US20070148151A1 - Processes for the manufacture and use of pancreatin - Google Patents

Processes for the manufacture and use of pancreatin Download PDF

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Publication number
US20070148151A1
US20070148151A1 US11/460,330 US46033006A US2007148151A1 US 20070148151 A1 US20070148151 A1 US 20070148151A1 US 46033006 A US46033006 A US 46033006A US 2007148151 A1 US2007148151 A1 US 2007148151A1
Authority
US
United States
Prior art keywords
pancreatin
heating
solvents
hours
pharmaceutical composition
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.)
Abandoned
Application number
US11/460,330
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English (en)
Inventor
Martin Frink
Claus-Juergen Koelln
Heinz Blume
Michael Rust
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.)
Abbott Products GmbH
Original Assignee
Solvay Pharmaceuticals GmbH
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=35457614&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=US20070148151(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Solvay Pharmaceuticals GmbH filed Critical Solvay Pharmaceuticals GmbH
Priority to US11/460,330 priority Critical patent/US20070148151A1/en
Assigned to SOLVAY PHARMACEUTICALS GMBH reassignment SOLVAY PHARMACEUTICALS GMBH ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: FRINK, MARTIN, BLUME, HEINZ, RUST, MICHAEL, KOELLN, CLAUS-JUERGEN
Publication of US20070148151A1 publication Critical patent/US20070148151A1/en
Assigned to ABBOTT PRODUCTS GMBH reassignment ABBOTT PRODUCTS GMBH CHANGE OF NAME (SEE DOCUMENT FOR DETAILS). Assignors: SOLVAY PHARMACEUTICALS GMBH
Priority to US15/214,973 priority patent/US10704037B2/en
Priority to US16/893,036 priority patent/US20200299669A1/en
Abandoned legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/94Pancreatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/37Digestive system
    • A61K35/39Pancreas; Islets of Langerhans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/54Mixtures of enzymes or proenzymes covered by more than a single one of groups A61K38/44 - A61K38/46 or A61K38/51 - A61K38/53
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/04Heat
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/14Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/18Drugs for disorders of the alimentary tract or the digestive system for pancreatic disorders, e.g. pancreatic enzymes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Genetics & Genomics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • General Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Cell Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Developmental Biology & Embryology (AREA)
  • Virology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
US11/460,330 2005-07-29 2006-07-27 Processes for the manufacture and use of pancreatin Abandoned US20070148151A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US11/460,330 US20070148151A1 (en) 2005-07-29 2006-07-27 Processes for the manufacture and use of pancreatin
US15/214,973 US10704037B2 (en) 2005-07-29 2016-07-20 Processes for the manufacture and use of pancreatin
US16/893,036 US20200299669A1 (en) 2005-07-29 2020-06-04 Processes for the Manufacture and Use of Pancreatin

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US70381305P 2005-07-29 2005-07-29
EP05016533 2005-07-29
US11/460,330 US20070148151A1 (en) 2005-07-29 2006-07-27 Processes for the manufacture and use of pancreatin

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US15/214,973 Continuation US10704037B2 (en) 2005-07-29 2016-07-20 Processes for the manufacture and use of pancreatin

Publications (1)

Publication Number Publication Date
US20070148151A1 true US20070148151A1 (en) 2007-06-28

Family

ID=35457614

Family Applications (3)

Application Number Title Priority Date Filing Date
US11/460,330 Abandoned US20070148151A1 (en) 2005-07-29 2006-07-27 Processes for the manufacture and use of pancreatin
US15/214,973 Active US10704037B2 (en) 2005-07-29 2016-07-20 Processes for the manufacture and use of pancreatin
US16/893,036 Abandoned US20200299669A1 (en) 2005-07-29 2020-06-04 Processes for the Manufacture and Use of Pancreatin

Family Applications After (2)

Application Number Title Priority Date Filing Date
US15/214,973 Active US10704037B2 (en) 2005-07-29 2016-07-20 Processes for the manufacture and use of pancreatin
US16/893,036 Abandoned US20200299669A1 (en) 2005-07-29 2020-06-04 Processes for the Manufacture and Use of Pancreatin

Country Status (18)

