CA2919114A1 - High potency pancreatin pharmaceutical compositions - Google Patents

High potency pancreatin pharmaceutical compositions Download PDF

Info

Publication number
CA2919114A1
CA2919114A1 CA2919114A CA2919114A CA2919114A1 CA 2919114 A1 CA2919114 A1 CA 2919114A1 CA 2919114 A CA2919114 A CA 2919114A CA 2919114 A CA2919114 A CA 2919114A CA 2919114 A1 CA2919114 A1 CA 2919114A1
Authority
CA
Canada
Prior art keywords
solvent
pancreatin
mixture
mpa
usp
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.)
Pending
Application number
CA2919114A
Other languages
English (en)
French (fr)
Inventor
Vincenza PIRONTI
Robert Becker
Luigi Boltri
Luigi Ghidorsi
Paola ARZUFFI
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 International Ltd
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=52117920&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2919114(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Aptalis Pharma Ltd filed Critical Aptalis Pharma Ltd
Publication of CA2919114A1 publication Critical patent/CA2919114A1/en
Pending legal-status Critical Current

Links

Classifications

    • 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)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/94—Pancreatin
    • 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)
    • A61K38/48—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
    • 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
    • A61K38/54—Mixtures of enzymes or proenzymes covered by more than a single one of groups A61K38/44 - A61K38/46 or A61K38/51 - A61K38/53
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Genetics & Genomics (AREA)
  • General Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Biochemistry (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Cephalosporin Compounds (AREA)
  • Compounds Of Unknown Constitution (AREA)
CA2919114A 2013-07-22 2014-07-15 High potency pancreatin pharmaceutical compositions Pending CA2919114A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361856952P 2013-07-22 2013-07-22
US61/856,952 2013-07-22
PCT/IB2014/002583 WO2015019198A2 (en) 2013-07-22 2014-07-15 High potency pancreatin pharmaceutical compositions

Publications (1)

Publication Number Publication Date
CA2919114A1 true CA2919114A1 (en) 2015-02-12

Family

ID=52117920

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2919114A Pending CA2919114A1 (en) 2013-07-22 2014-07-15 High potency pancreatin pharmaceutical compositions

Country Status (13)

Country Link
US (2) US20160152968A1 (enExample)
EP (1) EP3024479B2 (enExample)
JP (1) JP2016527247A (enExample)
KR (1) KR20160055123A (enExample)
CN (1) CN105392496A (enExample)
AU (1) AU2014304176A1 (enExample)
BR (1) BR112016001289A2 (enExample)
CA (1) CA2919114A1 (enExample)
ES (1) ES2743212T5 (enExample)
IL (1) IL243627A (enExample)
MX (1) MX2016000794A (enExample)
RU (1) RU2686460C2 (enExample)
WO (1) WO2015019198A2 (enExample)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT1319655B1 (it) 2000-11-15 2003-10-23 Eurand Int Microsfere di enzimi pancreatici con elevata stabilita' e relativometodo di preparazione.
PT2079445E (pt) 2007-02-20 2016-02-29 Allergan Pharmaceuticals Internat Ltd Composições de enzimas digestivas estáveis
WO2009109856A2 (en) 2008-03-07 2009-09-11 Axcan Pharma Inc. Method for detecting infectious parvovirus in pharmaceutical preparations
EA029101B1 (ru) 2010-10-01 2018-02-28 Апталис Фарма Лимитид Составы с низкой дозой панкрелипазы и кишечнорастворимым покрытием
CA2843556A1 (en) 2011-08-08 2013-02-14 Aptalis Pharma Ltd. Method for dissolution testing of solid compositions containing digestive enzymes
EP3639846B1 (en) 2013-08-09 2022-09-28 Allergan Pharmaceuticals International Limited Digestive enzyme composition suitable for enteral administration
EP3003360B1 (en) * 2013-11-05 2020-10-07 Allergan Pharmaceuticals International Limited High potency pancreatin pharmaceutical compositions
EP3157568A1 (en) 2014-06-19 2017-04-26 Aptalis Pharma Limited Methods for removing viral contaminants from pancreatic extracts
ES2970869T3 (es) * 2016-03-28 2024-05-31 Abbott Laboratories Gmbh Composiciones enzimáticas con contaminación vírica y microbiana reducida
US11278603B2 (en) 2016-03-28 2022-03-22 Abbvie Inc. Enzyme compositions with reduced viral and microbial contamination
US11291236B2 (en) * 2017-09-11 2022-04-05 Alcresta Therapeutics, Inc. Devices and methods for the preparation of a nutritional formula
BR112020006211A2 (pt) * 2017-09-27 2020-10-13 Abbott Laboratories Gmbh preparação de enzima produzida por um método, preparação de enzima, método para produzir um produto de pancreatina, composição farmacêutica e método para tratar insuficiência pancreática exócrina
CN111394275B (zh) * 2020-02-22 2022-05-27 华东师范大学 一株解淀粉芽孢杆菌及其应用、水产饲料和水产养殖方法
FR3111559A1 (fr) * 2020-06-18 2021-12-24 Azurrx Biopharma, Inc. Formulations non porcines et leurs procédés

