WO2020043749A1 - New delivery system - Google Patents

New delivery system Download PDF

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Publication number
WO2020043749A1
WO2020043749A1 PCT/EP2019/072897 EP2019072897W WO2020043749A1 WO 2020043749 A1 WO2020043749 A1 WO 2020043749A1 EP 2019072897 W EP2019072897 W EP 2019072897W WO 2020043749 A1 WO2020043749 A1 WO 2020043749A1
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WO
WIPO (PCT)
Prior art keywords
delivery system
enzyme
fatty acids
core
chosen
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/EP2019/072897
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French (fr)
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WO2020043749A8 (en
Inventor
Elger Funda
Odile KRAINZ
Guenter PAPPENBERGER
Robert STEINERT
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DSM IP Assets BV
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DSM IP Assets BV
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Publication of WO2020043749A1 publication Critical patent/WO2020043749A1/en
Anticipated expiration legal-status Critical
Publication of WO2020043749A8 publication Critical patent/WO2020043749A8/en
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Classifications

    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23K—FODDER
    • A23K40/00—Shaping or working-up of animal feeding-stuffs
    • A23K40/30—Shaping or working-up of animal feeding-stuffs by encapsulating; by coating
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23K—FODDER
    • A23K20/00—Accessory food factors for animal feeding-stuffs
    • A23K20/10—Organic substances
    • A23K20/163—Sugars; Polysaccharides
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23K—FODDER
    • A23K20/00—Accessory food factors for animal feeding-stuffs
    • A23K20/10—Organic substances
    • A23K20/189—Enzymes

Definitions

  • the present invention relates to a new delivery system of enzymes (especially in the field of animal nutrition). Enzymes are i.e. useful for gut and metabolic health in animals (such as swine and poultry as well as fish), as well as in humans.
  • Enzymes serve a wide variety of functions inside living organisms. They are indispensable for signal transduction and cell regulation, often via kinases and phosphatases. They also generate movement, with myosin hydrolyzing ATP to generate muscle contraction, and transport cargo around the cell as part of the cytoskeleton. Other ATPases in the cell membrane are ion pumps involved in active transport.
  • Enzymes such as amylases and proteases break down large molecules (starch or proteins, respectively) into smaller ones, so they can be absorbed by the intestines.
  • Starch molecules for exam- pie, are too large to be absorbed from the intestine, but enzymes hydrolyze the starch chains into smaller molecules such as maltose and eventually glucose, which can then be absorbed.
  • Different enzymes digest different food substances. In ruminants, which have herbivorous diets, microorganisms in the gut produce another enzyme, cellulase, to break down the cellulose cell walls of plant fiber.
  • the goal of the present invention was to find an improved multiparticulate delivery system (formulation) to improve the stability of enzymes during the transport through the stomach so that the availability in the intestine and the efficacy of the nutraceuticals are improved.
  • the new delivery system should be producible in a simple and industrial ap- plicable way. It was found that when a core comprising at least one enzyme is coated with a specific inner and a specific outer coating, then the delivery system has improved properties. Fur- thermore, the delivery system can be produced in bath-wise as well as in by continuous process.
  • the new delivery system (DS) according to the present invention consists of
  • the core of the delivery system of the present invention does only comprise at least one enzyme as an active ingredient.
  • Other ingredients which are auxiliary ingredients, which are used to formulate the core are also present.
  • the core of the delivery system according to the present invention is free of any nutraceu- ticals.
  • nutraceuticals are organic acids, water soluble vitamins (especially B-vita- mins), omega 3 fatty acids, omega 6 fatty acids, omega 8 fatty acids, long chain fatty acids, polyphenols (such as resveratrol or genistein), prebiotics, probiotics, essential oils, and antimicrobial peptides.
  • the invention is also related to a delivery system (DS1 ), which is delivery system (DS), wherein the core only comprises at least one enzyme as an active ingredient.
  • DS1 delivery system
  • DS delivery system
  • the invention is also related to a delivery system (DS2), which is delivery system (DS) or (DS1 ), wherein the core also comprises auxiliary ingredients, which are used to formulate the core.
  • DS2 delivery system
  • DS1 delivery system
  • auxiliary ingredients which are used to formulate the core.
  • the invention is also related to a delivery system (DS3), which is delivery system (DS), (DS1 ) or (DS2), wherein the core is free of any nutraceuticals.
  • DS3 delivery system
  • DS1 delivery system
  • DS2 delivery system
  • the invention is also related to a delivery system (DS3’), which is delivery system (DS3), wherein the nutraceuticals are those chosen from the group consisting of organic acids, water soluble vitamins (especially B-vitamins), omega 3 fatty acids, omega 6 fatty acids, omega 8 fatty acids, long chain fatty acids, polyphenols (such as resveratrol or genistein), prebiotics, probiotics, essential oils, and antimicrobial peptides.
  • the core comprises at least one enzyme.
  • Enzymes can be classified based on the handbook Enzyme Nomenclature from NC- IUBMB, 1992), see also the ENZYME site at the internet: http://www.expasy.ch/enzyme/.
