JP2016527247A - 高力価パンクレアチン医薬組成物 - Google Patents

高力価パンクレアチン医薬組成物 Download PDF

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Publication number
JP2016527247A
JP2016527247A JP2016528615A JP2016528615A JP2016527247A JP 2016527247 A JP2016527247 A JP 2016527247A JP 2016528615 A JP2016528615 A JP 2016528615A JP 2016528615 A JP2016528615 A JP 2016528615A JP 2016527247 A JP2016527247 A JP 2016527247A
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Japan
Prior art keywords
solvent
pancreatin
mixture
usp
mpa
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JP2016528615A
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English (en)
Japanese (ja)
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JP2016527247A5 (enExample
Inventor
ピロンティ，ヴィンセンツァ
ベッカー，ロバート
ボルトリ，ルイージ
ジドーシ，ルイージ
アーズッフィ，パオラ
Original Assignee
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
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
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Application filed by 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, 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 filed Critical 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
Publication of JP2016527247A publication Critical patent/JP2016527247A/ja
Publication of JP2016527247A5 publication Critical patent/JP2016527247A5/ja
Pending legal-status Critical Current

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    • 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

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  • 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)
JP2016528615A 2013-07-22 2014-07-15 高力価パンクレアチン医薬組成物 Pending JP2016527247A (ja)

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 (2)

Publication Number Publication Date
JP2016527247A true JP2016527247A (ja) 2016-09-08
JP2016527247A5 JP2016527247A5 (enExample) 2017-07-13

Family

ID=52117920

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2016528615A Pending JP2016527247A (ja) 2013-07-22 2014-07-15 高力価パンクレアチン医薬組成物

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

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH06501147A (ja) * 1990-06-06 1994-02-10 ノボ　ノルディスク　アクティーゼルスカブ 治療用に、組換方法で生産されたリパーゼ
JPH11315032A (ja) * 1998-02-26 1999-11-16 Il Yang Pharm Co Ltd 腸溶性コ―トを施したパンクレアチン顆粒の製造方法
JP2004524838A (ja) * 2001-01-19 2004-08-19 ゾルファイ　ファーマスーティカルズ　ゲゼルシャフト　ミット　ベシュレンクテル　ハフツング 微生物酵素の新規混合物
JP2013071929A (ja) * 2011-09-29 2013-04-22 Kobayashi Pharmaceutical Co Ltd 胃腸薬
JP2013522285A (ja) * 2010-03-19 2013-06-13 アプタリス・ファーマ・カナダ・インコーポレイテッド 膵酵素調合物におけるウィルスの不活性化のためのβ−プロピオラクトン

Family Cites Families (12)

* 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
DE69634248T2 (de) 1995-05-31 2006-01-12 Medzyme N.V. Zusammensetzungen zur verbesserung der verdaulichkeit und ausnutzung von nähestoffen
US20010046493A1 (en) 2000-02-24 2001-11-29 Alex Margolin Lipase-containing composition and methods of use thereof
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
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

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH06501147A (ja) * 1990-06-06 1994-02-10 ノボ　ノルディスク　アクティーゼルスカブ 治療用に、組換方法で生産されたリパーゼ
JPH11315032A (ja) * 1998-02-26 1999-11-16 Il Yang Pharm Co Ltd 腸溶性コ―トを施したパンクレアチン顆粒の製造方法
JP2004524838A (ja) * 2001-01-19 2004-08-19 ゾルファイ　ファーマスーティカルズ　ゲゼルシャフト　ミット　ベシュレンクテル　ハフツング 微生物酵素の新規混合物
JP2013522285A (ja) * 2010-03-19 2013-06-13 アプタリス・ファーマ・カナダ・インコーポレイテッド 膵酵素調合物におけるウィルスの不活性化のためのβ−プロピオラクトン
JP2013071929A (ja) * 2011-09-29 2013-04-22 Kobayashi Pharmaceutical Co Ltd 胃腸薬

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
INDUSTRIAL & ENGINEERING CHEMISTRY RESEARCH, vol. 46, JPN6018006887, 2007, pages 4289 - 4294, ISSN: 0003904320 *

Also Published As

Publication number Publication date
CA2919114A1 (en) 2015-02-12
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
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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