CA2798280A1 - Compositions de micropastilles comprenant des melanges d'enzymes digestives contenant de la pancreatine - Google Patents

Compositions de micropastilles comprenant des melanges d'enzymes digestives contenant de la pancreatine Download PDF

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Publication number
CA2798280A1
CA2798280A1 CA2798280A CA2798280A CA2798280A1 CA 2798280 A1 CA2798280 A1 CA 2798280A1 CA 2798280 A CA2798280 A CA 2798280A CA 2798280 A CA2798280 A CA 2798280A CA 2798280 A1 CA2798280 A1 CA 2798280A1
Authority
CA
Canada
Prior art keywords
pharmaceutical composition
particles
polymer
digestive enzyme
optionally
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.)
Abandoned
Application number
CA2798280A
Other languages
English (en)
Inventor
Gopi M. Venkatesh
Craig Kramer
Flavio Fabiani
Luigi Mapelli
Giovanni Ortenzi
Massimo Latino
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.)
Allergan Pharmaceuticals Holdings Ireland ULC
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 CA2798280A1 publication Critical patent/CA2798280A1/fr
Abandoned legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5073Microcapsules 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
    • A61K9/5078Microcapsules 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/465Hydrolases (3) acting on ester bonds (3.1), e.g. lipases, ribonucleases
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/47Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1641Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5036Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5036Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5089Processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/14Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Diabetes (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Nutrition Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Hematology (AREA)
  • Endocrinology (AREA)
  • Emergency Medicine (AREA)
  • Obesity (AREA)
  • Zoology (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
CA2798280A 2010-05-03 2011-05-03 Compositions de micropastilles comprenant des melanges d'enzymes digestives contenant de la pancreatine Abandoned CA2798280A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US33076810P 2010-05-03 2010-05-03
US61/330,768 2010-05-03
PCT/US2011/035023 WO2011140106A1 (fr) 2010-05-03 2011-05-03 Compositions de micropastilles comprenant des mélanges d'enzymes digestives contenant de la pancréatine

Publications (1)

Publication Number Publication Date
CA2798280A1 true CA2798280A1 (fr) 2011-11-10

Family

ID=44904036

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2798280A Abandoned CA2798280A1 (fr) 2010-05-03 2011-05-03 Compositions de micropastilles comprenant des melanges d'enzymes digestives contenant de la pancreatine

Country Status (10)

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

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20170052520A (ko) * 2013-11-05 2017-05-12 앨러간 파마슈티컬스 인터내셔널 리미티드 고효능 판크레아틴 약학적 조성물
JP6672277B2 (ja) * 2014-10-08 2020-04-01 シンセティック・バイオロジクス・インコーポレイテッド ベータラクタマーゼ製剤およびその使用
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
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
DE102017104482A1 (de) 2017-03-03 2018-09-06 Nordmark Arzneimittel Gmbh & Co. Kg Pharmazeutische Zusammensetzung umfassend Pankreatin und einen lipasehaltigen Überzug
SG11202007976WA (en) * 2018-02-23 2020-09-29 MUCPharm Pty Ltd Formulations containing mucin-affecting proteases
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
NZ514826A (en) * 1999-03-17 2003-08-29 Solvay Pharm Gmbh Medicinal product for the treatment of 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
WO2005092297A2 (fr) * 2004-03-03 2005-10-06 Teva Pharmaceutical Industries Ltd. Composition pharmaceutique stable comprenant un medicament labile en milieu acide
NZ565959A (en) * 2005-08-15 2011-10-28 Solvay Pharm Gmbh Pancreatin micropellet cores suitable for enteric coating
US11266607B2 (en) * 2005-08-15 2022-03-08 AbbVie Pharmaceuticals GmbH Process for the manufacture and use of pancreatin micropellet cores
WO2007020259A2 (fr) * 2005-08-15 2007-02-22 Solvay Pharmaceuticals Gmbh Compositions pharmaceutiques a liberation controlee destinees a des medicaments acido-labiles
WO2008102264A2 (fr) * 2007-02-20 2008-08-28 Eurand Pharmaceuticals Limited Compositions stables à base d'enzymes digestives
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
WO2011140106A1 (fr) 2011-11-10
CO6640298A2 (es) 2013-03-22
JP2013525488A (ja) 2013-06-20
AU2011248293A1 (en) 2012-11-15
IL222796A0 (en) 2012-12-31
EP2566466A1 (fr) 2013-03-13
RU2012148776A (ru) 2014-06-10
MX2012012794A (es) 2013-03-12
CN102946872A (zh) 2013-02-27

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Legal Events

Date Code Title Description
FZDE Discontinued

Effective date: 20160504