WO2007020260A3 - Pancreatin micropellet cores suitable for enteric coating - Google Patents

Pancreatin micropellet cores suitable for enteric coating Download PDF

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Publication number
WO2007020260A3
WO2007020260A3 PCT/EP2006/065313 EP2006065313W WO2007020260A3 WO 2007020260 A3 WO2007020260 A3 WO 2007020260A3 EP 2006065313 W EP2006065313 W EP 2006065313W WO 2007020260 A3 WO2007020260 A3 WO 2007020260A3
Authority
WO
WIPO (PCT)
Prior art keywords
pancreatin
enteric coating
pancreatin micropellet
micropellet cores
cores suitable
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/EP2006/065313
Other languages
French (fr)
Other versions
WO2007020260A2 (en
Inventor
George Shlieout
Claus-Juergen Koelln
Frithjof Sczesny
Jens Onken
Guido Ruesing
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.)
Abbott Products GmbH
Original Assignee
Solvay Pharmaceuticals 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=37401623&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2007020260(A3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to NZ565959A priority Critical patent/NZ565959A/en
Priority to MX2008001557A priority patent/MX2008001557A/en
Priority to KR1020087006201A priority patent/KR101302841B1/en
Application filed by Solvay Pharmaceuticals GmbH filed Critical Solvay Pharmaceuticals GmbH
Priority to CA2619477A priority patent/CA2619477C/en
Priority to AU2006281415A priority patent/AU2006281415B2/en
Priority to HK08110911.7A priority patent/HK1119559B/en
Priority to JP2008526493A priority patent/JP5284092B2/en
Priority to CN2006800297280A priority patent/CN101242812B/en
Priority to PL06778242T priority patent/PL1931317T3/en
Priority to EP06778242A priority patent/EP1931317B1/en
Priority to DE602006004471T priority patent/DE602006004471D1/en
Priority to BRPI0614411-0A priority patent/BRPI0614411A2/en
Publication of WO2007020260A2 publication Critical patent/WO2007020260A2/en
Publication of WO2007020260A3 publication Critical patent/WO2007020260A3/en
Priority to IL189457A priority patent/IL189457A/en
Anticipated expiration legal-status Critical
Priority to NO20081379A priority patent/NO20081379L/en
Ceased legal-status Critical Current

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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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)
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • 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
    • 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
    • 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)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Finger-Pressure Massage (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Described herein are a process for manufacturing and using pancreatin micropellet cores and pancreatin micropellet cores obtainable according to that process which are substantially free of synthetic oils. Further described are enteric coated pancreatin mi¬ cropellets. In one embodiment, a pharmaceutical composition is provided comprising a pancreatin micropellet with an enteric coating being designed to deliver pancreatin to the upper portion of the intestine of a mammal for release.
PCT/EP2006/065313 2005-08-15 2006-08-15 Pancreatin micropellet cores suitable for enteric coating Ceased WO2007020260A2 (en)

Priority Applications (14)

Application Number Priority Date Filing Date Title
BRPI0614411-0A BRPI0614411A2 (en) 2005-08-15 2006-08-15 pancreatin micropellet cores suitable for enteric coating
CN2006800297280A CN101242812B (en) 2005-08-15 2006-08-15 Pancreatin pellet cores suitable for enteric coating
KR1020087006201A KR101302841B1 (en) 2005-08-15 2006-08-15 Pancreatin micropellet cores suitable for enteric coating
EP06778242A EP1931317B1 (en) 2005-08-15 2006-08-15 Pancreatin micropellets suitable for enteric coating
CA2619477A CA2619477C (en) 2005-08-15 2006-08-15 Pancreatin micropellet cores suitable for enteric coating
AU2006281415A AU2006281415B2 (en) 2005-08-15 2006-08-15 Pancreatin micropellet cores suitable for enteric coating
HK08110911.7A HK1119559B (en) 2005-08-15 2006-08-15 Pancreatin micropellet cores suitable for enteric coating
JP2008526493A JP5284092B2 (en) 2005-08-15 2006-08-15 Pancreatine micropellet core suitable for enteric coating
PL06778242T PL1931317T3 (en) 2005-08-15 2006-08-15 Pancreatin micropellets suitable for enteric coating
NZ565959A NZ565959A (en) 2005-08-15 2006-08-15 Pancreatin micropellet cores suitable for enteric coating
MX2008001557A MX2008001557A (en) 2005-08-15 2006-08-15 Pancreatin micropellet cores suitable for enteric coating.
DE602006004471T DE602006004471D1 (en) 2005-08-15 2006-08-15 PANCREATINE MICROPELLETS SUITABLE FOR MASSAGE-SUPPRESSIVE COVERS
IL189457A IL189457A (en) 2005-08-15 2008-02-12 Extrusion process for the manufacture of synthetic oil- free micropellet cores comprising pancreatin and polyethylene glycol 4000
NO20081379A NO20081379L (en) 2005-08-15 2008-03-14 Pancreatin micropellet cores suitable for enteric coating

