CA2419572A1 - Preparation a forte concentration de protease - Google Patents
Preparation a forte concentration de protease Download PDFInfo
- Publication number
- CA2419572A1 CA2419572A1 CA002419572A CA2419572A CA2419572A1 CA 2419572 A1 CA2419572 A1 CA 2419572A1 CA 002419572 A CA002419572 A CA 002419572A CA 2419572 A CA2419572 A CA 2419572A CA 2419572 A1 CA2419572 A1 CA 2419572A1
- Authority
- CA
- Canada
- Prior art keywords
- protease
- uusp
- pharmaceutical composition
- pancreatin
- formulation
- 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
Links
- 239000000203 mixture Substances 0.000 title claims description 28
- 108091005804 Peptidases Proteins 0.000 title claims description 23
- 239000004365 Protease Substances 0.000 title claims description 23
- 102100037486 Reverse transcriptase/ribonuclease H Human genes 0.000 title claims description 22
- 238000009472 formulation Methods 0.000 title claims description 18
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 claims description 24
- 208000000668 Chronic Pancreatitis Diseases 0.000 claims description 20
- 206010033649 Pancreatitis chronic Diseases 0.000 claims description 20
- 108010019160 Pancreatin Proteins 0.000 claims description 16
- 229940055695 pancreatin Drugs 0.000 claims description 16
- 201000006549 dyspepsia Diseases 0.000 claims description 15
- 208000035404 Autolysis Diseases 0.000 claims description 14
- 206010057248 Cell death Diseases 0.000 claims description 14
- 230000028043 self proteolysis Effects 0.000 claims description 14
- 208000016222 Pancreatic disease Diseases 0.000 claims description 9
- 108090000631 Trypsin Proteins 0.000 claims description 9
- 102000004142 Trypsin Human genes 0.000 claims description 9
- 210000000496 pancreas Anatomy 0.000 claims description 9
- 239000012588 trypsin Substances 0.000 claims description 9
- 230000000694 effects Effects 0.000 claims description 8
- 210000004907 gland Anatomy 0.000 claims description 8
- 239000002244 precipitate Substances 0.000 claims description 8
- 239000008194 pharmaceutical composition Substances 0.000 claims description 7
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims description 6
- 230000001079 digestive effect Effects 0.000 claims description 6
- 238000000034 method Methods 0.000 claims description 6
- 108090001060 Lipase Proteins 0.000 claims description 5
- 102000004882 Lipase Human genes 0.000 claims description 5
- 239000004367 Lipase Substances 0.000 claims description 5
- 239000000706 filtrate Substances 0.000 claims description 5
- 235000019421 lipase Nutrition 0.000 claims description 5
- 238000002156 mixing Methods 0.000 claims description 5
- 230000008569 process Effects 0.000 claims description 5
- 239000000835 fiber Substances 0.000 claims description 4
- 238000000227 grinding Methods 0.000 claims description 4
- 238000004519 manufacturing process Methods 0.000 claims description 4
- 238000001556 precipitation Methods 0.000 claims description 4
- 238000000746 purification Methods 0.000 claims description 4
- 230000007812 deficiency Effects 0.000 claims description 3
- 238000001914 filtration Methods 0.000 claims description 3
- 238000002955 isolation Methods 0.000 claims description 3
- 238000012216 screening Methods 0.000 claims description 3
- 229910000030 sodium bicarbonate Inorganic materials 0.000 claims description 3
- 235000017557 sodium bicarbonate Nutrition 0.000 claims description 3
- 238000005086 pumping Methods 0.000 claims description 2
- 238000005406 washing Methods 0.000 claims description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 2
- 239000003937 drug carrier Substances 0.000 claims 1
- 102000004190 Enzymes Human genes 0.000 description 11
- 108090000790 Enzymes Proteins 0.000 description 11
- 229940088598 enzyme Drugs 0.000 description 11
- 208000002193 Pain Diseases 0.000 description 9
- 230000036407 pain Effects 0.000 description 9
- 239000000463 material Substances 0.000 description 7
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 6
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 5
- 230000002159 abnormal effect Effects 0.000 description 5
- 201000010099 disease Diseases 0.000 description 5
- 108090000765 processed proteins & peptides Proteins 0.000 description 4
- 230000028327 secretion Effects 0.000 description 4
- 208000024891 symptom Diseases 0.000 description 4
- 238000012360 testing method Methods 0.000 description 4
- 239000002253 acid Substances 0.000 description 3
- 239000003651 drinking water Substances 0.000 description 3
- 235000020188 drinking water Nutrition 0.000 description 3
- 210000001198 duodenum Anatomy 0.000 description 3
- 230000007246 mechanism Effects 0.000 description 3
- 238000002360 preparation method Methods 0.000 description 3
- 239000000047 product Substances 0.000 description 3
- 238000003860 storage Methods 0.000 description 3
- 206010000087 Abdominal pain upper Diseases 0.000 description 2
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 description 2
- 239000004382 Amylase Substances 0.000 description 2
- 108010065511 Amylases Proteins 0.000 description 2