  • ENZYME is a repository of information relative to the nomenclature of enzymes. It is pri marily based on the recommendations of the Nomenclature Committee of the International Union of Biochemistry and Molecular Biology (IUB-MB), Academic Press, Inc., 1992, and it describes each type of characterized enzyme for which an EC (Enzyme Commission) number has been provided (Bairoch A. The ENZYME database, 2000, Nucleic Acids Res 28:304-305).
  • This IUB-MB Enzyme nomenclature is based on their substrate specificity and occasionally on their molecular mechanism; such a classification does not reflect the structural features of these enzymes.
  • Another classification of certain glycoside hydrolase enzymes, such as endoglucanase, xylanase, galactanase, mannanase, dextranase, lyso- zyme and galactosidase is described in Henrissat et al,“The carbohydrate-active enzymes database (CAZy) in 2013”, Nucl. Acids Res. (1 January 2014) 42 (D1 ): D490-D495; see also www.cazy.org.
  • Feed enzymes catalyze chemical processes that convert nutrients into energy and new tissue. They do this by binding to substrates in the feed and breaking them down into smaller compounds. Feed enzymes can be classified by the type of sub- strate. For instance: proteases break down proteins into amino acids, carbohydrases split carbohydrates into simple sugars, and lipases take apart lipids into fatty acids and glyc- erol.
  • enzymes can be derived from plants and animals (e.g., actinidin from kiwi and rennet from calf stomachs) as well as microorganisms (e.g., amylase from Bacillus and lactase from Aspergillus).
  • plants and animals e.g., actinidin from kiwi and rennet from calf stomachs
  • microorganisms e.g., amylase from Bacillus and lactase from Aspergillus.
  • other industries that utilize enzymes include the brewing, dairy, paper, biofuel, and rubber industries.
  • composition of the invention may comprise an enzyme having phytase activity.
  • phytase activity means the hydrolysis of phytate (myo-inositol hexakisphosphate) to (1 ) myo-inositol and/or (2) mono-, di-, tri-, tetra- and/or penta-phosphates thereof and (3) inorganic phosphate.
  • phytases According to the ENZYME site (http://www.expasy.ch/enzyme/), three different types of phytases are known: the 3-phytase (alternative name 1 -phytase; a myo-inositol hexaphosphate 3-phosphohydrolase, EC 3.1.3.8), the 4-phytase (alternative name 6-phytase, name based on 1 L-numbering system and not 1 D-numbering, EC 3.1.3.26), and the 5-phytase (EC 3.1 .3.72). For the purposes of the present invention, all three types are included in the definition of phytase.
  • composition of the invention may also comprise an enzyme selected from the group comprising of xylanase (EC 3.2.1.8); galactanase (EC 3.2.1.89); alpha-galactosidase (EC 3.2.1.22); protease (EC 3.4); phospholipase A1 (EC 3.1 .1 .32); phospholipase A2 (EC
  • amylase such as, for example, alpha-amylase (EC 3.2.1.1 ); arabinofuranosidase (EC 3.2.1 .55); beta-xylosidase (EC 3.2.1.37); acetyl xylan esterase (EC 3.1.1.72); feruloyl esterase (EC 3.1.1.73); cellulase (EC 3.2.1.4); cellobiohydrolases (EC 3.2.1.91 ); beta-glu- cosidase (EC 3.2.1 .21 ); pullulanase (EC 3.2.1.41 ), alpha-mannosidase (EC 3.2.1 .24), mannanase (EC 3.2.1.25) and beta-glucanase (EC 3.2.1 .4 or EC 3.2.1 .6).
  • alpha-amylase EC 3.2.1.1
  • arabinofuranosidase EC 3.2.1 .55
  • beta-xylosidase EC 3.2.1.37
  • Preferred enzymes are phytase, xylanase, galactanase, alpha-galactosidase and prote- ase.
  • the invention is also related to a delivery system (DS4), which is delivery system (DS), (DS1 ), (DS2), (DS3) or (DS3’), wherein the at least one enzyme is chosen from the group consisting of phytase, xylanase, galactanase, alpha-galactosidase and protease.
  • DS4 delivery system
  • DS1 delivery system
  • DS2 delivery system
  • DS3 DS3
  • the at least one enzyme is chosen from the group consisting of phytase, xylanase, galactanase, alpha-galactosidase and protease.
  • the delivery system according to the present invention comprises an inner coating, which needs to fulfill the criteria as defined.
  • Suitable materials for the inner coating are for example alginate, chitosan, pectin, cyclodextrin as well as other gums.
  • Preferred coating materials for the inner coating are alginate or pectin.
  • the inner coating is crosslinked. This can be done by commonly known crosslinking corn- pounds. In case alginate is used that can be done by Na and/or Ca ion (by the use of a salt).
  • the crosslinker can be spray onto to core after having applied the inner coating or simultaneously. Or the coated particles can be dipped into a solution comprising the cross- linker. Preferably the crosslinker is sprayed onto the particles after having applies the inner coat- ing layer.
  • Another advantage of the present invention also lies therein that the production of the new delivery system according to the present invention can be done batch-wise as well as continuously. In contrast to the systems known from the prior art this is a huge advantage also in view of the industrial production of such product. The details of the process are disclosed below.