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US70852605P 2005-08-15 2005-08-15
US60/708,526 2005-08-15
EP05107474.8 2005-08-15
EP05107474 2005-08-15

Publications (2)

Publication Number Publication Date
WO2007020260A2 WO2007020260A2 (en) 2007-02-22
WO2007020260A3 true WO2007020260A3 (en) 2007-05-10

Family

ID=37401623

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2006/065313 Ceased WO2007020260A2 (en) 2005-08-15 2006-08-15 Pancreatin micropellet cores suitable for enteric coating

Country Status (15)

Country Link
EP (1) EP1931317B1 (en)
JP (1) JP5284092B2 (en)
KR (1) KR101302841B1 (en)
AT (1) ATE418329T1 (en)
AU (1) AU2006281415B2 (en)
CA (1) CA2619477C (en)
DE (1) DE602006004471D1 (en)
ES (1) ES2320174T3 (en)
IL (1) IL189457A (en)
MX (1) MX2008001557A (en)
NO (1) NO20081379L (en)
PL (1) PL1931317T3 (en)
PT (1) PT1931317E (en)
RU (1) RU2408364C2 (en)
WO (1) WO2007020260A2 (en)

Families Citing this family (41)

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Publication number Priority date Publication date Assignee Title
US6632429B1 (en) 1999-12-17 2003-10-14 Joan M. Fallon Methods for treating pervasive development disorders
US20070053895A1 (en) 2000-08-14 2007-03-08 Fallon Joan M Method of treating and diagnosing parkinsons disease and related dysautonomic disorders
IT1319655B1 (en) 2000-11-15 2003-10-23 Eurand Int PANCREATIC ENZYME MICROSPHERES WITH HIGH STABILITY AND RELATIVE PREPARATION METHOD.
US8030002B2 (en) 2000-11-16 2011-10-04 Curemark Llc Methods for diagnosing pervasive development disorders, dysautonomia and other neurological conditions
CA2560613C (en) 2004-03-22 2015-11-24 Solvay Pharmaceuticals Gmbh Oral pharmaceutical compositions of lipase-containing products, in particular of pancreatin, containing surfactants
KR101555058B1 (en) 2005-07-29 2015-09-22 애보트 래버러토리즈 게엠베하 Process for producing sterilized pancreatin powder
US9198871B2 (en) 2005-08-15 2015-12-01 Abbott Products Gmbh Delayed release pancreatin compositions
US11266607B2 (en) 2005-08-15 2022-03-08 AbbVie Pharmaceuticals GmbH Process for the manufacture and use of pancreatin micropellet cores
US20080058282A1 (en) 2005-08-30 2008-03-06 Fallon Joan M Use of lactulose in the treatment of autism
US8497258B2 (en) 2005-11-12 2013-07-30 The Regents Of The University Of California Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract
US10072256B2 (en) 2006-05-22 2018-09-11 Abbott Products Gmbh Process for separating and determining the viral load in a pancreatin sample
JP5966202B2 (en) 2007-02-20 2016-08-10 アラガン ファーマシューティカルズ インターナショナル リミテッド Stable digestive enzyme composition
WO2009083607A1 (en) * 2008-01-03 2009-07-09 Solvay Pharmaceuticals Gmbh Pharmaceutical compositions comprising granules of purified microbial lipase and methods for preventing or treating digestive disorders
US10087493B2 (en) 2008-03-07 2018-10-02 Aptalis Pharma Canada Ulc Method for detecting infectious parvovirus in pharmaceutical preparations
US8658163B2 (en) 2008-03-13 2014-02-25 Curemark Llc Compositions and use thereof for treating symptoms of preeclampsia
US8084025B2 (en) 2008-04-18 2011-12-27 Curemark Llc Method for the treatment of the symptoms of drug and alcohol addiction
US9320780B2 (en) 2008-06-26 2016-04-26 Curemark Llc Methods and compositions for the treatment of symptoms of Williams Syndrome
