), Anthocyanin (E163), and mixtures thereof. Most preferably, the colorant is Copper Chlorophyllin (E141(ii)).
  • Substances to enhance the storage stability of the at least one colorant such as emulsifiers and / or antioxidants may also be comprised in the device.
  • the device is selected from the group consisting of syringes, bottles, ampules, bags, pouches, such as stand-up pouches, vials, tubes and capsules, preferably from syringes, bottles, bags, and pouches, such as stand-up pouches, more preferably the device is a syringe.
  • the device comprises a connector that fits to a connector of the compartment comprising a tube feed composition. This allows for the mixing of colorant and tube feed composition under sterile conditions and avoids the contamination of the tube feed composition prior to its administration to the patient. [0082] In one embodiment the device comprises a coupling link.
  • the colorant may be transferred from the device to the tube feed composition by the application of force.
  • the force is applied to the piston of the syringe to transfer the colorant comprised in the syringe to the compartment comprising the tube feed composition, preferably through a needle.
  • the force may also be applied to the devise, for example in case the device is a pouch, a bag or a capsule, to transfer the at least one colorant comprised in the device to the tube feed composition comprised in the compartment, optionally through a connector or a coupling link.
  • the force may also be applied to the compartment, the device or to both, to allow for a mixing of the colorant comprised in the device and the tube feed composition comprised in the compartment.
  • the force may be applied to the compartment and the device stepwise or simultaneously.
  • the at least one colorant is transferred from the device to the tube feed composition through a needle, preferably through a septum comprised in the compartment.
  • the septum is preferably comprised in a connector comprised in the compartment.
  • the device is a syringe and the colorant is transferred from the device to the tube feed composition through a needle, preferably through a septum comprised in the compartment.
  • the septum is preferably comprised in a connector comprised in the compartment.
  • kits for the administration of at least one colorant into a tube feed composition as described under this section. Preparation of a colored tube feed.
  • the present invention also relates to a method for preparing a colored tube feed composition
  • a method for preparing a colored tube feed composition comprising the steps of a) providing a first compartment comprising a tube feed composition, b) providing a second compartment comprising at least one colorant selected from the group consisting of copper complexes of chlorophyllins, copper complexes of chlorophylls, vegetable charcoal, anthocyanins, spirulina, and mixtures thereof, c) transferring the at least one colorant from the second compartment to the first compartment, optionally by means of a third compartment, to allow a mixing of the at least one colorant with the tube feed composition to obtain a colored tube feed composition, optionally, the colored tube feed composition obtained in step c) is administered to a patient.
  • the second compartment is a syringe and the at least one colorant is transferred from the second compartment to the tube feed composition comprised in the first compartment through a needle, preferably through a septum comprised in the first compartment.
  • the septum is preferably comprised in a connector comprised in the first compartment.
  • the at least one colorant comprised in the second compartment is transferred in a first step from the second compartment to a third compartment comprised in a syringe through a needle injected in a septum comprised in a connector comprised in the second compartment.
  • the colorant is transferred from the third compartment to the first compartment through a needle injected in a septum comprised in a connector comprised in the first compartment.
  • the colorant comprised in the second compartment is transferred to the tube feed composition comprised in the first compartment through a seal by the application of force, wherein the first and the second compartment are positioned within a multi chamber bag.
  • Figure 1 shows a first embodiment of the present invention.
  • the kit comprises a first compartment 1 comprising a tube feed composition and a connector 11, a syringe 40 comprising the second compartment 2 comprising at least one colorant.
  • the at least one colorant can be transferred from the second compartment 2 to the first compartment 1 comprising the tube feed composition through a needle 41 by injecting the needle 41 through the connector 11.
  • the kit is included in a secondary packaging 100.
  • FIG. 2 shows another embodiment of the present invention.
  • the kit comprises a first compartment 1 comprising a connector 11 and a tube feed composition, a second compartment 2 comprising a connector 21 and at least one colorant, and a syringe 40 comprising a third compartment 3.
  • the at least one colorant can be transferred in a first step from the second compartment 2 to the third compartment 3 through the needle 41 by injecting the needle 41 through the connector 21.
  • the at least one colorant can be transferred in a second step from the third compartment 3 to the first compartment 1 comprising the tube feed composition through the needle 41, by injecting the needle 41 through the connector 11.
  • the kit is included in a secondary packaging 100.
  • Figures 3a) and 3b) show kits, in which the first compartment 1 comprising the tube feed composition and the second compartment 2 comprising the at least one colorant are placed inside one container 60.
  • the first 1 and the second compartment 2 are separated by a seal 50.
  • the at least one colorant comprised in the second compartment 2 can be transferred to the first compartment 1 comprising the tube feed composition by the application of force.
  • the force is applied to the first compartment 1, the second compartment 2 or to both, to break the seal 50 and allow for a mixing of the at least one colorant comprised in the second compartment 2 and the tube feed composition comprised in the first compartment 1.
  • the force may be applied to both compartments stepwise or simultaneously.
  • the kits are included in a secondary packaging 100.
  • a set of colorants was investigated for coloring properties, pH-stability and stability in the presence of secretions from the Gl tract.
  • Marine Blue Marine Blue L-WS (SENSIENT Colors Europe GmbH, Product number 419174.
  • Carbon Black L-WS (E153) (SENSIENT Colors Europe GmbH, Product number 409208).
  • Anthocyanin L-WS (E163) (SENSIENT Colors Europe GmbH, Product number 409291).
  • Green Plant Extract (E140) (SENSIENT Colors Europe GmbH, Product number 409290).
  • Example la Coloring of Reconvan ® :
  • Example lb Coloring of Diben ® :
  • Table Elb Results coloring and pH-stability testing of Diben ® :
  • Example 2 Stability against Gl secretions [0101] Copper Chlorophyllin(E141(ii)), Marine Blue, Carbon Black (E153) and Anthocyanin (E163) were investigated for stability against secretions from the Gl tract. Riboflavin (E1011) and Green Plant Extract were not further investigated due to their insufficient coloring properties as demonstrated in example lb. The following secretions were used:
  • Gastric enzyme solution consisting of:
  • Bile
  • Pancreatic enzyme solution consisting of:
  • Small intestine electrolyte concentrate 25 x concentrated SIES
  • 1250 g NaCI Honeywell S9888 or comparable
  • Copper Chlorophyllin, Carbon Black and Anthocyanin are stable against all the tested secretions from the Gl tract, whereas Marine Blue is not stable against Bile and pancreatic enzymes.
  • Example 3 Stability in a dynamic in vitro test (TIM-1 model)
  • Copper Chlorophyllin ( E141(ii ) was tested for its stability against secretion from the Gl tract during the digestion process in the dynamic in vitro test.
  • the TIM-1 model is an established model for the in vitro investigation of the stability of samples against Gl secretions, which is in detail described in the following publications:
  • the starting volume of the gastric compartment comprises a total of 300 g, whereof 100 g were the colored tube feed.
  • the samples were visually inspected for color appearance. Furthermore, the dialyzed samples of jejunum and ilieum were analyzed for color absorbance by means of a UV-spectrometer (Biospectrometer kinetic, Eppendorf). The samples were scanned in the wavelength range of 250-700 nm. Additionally, all samples were analyzed by using a colorimeter (Hunterlab). Copper-Chlorophyllin showed an absorption maximum in a wavelength range between 530-560 nm.