  • the present invention relates to a delivery system (DS5), which is the delivery system (DS), (DS1 ), (DS2), (DS3), (DS3’) or (DS4), wherein the material of the inner coat- ing is chosen from group consisting of alginate, chitosan, pectin, cyclodextrin as well as other gums.
  • the present invention relates to a delivery system (DS5’), which is the delivery system (DS5), wherein the material of the inner coating is alginate or pectin.
  • the inner coating layer is covering the core (more or less) completely. Ideally the (layer of the inner coating has (more or less) the same thickness when applied on the core.
  • the thickness of the inner coating layer is at least 5pm and not more than 20pm.
  • the thickness of the inner coating layer is between 5pm - 10pm.
  • the present invention relates to a delivery system (DS6), which is the delivery system (DS), (DS1 ), (DS2), (DS3), (DS3’), (DS4), (DS5) or (DS5’), wherein the thickness of the inner coating layer is 5pm - 10pm.
  • the inner coating layer is crosslinked with at least one crosslinking agent.
  • Any suitable crosslinker can be used. Very suitable (and therefore preferred are Na and Ca ions (they are added in form of a salt).
  • the present invention relates to a delivery system (DS7), which is the delivery system (DS), (DS1 ), (DS2), (DS3), (DS3’), (DS3”), (DS4), (DS5), (DS5’) or (DS6), wherein the inner coating layer is crosslinked with at least one crosslinking agent (preferably with Na and/or Ca ions).
  • DS7 is the delivery system (DS), (DS1 ), (DS2), (DS3), (DS3’), (DS3”), (DS4), (DS5), (DS5’) or (DS6), wherein the inner coating layer is crosslinked with at least one crosslinking agent (preferably with Na and/or Ca ions).
  • the present invention relates to a delivery system (DS8), which is the delivery system (DS), (DS1 ), (DS2), (DS3), (DS3’), (DS4), (DS5), (DS5’), (DS6) or (DS7), wherein the crosslinked inner coating layer Na alginate or Na pectin.
  • DS8 is the delivery system (DS), (DS1 ), (DS2), (DS3), (DS3’), (DS4), (DS5), (DS5’), (DS6) or (DS7), wherein the crosslinked inner coating layer Na alginate or Na pectin.
  • the delivery system according to the present invention comprises an outer coating, which needs to fulfill the criteria as defined.
  • Suitable materials which fulfill the criteria for the outer coating is for example shellac, methacrylate copolymers and fats.
  • the present invention relates to a delivery system (DS9), which is the delivery system (DS), (DS1 ), (DS2), (DS3), (DS3’), (DS4), (DS5), (DS5’), (DS6), (DS7) or (DS8), wherein the material of the inner coating is chosen from group consisting of shellac, meth- acrylate copolymers and fats.
  • the outer coating layer is covering the inner coating (more or less) completely. Ideally the layer of the outer coating has (more or less) the same thickness.
  • the thickness of the outer layer is at least 10pm and usually less than 30 pm.
  • the thickness of the inner coating layer is between 10 and 20pm.
  • the present invention relates to a delivery system (DS10), which is the delivery system (DS), (DS1 ), (DS2), (DS3), (DS3’), (DS4), (DS5), (DS5’), (DS6), (DS7), (DS8) or (DS9), wherein the thickness of the outer coating layer is 10pm - 20pm.
  • DS10 is the delivery system (DS), (DS1 ), (DS2), (DS3), (DS3’), (DS4), (DS5), (DS5’), (DS6), (DS7), (DS8) or (DS9), wherein the thickness of the outer coating layer is 10pm - 20pm.
  • the core of the delivery system according to the present invention is usually 10 - 85 wt- %, preferably 50 - 75 wt-%, based on the total weight of the delivery system.
  • the present invention relates to a delivery system (DS1 1 ), which is the delivery system (DS), (DS1 ), (DS2), (DS3), (DS3’), (DS4), (DS5), (DS5’), (DS6), (DS7), (DS8), (DS9) or (DS10), wherein the core of the delivery system is 10 - 85 wt- %, preferably 50 - 75 wt-%, based on the total weight of the delivery system.
  • the inner coating of the delivery system according to the present invention is usually 1 - 20 wt- %, preferably 1 - 10 wt-%, based on the total weight of the delivery system.
  • the present invention relates to a delivery system (DS12), which is the delivery system (DS), (DS1 ), (DS2), (DS3), (DS3’), (DS4), (DS5), (DS5’), (DS6), (DS7), (DS8), (DS9), (DS10) or (DS1 1 ), wherein the inner coating of the delivery system is 10 - 85 wt- %, preferably 1 - 10 wt-%, based on the total weight of the delivery system.
  • the outer coating of the delivery system according to the present invention is usually 1 - 30 wt- %, preferably 15 - 30 wt-%, based on the total weight of the delivery system.
  • the present invention relates to a delivery system (DS13), which is the delivery system (DS), (DS1 ), (DS2), (DS3), (DS3’), (DS4), (DS5), (DS5’), (DS6), (DS7), (DS8), (DS9), (DS10), (DS1 1 ) or (DS12), wherein the outer coating of the delivery system is 1 - 30 wt- %, preferably 15 - 30 wt-%, based on the total weight of the delivery system
  • the delivery system according to the present invention can be up to 2mm in size.
