DE60110106D1 - Verfahren zur herstellung von pankreasenzym enthaltende mikrosphären mit hoher stabilität - Google Patents
Verfahren zur herstellung von pankreasenzym enthaltende mikrosphären mit hoher stabilitätInfo
- Publication number
- DE60110106D1 DE60110106D1 DE60110106T DE60110106T DE60110106D1 DE 60110106 D1 DE60110106 D1 DE 60110106D1 DE 60110106 T DE60110106 T DE 60110106T DE 60110106 T DE60110106 T DE 60110106T DE 60110106 D1 DE60110106 D1 DE 60110106D1
- Authority
- DE
- Germany
- Prior art keywords
- producing
- pancreasenzym
- high stability
- containing microspheres
- microspheres
- 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.)
- Expired - Lifetime
Links
- 239000004005 microsphere Substances 0.000 title abstract 3
- 238000004519 manufacturing process Methods 0.000 title 1
- 238000000034 method Methods 0.000 abstract 3
- 102000004190 Enzymes Human genes 0.000 abstract 2
- 108090000790 Enzymes Proteins 0.000 abstract 2
- 230000002255 enzymatic effect Effects 0.000 abstract 1
- 238000002844 melting Methods 0.000 abstract 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 1
- 239000000546 pharmaceutical excipient Substances 0.000 abstract 1
- 229920000642 polymer Polymers 0.000 abstract 1
- 239000002904 solvent Substances 0.000 abstract 1
Classifications
-
- 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
-
- 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
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
-
- 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
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
- A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
-
- 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
- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
-
- 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
- A61P11/00—Drugs for disorders of the respiratory system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- 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
- C12N11/00—Carrier-bound or immobilised enzymes; Carrier-bound or immobilised microbial cells; Preparation thereof
- C12N11/02—Enzymes or microbial cells immobilised on or in an organic carrier
- C12N11/08—Enzymes or microbial cells immobilised on or in an organic carrier the carrier being a synthetic polymer
- C12N11/082—Enzymes or microbial cells immobilised on or in an organic carrier the carrier being a synthetic polymer obtained by reactions only involving carbon-to-carbon unsaturated bonds
-
- 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
- C12N11/00—Carrier-bound or immobilised enzymes; Carrier-bound or immobilised microbial cells; Preparation thereof
- C12N11/02—Enzymes or microbial cells immobilised on or in an organic carrier
- C12N11/08—Enzymes or microbial cells immobilised on or in an organic carrier the carrier being a synthetic polymer
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Gastroenterology & Hepatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Genetics & Genomics (AREA)
- Wood Science & Technology (AREA)
- Zoology (AREA)
- Biotechnology (AREA)
- General Engineering & Computer Science (AREA)
- Pulmonology (AREA)
- Nutrition Science (AREA)
- Biochemistry (AREA)
- Microbiology (AREA)
- Biomedical Technology (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Enzymes And Modification Thereof (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT2000MI002456A IT1319655B1 (it) | 2000-11-15 | 2000-11-15 | Microsfere di enzimi pancreatici con elevata stabilita' e relativometodo di preparazione. |
