RU2008107261A - Способ получения стерилизованного порошкообразного панкреатина - Google Patents
Способ получения стерилизованного порошкообразного панкреатина Download PDFInfo
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- RU2008107261A RU2008107261A RU2008107261/15A RU2008107261A RU2008107261A RU 2008107261 A RU2008107261 A RU 2008107261A RU 2008107261/15 A RU2008107261/15 A RU 2008107261/15A RU 2008107261 A RU2008107261 A RU 2008107261A RU 2008107261 A RU2008107261 A RU 2008107261A
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- 108010019160 Pancreatin Proteins 0.000 title claims abstract 32
- 229940055695 pancreatin Drugs 0.000 title claims abstract 32
- 239000000843 powder Substances 0.000 title claims 6
- 238000004519 manufacturing process Methods 0.000 title 1
- 238000000034 method Methods 0.000 claims abstract 48
- 238000010438 heat treatment Methods 0.000 claims abstract 20
- 239000002904 solvent Substances 0.000 claims abstract 18
- 239000008187 granular material Substances 0.000 claims 6
- 239000008194 pharmaceutical composition Substances 0.000 claims 6
- 102000004882 Lipase Human genes 0.000 claims 4
- 108090001060 Lipase Proteins 0.000 claims 4
- 239000004367 Lipase Substances 0.000 claims 4
- 239000002552 dosage form Substances 0.000 claims 4
- 230000000694 effects Effects 0.000 claims 4
- 235000019421 lipase Nutrition 0.000 claims 4
- 239000004005 microsphere Substances 0.000 claims 3
- 239000008188 pellet Substances 0.000 claims 3
- 239000002775 capsule Substances 0.000 claims 2
- 239000012535 impurity Substances 0.000 claims 2
- -1 micropellets Substances 0.000 claims 2
- 239000000546 pharmaceutical excipient Substances 0.000 claims 2
- 238000004448 titration Methods 0.000 claims 2
- 230000003612 virological effect Effects 0.000 claims 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 2
- 239000006185 dispersion Substances 0.000 claims 1
- 239000000839 emulsion Substances 0.000 claims 1
- 239000012055 enteric layer Substances 0.000 claims 1
- 210000004211 gastric acid Anatomy 0.000 claims 1
- 239000000725 suspension Substances 0.000 claims 1
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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)
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- 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
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/37—Digestive system
- A61K35/39—Pancreas; Islets of Langerhans
-
- 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
- A61L—METHODS 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
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/04—Heat
-
- 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
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
-
- 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
- A61K9/10—Dispersions; Emulsions
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
-
- 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
- A61K9/20—Pills, tablets, discs, rods
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- 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)
- Genetics & Genomics (AREA)
- Wood Science & Technology (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
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- Pharmacology & Pharmacy (AREA)
- Biomedical Technology (AREA)
- Biotechnology (AREA)
- Molecular Biology (AREA)
- General Engineering & Computer Science (AREA)
- Biochemistry (AREA)
- Microbiology (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Nutrition Science (AREA)
- Cell Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Virology (AREA)
- Physiology (AREA)
- Developmental Biology & Embryology (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)
Abstract
1. Способ получения панкреатина, включающий нагревание диспергированной формы панкреатина, содержащей один или более растворителей, при температуре по крайней мере 85°С с получением общего содержания растворителей в диспергированной форме панкреатина менее 9 мас.% в любой момент процесса указанного нагревания. ! 2. Способ по п.1, включающий следующие стадии ! (а) предварительное нагревание диспергированной формы панкреатина, содержащего один или более растворителей, до температуры по крайней мере 85°С и ! (б) продолжение нагревания диспергированной формы панкреатина при температуре по крайней мере 85°С в течение периода до 48 ч, с получением общего содержания растворителей в диспергированной форме панкреатина менее 9 мас.% в любой момент процесса стадии (б). ! 3. Способ по п.1, в котором полученное общее содержание растворителей равно или менее 3,5 мас.%. ! 4. Способ по п.2, в котором полученное общее содержание растворителей равно или менее 3,5 мас.%. ! 5. Способ по п.1, который обеспечивает содержание растворителей от 0,1 до 3,5 мас.%. ! 6. Способ по п.2, который обеспечивает содержание растворителей от 0,1 до 3,5 мас.%. ! 7. Способ по п.2, в котором нагревание панкреатина на стадии (б) проводят в течение от 1 до 36 ч. ! 8. Способ по п.2, в котором нагревание панкреатина на стадии (б) проводят в течение от 8 до 30 ч. ! 9. Способ по п.1, в котором температура составляет от 85 до 100°С. ! 10. Способ по п.2, в котором температура процесса на стадии а) и температура процесса на стадии б) в обоих случаях составляет от 85 до 100°С. ! 11. Способ по п.1, в котором температура составляет от 85 до 95°С. ! 12. Способ по п.2, в котором температура на стадии а) и на стадии б) в обоих случаях составля
Claims (32)
1. Способ получения панкреатина, включающий нагревание диспергированной формы панкреатина, содержащей один или более растворителей, при температуре по крайней мере 85°С с получением общего содержания растворителей в диспергированной форме панкреатина менее 9 мас.% в любой момент процесса указанного нагревания.