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  • Polymers & Plastics (AREA)
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  • Food Science & Technology (AREA)
  • Pharmacology & Pharmacy (AREA)
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  • General Health & Medical Sciences (AREA)
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  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

La présente invention concerne un kit de coloration de compositions d'alimentation par sonde comprenant un aliment pour alimentation par sonde et un colorant, un dispositif pour l'administration d'un colorant dans une composition d'alimentation par sonde et un procédé de préparation d'une composition d'alimentation par sonde colorée.
EP21739062.4A 2020-07-02 2021-06-30 Kit de coloration d'aliments pour alimentation par sonde Pending EP4175491A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP20183725 2020-07-02
PCT/EP2021/068007 WO2022003027A1 (fr) 2020-07-02 2021-06-30 Kit de coloration d'aliments pour alimentation par sonde

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EP4175491A1 true EP4175491A1 (fr) 2023-05-10

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Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5531682A (en) * 1995-01-13 1996-07-02 Abbott Laboratories Apparatus for adding marker dye to nutritional product during enternal tube feeding
US20030006159A1 (en) * 1999-09-01 2003-01-09 Jorgen Thorball Additive tube for enteral nutrition apparatus
EP1621177A1 (fr) 2004-07-29 2006-02-01 Fresenius Kabi Deutschland GmbH Récéptacle médical avec un scellement détachable amélioré
JP5902815B2 (ja) * 2012-07-25 2016-04-13 テルモ株式会社 酸性液状栄養剤
WO2015052209A1 (fr) 2013-10-09 2015-04-16 Fresenius Kabi Deutschland Gmbh Contenant destiné à recevoir un liquide nutritif ou pharmaceutique et procédé de fabrication d'un contenant destiné à recevoir un liquide nutritif ou pharmaceutique

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