RU2015155470A - Высокоэффективные фармацевтические композиции панкреатина - Google Patents
Высокоэффективные фармацевтические композиции панкреатина Download PDFInfo
- Publication number
- RU2015155470A RU2015155470A RU2015155470A RU2015155470A RU2015155470A RU 2015155470 A RU2015155470 A RU 2015155470A RU 2015155470 A RU2015155470 A RU 2015155470A RU 2015155470 A RU2015155470 A RU 2015155470A RU 2015155470 A RU2015155470 A RU 2015155470A
- Authority
- RU
- Russia
- Prior art keywords
- pancreatin
- stage
- solvent
- mpa
- hildebrand
- Prior art date
Links
- 108010019160 Pancreatin Proteins 0.000 title claims 34
- 229940055695 pancreatin Drugs 0.000 title claims 34
- 239000000203 mixture Substances 0.000 title claims 19
- 238000000034 method Methods 0.000 claims 53
- 239000002904 solvent Substances 0.000 claims 25
- 239000003960 organic solvent Substances 0.000 claims 19
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 claims 18
- 239000003125 aqueous solvent Substances 0.000 claims 15
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 13
- 239000007853 buffer solution Substances 0.000 claims 13
- 235000019626 lipase activity Nutrition 0.000 claims 11
- BFNBIHQBYMNNAN-UHFFFAOYSA-N ammonium sulfate Chemical class N.N.OS(O)(=O)=O BFNBIHQBYMNNAN-UHFFFAOYSA-N 0.000 claims 9
- 230000000694 effects Effects 0.000 claims 6
- 239000000725 suspension Substances 0.000 claims 6
- 238000001035 drying Methods 0.000 claims 5
- 239000000243 solution Substances 0.000 claims 5
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 claims 4
- 229910052921 ammonium sulfate Inorganic materials 0.000 claims 4
- 235000011130 ammonium sulphate Nutrition 0.000 claims 4
- 239000002244 precipitate Substances 0.000 claims 4
- 238000001556 precipitation Methods 0.000 claims 4
- 102000004169 proteins and genes Human genes 0.000 claims 4
- 108090000623 proteins and genes Proteins 0.000 claims 4
- 239000006228 supernatant Substances 0.000 claims 4
- WEVYAHXRMPXWCK-UHFFFAOYSA-N Acetonitrile Chemical compound CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 claims 3
- 239000004382 Amylase Substances 0.000 claims 3
- 102000013142 Amylases Human genes 0.000 claims 3
- 108010065511 Amylases Proteins 0.000 claims 3
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 claims 3
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 claims 3
- XEKOWRVHYACXOJ-UHFFFAOYSA-N Ethyl acetate Chemical compound CCOC(C)=O XEKOWRVHYACXOJ-UHFFFAOYSA-N 0.000 claims 3
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 claims 3
- ZMXDDKWLCZADIW-UHFFFAOYSA-N N,N-Dimethylformamide Chemical compound CN(C)C=O ZMXDDKWLCZADIW-UHFFFAOYSA-N 0.000 claims 3
- IMNFDUFMRHMDMM-UHFFFAOYSA-N N-Heptane Chemical compound CCCCCCC IMNFDUFMRHMDMM-UHFFFAOYSA-N 0.000 claims 3
- 108091005804 Peptidases Proteins 0.000 claims 3
- 239000004365 Protease Substances 0.000 claims 3
- 102100037486 Reverse transcriptase/ribonuclease H Human genes 0.000 claims 3
- 235000019418 amylase Nutrition 0.000 claims 3
- HEDRZPFGACZZDS-UHFFFAOYSA-N Chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 claims 2
- IAZDPXIOMUYVGZ-UHFFFAOYSA-N Dimethylsulphoxide Chemical compound CS(C)=O IAZDPXIOMUYVGZ-UHFFFAOYSA-N 0.000 claims 2