PL2318035T3 (en) 2008-07-01 2019-10-31 Curemark Llc Methods and compositions for treating the symptoms of neurological disorders and mental health disorders
US10776453B2 (en) 2008-08-04 2020-09-15 Galenagen, Llc Systems and methods employing remote data gathering and monitoring for diagnosing, staging, and treatment of Parkinsons disease, movement and neurological disorders, and chronic pain
US20100092447A1 (en) 2008-10-03 2010-04-15 Fallon Joan M Methods and compositions for the treatment of symptoms of prion diseases
KR20170005191A (en) 2009-01-06 2017-01-11 큐어론 엘엘씨 Compositions and methods for the treatment or the prevention oral infections by e. coli
CN102300989B (en) 2009-01-06 2015-12-09 柯尔朗恩有限责任公司 Compositions and methods for treating or preventing staphylococcus aureus infection and for eradicating or reducing staphylococcus aureus on surfaces
US9056050B2 (en) 2009-04-13 2015-06-16 Curemark Llc Enzyme delivery systems and methods of preparation and use
US20110097401A1 (en) 2009-06-12 2011-04-28 Meritage Pharma, Inc. Methods for treating gastrointestinal disorders
PL2295039T5 (en) 2009-08-28 2023-02-27 Nordmark Pharma Gmbh Method of preparing pancreatin pellets, in particular pancreatin micropellets, and pancreatin pellets prepared thereby
US9511125B2 (en) 2009-10-21 2016-12-06 Curemark Llc Methods and compositions for the treatment of influenza
ES2657673T3 (en) 2010-10-01 2018-03-06 Aptalis Pharma Limited Enteric coated pancrelipase formulations, low intensity
DE202011000728U1 (en) 2011-03-30 2011-06-09 Nordmark Arzneimittel GmbH & Co. KG, 25436 Pancreatin pellets, especially pancreatin micropellets
EP2489349B1 (en) 2011-02-17 2014-05-28 Nordmark Arzneimittel GmbH & Co.KG Pancreatin pellets, in particular pancreatin micropellets and method for producing same
US8980252B2 (en) 2011-04-21 2015-03-17 Curemark Llc Methods of treatment of schizophrenia
CA2843556A1 (en) 2011-08-08 2013-02-14 Aptalis Pharma Ltd. Method for dissolution testing of solid compositions containing digestive enzymes
US10350278B2 (en) * 2012-05-30 2019-07-16 Curemark, Llc Methods of treating Celiac disease
US10184121B2 (en) 2013-06-28 2019-01-22 Allergan Pharmaceuticals International Limited Methods for removing viral contaminants from pancreatic extracts
CA2920844A1 (en) 2013-08-09 2015-02-12 Allergan Pharmaceuticals International Limited Digestive enzyme composition suitable for enteral administration
EP3215181B1 (en) 2014-11-05 2024-12-18 Abbott Laboratories GmbH Processes for producing compositions with improved safety profile comprising pancreatin and compositions suitable for pharmaceutical use
DE102017104482A1 (en) * 2017-03-03 2018-09-06 Nordmark Arzneimittel Gmbh & Co. Kg A pharmaceutical composition comprising pancreatin and a lipase-containing coating
AU2018250823A1 (en) 2017-04-10 2019-10-17 Curemark, Llc Compositions for treating addiction
RU2706003C1 (en) * 2019-09-09 2019-11-13 Акционерное общество "АВВА РУС" Microgranules containing pancreatin
PH12022553091A1 (en) * 2020-06-10 2023-10-16 Kusum Healthcare Pvt Ltd Pharmaceutical composition of pancreatin
US11541009B2 (en) 2020-09-10 2023-01-03 Curemark, Llc Methods of prophylaxis of coronavirus infection and treatment of coronaviruses
KR102950325B1 (en) 2024-01-26 2026-04-08 황준영 A immediate-release enteric tablet comprising pancreatin