Country Link
US (3) US20070148151A1 (pt)
EP (2) EP2278002B1 (pt)
JP (1) JP5140586B2 (pt)
KR (1) KR101555058B1 (pt)
CN (1) CN101233229B (pt)
AU (1) AU2006274835B2 (pt)
BR (1) BRPI0614914A2 (pt)
CA (1) CA2616943C (pt)
ES (2) ES2635308T3 (pt)
HK (1) HK1120288A1 (pt)
HU (2) HUE031042T2 (pt)
IL (1) IL189103A (pt)
MX (1) MX2008000850A (pt)
NO (2) NO340996B1 (pt)
PL (2) PL2278002T3 (pt)
RU (1) RU2413532C2 (pt)
UA (1) UA93384C2 (pt)
WO (1) WO2007014896A1 (pt)

Cited By (36)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040071683A1 (en) * 1999-12-17 2004-04-15 Fallon Joan M. Methods for treating pervasive development disorders
US20050250817A1 (en) * 2004-03-22 2005-11-10 Solvay Pharmaceuticals Gmbh Pharmaceutical compositions of lipase-containing products, in particular of pancreation
US20070116695A1 (en) * 2005-09-21 2007-05-24 Fallon Joan M Pharmaceutical preparations for attention deficit disorder, attention deficit hyperactivity disorder and other associated disorders
US20070148153A1 (en) * 2005-08-15 2007-06-28 George Shlieout Controlled release pharmaceutical compositions for acid-labile drugs
US20070148152A1 (en) * 2005-08-15 2007-06-28 George Shlieout Process for the manufacture and use of pancreatin micropellet cores
US20070270976A1 (en) * 2002-04-25 2007-11-22 Ultraflex Systems, Inc. Ambulating ankle & knee joints with bidirectional dampening and assistance using elastomeric restraint
US20080019959A1 (en) * 2006-05-22 2008-01-24 Dietmar Becher Process for separating and determining the viral load in a pancreatin sample
US20080152637A1 (en) * 2000-08-14 2008-06-26 Fallon Joan M Methods of treating and diagnosing parkinsons disease and related dysautonomic disorders
US20080166334A1 (en) * 2004-09-28 2008-07-10 Fallon Joan M Combination enzyme for cystic fibrosis
DE202008014562U1 (de) 2008-11-03 2009-02-26 Nordmark Arzneimittel Gmbh & Co. Kg Pankreatin
US20090130063A1 (en) * 2007-11-15 2009-05-21 Solvay Pharmaceuticals Gmbh Process for separating and determining the viral load in a pancreatin sample
US20090226414A1 (en) * 2008-03-07 2009-09-10 Axcan Pharma Inc. Method for detecting infectious parvovirus in pharmaceutical preparations
US20090233344A1 (en) * 2008-03-11 2009-09-17 Nordmark Arzneimittel Gmbh & Co. Kg Pancreatin and method for reducing the viral and microbial contamination of pancreatin
US20090232789A1 (en) * 2008-03-13 2009-09-17 Fallon Joan M Novel pharmaceutical preparation for preeclampsia, eclampsia, and toxemia, and their related symptoms and related disorders of pregnancy
US20090324572A1 (en) * 2008-06-26 2009-12-31 Fallon Joan M Methods and compositions for the treatment of symptoms of williams syndrome
US20090324730A1 (en) * 2008-06-26 2009-12-31 Fallon Joan M Methods and compositions for the treatment of symptoms of complex regional pain syndrome
US20100092447A1 (en) * 2008-10-03 2010-04-15 Fallon Joan M Methods and compositions for the treatment of symptoms of prion diseases
US20100169409A1 (en) * 2008-08-04 2010-07-01 Fallon Joan M Systems and methods employing remote data gathering and monitoring for diagnosing, staging, and treatment of parkinsons disease, movement and neurological disorders, and chronic pain
US20100260857A1 (en) * 2009-04-13 2010-10-14 Joan Fallon Enzyme delivery systems and methods of preparation and use
WO2011035079A1 (en) 2009-09-17 2011-03-24 Eurand, Inc. Pancreatic enzyme compositions and methods for treating pancreatitis and pancreatic insufficiency
US20110182818A1 (en) * 2008-07-01 2011-07-28 Fallon Joan M Methods and compositions for the treatment of symptoms of neurological and mental health disorders
US8318158B2 (en) 2008-04-18 2012-11-27 Curemark, Llc Pharmaceutical preparation for the treatment of the symptoms of addiction and method of diagnosing same
US8580522B2 (en) 2000-11-16 2013-11-12 Curemark, Llc Methods for diagnosing pervasive development disorders, dysautonomia and other neurological conditions
US8673877B2 (en) 2005-08-30 2014-03-18 Curemark, Llc Use of lactulose in the treatment of autism
US8980252B2 (en) 2011-04-21 2015-03-17 Curemark Llc Methods of treatment of schizophrenia
US9084784B2 (en) 2009-01-06 2015-07-21 Curelon Llc Compositions and methods for the treatment or the prevention of E. coli infections and for the eradication or reduction of E. coli surfaces
US9107419B2 (en) 2009-01-06 2015-08-18 Curelon Llc Compositions and methods for treatment or prevention of Staphylococcus aureus infections and for the eradication or reduction of Staphylococcus aureus on surfaces
US9259393B2 (en) 2000-11-15 2016-02-16 Aptalis Pharma S.R.L. Microspheres of pancreatic enzymes with high stability and production method thereof
US9511125B2 (en) 2009-10-21 2016-12-06 Curemark Llc Methods and compositions for the treatment of influenza
US9976171B2 (en) 2011-08-08 2018-05-22 Allergan Pharmaceuticals International Limited 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
US10206882B2 (en) 2007-02-20 2019-02-19 Allergan Pharmaceuticals International Limited Stable digestive enzyme compositions
US10350278B2 (en) 2012-05-30 2019-07-16 Curemark, Llc Methods of treating Celiac disease
US10993996B2 (en) 2013-08-09 2021-05-04 Allergan Pharmaceuticals International Limited Digestive enzyme composition suitable for enteral administration
US11364205B2 (en) 2010-10-01 2022-06-21 Societe Des Produits Nestle S.A. Stable low digestive enzyme content formulation
US11541009B2 (en) 2020-09-10 2023-01-03 Curemark, Llc Methods of prophylaxis of coronavirus infection and treatment of coronaviruses

