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 (https=
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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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

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  • 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)
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 (https=) 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 (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=)

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.
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
EP3003360B1 (en) * 2013-11-05 2020-10-07 Allergan Pharmaceuticals International Limited High potency pancreatin pharmaceutical compositions
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
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
CA2843556A1 (en) * 2011-08-08 2013-02-14 Aptalis Pharma Ltd. Method for dissolution testing of solid compositions containing digestive enzymes
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 (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
KR20160055123A (ko) 2016-05-17
US20250327059A1 (en) 2025-10-23
RU2016101760A (ru) 2017-08-28
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
CN105392496A (zh) 2016-03-09
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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