- 102000013142 Amylases Human genes 0.000 description 2
- 206010003694 Atrophy Diseases 0.000 description 2
- XRHVZWWRFMCBAZ-UHFFFAOYSA-L Endothal-disodium Chemical compound [Na+].[Na+].C1CC2C(C([O-])=O)C(C(=O)[O-])C1O2 XRHVZWWRFMCBAZ-UHFFFAOYSA-L 0.000 description 2
- 206010033645 Pancreatitis Diseases 0.000 description 2
- 108010067035 Pancrelipase Proteins 0.000 description 2
- 239000008186 active pharmaceutical agent Substances 0.000 description 2
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 2
- 229910052782 aluminium Inorganic materials 0.000 description 2
- 235000019418 amylase Nutrition 0.000 description 2
- 230000037444 atrophy Effects 0.000 description 2
- 230000015572 biosynthetic process Effects 0.000 description 2
- 239000000872 buffer Substances 0.000 description 2
- 230000001684 chronic effect Effects 0.000 description 2
- 230000003292 diminished effect Effects 0.000 description 2
- AMTWCFIAVKBGOD-UHFFFAOYSA-N dioxosilane;methoxy-dimethyl-trimethylsilyloxysilane Chemical compound O=[Si]=O.CO[Si](C)(C)O[Si](C)(C)C AMTWCFIAVKBGOD-UHFFFAOYSA-N 0.000 description 2
- 229940088679 drug related substance Drugs 0.000 description 2
- 238000001035 drying Methods 0.000 description 2
- 239000000839 emulsion Substances 0.000 description 2
- 238000005187 foaming Methods 0.000 description 2
- 235000019626 lipase activity Nutrition 0.000 description 2
- 235000012054 meals Nutrition 0.000 description 2
- 238000011169 microbiological contamination Methods 0.000 description 2
- 239000004081 narcotic agent Substances 0.000 description 2
- 230000004203 pancreatic function Effects 0.000 description 2
- 229940045258 pancrelipase Drugs 0.000 description 2
- 102000004169 proteins and genes Human genes 0.000 description 2
- 108090000623 proteins and genes Proteins 0.000 description 2
- 238000000926 separation method Methods 0.000 description 2
- 229940083037 simethicone Drugs 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- 230000000638 stimulation Effects 0.000 description 2
- 238000003756 stirring Methods 0.000 description 2
- 208000007848 Alcoholism Diseases 0.000 description 1
- 208000008035 Back Pain Diseases 0.000 description 1
- BVKZGUZCCUSVTD-UHFFFAOYSA-M Bicarbonate Chemical compound OC([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-M 0.000 description 1
- 208000015163 Biliary Tract disease Diseases 0.000 description 1
- 206010004663 Biliary colic Diseases 0.000 description 1
- 108090000317 Chymotrypsin Proteins 0.000 description 1
- 206010016654 Fibrosis Diseases 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- 208000004404 Intractable Pain Diseases 0.000 description 1
- 108010028688 Isoamylase Proteins 0.000 description 1
- 102000035195 Peptidases Human genes 0.000 description 1
- 230000005856 abnormality Effects 0.000 description 1
- 201000007930 alcohol dependence Diseases 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 239000000730 antalgic agent Substances 0.000 description 1
- 239000003242 anti bacterial agent Substances 0.000 description 1
- 229940088710 antibiotic agent Drugs 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 230000002308 calcification Effects 0.000 description 1
- 238000002192 cholecystectomy Methods 0.000 description 1
- 229960002376 chymotrypsin Drugs 0.000 description 1
- 238000002591 computed tomography Methods 0.000 description 1
- 239000002274 desiccant Substances 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 208000035475 disorder Diseases 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 230000002183 duodenal effect Effects 0.000 description 1
- 230000007613 environmental effect Effects 0.000 description 1
- 210000003238 esophagus Anatomy 0.000 description 1
- 230000003203 everyday effect Effects 0.000 description 1
- 230000004204 exocrine pancreatic function Effects 0.000 description 1
- 230000004761 fibrosis Effects 0.000 description 1
- 239000012065 filter cake Substances 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 239000011888 foil Substances 0.000 description 1
- 230000006870 function Effects 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 229940088597 hormone Drugs 0.000 description 1
- 239000005556 hormone Substances 0.000 description 1
- 230000008595 infiltration Effects 0.000 description 1
- 238000001764 infiltration Methods 0.000 description 1
- 210000004969 inflammatory cell Anatomy 0.000 description 1
- 230000005764 inhibitory process Effects 0.000 description 1
- 239000002085 irritant Substances 0.000 description 1
- 231100000021 irritant Toxicity 0.000 description 1
- 238000002372 labelling Methods 0.000 description 1
- 235000015263 low fat diet Nutrition 0.000 description 1
- 235000013372 meat Nutrition 0.000 description 1
- 230000001404 mediated effect Effects 0.000 description 1
- 238000010197 meta-analysis Methods 0.000 description 1
- 238000003801 milling Methods 0.000 description 1
- 230000004899 motility Effects 0.000 description 1
- 210000004877 mucosa Anatomy 0.000 description 1
- 230000001613 neoplastic effect Effects 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 230000037040 pain threshold Effects 0.000 description 1