| ITMI20002456 | 2000-11-15 | ||
| PCT/EP2001/013115 WO2002040045A2 (en) | 2000-11-15 | 2001-11-13 | Microspheres of pancreatic enzymes with high stability |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| DE60110106D1 true DE60110106D1 (de) | 2005-05-19 |
| DE60110106T2 DE60110106T2 (de) | 2006-03-02 |
Family
ID=11446110
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DE60110106T Expired - Lifetime DE60110106T2 (de) | 2000-11-15 | 2001-11-13 | Verfahren zur herstellung von pankreasenzym enthaltende mikrosphären mit hoher stabilität |
Country Status (11)
| Country | Link |
|---|---|
| US (2) | US9259393B2 (de) |
| EP (1) | EP1335706B1 (de) |
| JP (1) | JP4555981B2 (de) |
| KR (1) | KR20030060105A (de) |
| AT (1) | ATE292959T1 (de) |
| AU (1) | AU2002224843A1 (de) |
| CA (1) | CA2428837A1 (de) |
| DE (1) | DE60110106T2 (de) |
| ES (1) | ES2240559T3 (de) |
| IT (1) | IT1319655B1 (de) |
| WO (1) | WO2002040045A2 (de) |
Families Citing this family (48)
| 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 |
| AU2006274835B2 (en) * | 2005-07-29 | 2012-05-24 | Abbott Laboratories Gmbh | Processes for the manufacture of sterilized pancreatin powder |
| US9198871B2 (en) | 2005-08-15 | 2015-12-01 | Abbott Products Gmbh | Delayed release pancreatin compositions |
| DE602006012346D1 (de) * | 2005-08-15 | 2010-04-01 | Solvay Pharm Gmbh | Pharmazeutische zusammensetzungen mit kontrollierter freisetzung für säurelabile arzneimittel |
| US11266607B2 (en) | 2005-08-15 | 2022-03-08 | AbbVie Pharmaceuticals GmbH | Process for the manufacture and use of pancreatin micropellet cores |
| DK1931316T4 (en) * | 2005-08-15 | 2017-05-15 | Abbott Laboratories Gmbh | Controlled-release pharmaceutical compositions for use in acid-labile drugs |
| JP5284092B2 (ja) * | 2005-08-15 | 2013-09-11 | アボット ラボラトリーズ ゲゼルシャフト ミット ベシュレンクテル ハフツング | 腸溶コーティングに適したパンクレアチンマイクロペレットコア |
| CN101242812B (zh) * | 2005-08-15 | 2012-12-26 | 雅培产品有限公司 | 适合肠溶包衣的胰酶微丸芯 |
| 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 |
| TWI421090B (zh) | 2007-02-20 | 2014-01-01 | Aptalis Pharma Ltd | 穩定之消化酵素組合物 |
| RU2445952C2 (ru) * | 2007-02-20 | 2012-03-27 | Юранд Фармасьютикалз Лимитед | Стабильные композиции пищеварительных ферментов |
| US20090130063A1 (en) * | 2007-11-15 | 2009-05-21 | Solvay Pharmaceuticals Gmbh | Process for separating and determining the viral load in a pancreatin sample |
| US10087493B2 (en) | 2008-03-07 | 2018-10-02 | Aptalis Pharma Canada Ulc | 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 |
| PL2318035T3 (pl) * | 2008-07-01 | 2019-10-31 | Curemark Llc | Sposoby i kompozycje do leczenia objawów zaburzeń neurologicznych i zaburzeń zdrowia psychicznego |
| 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 |
| US20100092447A1 (en) | 2008-10-03 | 2010-04-15 | Fallon Joan M | Methods and compositions for the treatment of symptoms of prion diseases |
| EP2373693A4 (de) | 2009-01-06 | 2012-04-25 | Curelon Llc | Zusammensetzungen und verfahren zur behandlung bzw. prävention von mundinfektionen durch e.coli |
| CN102300989B (zh) | 2009-01-06 | 2015-12-09 | 柯尔朗恩有限责任公司 | 用于治疗或预防金黄色葡萄球菌感染以及用于根除或减少表面上金黄色葡萄球菌的组合物和方法 |
| US9056050B2 (en) | 2009-04-13 | 2015-06-16 | Curemark Llc | Enzyme delivery systems and methods of preparation and use |
| WO2011050135A1 (en) | 2009-10-21 | 2011-04-28 | Curemark Llc | Methods and compositions for the prevention and treatment of influenza |
| WO2011090725A2 (en) * | 2009-12-29 | 2011-07-28 | Impax Laboratories, Inc. | Gastroretentive solid oral dosage forms with swellable hydrophilic polymer |
