CO6220903A2 - Composiciones que comprenden una pluralidad de particulas, cada una de las cuales comprende una enzima digestiva que contiene un nucleo recubierto con por lo menos un polimero enterico y un agente alcalinizante - Google Patents

Composiciones que comprenden una pluralidad de particulas, cada una de las cuales comprende una enzima digestiva que contiene un nucleo recubierto con por lo menos un polimero enterico y un agente alcalinizante

Info

Publication number
CO6220903A2
CO6220903A2 CO09101677A CO09101677A CO6220903A2 CO 6220903 A2 CO6220903 A2 CO 6220903A2 CO 09101677 A CO09101677 A CO 09101677A CO 09101677 A CO09101677 A CO 09101677A CO 6220903 A2 CO6220903 A2 CO 6220903A2
Authority
CO
Colombia
Prior art keywords
composition
lipase
digestive enzyme
mixtures
pharmaceutically acceptable
Prior art date
Application number
CO09101677A
Other languages
English (en)
Inventor
Giovanni Ortenzi
Marco Marconi
Luigi Mapelli
Original Assignee
Eurand Pharmaceuticals Ltd
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 Eurand Pharmaceuticals Ltd filed Critical Eurand Pharmaceuticals Ltd
Publication of CO6220903A2 publication Critical patent/CO6220903A2/es

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/465—Hydrolases (3) acting on ester bonds (3.1), e.g. lipases, ribonucleases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/47—Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482—Serine endopeptidases (3.4.21)
    • A61K38/4826—Trypsin (3.4.21.4) Chymotrypsin (3.4.21.1)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/501—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5015—Organic compounds, e.g. fats, sugars
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/12—Antidiarrhoeals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/18—Drugs for disorders of the alimentary tract or the digestive system for pancreatic disorders, e.g. pancreatic enzymes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y301/00—Hydrolases acting on ester bonds (3.1)
    • C12Y301/01—Carboxylic ester hydrolases (3.1.1)
    • C12Y301/01003—Triacylglycerol lipase (3.1.1.3)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2813—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Abstract

1.- Una composición que comprende por lo menos una enzima digestiva, en donde la composición tiene un contenido de humedad de aproximadamente 3% o menos. 2.- La composición de la reivindicación 1, en donde el contenido de humedad es aproximadamente 2% o menos. 3.- La composición de la reivindicación 1, en donde la por lo menos una enzima digestiva se selecciona del grupo que consiste de pancrelipasa, lipasa, tripsina, quimiotripsina, quimiotripsina B, pancreatopeptidasa, carboxipeptidasa A, carboxipeptidasa B, éster de glicerol hidrolasa, fosfolipasa, fosfolipasa A2, éster de esterol hidrolasa, ribonucleasa, desoxiribonucleasa, a-amilasa, papaína, chimopapaína, bromelaína, ficina, ß-amilasa, celulasa, ß-Galactosidasa, y mezclas de las mismas. 4.- La composición de la reivindicación 3, en donde la por o menos una enzima digestiva es una lipasa. 5.- La composición de la reivindicación 3, en donde la por lo menos una enzima digestiva es pancrelipasa. 6.- La composición de la reivindicación 4, en donde la lipasa es lipasa animal, lipasa bacteriana, lipasa fúngica, lipasa vegetal, lipasa recombinante, lipasa sintética, lipasa modificada químicamente, o mezclas de las mismas. 7.- La composición de la reivindicación 1 que comprende adicionalmente por lo menos un excipiente farmacéuticamente aceptable. 8.- La composición de la reivindicación 7, en donde el por lo menos un excipiente farmacéuticamente aceptable se selecciona del grupo que consiste de un aglutinante, desintegrante, lubricante, deslizante, diluyente, y mezclas de los mismos. 9.- La composición de la reivindicación 7, en donde el por lo menos un excipiente farmacéuticamente aceptable es por lo menos un estabilizador seleccionado del grupo que consiste de trehalosa, prolina, dextrano, maltosa, sacarosa, manitol, polioles, gel de sílice, aminoguanidina, piridoxamina, y mezclas de los mismos. 10.- La composición de la reivindicación 7, en donde el por lo menos un excipiente farmacéuticamente aceptable es por lo menos un aglutinante seleccionado del grupo que consiste de almidones, azúcares, lactosa, sus alcoholes de azúcar, un xilitol, sorbitol, maltitol, celulosa, celulosa microcristalina, celulosas modificadas, hidroxipropilcelulosa, carboximetilcelulosa de sodio, ácido algínico, y polivinilpirrolidona.
CO09101677A 2007-02-20 2009-09-18 Composiciones que comprenden una pluralidad de particulas, cada una de las cuales comprende una enzima digestiva que contiene un nucleo recubierto con por lo menos un polimero enterico y un agente alcalinizante CO6220903A2 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US90209207P 2007-02-20 2007-02-20
US90209307P 2007-02-20 2007-02-20
US90209107P 2007-02-20 2007-02-20

Publications (1)

Publication Number Publication Date
CO6220903A2 true CO6220903A2 (es) 2010-11-19

Family

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CO09101677A CO6220903A2 (es) 2007-02-20 2009-09-18 Composiciones que comprenden una pluralidad de particulas, cada una de las cuales comprende una enzima digestiva que contiene un nucleo recubierto con por lo menos un polimero enterico y un agente alcalinizante

Country Status (27)

Country Link
US (9) US8221747B2 (es)
EP (2) EP2079445B1 (es)
JP (2) JP5966202B2 (es)
KR (2) KR101670016B1 (es)
CN (2) CN101686943B (es)
AR (1) AR065405A1 (es)
AU (1) AU2008218595B2 (es)
BR (1) BRPI0807718B1 (es)
CA (1) CA2677989C (es)
CL (1) CL2008000517A1 (es)
CO (1) CO6220903A2 (es)
CR (2) CR11031A (es)
DK (1) DK2079445T3 (es)
ES (2) ES2674681T3 (es)
HK (1) HK1142818A1 (es)
HU (1) HUE026168T2 (es)
IL (1) IL200407A (es)
MX (1) MX2009008828A (es)
MY (1) MY163469A (es)
NZ (2) NZ598477A (es)
PL (1) PL2079445T3 (es)
PT (1) PT2079445E (es)
SG (1) SG186648A1 (es)
TR (1) TR201808840T4 (es)
TW (2) TWI421090B (es)
WO (1) WO2008102264A2 (es)
ZA (1) ZA200905630B (es)

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