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CO6640298A2 - Composiciones de microgranulados que comptenden pancreatina que contiene una mezcla de enzimas digestivas - Google Patents

Composiciones de microgranulados que comptenden pancreatina que contiene una mezcla de enzimas digestivas

Info

Publication number
CO6640298A2
CO6640298A2 CO12217880A CO12217880A CO6640298A2 CO 6640298 A2 CO6640298 A2 CO 6640298A2 CO 12217880 A CO12217880 A CO 12217880A CO 12217880 A CO12217880 A CO 12217880A CO 6640298 A2 CO6640298 A2 CO 6640298A2
Authority
CO
Colombia
Prior art keywords
composition
digestive enzymes
microgranulate
compositions
mixture
Prior art date
Application number
CO12217880A
Other languages
English (en)
Inventor
Gopi M Venkatesh
Craig Kramer
Flavio Fabiani
Luigi Mapelli
Giovanni Ortenzi
Original Assignee
Aptalis Pharma 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 Aptalis Pharma Ltd filed Critical Aptalis Pharma Ltd
Publication of CO6640298A2 publication Critical patent/CO6640298A2/es

Links

Classifications

    • 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
    • A61K9/5078—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 with drug-free core
    • 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)
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • 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
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • 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
    • A61K9/50—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
    • 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
    • A61K9/5089—Processes
    • 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
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Diabetes (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Zoology (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

La presente invención se refiere a una composición de tamaño pequeño de partículas que comprende enzimas digestivas que contienen pancreatina para utilizar en pacientes que lo necesitan, incluidos pacientes pediátricos, geriátricos y adultos, particularmente aquellos pacientes con disfagia o en donde la administración entérica utilizando dicha composición sería apropiada. Adicionalmente, la invención está dirigida a la composición en forma de partículas, tales como microgranulados o microgránulos que tienen alta potencia, alto rendimiento de uso y al menos 10% - 90% de 400-800 µm. Asimismo, la composición opcionalmente tiene un recubrimiento entérico mejorado y estabilidad y actividad enzimática concomitante mejorada en comparación con partículas de enzimas pancreáticas entéricamente recubiertas.
CO12217880A 2010-05-03 2012-11-30 Composiciones de microgranulados que comptenden pancreatina que contiene una mezcla de enzimas digestivas CO6640298A2 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US33076810P 2010-05-03 2010-05-03

Publications (1)

Publication Number Publication Date
CO6640298A2 true CO6640298A2 (es) 2013-03-22

Family

ID=44904036

Family Applications (1)

Application Number Title Priority Date Filing Date
CO12217880A CO6640298A2 (es) 2010-05-03 2012-11-30 Composiciones de microgranulados que comptenden pancreatina que contiene una mezcla de enzimas digestivas

Country Status (10)

Country Link
EP (1) EP2566466A1 (es)
JP (1) JP2013525488A (es)
CN (1) CN102946872A (es)
AU (1) AU2011248293A1 (es)
CA (1) CA2798280A1 (es)
CO (1) CO6640298A2 (es)
IL (1) IL222796A0 (es)
MX (1) MX2012012794A (es)
RU (1) RU2012148776A (es)
WO (1) WO2011140106A1 (es)