  • the size is defined by the longest diameter of the particle.
  • the shape of the particle is not an es- sential feature of the present invention.
  • the size distribution of the particles is no essential.
  • the size and the shape of the particle is mainly defined by the core of the deliv- ery system. Depending on the use of the delivery system the size can be adjusted.
  • the delivery system according to the present invention is produced by commonly known technology.
  • the core is produced in a first step and then the inner and outer coatings are ap- plied.
  • the enzyme of the invention is formulated into a solid core.
  • the core can comprise one or more auxiliary ingredients, which are useful to formulate the core.
  • Such auxiliary ingredients can be a salt (organic or inorganic zinc, sodium, potassium or calcium salts such as e.g. such as calcium acetate, calcium benzoate, calcium carbonate, calcium chloride, calcium citrate, calcium sorbate, calcium sulfate, potassium acetate, po- tassium benzoate, potassium carbonate, potassium chloride, potassium citrate, potassium sorbate, potassium sulfate, sodium acetate, sodium benzoate, sodium carbonate, sodium chloride, sodium citrate, sodium sulfate, zinc acetate, zinc benzoate, zinc carbonate, zinc chloride, zinc citrate, zinc sorbate, zinc sulfate), starch or a sugar or sugar derivative (such as e.g. sucrose, dextrin, glucose, lactose, sorbitol), small organic molecules, flour, cellu- lose and minerals.
  • a sugar or sugar derivative such as e.g. sucrose, dextrin, glucose, lactose, sorbi
  • the present invention also related to a process of production (P) of any of the particles (DS), (DS1 ), (DS2), (DS3), (DS3’), (DS4), (DS5), (DS5’), (DS6), (DS7), (DS8), (DS9), (DS10), (DS1 1 ), (DS12) or (DS13), wherein the process is carried out batch wise.
  • the present invention also related to a process of production (P1 ) of any of the particles (DS), (DS1 ), (DS2), (DS3), (DS3”), (DS4), (DS5), (DS5’), (DS6), (DS7), (DS8), (DS9), (DS10), (DS1 1 ), (DS12) or (DS13), wherein the process is carried out continuously.
  • the new delivery systems (DS), (DS1 ), (DS2), (DS3), (DS3’), (DS3”), (DS4), (DS5), (DS5’), (DS6), (DS7), (DS8), (DS9), (DS10), (DS1 1 ), (DS12) and/or (DS13) according to the present invention can be used as such or incorporated into application forms.
  • the new delivery systems (DS), (DS1 ), (DS2), (DS3), (DS3’), (DS4), (DS5), (DS5’), (DS6), (DS7), (DS8), (DS9), (DS10), (DS1 1 ), (DS12) and/or (DS13) can used in any feed product.
  • animal feed refers to all animals except humans.
  • animals are non- ruminants, and ruminants.
  • Ruminant animals include, for example, animals such as sheep, goats, cattle, e.g. beef cattle, cows, and young calves, deer, yank, camel, lama, and kangaroo.
  • Non-ruminant animals include mono-gastric animals, e.g.
  • pigs or swine including, but not limited to, piglets, growing pigs, and sows
  • poultry such as turkeys, ducks and chicken (including but not limited to broiler chicks, layers); horses (including but not limited to hotbloods, coldbloods and warm bloods), young calves; fish (including but not limited to amberjack, arapaima, barb, bass, bluefish, bocachico, bream, bullhead, cachama, carp, catfish, catla, chanos, char, cichlid, cobia, cod, crappie, dorada, drum, eel, goby, goldfish, gourami, grouper, guapote, halibut, java, labeo, lai, loach, mackerel, milk- fish, mojarra, mudfish, mullet, paco, pearlspot, pejerrey, perch, pike, pompano, roach, salmon, sampa, sauger, sea
  • animal feed refers to any compound, preparation, or mixture suitable for, or intended for intake by an animal.
  • Animal feed for a mono-gastric animal typically corn- prises concentrates as well as vitamins, minerals, enzymes, direct fed microbial, amino acids and/or other feed ingredients (such as in a premix) whereas animal feed for rumi- nants generally comprises forage (including roughage and silage) and may further corn- prise concentrates as well as vitamins, minerals, enzymes direct fed microbial, amino acid and/or other feed ingredients (such as in a premix).
  • the new delivery systems (DS), (DS1 ), (DS2), (DS3), (DS3’), (DS4), (DS5), (DS5’), (DS6), (DS7), (DS8), (DS9), (DS10), (DS1 1 ), (DS12) and/or (DS13) can also be part of a premix formulation, which can then be used to formulate any feed product.
  • the invention also relates to a process for the production of a premix or a feed product using at least one delivery systems (DS), (DS1 ), (DS2), (DS3), (DS3’), (DS4), (DS5), (DS5’), (DS6), (DS7), (DS8), (DS9), (DS10), (DS1 1 ), (DS12) or (DS13).