2. Способ по п.1, включающий следующие стадии
(а) предварительное нагревание диспергированной формы панкреатина, содержащего один или более растворителей, до температуры по крайней мере 85°С и
(б) продолжение нагревания диспергированной формы панкреатина при температуре по крайней мере 85°С в течение периода до 48 ч, с получением общего содержания растворителей в диспергированной форме панкреатина менее 9 мас.% в любой момент процесса стадии (б).
3. Способ по п.1, в котором полученное общее содержание растворителей равно или менее 3,5 мас.%.
4. Способ по п.2, в котором полученное общее содержание растворителей равно или менее 3,5 мас.%.
5. Способ по п.1, который обеспечивает содержание растворителей от 0,1 до 3,5 мас.%.
6. Способ по п.2, который обеспечивает содержание растворителей от 0,1 до 3,5 мас.%.
7. Способ по п.2, в котором нагревание панкреатина на стадии (б) проводят в течение от 1 до 36 ч.
8. Способ по п.2, в котором нагревание панкреатина на стадии (б) проводят в течение от 8 до 30 ч.
9. Способ по п.1, в котором температура составляет от 85 до 100°С.
10. Способ по п.2, в котором температура процесса на стадии а) и температура процесса на стадии б) в обоих случаях составляет от 85 до 100°С.
11. Способ по п.1, в котором температура составляет от 85 до 95°С.
12. Способ по п.2, в котором температура на стадии а) и на стадии б) в обоих случаях составляет от 85 до 95°С.
13. Способ по п.1, в котором нагревание проводят в непрерывном режиме.
14. Способ по п.1, в котором нагревание проводят в ступенчатом режиме.
15. Способ по п.2, в котором нагревание на стадии б) проводят в непрерывном режиме.
16. Способ по п.2, в котором нагревание на стадии б) проводят в ступенчатом режиме.
17. Способ по любому из предшествующих пунктов, в котором титр вирусной примеси в диспергированном панкреатине после нагревания по крайней мере в 1000 раз меньше, предпочтительно в 10000 раз меньше, чем титр указанной вирусной примеси в диспергированном панкреатине до нагревания.
18. Способ по п.1, в котором содержание растворителей в диспергированной форме панкреатина в процессе нагревания определяют термогравиметрическим методом и/или методом водного титрования по Карлу Фишеру.
19. Способ по п.2, в котором содержание растворителей в диспергированной форме панкреатина в процессе нагревания определяют термогравиметрическим методом и/или методом водного титрования по Карлу Фишеру.
20. Способ по п.1, в котором диспергированную форму панкреатина выбирают из порошка, пеллет, микропеллет, микросфер, гранул и гранулятов.
21. Способ по п.2, в котором диспергированную форму панкреатина выбирают из порошка, пеллет, микропеллет, микросфер, гранул и гранулятов.
22. Способ по п.1, в котором диспергированную форму панкреатина выбирают из порошка.
23. Способ по п.2, в котором диспергированную форму панкреатина выбирают из порошка.
24. Способ по п.1, в котором активность липазы в панкреатине после нагревания составляет по крайней мере 50% по сравнению с активностью липазы до нагревания.
