JP2017500885A - 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

Info

Publication number
JP2017500885A
JP2017500885A JP2016552457A JP2016552457A JP2017500885A JP 2017500885 A JP2017500885 A JP 2017500885A JP 2016552457 A JP2016552457 A JP 2016552457A JP 2016552457 A JP2016552457 A JP 2016552457A JP 2017500885 A JP2017500885 A JP 2017500885A
Authority
JP
Japan
Prior art keywords
pancreatin
solvent
mpa
lipase
activity
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
JP2016552457A
Other languages
English (en)
Japanese (ja)
Other versions
JP2017500885A5 (enExample
Inventor
パーレット，ステファン
ベッカー，ロバート
ボルトゥリ，ルイギ
グヒドルシ，ルイギ
アーズッフィ，パオラ
ピロンティ，ヴィンセンツァ
トタ，マイケル
ワード，ウィリアム
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=53042009&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=JP2017500885(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 JP2017500885A publication Critical patent/JP2017500885A/ja
Publication of JP2017500885A5 publication Critical patent/JP2017500885A5/ja
Pending legal-status Critical Current

Links

Images

Classifications

    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Wood Science & Technology (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • General Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Nutrition Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (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)
JP2016552457A 2013-11-05 2014-11-05 高力価パンクレアチン医薬組成物 Pending JP2017500885A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361900092P 2013-11-05 2013-11-05
US61/900,092 2013-11-05
PCT/US2014/063984 WO2015069677A1 (en) 2013-11-05 2014-11-05 High potency pancreatin pharmaceutical compositions

Publications (2)

Publication Number Publication Date
JP2017500885A true JP2017500885A (ja) 2017-01-12
JP2017500885A5 JP2017500885A5 (enExample) 2017-11-09

Family

ID=53042009

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2016552457A Pending JP2017500885A (ja) 2013-11-05 2014-11-05 高力価パンクレアチン医薬組成物

Country Status (13)

Country Link
EP (2) EP3613429A1 (enExample)
JP (1) JP2017500885A (enExample)
KR (1) KR20170052520A (enExample)
CN (1) CN106659773A (enExample)
AU (1) AU2014346930A1 (enExample)
BR (1) BR112016000658A2 (enExample)
CA (1) CA2915671A1 (enExample)
ES (1) ES2834483T3 (enExample)
HK (1) HK1222325A1 (enExample)
IL (3) IL243435B (enExample)
MX (1) MX2016000480A (enExample)
RU (1) RU2015155470A (enExample)
WO (1) WO2015069677A1 (enExample)

Families Citing this family (8)

* 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.
EP2079445B1 (en) 2007-02-20 2015-11-04 Aptalis Pharma Limited Stable digestive enzyme compositions
WO2009109856A2 (en) 2008-03-07 2009-09-11 Axcan Pharma Inc. Method for detecting infectious parvovirus in pharmaceutical preparations
EP2621476B8 (en) 2010-10-01 2020-12-23 Société des Produits Nestlé S.A. Enteric coated, low-strength pancrelipase formulations
RU2602183C2 (ru) 2011-08-08 2016-11-10 Апталис Фарма Лтд. Способ проведения теста на растворение твердых композиций, содержащих пищеварительные ферменты
US10184121B2 (en) 2013-06-28 2019-01-22 Allergan Pharmaceuticals International Limited Methods for removing viral contaminants from pancreatic extracts
ES2743212T5 (es) 2013-07-22 2023-04-25 Allergan Pharmaceuticals Int Ltd Métodos para preparar pancreatina
WO2015020943A2 (en) 2013-08-09 2015-02-12 Aptalis Pharma Ltd. Digestive enzyme composition suitable for enteral administration

Citations (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2751330A (en) * 1952-08-27 1956-06-19 Armour & Co Use of a salt in the extraction slurry in recovering proteolytic enzymes from pancreas gland material
JPS5186113A (en) * 1974-12-20 1976-07-28 Hoechst Ag Inshurin oyobi pankureachinnodojiseizohoho
US4623624A (en) * 1982-12-30 1986-11-18 Basf Aktiengesellschaft Isolation of pancreatin
JPS6379589A (ja) * 1986-09-17 1988-04-09 ジユベイナル　エス．エイ． リパーゼ及びリパーゼ抽出物、その調製方法及び治療学上の用途
JPH0398580A (ja) * 1989-08-18 1991-04-24 Roehm Gmbh 十分な安定性を有するタンパク質分解作用酵素の水性酵素懸濁液組成物の製造方法
JPH1077236A (ja) * 1996-08-28 1998-03-24 Solvay Pharmaceut Gmbh リパーゼおよびプロテアーゼ含有消化酵素混合物の水溶性医薬製剤中の安定化添加物、該添加物を含有する製剤および消化酵素混合物を製造するためのキット
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
WO2004074470A1 (en) * 2003-02-18 2004-09-02 Norax & Company, Limited Partnership High protease content pancreatin
US20060198838A1 (en) * 2004-09-28 2006-09-07 Fallon Joan M Combination enzyme for cystic fibrosis
JP2008516965A (ja) * 2004-10-14 2008-05-22 アルタス ファーマシューティカルズ インコーポレイテッド 膵機能不全を治療するための、リパーゼ、プロテアーゼおよびアミラーゼを含有する組成物
JP2010519217A (ja) * 2007-02-20 2010-06-03 ユーランド ファーマシューティカルズ リミテッド 安定な消化酵素組成物
CN103060296A (zh) * 2012-12-30 2013-04-24 青岛九龙生物医药有限公司 从动物胰脏中提取胰蛋白酶的方法
JP2013522284A (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 胃耐性の酵素医薬組成物
JP2013538846A (ja) * 2010-10-01 2013-10-17 アプタリス ファーマ リミテッド 腸溶コーティングされた低力価パンクレリパーゼ製剤