  • DS delivery systems
  • the invention also relates to a premix, or a feed product comprising at least one delivery systems (DS), (DS1 ), (DS2), (DS3), (DS3’), (DS4), (DS5), (DS5’), (DS6), (DS7), (DS8), (DS9), (DS10), (DS1 1 ), (DS12) or (DS13).
  • DS delivery systems

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  • Chemical & Material Sciences (AREA)
  • Polymers & Plastics (AREA)
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  • Engineering & Computer Science (AREA)
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Abstract

The present invention relates to a new delivery system for enzymes.

Description

New Delivery System
The present invention relates to a new delivery system of enzymes (especially in the field of animal nutrition). Enzymes are i.e. useful for gut and metabolic health in animals (such as swine and poultry as well as fish), as well as in humans.
Enzymes serve a wide variety of functions inside living organisms. They are indispensable for signal transduction and cell regulation, often via kinases and phosphatases. They also generate movement, with myosin hydrolyzing ATP to generate muscle contraction, and transport cargo around the cell as part of the cytoskeleton. Other ATPases in the cell membrane are ion pumps involved in active transport.
An important function of enzymes is in the digestive systems of animals. Enzymes such as amylases and proteases break down large molecules (starch or proteins, respectively) into smaller ones, so they can be absorbed by the intestines. Starch molecules, for exam- pie, are too large to be absorbed from the intestine, but enzymes hydrolyze the starch chains into smaller molecules such as maltose and eventually glucose, which can then be absorbed. Different enzymes digest different food substances. In ruminants, which have herbivorous diets, microorganisms in the gut produce another enzyme, cellulase, to break down the cellulose cell walls of plant fiber.
Due to the importance of the enzymes in the digestive systems of animals, there is always a need for formulation comprising enzymes.
Now the goal of the present invention was to find an improved multiparticulate delivery system (formulation) to improve the stability of enzymes during the transport through the stomach so that the availability in the intestine and the efficacy of the nutraceuticals are improved.
Furthermore, the new delivery system should be producible in a simple and industrial ap- plicable way. It was found that when a core comprising at least one enzyme is coated with a specific inner and a specific outer coating, then the delivery system has improved properties. Fur- thermore, the delivery system can be produced in bath-wise as well as in by continuous process.
The new delivery system (DS) according to the present invention consists of
(a) a core, which comprises at least one enzyme, and
(b) an inner coating comprising at least one fermentable biopolymer, which is crosslinked, and
(c) an outer coating which is resistant to stomach conditions.
The core of the delivery system of the present invention does only comprise at least one enzyme as an active ingredient. Other ingredients (which are auxiliary ingredients), which are used to formulate the core are also present.
The core of the delivery system according to the present invention is free of any nutraceu- ticals. Such nutraceuticals are organic acids, water soluble vitamins (especially B-vita- mins), omega 3 fatty acids, omega 6 fatty acids, omega 8 fatty acids, long chain fatty acids, polyphenols (such as resveratrol or genistein), prebiotics, probiotics, essential oils, and antimicrobial peptides.
The invention is also related to a delivery system (DS1 ), which is delivery system (DS), wherein the core only comprises at least one enzyme as an active ingredient.
The invention is also related to a delivery system (DS2), which is delivery system (DS) or (DS1 ), wherein the core also comprises auxiliary ingredients, which are used to formulate the core.
The invention is also related to a delivery system (DS3), which is delivery system (DS), (DS1 ) or (DS2), wherein the core is free of any nutraceuticals.
The invention is also related to a delivery system (DS3’), which is delivery system (DS3), wherein the nutraceuticals are those chosen from the group consisting of organic acids, water soluble vitamins (especially B-vitamins), omega 3 fatty acids, omega 6 fatty acids, omega 8 fatty acids, long chain fatty acids, polyphenols (such as resveratrol or genistein), prebiotics, probiotics, essential oils, and antimicrobial peptides. The core comprises at least one enzyme.
Enzymes can be classified based on the handbook Enzyme Nomenclature from NC- IUBMB, 1992), see also the ENZYME site at the internet: http://www.expasy.ch/enzyme/. ENZYME is a repository of information relative to the nomenclature of enzymes. It is pri marily based on the recommendations of the Nomenclature Committee of the International Union of Biochemistry and Molecular Biology (IUB-MB), Academic Press, Inc., 1992, and it describes each type of characterized enzyme for which an EC (Enzyme Commission) number has been provided (Bairoch A. The ENZYME database, 2000, Nucleic Acids Res 28:304-305). This IUB-MB Enzyme nomenclature is based on their substrate specificity and occasionally on their molecular mechanism; such a classification does not reflect the structural features of these enzymes. Another classification of certain glycoside hydrolase enzymes, such as endoglucanase, xylanase, galactanase, mannanase, dextranase, lyso- zyme and galactosidase is described in Henrissat et al,“The carbohydrate-active enzymes database (CAZy) in 2013”, Nucl. Acids Res. (1 January 2014) 42 (D1 ): D490-D495; see also www.cazy.org.
Of particular interest are“Feed Enzymes”. To save on costs, many producers supplement feed with enzyme additives (Feed Enzymes”), which enable them to produce more meat per animal or to produce the same amount of meat cheaper and faster.