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2915671A1 (en) * 2013-11-05 2015-05-14 Aptalis Pharma Ltd. High potency pancreatin pharmaceutical compositions
MX2017004473A (es) * 2014-10-08 2017-10-12 Synthetic Biologics Inc Formulaciones de betalactamasa y usos de las mismas.
CN104906565B (zh) * 2015-05-13 2018-06-19 西南大学 一种胰酶肠溶微丸及其制备方法
CN106237315A (zh) * 2016-08-02 2016-12-21 马南行 一种外用治疗糖尿病的组合物及其制备方法
IT201700021852A1 (it) * 2017-02-27 2018-08-27 Bioscreen Tech S R L Composizione a rilascio controllato di sostanze fisiologicamente attive e processo per la sua preparazione
IT201700021879A1 (it) 2017-02-27 2018-08-27 Bioscreen Tech S R L Composizione a rilascio controllato di sostanze fisiologicamente attive e processo per la sua preparazione
DE102017104482A1 (de) 2017-03-03 2018-09-06 Nordmark Arzneimittel Gmbh & Co. Kg Pharmazeutische Zusammensetzung umfassend Pankreatin und einen lipasehaltigen Überzug
DE102017104501A1 (de) 2017-03-03 2018-09-06 Nordmark Arzneimittel Gmbh & Co. Kg Pharmazeutische Zusammensetzung umfassend einen Träger und einen Überzug enthaltend wenigstens eine Lipase
CN112236171A (zh) * 2018-02-23 2021-01-15 Muc制药有限公司 含有影响粘蛋白的蛋白酶的制剂
CN108531538A (zh) * 2018-04-08 2018-09-14 武汉藤欣生物工程有限公司 一种酶法制备植物甾醇酯的方法
NL2021893B1 (en) 2018-10-26 2020-05-13 Citeq B V Biological pest control agent
CN110075279A (zh) * 2019-04-25 2019-08-02 淮安麦德森制药有限公司 胰酶微球及其生产方法
CN110331138A (zh) * 2019-06-29 2019-10-15 南京永正生物科技有限公司 一种生物复合酶微胶囊的生产工艺
RU2706003C1 (ru) * 2019-09-09 2019-11-13 Акционерное общество "АВВА РУС" Микрогранулы, содержащие панкреатин
CN112220916A (zh) * 2020-10-26 2021-01-15 西南药业股份有限公司 生物酶片剂的制备工艺及其产品
CN114767639A (zh) * 2022-05-13 2022-07-22 天津博菲德科技有限公司 一种耐酸型酶制剂颗粒及其制备方法

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4227385A1 (de) * 1992-08-19 1994-02-24 Kali Chemie Pharma Gmbh Pankreatinmikropellets
WO2000054799A2 (de) * 1999-03-17 2000-09-21 Solvay Pharmaceuticals Gmbh Arzneimittel zur behandlung von diabetes
IT1319655B1 (it) * 2000-11-15 2003-10-23 Eurand Int Microsfere di enzimi pancreatici con elevata stabilita' e relativometodo di preparazione.
US7578951B2 (en) * 2004-01-27 2009-08-25 Hewlett-Packard Development Company, L.P. Method of making microcapsules utilizing a fluid ejector
US20050214372A1 (en) * 2004-03-03 2005-09-29 Simona Di Capua Stable pharmaceutical composition comprising an acid labile drug
PL1931316T5 (pl) * 2005-08-15 2017-10-31 Abbott Laboratories Gmbh Kompozycje farmaceutyczne o kontrolowanym uwalnianiu dla leków labilnych kwasowo
US11266607B2 (en) * 2005-08-15 2022-03-08 AbbVie Pharmaceuticals GmbH Process for the manufacture and use of pancreatin micropellet cores
BRPI0614411A2 (pt) * 2005-08-15 2011-03-29 Solvay Pharm Gmbh núcleos de micropéletes de pancreatina adequados para revestimento entérico
CN101686943B (zh) * 2007-02-20 2014-03-26 阿普塔利斯制药有限公司 稳定的消化酶组合物
CN101279091A (zh) * 2007-04-04 2008-10-08 常州市第四制药厂有限公司 胰酶肠溶微丸及制备方法

Also Published As

Publication number Publication date
MX2012012794A (es) 2013-03-12
EP2566466A1 (en) 2013-03-13
WO2011140106A1 (en) 2011-11-10
CN102946872A (zh) 2013-02-27
AU2011248293A1 (en) 2012-11-15
IL222796A0 (en) 2012-12-31
RU2012148776A (ru) 2014-06-10
JP2013525488A (ja) 2013-06-20
CA2798280A1 (en) 2011-11-10

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