Family Cites Families (9)

* 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
US6051220A (en) 1995-05-31 2000-04-18 Medzyme N.V. And Simon Lodewijk Scharpe Composition to improve digestibility and utilization of nutrients
US5750104A (en) * 1996-05-29 1998-05-12 Digestive Care Inc. High buffer-containing enteric coating digestive enzyme bile acid compositions and method of treating digestive disorders therewith
US20010046493A1 (en) 2000-02-24 2001-11-29 Alex Margolin Lipase-containing composition and methods of use thereof
MX2008000850A (es) 2005-07-29 2008-03-18 Solvay Pharm Gmbh Procedimientos para la fabricacion de polvo de pancreatina esterilizada.
JP2013525488A (ja) * 2010-05-03 2013-06-20 アプタリス ファーマ リミテッド 消化酵素混合物を含有するパンクレアチンを含むマイクロペレット組成物
CN103060297B (zh) * 2012-12-28 2014-06-25 青岛九龙生物医药有限公司 一种分离纯化胰蛋白酶的方法
ES2743212T5 (es) * 2013-07-22 2023-04-25 Allergan Pharmaceuticals Int Ltd Métodos para preparar pancreatina

Patent Citations (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2751330A (en) * 1952-08-27 1956-06-19 Armour & Co Use of a salt in the extraction slurry in recovering proteolytic enzymes from pancreas gland material
JPS5186113A (en) * 1974-12-20 1976-07-28 Hoechst Ag Inshurin oyobi pankureachinnodojiseizohoho
US4623624A (en) * 1982-12-30 1986-11-18 Basf Aktiengesellschaft Isolation of pancreatin
JPS6379589A (ja) * 1986-09-17 1988-04-09 ジユベイナル　エス．エイ． リパーゼ及びリパーゼ抽出物、その調製方法及び治療学上の用途
JPH0398580A (ja) * 1989-08-18 1991-04-24 Roehm Gmbh 十分な安定性を有するタンパク質分解作用酵素の水性酵素懸濁液組成物の製造方法
JPH1077236A (ja) * 1996-08-28 1998-03-24 Solvay Pharmaceut Gmbh リパーゼおよびプロテアーゼ含有消化酵素混合物の水溶性医薬製剤中の安定化添加物、該添加物を含有する製剤および消化酵素混合物を製造するためのキット
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
WO2004074470A1 (en) * 2003-02-18 2004-09-02 Norax & Company, Limited Partnership High protease content pancreatin
US20060198838A1 (en) * 2004-09-28 2006-09-07 Fallon Joan M Combination enzyme for cystic fibrosis
JP2008516965A (ja) * 2004-10-14 2008-05-22 アルタス ファーマシューティカルズ インコーポレイテッド 膵機能不全を治療するための、リパーゼ、プロテアーゼおよびアミラーゼを含有する組成物
JP2010519217A (ja) * 2007-02-20 2010-06-03 ユーランド ファーマシューティカルズ リミテッド 安定な消化酵素組成物
JP2013522284A (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 胃耐性の酵素医薬組成物
JP2013538846A (ja) * 2010-10-01 2013-10-17 アプタリス ファーマ リミテッド 腸溶コーティングされた低力価パンクレリパーゼ製剤
CN103060296A (zh) * 2012-12-30 2013-04-24 青岛九龙生物医药有限公司 从动物胰脏中提取胰蛋白酶的方法

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
"Effects of High-Lipase Pancreatin on Facal Fat, Neutral Sterol, Bile Acid, and Short-Chain Fatty Aci", INTERNATIONAL JOURNAL OF PANCREATOLOGY, vol. 23(1), JPN6018032879, 1998, pages 63 - 70, ISSN: 0004019071 *
"Selective precipitation of Proteins from Pancreatin Using Designed Antisolvents", INDUSTRIAL & ENGINEERING CHEMISTRY RESEARCH, vol. 46(12), JPN6018032876, 2007, pages 4289 - 4294, ISSN: 0004019072 *

Also Published As

Publication number Publication date
BR112016000658A2 (pt) 2018-03-20
MX2016000480A (es) 2016-10-21
EP3613429A1 (en) 2020-02-26
IL274583B (en) 2022-06-01
CA2915671A1 (en) 2015-05-14
IL274583A (en) 2020-06-30
IL243435B (en) 2020-06-30
IL243435A0 (en) 2016-03-31
EP3003360A4 (en) 2017-04-26
EP3003360A1 (en) 2016-04-13
CN106659773A (zh) 2017-05-10
WO2015069677A1 (en) 2015-05-14
KR20170052520A (ko) 2017-05-12
EP3003360B1 (en) 2020-10-07
ES2834483T3 (es) 2021-06-17
HK1222325A1 (zh) 2017-06-30
RU2015155470A3 (enExample) 2018-09-10
AU2014346930A1 (en) 2016-01-07
RU2015155470A (ru) 2017-08-21
IL284419A (en) 2021-07-29

Similar Documents

Publication Publication Date Title
US20250327059A1 (en) High potency pancreatin pharmaceutical compositions
JP2017500885A (ja) 高力価パンクレアチン医薬組成物
US12364666B2 (en) Stable low digestive enzyme content formulation
TWI609693B (zh) 穩定之消化酵素組合物
JP2013525488A (ja) 消化酵素混合物を含有するパンクレアチンを含むマイクロペレット組成物
US20200255817A1 (en) High potency pancreatin pharmaceutical compositions
AU2012202620B2 (en) Stable digestive enzyme compositions

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20170929

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20170929

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20180718

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20180828

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20181127

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20190423