25. Способ по п.2, в котором активность липазы в панкреатине после нагревания составляет по крайней мере 50% по сравнению с активностью липазы до нагревания.
26. Панкреатин, полученный согласно способу по любому из пп.1-24.
27. Фармацевтическая композиция, включающая фармацевтически эффективное количество панкреатина по п.26 и один или более фармацевтически приемлемых экципиентов.
28. Фармацевтическая композиция по п.27, содержащая панкреатин в виде лекарственной формы, предназначенной для перорального введения, с немедленным и/или модифицированным высвобождением, и указанную лекарственную форму выбирают из группы, включающей таблетки, микротаблетки, пеллеты, микропеллеты, микросферы, гранулы, грануляты, порошки, суспензии, эмульсии, дисперсии, капсулы и пакетики.
29. Фармацевтическая композиция по п.28, в которой панкреатин получают в виде лекарственной формы, покрытой энтеросолюбильным слоем, устойчивым к кислоте желудочного сока.
30. Фармацевтическая композиция по п.28 в форме капсулы или пакетика.
31. Фармацевтическая композиция по п.28 или 29, которая представляет собой лекарственную форму для перорального введения с немедленным и/или модифицированным высвобождением.
32. Фармацевтическая композиция по п.27, содержащая
(а) от 50 до 90 мас.% панкреатина и
(б) от 10 до 50 мас.% фармацевтически приемлемых эксципиентов.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US70381305P | 2005-07-29 | 2005-07-29 | |
| US60/703,813 | 2005-07-29 | ||
| EP05016533,1 | 2005-07-29 | ||
| EP05016533 | 2005-07-29 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RU2008107261A true RU2008107261A (ru) | 2009-09-10 |
| RU2413532C2 RU2413532C2 (ru) | 2011-03-10 |
Family
ID=35457614
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2008107261/15A RU2413532C2 (ru) | 2005-07-29 | 2006-07-27 | Способ получения стерилизованного порошкообразного панкреатина |
Country Status (17)
| Country | Link |
|---|---|
| US (3) | US20070148151A1 (ru) |
| EP (2) | EP2278002B1 (ru) |
| JP (1) | JP5140586B2 (ru) |
| KR (1) | KR101555058B1 (ru) |
| CN (1) | CN101233229B (ru) |
| AU (1) | AU2006274835B2 (ru) |
| BR (1) | BRPI0614914A2 (ru) |
| CA (1) | CA2616943C (ru) |
| ES (2) | ES2635308T3 (ru) |
| HU (2) | HUE031042T2 (ru) |
| IL (1) | IL189103A (ru) |
| MX (1) | MX2008000850A (ru) |
| NO (2) | NO340996B1 (ru) |
| PL (2) | PL1913138T3 (ru) |
| RU (1) | RU2413532C2 (ru) |
| UA (1) | UA93384C2 (ru) |
| WO (1) | WO2007014896A1 (ru) |
Families Citing this family (50)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6632429B1 (en) | 1999-12-17 | 2003-10-14 | Joan M. Fallon | Methods for treating pervasive development disorders |
| US20070053895A1 (en) * | 2000-08-14 | 2007-03-08 | Fallon Joan M | Method of treating and diagnosing parkinsons disease and related dysautonomic disorders |
| IT1319655B1 (it) | 2000-11-15 | 2003-10-23 | Eurand Int | Microsfere di enzimi pancreatici con elevata stabilita' e relativometodo di preparazione. |
| US8030002B2 (en) | 2000-11-16 | 2011-10-04 | Curemark Llc | Methods for diagnosing pervasive development disorders, dysautonomia and other neurological conditions |
| US8100844B2 (en) * | 2002-04-25 | 2012-01-24 | Ultraflex Systems, Inc. | Ambulating ankle and knee joints with bidirectional dampening and assistance using elastomeric restraint |
| JP5032300B2 (ja) * | 2004-03-22 | 2012-09-26 | アボット プロダクツ ゲゼルシャフト ミット ベシュレンクテル ハフツング | 界面活性剤を含有している、リパーゼを含有する生成物の、とりわけパンクレアチンの経口医薬組成物 |
| US20060198838A1 (en) * | 2004-09-28 | 2006-09-07 | Fallon Joan M | Combination enzyme for cystic fibrosis |