Citations (4)

* Cited by examiner, † Cited by third party
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US5378462A (en) * 1992-08-19 1995-01-03 Kali-Chemie Pharma Gmbh Pancreatin micropellets prepared with polyethylene glycol 4000, paraffin and a lower alcohol by extrusion and rounding
DE19907764A1 (en) * 1998-02-26 1999-11-04 Il Yang Pharm Co Ltd Preparation of acid-resistant pancreatin granulates
US20020061302A1 (en) * 1999-03-17 2002-05-23 Suntje Sander-Struckmeier Method for the treatment of diabetes
US20040101562A1 (en) * 2000-11-15 2004-05-27 Mario Maio Microspheres of pancreatic enzymes with high stability and production method thereof

Family Cites Families (3)

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GB1509866A (en) * 1975-06-10 1978-05-04 Johnson & Johnson Enteric coated digestive enzyme compositions
UA69413C2 (en) * 1998-05-22 2004-09-15 Брістол-Майерс Сквібб Компані Enteric coated pharmaceutical composition, pharmaceutical composition in form of spheroid beads, method for manufacturing pharmaceutical composition
AR032392A1 (en) * 2001-01-19 2003-11-05 Solvay Pharm Gmbh ENZYMES MIX, PHARMACEUTICAL PREPARATION AND USE OF PREPARED SAID.

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5378462A (en) * 1992-08-19 1995-01-03 Kali-Chemie Pharma Gmbh Pancreatin micropellets prepared with polyethylene glycol 4000, paraffin and a lower alcohol by extrusion and rounding
DE19907764A1 (en) * 1998-02-26 1999-11-04 Il Yang Pharm Co Ltd Preparation of acid-resistant pancreatin granulates
US20020061302A1 (en) * 1999-03-17 2002-05-23 Suntje Sander-Struckmeier Method for the treatment of diabetes
US20040101562A1 (en) * 2000-11-15 2004-05-27 Mario Maio Microspheres of pancreatic enzymes with high stability and production method thereof

Also Published As

Publication number Publication date
EP1931317A2 (en) 2008-06-18
PT1931317E (en) 2009-02-02
KR20080034516A (en) 2008-04-21
HK1119559A1 (en) 2009-03-13
EP1931317B1 (en) 2008-12-24
RU2408364C2 (en) 2011-01-10
AU2006281415B2 (en) 2012-01-19
JP2009504710A (en) 2009-02-05
JP5284092B2 (en) 2013-09-11
RU2008109651A (en) 2009-09-27
AU2006281415A1 (en) 2007-02-22
WO2007020260A2 (en) 2007-02-22
NO20081379L (en) 2008-05-14
DE602006004471D1 (en) 2009-02-05
ATE418329T1 (en) 2009-01-15
CA2619477A1 (en) 2007-02-22
IL189457A (en) 2014-05-28
PL1931317T3 (en) 2009-06-30
CA2619477C (en) 2015-05-26
KR101302841B1 (en) 2013-09-02
IL189457A0 (en) 2008-06-05
MX2008001557A (en) 2008-02-15
ES2320174T3 (en) 2009-05-19

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