Found in all living cells, enzymes catalyze chemical processes that convert nutrients into energy and new tissue. They do this by binding to substrates in the feed and breaking them down into smaller compounds. Feed enzymes can be classified by the type of sub- strate. For instance: proteases break down proteins into amino acids, carbohydrases split carbohydrates into simple sugars, and lipases take apart lipids into fatty acids and glyc- erol.
Commercially-available enzymes can be derived from plants and animals (e.g., actinidin from kiwi and rennet from calf stomachs) as well as microorganisms (e.g., amylase from Bacillus and lactase from Aspergillus). Aside from agriculture, other industries that utilize enzymes include the brewing, dairy, paper, biofuel, and rubber industries.
The composition of the invention may comprise an enzyme having phytase activity. The term“phytase activity” means the hydrolysis of phytate (myo-inositol hexakisphosphate) to (1 ) myo-inositol and/or (2) mono-, di-, tri-, tetra- and/or penta-phosphates thereof and (3) inorganic phosphate. According to the ENZYME site (http://www.expasy.ch/enzyme/), three different types of phytases are known: the 3-phytase (alternative name 1 -phytase; a myo-inositol hexaphosphate 3-phosphohydrolase, EC 3.1.3.8), the 4-phytase (alternative name 6-phytase, name based on 1 L-numbering system and not 1 D-numbering, EC 3.1.3.26), and the 5-phytase (EC 3.1 .3.72). For the purposes of the present invention, all three types are included in the definition of phytase.
The composition of the invention may also comprise an enzyme selected from the group comprising of xylanase (EC 3.2.1.8); galactanase (EC 3.2.1.89); alpha-galactosidase (EC 3.2.1.22); protease (EC 3.4); phospholipase A1 (EC 3.1 .1 .32); phospholipase A2 (EC
3.1 .1.4); lysophospholipase (EC 3.1 .1.5); phospholipase C (3.1.4.3); phospholipase D (EC
3.1 .4.4); amylase such as, for example, alpha-amylase (EC 3.2.1.1 ); arabinofuranosidase (EC 3.2.1 .55); beta-xylosidase (EC 3.2.1.37); acetyl xylan esterase (EC 3.1.1.72); feruloyl esterase (EC 3.1.1.73); cellulase (EC 3.2.1.4); cellobiohydrolases (EC 3.2.1.91 ); beta-glu- cosidase (EC 3.2.1 .21 ); pullulanase (EC 3.2.1.41 ), alpha-mannosidase (EC 3.2.1 .24), mannanase (EC 3.2.1.25) and beta-glucanase (EC 3.2.1 .4 or EC 3.2.1 .6).
Preferred enzymes are phytase, xylanase, galactanase, alpha-galactosidase and prote- ase.
The invention is also related to a delivery system (DS4), which is delivery system (DS), (DS1 ), (DS2), (DS3) or (DS3’), wherein the at least one enzyme is chosen from the group consisting of phytase, xylanase, galactanase, alpha-galactosidase and protease.
The delivery system according to the present invention comprises an inner coating, which needs to fulfill the criteria as defined. Suitable materials for the inner coating (fermentable biopolymer) are for example alginate, chitosan, pectin, cyclodextrin as well as other gums. Preferred coating materials for the inner coating are alginate or pectin.
The inner coating is crosslinked. This can be done by commonly known crosslinking corn- pounds. In case alginate is used that can be done by Na and/or Ca ion (by the use of a salt). The crosslinker can be spray onto to core after having applied the inner coating or simultaneously. Or the coated particles can be dipped into a solution comprising the cross- linker. Preferably the crosslinker is sprayed onto the particles after having applies the inner coat- ing layer.
Another advantage of the present invention also lies therein that the production of the new delivery system according to the present invention can be done batch-wise as well as continuously. In contrast to the systems known from the prior art this is a huge advantage also in view of the industrial production of such product. The details of the process are disclosed below.
Therefore, the present invention relates to a delivery system (DS5), which is the delivery system (DS), (DS1 ), (DS2), (DS3), (DS3’) or (DS4), wherein the material of the inner coat- ing is chosen from group consisting of alginate, chitosan, pectin, cyclodextrin as well as other gums.
Therefore, the present invention relates to a delivery system (DS5’), which is the delivery system (DS5), wherein the material of the inner coating is alginate or pectin.
The inner coating layer is covering the core (more or less) completely. Ideally the (layer of the inner coating has (more or less) the same thickness when applied on the core.
Usually the thickness of the inner coating layer is at least 5pm and not more than 20pm. Preferably, the thickness of the inner coating layer is between 5pm - 10pm.
Therefore, the present invention relates to a delivery system (DS6), which is the delivery system (DS), (DS1 ), (DS2), (DS3), (DS3’), (DS4), (DS5) or (DS5’), wherein the thickness of the inner coating layer is 5pm - 10pm.
The inner coating layer is crosslinked with at least one crosslinking agent. Any suitable crosslinker can be used. Very suitable (and therefore preferred are Na and Ca ions (they are added in form of a salt).