| AU2011248293A1 (en) * | 2010-05-03 | 2012-11-15 | Eurand Pharmaceuticals Limited | Micropellet compositions comprising pancreatin containing digestive enzyme mixtures |
| PT2621476E (pt) | 2010-10-01 | 2014-10-16 | Aptalis Pharma Ltd | Formulações de pancrelipase de baixa potência com revestimento entérico |
| US20140147500A1 (en) * | 2010-11-19 | 2014-05-29 | Joan M. Fallon | Preparation and Use of Combination Enzyme and Gastrointestinal Modulator Delivery Systems |
| JP5976100B2 (ja) | 2011-04-21 | 2016-08-23 | キュアマーク リミテッド ライアビリティ カンパニー | 神経精神障害の処置のための化合物 |
| RU2016119726A (ru) | 2011-08-08 | 2018-11-02 | Апталис Фарма Лтд. | Способ проведения теста на растворение твердых композиций, содержащих пищеварительные ферменты |
| US10350278B2 (en) | 2012-05-30 | 2019-07-16 | Curemark, Llc | Methods of treating Celiac disease |
| EP2903603A4 (de) | 2012-09-27 | 2016-08-10 | Cynvenio Biosystems Inc | Stimulusempfindliche mikropartikel und verfahren zur verwendung |
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| JP2017519490A (ja) | 2014-06-19 | 2017-07-20 | アプタリス ファルマ リミテッド | 膵臓抽出物からのウイルス汚染の除去方法 |
| CN107073084B (zh) | 2014-11-05 | 2022-03-25 | 雅培制药股份有限公司 | 用于生产具有改善的安全特性的具有脂肪酶活性的组合物和适用于药物用途的组合物的方法 |
| US12226464B2 (en) | 2017-04-10 | 2025-02-18 | Curemark, Llc | Compositions for treating addiction |
| CN110075279A (zh) * | 2019-04-25 | 2019-08-02 | 淮安麦德森制药有限公司 | 胰酶微球及其生产方法 |
| US11541009B2 (en) | 2020-09-10 | 2023-01-03 | Curemark, Llc | Methods of prophylaxis of coronavirus infection and treatment of coronaviruses |
| CN113046233B (zh) * | 2021-03-15 | 2022-07-15 | 中国科学院过程工程研究所 | 一种微球-膜集成酶反应器及其制备方法和应用 |
| US12350641B2 (en) * | 2021-07-16 | 2025-07-08 | Clearh2O, Inc. | Methods of high throughput hydrocolloid bead production and apparatuses thereof |
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-
2000
- 2000-11-15 IT IT2000MI002456A patent/IT1319655B1/it active
-
2001
- 2001-11-13 DE DE60110106T patent/DE60110106T2/de not_active Expired - Lifetime
- 2001-11-13 AT AT01994654T patent/ATE292959T1/de not_active IP Right Cessation
- 2001-11-13 AU AU2002224843A patent/AU2002224843A1/en not_active Abandoned
- 2001-11-13 KR KR10-2003-7006513A patent/KR20030060105A/ko not_active Withdrawn
- 2001-11-13 US US10/416,702 patent/US9259393B2/en not_active Expired - Fee Related
- 2001-11-13 CA CA002428837A patent/CA2428837A1/en not_active Abandoned
- 2001-11-13 JP JP2002542417A patent/JP4555981B2/ja not_active Expired - Fee Related
- 2001-11-13 EP EP01994654A patent/EP1335706B1/de not_active Revoked
- 2001-11-13 WO PCT/EP2001/013115 patent/WO2002040045A2/en not_active Ceased
- 2001-11-13 ES ES01994654T patent/ES2240559T3/es not_active Expired - Lifetime
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2015
- 2015-11-30 US US14/953,638 patent/US9884025B2/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| ES2240559T3 (es) | 2005-10-16 |
| EP1335706B1 (de) | 2005-04-13 |
| CA2428837A1 (en) | 2002-05-23 |
| WO2002040045A2 (en) | 2002-05-23 |
| US9259393B2 (en) | 2016-02-16 |
| US20040101562A1 (en) | 2004-05-27 |
| ATE292959T1 (de) | 2005-04-15 |
| WO2002040045A3 (en) | 2002-10-31 |
| EP1335706A2 (de) | 2003-08-20 |
| AU2002224843A1 (en) | 2002-05-27 |
| US9884025B2 (en) | 2018-02-06 |
| US20160120815A1 (en) | 2016-05-05 |
| ITMI20002456A1 (it) | 2002-05-15 |
| JP4555981B2 (ja) | 2010-10-06 |
| JP2004513645A (ja) | 2004-05-13 |
| IT1319655B1 (it) | 2003-10-23 |
| KR20030060105A (ko) | 2003-07-12 |
| DE60110106T2 (de) | 2006-03-02 |
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