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007014896A1 (en) 2005-07-29 2007-02-08 Solvay Pharmaceuticals Gmbh Processes for the manufacture of sterilized pancreatin powder
WO2009063065A1 (en) * 2007-11-15 2009-05-22 Solvay Pharmaceuticals Gmbh Novel process for separating and determining the viral load in a pancreatin sample
EP2165717A1 (de) 2008-08-27 2010-03-24 Nordmark Arzneimittel GmbH & Co.KG Verfahren zur Verringerung der viralen und mikrobiellen Belastung feststoffhaltiger biologischer Extrakte
CN102884181A (zh) * 2010-03-19 2013-01-16 加拿大阿普塔利斯制药公司 用于药用胰腺酶制剂中的病毒灭活的β-丙内酯
JP5814094B2 (ja) * 2011-11-30 2015-11-17 ふたみ青果株式会社 遠赤外線ヒーターによる凍結乾燥方法とその装置
ES2834483T3 (es) 2013-11-05 2021-06-17 Allergan Pharmaceuticals Int Ltd Composiciones farmacéuticas de pancreatina de alta potencia
EP3215181A1 (en) * 2014-11-05 2017-09-13 Abbott Laboratories GmbH Processes for producing compositions with improved safety profile comprising pancreatin and compositions suitable for pharmaceutical use
WO2016187455A1 (en) 2015-05-19 2016-11-24 Scientific Protein Laboratories, Llc Method for reducing or inactivating viral and microbial content in the processes for the manufacture of pancreatin
DE102015119006A1 (de) 2015-11-05 2017-05-11 Nordmark Arzneimittel Gmbh & Co. Kg Verfahren zur Reduzierung der Belastung von Pankreatin mit Mikroorganismen
PT3436055T (pt) 2016-03-28 2024-01-29 Abbott Laboratories Gmbh Composições enzimáticas com uma reduzida contaminação viral e microbiana
US11278603B2 (en) 2016-03-28 2022-03-22 Abbvie Inc. Enzyme compositions with reduced viral and microbial contamination
KR101813920B1 (ko) * 2016-07-06 2018-01-04 넨시스(주) 판크레아틴의 살균방법 및 이를 이용한 판크레아틴 제조방법
WO2019067743A1 (en) 2017-09-27 2019-04-04 Abbvie Inc. ENZYME COMPOSITIONS HAVING MICROBIAL CONTAMINATION AND REDUCED VIRAL

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