Therefore, the present invention relates to a delivery system (DS7), which is the delivery system (DS), (DS1 ), (DS2), (DS3), (DS3’), (DS3”), (DS4), (DS5), (DS5’) or (DS6), wherein the inner coating layer is crosslinked with at least one crosslinking agent (preferably with Na and/or Ca ions).
Therefore, the present invention relates to a delivery system (DS8), which is the delivery system (DS), (DS1 ), (DS2), (DS3), (DS3’), (DS4), (DS5), (DS5’), (DS6) or (DS7), wherein the crosslinked inner coating layer Na alginate or Na pectin.
The delivery system according to the present invention comprises an outer coating, which needs to fulfill the criteria as defined. Suitable materials which fulfill the criteria for the outer coating is for example shellac, methacrylate copolymers and fats.
Therefore, the present invention relates to a delivery system (DS9), which is the delivery system (DS), (DS1 ), (DS2), (DS3), (DS3’), (DS4), (DS5), (DS5’), (DS6), (DS7) or (DS8), wherein the material of the inner coating is chosen from group consisting of shellac, meth- acrylate copolymers and fats.
The outer coating layer is covering the inner coating (more or less) completely. Ideally the layer of the outer coating has (more or less) the same thickness.
Usually the thickness of the outer layer is at least 10pm and usually less than 30 pm. Preferably, the thickness of the inner coating layer is between 10 and 20pm.
Therefore, the present invention relates to a delivery system (DS10), which is the delivery system (DS), (DS1 ), (DS2), (DS3), (DS3’), (DS4), (DS5), (DS5’), (DS6), (DS7), (DS8) or (DS9), wherein the thickness of the outer coating layer is 10pm - 20pm.
The core of the delivery system according to the present invention is usually 10 - 85 wt- %, preferably 50 - 75 wt-%, based on the total weight of the delivery system.
Therefore, the present invention relates to a delivery system (DS1 1 ), which is the delivery system (DS), (DS1 ), (DS2), (DS3), (DS3’), (DS4), (DS5), (DS5’), (DS6), (DS7), (DS8), (DS9) or (DS10), wherein the core of the delivery system is 10 - 85 wt- %, preferably 50 - 75 wt-%, based on the total weight of the delivery system. The inner coating of the delivery system according to the present invention is usually 1 - 20 wt- %, preferably 1 - 10 wt-%, based on the total weight of the delivery system.
Therefore, the present invention relates to a delivery system (DS12), which is the delivery system (DS), (DS1 ), (DS2), (DS3), (DS3’), (DS4), (DS5), (DS5’), (DS6), (DS7), (DS8), (DS9), (DS10) or (DS1 1 ), wherein the inner coating of the delivery system is 10 - 85 wt- %, preferably 1 - 10 wt-%, based on the total weight of the delivery system.
The outer coating of the delivery system according to the present invention is usually 1 - 30 wt- %, preferably 15 - 30 wt-%, based on the total weight of the delivery system.
Therefore, the present invention relates to a delivery system (DS13), which is the delivery system (DS), (DS1 ), (DS2), (DS3), (DS3’), (DS4), (DS5), (DS5’), (DS6), (DS7), (DS8), (DS9), (DS10), (DS1 1 ) or (DS12), wherein the outer coating of the delivery system is 1 - 30 wt- %, preferably 15 - 30 wt-%, based on the total weight of the delivery system
The delivery system according to the present invention can be up to 2mm in size. The size is defined by the longest diameter of the particle. The shape of the particle is not an es- sential feature of the present invention. Also, the size distribution of the particles is no essential. The size and the shape of the particle is mainly defined by the core of the deliv- ery system. Depending on the use of the delivery system the size can be adjusted.
The delivery system according to the present invention is produced by commonly known technology.
Usually the core is produced in a first step and then the inner and outer coatings are ap- plied.
The enzyme of the invention is formulated into a solid core. As stated above the core can comprise one or more auxiliary ingredients, which are useful to formulate the core.
Such auxiliary ingredients can be a salt (organic or inorganic zinc, sodium, potassium or calcium salts such as e.g. such as calcium acetate, calcium benzoate, calcium carbonate, calcium chloride, calcium citrate, calcium sorbate, calcium sulfate, potassium acetate, po- tassium benzoate, potassium carbonate, potassium chloride, potassium citrate, potassium sorbate, potassium sulfate, sodium acetate, sodium benzoate, sodium carbonate, sodium chloride, sodium citrate, sodium sulfate, zinc acetate, zinc benzoate, zinc carbonate, zinc chloride, zinc citrate, zinc sorbate, zinc sulfate), starch or a sugar or sugar derivative (such as e.g. sucrose, dextrin, glucose, lactose, sorbitol), small organic molecules, flour, cellu- lose and minerals.
Therefore the present invention also related to a process of production (P) of any of the particles (DS), (DS1 ), (DS2), (DS3), (DS3’), (DS4), (DS5), (DS5’), (DS6), (DS7), (DS8), (DS9), (DS10), (DS1 1 ), (DS12) or (DS13), wherein the process is carried out batch wise.
Therefore the present invention also related to a process of production (P1 ) of any of the particles (DS), (DS1 ), (DS2), (DS3), (DS3”), (DS4), (DS5), (DS5’), (DS6), (DS7), (DS8), (DS9), (DS10), (DS1 1 ), (DS12) or (DS13), wherein the process is carried out continuously.