| EP2278002B1 (en) | 2005-07-29 | 2017-07-12 | Abbott Laboratories GmbH | Pancreatin with reduced viral content |
| US9198871B2 (en) * | 2005-08-15 | 2015-12-01 | Abbott Products Gmbh | Delayed release pancreatin compositions |
| US11266607B2 (en) * | 2005-08-15 | 2022-03-08 | AbbVie Pharmaceuticals GmbH | Process for the manufacture and use of pancreatin micropellet cores |
| US20080058282A1 (en) | 2005-08-30 | 2008-03-06 | Fallon Joan M | Use of lactulose in the treatment of autism |
| 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 |
| US10072256B2 (en) | 2006-05-22 | 2018-09-11 | Abbott Products Gmbh | Process for separating and determining the viral load in a pancreatin sample |
| US8246950B2 (en) | 2007-02-20 | 2012-08-21 | Aptalis Pharma Limited | Stable digestive enzyme compositions |
| US20090130063A1 (en) * | 2007-11-15 | 2009-05-21 | Solvay Pharmaceuticals Gmbh | Process for separating and determining the viral load in a pancreatin sample |
| CN101821389B (zh) * | 2007-11-15 | 2012-05-30 | 索尔瓦药物有限公司 | 用于分离和测定胰酶样品中病毒载量的新方法 |
| WO2009109856A2 (en) * | 2008-03-07 | 2009-09-11 | Axcan Pharma Inc. | Method for detecting infectious parvovirus in pharmaceutical preparations |
| US8658163B2 (en) * | 2008-03-13 | 2014-02-25 | Curemark Llc | Compositions and use thereof for treating symptoms of preeclampsia |
| US8084025B2 (en) | 2008-04-18 | 2011-12-27 | Curemark Llc | Method for the treatment of the symptoms of drug and alcohol addiction |
| US20090324730A1 (en) * | 2008-06-26 | 2009-12-31 | Fallon Joan M | Methods and compositions for the treatment of symptoms of complex regional pain syndrome |
| US9320780B2 (en) * | 2008-06-26 | 2016-04-26 | Curemark Llc | Methods and compositions for the treatment of symptoms of Williams Syndrome |
| EP2318035B1 (en) * | 2008-07-01 | 2019-06-12 | Curemark, Llc | Methods and compositions for the treatment of symptoms of neurological and mental health disorders |
| US10776453B2 (en) * | 2008-08-04 | 2020-09-15 | Galenagen, Llc | Systems and methods employing remote data gathering and monitoring for diagnosing, staging, and treatment of Parkinsons disease, movement and neurological disorders, and chronic pain |
| EP2165717A1 (de) * | 2008-08-27 | 2010-03-24 | Nordmark Arzneimittel GmbH & Co.KG | Verfahren zur Verringerung der viralen und mikrobiellen Belastung feststoffhaltiger biologischer Extrakte |
| US20100092447A1 (en) | 2008-10-03 | 2010-04-15 | Fallon Joan M | Methods and compositions for the treatment of symptoms of prion diseases |
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- 2006-07-27 EP EP10178590.5A patent/EP2278002B1/en not_active Revoked
- 2006-07-27 CA CA2616943A patent/CA2616943C/en active Active
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- 2006-07-27 ES ES10178590.5T patent/ES2635308T3/es active Active
- 2006-07-27 WO PCT/EP2006/064717 patent/WO2007014896A1/en not_active Ceased
- 2006-07-27 BR BRPI0614914-6A patent/BRPI0614914A2/pt not_active Application Discontinuation
- 2006-07-27 MX MX2008000850A patent/MX2008000850A/es active IP Right Grant
- 2006-07-27 PL PL06778012T patent/PL1913138T3/pl unknown
- 2006-07-27 ES ES06778012.2T patent/ES2597381T3/es active Active
- 2006-07-27 UA UAA200802536A patent/UA93384C2/ru unknown
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- 2006-07-27 RU RU2008107261/15A patent/RU2413532C2/ru active
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- 2006-07-27 CN CN2006800277018A patent/CN101233229B/zh active Active
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