RU2686460C2 - Высокоэффективные фармацевтические композиции панкреатина - Google Patents

Высокоэффективные фармацевтические композиции панкреатина Download PDF

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Publication number
RU2686460C2
RU2686460C2 RU2016101760A RU2016101760A RU2686460C2 RU 2686460 C2 RU2686460 C2 RU 2686460C2 RU 2016101760 A RU2016101760 A RU 2016101760A RU 2016101760 A RU2016101760 A RU 2016101760A RU 2686460 C2 RU2686460 C2 RU 2686460C2
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Russia
Prior art keywords
solvent
pancreatin
mixture
stage
mpa
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RU2016101760A
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English (en)
Russian (ru)
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RU2016101760A (ru
RU2016101760A3 (https=
Inventor
Винченца ПИРОНТИ
Роберт БЕКЕР
Луиджи Больтри
Луиджи ГИДОРСИ
Паола АРЦУФФИ
Original Assignee
Апталис Фарма Лтд.
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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=RU2686460(C2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Апталис Фарма Лтд. filed Critical Апталис Фарма Лтд.
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Publication of RU2016101760A3 publication Critical patent/RU2016101760A3/ru
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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)
  • 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)
RU2016101760A 2013-07-22 2014-07-15 Высокоэффективные фармацевтические композиции панкреатина RU2686460C2 (ru)

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 (3)

Publication Number Publication Date
RU2016101760A RU2016101760A (ru) 2017-08-28
RU2016101760A3 RU2016101760A3 (https=) 2018-05-14
RU2686460C2 true RU2686460C2 (ru) 2019-04-26

Family

ID=52117920

Family Applications (1)

Application Number Title Priority Date Filing Date
RU2016101760A RU2686460C2 (ru) 2013-07-22 2014-07-15 Высокоэффективные фармацевтические композиции панкреатина

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 (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0115023A2 (de) * 1982-12-30 1984-08-08 Nordmark Arzneimittel GmbH Verfahren zur Gewinnung von Pankreatin
US20040057944A1 (en) * 2001-01-19 2004-03-25 Solvay Pharmaceuticals Gmbh Microbial enzyme mixtures useful to treat digestive disorders
CA2419572A1 (en) * 2003-02-18 2004-08-18 Axcan Pharma Inc. High dosage protease formulation
RU2445952C2 (ru) * 2007-02-20 2012-03-27 Юранд Фармасьютикалз Лимитед Стабильные композиции пищеварительных ферментов

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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
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
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
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
EP0115023A2 (de) * 1982-12-30 1984-08-08 Nordmark Arzneimittel GmbH Verfahren zur Gewinnung von Pankreatin
US20040057944A1 (en) * 2001-01-19 2004-03-25 Solvay Pharmaceuticals Gmbh Microbial enzyme mixtures useful to treat digestive disorders
CA2419572A1 (en) * 2003-02-18 2004-08-18 Axcan Pharma Inc. High dosage protease formulation
RU2445952C2 (ru) * 2007-02-20 2012-03-27 Юранд Фармасьютикалз Лимитед Стабильные композиции пищеварительных ферментов

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
DELHAYE M. "Comparative evaluation of a high lipase pancreatic enzyme preparation and a standard pancreatic supplement for treating exocrine pancreatic insufficiency in chronic pancreatitis" Eur J Gastroenterol Hepatol. 1996 Jul; 8(7): 699-703. *
DELHAYE M. "Comparative evaluation of a high lipase pancreatic enzyme preparation and a standard pancreatic supplement for treating exocrine pancreatic insufficiency in chronic pancreatitis" Eur J Gastroenterol Hepatol. 1996 Jul; 8(7): 699-703. JI-HWAN HWANG "Selective Precipitation of Proteins from Pancreatin Using Designed Antisolvents" Ind. Eng. Chem. Res. 2007, 46, 4289-4294. *
JI-HWAN HWANG "Selective Precipitation of Proteins from Pancreatin Using Designed Antisolvents" Ind. Eng. Chem. Res. 2007, 46, 4289-4294. *
TERUO NAKAMURA et al. "Effects of high-lipase pancreatin on fecal fat, neutral sterol, bile acid, and short-chain fatty acid excretion in patients with pancreatic insufficiency resulting from chronic pancreatitis" International Journal of Pancreatology, February 1998, Volume 23, Issue 1, pp. 63-70. *

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
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
ES2743212T5 (es) 2023-04-25
IL243627A0 (en) 2016-03-31

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