The new delivery systems (DS), (DS1 ), (DS2), (DS3), (DS3’), (DS3”), (DS4), (DS5), (DS5’), (DS6), (DS7), (DS8), (DS9), (DS10), (DS1 1 ), (DS12) and/or (DS13) according to the present invention can be used as such or incorporated into application forms.
The new delivery systems (DS), (DS1 ), (DS2), (DS3), (DS3’), (DS4), (DS5), (DS5’), (DS6), (DS7), (DS8), (DS9), (DS10), (DS1 1 ), (DS12) and/or (DS13) can used in any feed product.
The term“animal feed” refers to all animals except humans. Examples of animals are non- ruminants, and ruminants. Ruminant animals include, for example, animals such as sheep, goats, cattle, e.g. beef cattle, cows, and young calves, deer, yank, camel, lama, and kangaroo. Non-ruminant animals include mono-gastric animals, e.g. pigs or swine (including, but not limited to, piglets, growing pigs, and sows); poultry such as turkeys, ducks and chicken (including but not limited to broiler chicks, layers); horses (including but not limited to hotbloods, coldbloods and warm bloods), young calves; fish (including but not limited to amberjack, arapaima, barb, bass, bluefish, bocachico, bream, bullhead, cachama, carp, catfish, catla, chanos, char, cichlid, cobia, cod, crappie, dorada, drum, eel, goby, goldfish, gourami, grouper, guapote, halibut, java, labeo, lai, loach, mackerel, milk- fish, mojarra, mudfish, mullet, paco, pearlspot, pejerrey, perch, pike, pompano, roach, salmon, sampa, sauger, sea bass, seabream, shiner, sleeper, snakehead, snap-per, snook, sole, spinefoot, sturgeon, sunfish, sweetfish, tench, terror, tilapia, trout, tuna, tur- bot, vendace, walleye and whitefish); and crustaceans (including but not limited to shrimps and prawns).
The term“animal feed” refers to any compound, preparation, or mixture suitable for, or intended for intake by an animal. Animal feed for a mono-gastric animal typically corn- prises concentrates as well as vitamins, minerals, enzymes, direct fed microbial, amino acids and/or other feed ingredients (such as in a premix) whereas animal feed for rumi- nants generally comprises forage (including roughage and silage) and may further corn- prise concentrates as well as vitamins, minerals, enzymes direct fed microbial, amino acid and/or other feed ingredients (such as in a premix).
The new delivery systems (DS), (DS1 ), (DS2), (DS3), (DS3’), (DS4), (DS5), (DS5’), (DS6), (DS7), (DS8), (DS9), (DS10), (DS1 1 ), (DS12) and/or (DS13) can also be part of a premix formulation, which can then be used to formulate any feed product.
The invention also relates to a process for the production of a premix or a feed product using at least one delivery systems (DS), (DS1 ), (DS2), (DS3), (DS3’), (DS4), (DS5), (DS5’), (DS6), (DS7), (DS8), (DS9), (DS10), (DS1 1 ), (DS12) or (DS13).
The invention also relates to a premix, or a feed product comprising at least one delivery systems (DS), (DS1 ), (DS2), (DS3), (DS3’), (DS4), (DS5), (DS5’), (DS6), (DS7), (DS8), (DS9), (DS10), (DS1 1 ), (DS12) or (DS13).

Claims

Claims
1. Delivery system consisting of
(a) a core, which comprises at least one enzyme, and
(b) an inner coating comprising at least one fermentable biopolymer, which is crosslinked, and
(c) an outer coating which is resistant to stomach conditions and releasing in the intestine.
2. Delivery system according to claim 1 , wherein the core is free of any nutraceutical is chosen from the group consisting of organic acids, water soluble vitamins (es- pecially B-vitamins), omega 3 fatty acids, omega 6 fatty acids, omega 8 fatty acids, long chain fatty acids, polyphenols (such as resveratrol or genistein), prebiotics, probiotics, essential oils, or antimicrobial peptides.
3. Delivery system according to claim 1 or claim 2, wherein the enzyme is chosen from the group consisting of phytase, xylanase, galactanase, alpha-galactosidase and protease.
4. Delivery system according to anyone of the preceding claims, wherein the inner coating layer is chosen from group consisting of alginate, chitosan, pectin, cy- clodextrin as well as other gums and it is crosslinked with Na and/or Ca ions.
5. Delivery system according to anyone of the preceding claims, wherein the outer coating is chosen from group consisting of shellac, methacrylate copolymers and fats.
6. Process of production delivery systems according to any of the preceding claims, wherein the process is carried out batch wise.
7. Process of production delivery systems according to any of the preceding claims, 1 - 5, wherein the process is carried out continuously.
8. Process for the production of a premix or feed product using at least one delivery system according to any one of claims 1 - 5.
9. Premix or feed product comprising at least one delivery system according to claims 1 - 5.
PCT/EP2019/072897 2018-08-31 2019-08-28 New delivery system Ceased WO2020043749A1 (en)

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