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB928654A (en) 1960-10-25 1963-06-12 Philips Nv Improvements in or relating to the production of pancreatin
US3168448A (en) 1963-01-07 1965-02-02 Wilson & Co Inc Process of preparing a lipolytic enzyme composition
DE3377506D1 (en) * 1982-12-30 1988-09-01 Nordmark Arzneimittel Gmbh Process for obtaining pancreatin
DK173590D0 (da) * 1990-06-06 1990-07-19 Novo Nordisk As Rekombinante terapeutiske lipaser
DE69634248T2 (de) 1995-05-31 2006-01-12 Medzyme N.V. Zusammensetzungen zur verbesserung der verdaulichkeit und ausnutzung von nähestoffen
KR19990072826A (ko) * 1998-02-26 1999-09-27 우재영 판크레아틴장용코팅과립의제조방법
US20010046493A1 (en) 2000-02-24 2001-11-29 Alex Margolin Lipase-containing composition and methods of use thereof
AR032392A1 (es) * 2001-01-19 2003-11-05 Solvay Pharm Gmbh Mezcla de enzimas, preparado farmaceutico y utilizacion de dicho preparado.
CA2419572A1 (en) * 2003-02-18 2004-08-18 Axcan Pharma Inc. High dosage protease formulation
US20060198838A1 (en) * 2004-09-28 2006-09-07 Fallon Joan M Combination enzyme for cystic fibrosis
DK1809320T3 (da) 2004-10-14 2010-11-15 Cystic Fibrosis Foundation The Præparater indeholdende lipase, protease og amylase til behandling af pankreatisk insufficiens
RU2445952C2 (ru) * 2007-02-20 2012-03-27 Юранд Фармасьютикалз Лимитед Стабильные композиции пищеварительных ферментов
RU2012142140A (ru) * 2010-03-19 2014-04-27 Апталис Фарма Кэнэда Инк. Бета-пропиолактон для инактивации вирусов в фармацевтических препаратах фермента поджелудочной железы
CA2843556A1 (en) * 2011-08-08 2013-02-14 Aptalis Pharma Ltd. Method for dissolution testing of solid compositions containing digestive enzymes
JP2013071929A (ja) * 2011-09-29 2013-04-22 Kobayashi Pharmaceutical Co Ltd 胃腸薬
EP3639846B1 (en) * 2013-08-09 2022-09-28 Allergan Pharmaceuticals International Limited Digestive enzyme composition suitable for enteral administration
EP3003360B1 (en) 2013-11-05 2020-10-07 Allergan Pharmaceuticals International Limited High potency pancreatin pharmaceutical compositions

Also Published As

Publication number Publication date
IL243627A0 (en) 2016-03-31
WO2015019198A2 (en) 2015-02-12
CN105392496A (zh) 2016-03-09
MX2016000794A (es) 2016-12-02
IL243627A (en) 2017-12-31
AU2014304176A1 (en) 2016-02-11
RU2016101760A3 (enExample) 2018-05-14
US20160152968A1 (en) 2016-06-02
EP3024479B1 (en) 2019-06-05
WO2015019198A3 (en) 2015-05-28
ES2743212T3 (es) 2020-02-18
KR20160055123A (ko) 2016-05-17
RU2686460C2 (ru) 2019-04-26
US20250327059A1 (en) 2025-10-23
JP2016527247A (ja) 2016-09-08
ES2743212T5 (es) 2023-04-25
BR112016001289A2 (en) 2018-03-20
EP3024479B2 (en) 2023-02-08
EP3024479A2 (en) 2016-06-01
RU2016101760A (ru) 2017-08-28

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