CN105392496A - 高效的胰酶药物组合物 - Google Patents

高效的胰酶药物组合物 Download PDF

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Publication number
CN105392496A
CN105392496A CN201480041135.0A CN201480041135A CN105392496A CN 105392496 A CN105392496 A CN 105392496A CN 201480041135 A CN201480041135 A CN 201480041135A CN 105392496 A CN105392496 A CN 105392496A
Authority
CN
China
Prior art keywords
solvent
pancreatin
mixture
lipase
mpa
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
CN201480041135.0A
Other languages
English (en)
Chinese (zh)
Inventor
温琴扎·皮隆蒂
罗伯特·贝克尔
路易吉·波尔特里
路易吉·吉多斯
保拉·阿尔祖菲
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
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=CN105392496(A) "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 CN105392496A publication Critical patent/CN105392496A/zh
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)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Biotechnology (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • General Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (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)
CN201480041135.0A 2013-07-22 2014-07-15 高效的胰酶药物组合物 Pending CN105392496A (zh)

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
CN105392496A true CN105392496A (zh) 2016-03-09

Family

ID=52117920

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201480041135.0A Pending CN105392496A (zh) 2013-07-22 2014-07-15 高效的胰酶药物组合物

Country Status (13)

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

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106659773A (zh) * 2013-11-05 2017-05-10 阿勒根制药国际有限公司 高效的胰酶药物组合物
CN109475610A (zh) * 2016-03-28 2019-03-15 雅培制药股份有限公司 病毒和微生物污染减少的酶组合物
CN111630164A (zh) * 2017-09-27 2020-09-04 雅培制药股份有限公司 具有减少的病毒和微生物污染的酶组合物

Families Citing this family (11)

* 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.
JP5966202B2 (ja) 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 安定な消化酵素組成物
US10087493B2 (en) 2008-03-07 2018-10-02 Aptalis Pharma Canada Ulc Method for detecting infectious parvovirus in pharmaceutical preparations
ES2657673T3 (es) 2010-10-01 2018-03-06 Aptalis Pharma Limited Formulaciones recubiertas entéricas de pancrelipasa, de baja intensidad
CA2843556A1 (en) 2011-08-08 2013-02-14 Aptalis Pharma Ltd. Method for dissolution testing of solid compositions containing digestive enzymes
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
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
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

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3168448A (en) * 1963-01-07 1965-02-02 Wilson & Co Inc Process of preparing a lipolytic enzyme composition
CN1487837A (zh) * 2001-01-19 2004-04-07 ������ҩ�����޹�˾ 新的微生物酶混合物
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

Family Cites Families (13)

* 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
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
WO2006044529A1 (en) 2004-10-14 2006-04-27 Altus Pharmaceuticals Inc. Compositions containing lipase; protease and amylase for treating pancreatic insufficiency
RU2445952C2 (ru) * 2007-02-20 2012-03-27 Юранд Фармасьютикалз Лимитед Стабильные композиции пищеварительных ферментов
BR112012023517A2 (pt) * 2010-03-19 2017-10-03 Aptalis Pharma Canada Inc Preparação de enzima pancreática (pep) tendo infectividade viral reduzida, composição farmacêutica tendo infectividade viral reduzida, forma de dosagem oral sólida, método para tratar insuficiência pancreática em um paciente que necessita disso e método para preparar um apreparação de enzima pancreática (pep)
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
CA2920844A1 (en) * 2013-08-09 2015-02-12 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

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3168448A (en) * 1963-01-07 1965-02-02 Wilson & Co Inc Process of preparing a lipolytic enzyme composition
CN1487837A (zh) * 2001-01-19 2004-04-07 ������ҩ�����޹�˾ 新的微生物酶混合物
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

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
I-HWAN HWANG等: "Selective Precipitation of Proteins from Pancreatin Using Designed Antisolvents", 《IND. ENG. CHEM. RES.》 *

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106659773A (zh) * 2013-11-05 2017-05-10 阿勒根制药国际有限公司 高效的胰酶药物组合物
CN109475610A (zh) * 2016-03-28 2019-03-15 雅培制药股份有限公司 病毒和微生物污染减少的酶组合物
CN111630164A (zh) * 2017-09-27 2020-09-04 雅培制药股份有限公司 具有减少的病毒和微生物污染的酶组合物

Also Published As

Publication number Publication date
KR20160055123A (ko) 2016-05-17
US20250327059A1 (en) 2025-10-23
RU2016101760A (ru) 2017-08-28
JP2016527247A (ja) 2016-09-08
EP3024479B2 (en) 2023-02-08
MX2016000794A (es) 2016-12-02
WO2015019198A2 (en) 2015-02-12
EP3024479A2 (en) 2016-06-01
AU2014304176A1 (en) 2016-02-11
EP3024479B1 (en) 2019-06-05
ES2743212T3 (es) 2020-02-18
RU2016101760A3 (https=) 2018-05-14
BR112016001289A2 (en) 2018-03-20
US20160152968A1 (en) 2016-06-02
CA2919114A1 (en) 2015-02-12
WO2015019198A3 (en) 2015-05-28
IL243627A (en) 2017-12-31
RU2686460C2 (ru) 2019-04-26
ES2743212T5 (es) 2023-04-25
IL243627A0 (en) 2016-03-31

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Legal Events

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C06 Publication
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
CB02 Change of applicant information
CB02 Change of applicant information

Address after: Ai Erlandubailin

Applicant after: ELASTAGEN Pty Ltd.

Address before: Wickrow, Ireland

Applicant before: Aptalis Pharma Ltd.

RJ01 Rejection of invention patent application after publication

Application publication date: 20160309