- LRHPLDYGYMQRHN-UHFFFAOYSA-N N-Butanol Chemical compound CCCCO LRHPLDYGYMQRHN-UHFFFAOYSA-N 0.000 claims 2
- OFBQJSOFQDEBGM-UHFFFAOYSA-N Pentane Chemical compound CCCCC OFBQJSOFQDEBGM-UHFFFAOYSA-N 0.000 claims 2
- WYURNTSHIVDZCO-UHFFFAOYSA-N Tetrahydrofuran Chemical compound C1CCOC1 WYURNTSHIVDZCO-UHFFFAOYSA-N 0.000 claims 2
- 239000012062 aqueous buffer Substances 0.000 claims 2
- 238000001914 filtration Methods 0.000 claims 2
- VLKZOEOYAKHREP-UHFFFAOYSA-N n-Hexane Chemical compound CCCCCC VLKZOEOYAKHREP-UHFFFAOYSA-N 0.000 claims 2
- 239000002245 particle Substances 0.000 claims 2
- 239000008194 pharmaceutical composition Substances 0.000 claims 2
- 230000001376 precipitating effect Effects 0.000 claims 2
- 238000003756 stirring Methods 0.000 claims 2
- VZGDMQKNWNREIO-UHFFFAOYSA-N tetrachloromethane Chemical compound ClC(Cl)(Cl)Cl VZGDMQKNWNREIO-UHFFFAOYSA-N 0.000 claims 2
- 230000003612 virological effect Effects 0.000 claims 2
- RYHBNJHYFVUHQT-UHFFFAOYSA-N 1,4-Dioxane Chemical compound C1COCCO1 RYHBNJHYFVUHQT-UHFFFAOYSA-N 0.000 claims 1
- XDTMQSROBMDMFD-UHFFFAOYSA-N Cyclohexane Chemical compound C1CCCCC1 XDTMQSROBMDMFD-UHFFFAOYSA-N 0.000 claims 1
- 102000004190 Enzymes Human genes 0.000 claims 1
- 108090000790 Enzymes Proteins 0.000 claims 1
- 239000004367 Lipase Substances 0.000 claims 1
- 102000004882 Lipase Human genes 0.000 claims 1
- 108090001060 Lipase Proteins 0.000 claims 1
- 229920005654 Sephadex Polymers 0.000 claims 1
- XSTXAVWGXDQKEL-UHFFFAOYSA-N Trichloroethylene Chemical group ClC=C(Cl)Cl XSTXAVWGXDQKEL-UHFFFAOYSA-N 0.000 claims 1
- 230000029936 alkylation Effects 0.000 claims 1
- 238000005804 alkylation reaction Methods 0.000 claims 1
- 230000001580 bacterial effect Effects 0.000 claims 1
- 230000015572 biosynthetic process Effects 0.000 claims 1
- 239000002775 capsule Substances 0.000 claims 1
- 238000010908 decantation Methods 0.000 claims 1
- 230000007812 deficiency Effects 0.000 claims 1
- 239000002552 dosage form Substances 0.000 claims 1
- 229940088598 enzyme Drugs 0.000 claims 1
- 238000002523 gelfiltration Methods 0.000 claims 1
- 239000008187 granular material Substances 0.000 claims 1
- 238000010438 heat treatment Methods 0.000 claims 1
- 230000005865 ionizing radiation Effects 0.000 claims 1
- 235000019421 lipase Nutrition 0.000 claims 1
- 239000006193 liquid solution Substances 0.000 claims 1
- 239000006194 liquid suspension Substances 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 230000002906 microbiologic effect Effects 0.000 claims 1
- 239000004005 microsphere Substances 0.000 claims 1
- 238000002156 mixing Methods 0.000 claims 1
- 230000004962 physiological condition Effects 0.000 claims 1
- 229920000642 polymer Polymers 0.000 claims 1
- 239000000843 powder Substances 0.000 claims 1
- BDERNNFJNOPAEC-UHFFFAOYSA-N propan-1-ol Chemical compound CCCO BDERNNFJNOPAEC-UHFFFAOYSA-N 0.000 claims 1
- -1 sachets Substances 0.000 claims 1
- 239000012047 saturated solution Substances 0.000 claims 1
- 239000003826 tablet Substances 0.000 claims 1
- YLQBMQCUIZJEEH-UHFFFAOYSA-N tetrahydrofuran Natural products C=1C=COC=1 YLQBMQCUIZJEEH-UHFFFAOYSA-N 0.000 claims 1
- 238000005406 washing Methods 0.000 claims 1
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)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Genetics & Genomics (AREA)
- Wood Science & Technology (AREA)
- Zoology (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Biotechnology (AREA)
- Biochemistry (AREA)
- Microbiology (AREA)
- General Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- Biomedical Technology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nutrition Science (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)
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 |
|---|---|
| RU2015155470A true RU2015155470A (ru) | 2017-08-21 |
| RU2015155470A3 RU2015155470A3 (enExample) | 2018-09-10 |
Family
ID=53042009
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2015155470A RU2015155470A (ru) | 2013-11-05 | 2014-11-05 | Высокоэффективные фармацевтические композиции панкреатина |
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)
| 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. |
| AU2008218595B2 (en) | 2007-02-20 | 2012-05-24 | Allergan Therapeutics LLC | Stable digestive enzyme compositions |
| WO2009109856A2 (en) | 2008-03-07 | 2009-09-11 | Axcan Pharma Inc. | Method for detecting infectious parvovirus in pharmaceutical preparations |
| UA111726C2 (uk) | 2010-10-01 | 2016-06-10 | Апталіс Фарма Лімітед | Препарат панкреліпази низької сили з кишковорозчинним покриттям |
| MX351014B (es) | 2011-08-08 | 2017-09-28 | Aptalis Pharma Ltd | Metodo para la prueba de disolucion de composiciones solidas que contienen enzimas digestivas. |
| US10184121B2 (en) | 2013-06-28 | 2019-01-22 | Allergan Pharmaceuticals International Limited | Methods for removing viral contaminants from pancreatic extracts |
| US20160152968A1 (en) | 2013-07-22 | 2016-06-02 | Aptalis Pharma Ltd. | High potency pancreatin pharmaceutical compositions |
| CN106163544A (zh) | 2013-08-09 | 2016-11-23 | 阿勒根制药国际有限公司 | 适于经肠施用的消化酶组合物 |
Family Cites Families (23)
| 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 |
| 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 |
| DE2460334C3 (de) * | 1974-12-20 | 1979-09-06 | Hoechst Ag, 6000 Frankfurt | Verfahren zur Gewinnung von Insulin und Pankreatin aus Schweinepankreas |
| DE3377506D1 (en) * | 1982-12-30 | 1988-09-01 | Nordmark Arzneimittel Gmbh | Process for obtaining pancreatin |
| FR2603804B1 (fr) * | 1986-09-17 | 1989-10-27 | Jouveinal Sa | Lipases et extraits lipasiques, leur procede de preparation et leur application en therapeutique |
| DE3927286C2 (de) * | 1989-08-18 | 1997-07-24 | Roehm Gmbh | Wäßrige Enzym-Flüssigformulierungen |
| DE69634248T2 (de) | 1995-05-31 | 2006-01-12 | Medzyme N.V. | Zusammensetzungen zur verbesserung der verdaulichkeit und ausnutzung von nähestoffen |
| 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 |
| DE19724845A1 (de) * | 1996-08-28 | 1998-03-05 | Solvay Pharm Gmbh | Verwendung von komplexen Lipiden als stabilisierende Zusätze zu pharmazeutischen Zubereitungen von Verdauungsenzymgemischen |
| US20010046493A1 (en) | 2000-02-24 | 2001-11-29 | Alex Margolin | Lipase-containing composition and methods of use thereof |
| AR032392A1 (es) * | 2001-01-19 | 2003-11-05 | Solvay Pharm Gmbh | Mezcla de enzimas, preparado farmaceutico y utilizacion de dicho preparado. |
| CA2419572A1 (en) * | 2003-02-18 | 2004-08-18 | Axcan Pharma Inc. | High dosage protease formulation |
| US20060198838A1 (en) * | 2004-09-28 | 2006-09-07 | Fallon Joan M | Combination enzyme for cystic fibrosis |
| SI1809320T1 (sl) | 2004-10-14 | 2010-11-30 | Cystic Fibrosis Foundation Therapeutics Inc | Sestavki ki vsebujejo lipazo proteazo in amilazo za zdravljenje pankreasne insuficience |
| HUE031042T2 (en) | 2005-07-29 | 2017-06-28 | Abbott Laboratories Gmbh | Methods for producing pancreatin powder with low viral content |
| AU2008218595B2 (en) * | 2007-02-20 | 2012-05-24 | Allergan Therapeutics LLC | Stable digestive enzyme compositions |
| 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 |
| 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 |
| UA111726C2 (uk) * | 2010-10-01 | 2016-06-10 | Апталіс Фарма Лімітед | Препарат панкреліпази низької сили з кишковорозчинним покриттям |
| 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 |
| CN103060296B (zh) * | 2012-12-30 | 2014-05-21 | 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 |
| US20160152968A1 (en) | 2013-07-22 | 2016-06-02 | Aptalis Pharma Ltd. | High potency pancreatin pharmaceutical compositions |
-
2014
- 2014-11-05 CN CN201480040273.7A patent/CN106659773A/zh active Pending
- 2014-11-05 EP EP19201877.8A patent/EP3613429A1/en not_active Withdrawn
- 2014-11-05 AU AU2014346930A patent/AU2014346930A1/en not_active Abandoned
- 2014-11-05 HK HK16110490.6A patent/HK1222325A1/zh unknown
- 2014-11-05 CA CA2915671A patent/CA2915671A1/en active Pending
- 2014-11-05 ES ES14859866T patent/ES2834483T3/es active Active
- 2014-11-05 KR KR1020167001052A patent/KR20170052520A/ko not_active Withdrawn
- 2014-11-05 BR BR112016000658A patent/BR112016000658A2/pt not_active Application Discontinuation
- 2014-11-05 JP JP2016552457A patent/JP2017500885A/ja active Pending
- 2014-11-05 WO PCT/US2014/063984 patent/WO2015069677A1/en not_active Ceased
- 2014-11-05 RU RU2015155470A patent/RU2015155470A/ru not_active Application Discontinuation
- 2014-11-05 EP EP14859866.7A patent/EP3003360B1/en not_active Revoked
- 2014-11-05 MX MX2016000480A patent/MX2016000480A/es unknown
-
2015
- 2015-12-31 IL IL243435A patent/IL243435B/en active IP Right Grant
-
2020
- 2020-05-11 IL IL274583A patent/IL274583B/en unknown
-
2021
- 2021-06-27 IL IL284419A patent/IL284419A/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| IL243435B (en) | 2020-06-30 |
| EP3613429A1 (en) | 2020-02-26 |
| CA2915671A1 (en) | 2015-05-14 |
| KR20170052520A (ko) | 2017-05-12 |
| AU2014346930A1 (en) | 2016-01-07 |
| JP2017500885A (ja) | 2017-01-12 |
| HK1222325A1 (zh) | 2017-06-30 |
| EP3003360B1 (en) | 2020-10-07 |
| ES2834483T3 (es) | 2021-06-17 |
| WO2015069677A1 (en) | 2015-05-14 |
| EP3003360A1 (en) | 2016-04-13 |
| EP3003360A4 (en) | 2017-04-26 |
| MX2016000480A (es) | 2016-10-21 |
| RU2015155470A3 (enExample) | 2018-09-10 |
| IL284419A (en) | 2021-07-29 |
| IL243435A0 (en) | 2016-03-31 |
| BR112016000658A2 (pt) | 2018-03-20 |
| IL274583A (en) | 2020-06-30 |
| CN106659773A (zh) | 2017-05-10 |
| IL274583B (en) | 2022-06-01 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FA92 | Acknowledgement of application withdrawn (lack of supplementary materials submitted) |
Effective date: 20190326 |