- 229960005489 paracetamol Drugs 0.000 description 1
- 230000007170 pathology Effects 0.000 description 1
- 230000003389 potentiating effect Effects 0.000 description 1
- 230000006920 protein precipitation Effects 0.000 description 1
- 239000012264 purified product Substances 0.000 description 1
- 238000003908 quality control method Methods 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 230000003979 response to food Effects 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 210000002966 serum Anatomy 0.000 description 1
- 238000007873 sieving Methods 0.000 description 1
- 210000000813 small intestine Anatomy 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 238000007464 sphincterotomy Methods 0.000 description 1
- 239000012258 stirred mixture Substances 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 239000004575 stone Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 239000013589 supplement Substances 0.000 description 1
- 230000001629 suppression Effects 0.000 description 1
- 238000007460 surgical drainage Methods 0.000 description 1
- 208000011580 syndromic disease Diseases 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 238000002627 tracheal intubation Methods 0.000 description 1
- 238000002604 ultrasonography Methods 0.000 description 1
- 230000009278 visceral effect Effects 0.000 description 1
- 208000009935 visceral pain Diseases 0.000 description 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
- A61P1/18—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
- 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)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Zoology (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Genetics & Genomics (AREA)
- Wood Science & Technology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Veterinary Medicine (AREA)
- Biochemistry (AREA)
- General Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Biotechnology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Microbiology (AREA)
- Molecular Biology (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- General Chemical & Material Sciences (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA002419572A CA2419572A1 (fr) | 2003-02-18 | 2003-02-18 | Preparation a forte concentration de protease |
| PCT/CA2004/000228 WO2004074470A1 (fr) | 2003-02-18 | 2004-02-18 | Pancreatine a haute teneur en protease |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA002419572A CA2419572A1 (fr) | 2003-02-18 | 2003-02-18 | Preparation a forte concentration de protease |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2419572A1 true CA2419572A1 (fr) | 2004-08-18 |
Family
ID=32855086
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002419572A Abandoned CA2419572A1 (fr) | 2003-02-18 | 2003-02-18 | Preparation a forte concentration de protease |
Country Status (2)
| Country | Link |
|---|---|
| CA (1) | CA2419572A1 (fr) |
| WO (1) | WO2004074470A1 (fr) |
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2015019198A3 (fr) * | 2013-07-22 | 2015-05-28 | Aptalis Pharma Ltd. | Compositions pharmaceutiques de pancréatine de puissance élevée |
| US9259393B2 (en) | 2000-11-15 | 2016-02-16 | Aptalis Pharma S.R.L. | Microspheres of pancreatic enzymes with high stability and production method thereof |
| US9976171B2 (en) | 2011-08-08 | 2018-05-22 | Allergan Pharmaceuticals International Limited | Method for dissolution testing of solid compositions containing digestive enzymes |
| US10087493B2 (en) | 2008-03-07 | 2018-10-02 | Aptalis Pharma Canada Ulc | Method for detecting infectious parvovirus in pharmaceutical preparations |
| 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 |
| 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 |
| EP4314008A4 (fr) * | 2021-03-23 | 2025-07-02 | Kashiv Biosciences Llc | Procédé d'extraction de pancrélipase et évaluation de celui-ci |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2015069677A1 (fr) * | 2013-11-05 | 2015-05-14 | Aptalis Pharma Ltd. | Compositions pharmaceutiques de pancréatine de haute puissance |
| CN112080487B (zh) * | 2019-06-14 | 2024-03-26 | 苏州融析生物科技有限公司 | 一种羊胰酶制备方法 |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0115023B1 (fr) * | 1982-12-30 | 1988-07-27 | Nordmark Arzneimittel GmbH | Procédé d'obtention de pancréatine |
| DE3248588A1 (de) * | 1982-12-30 | 1984-07-12 | Nordmark-Werke Gmbh, 2000 Hamburg | Verfahren zur gewinnung von pankreatin von hohem schuettgewicht |
| DE4203315A1 (de) * | 1991-02-14 | 1992-08-20 | Kali Chemie Pharma Gmbh | Verfahren zur gewinnung von pankreatin |
| CA2198317C (fr) * | 1997-02-24 | 2003-01-07 | Mouhsine El Abboudi | Methode pour preparer de la pancreatine qui contient de faibles quantites residuelles de solvant organique et produit contenant cette derniere |
-
2003
- 2003-02-18 CA CA002419572A patent/CA2419572A1/fr not_active Abandoned
-
2004
- 2004-02-18 WO PCT/CA2004/000228 patent/WO2004074470A1/fr not_active Ceased
Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9259393B2 (en) | 2000-11-15 | 2016-02-16 | Aptalis Pharma S.R.L. | Microspheres of pancreatic enzymes with high stability and production method thereof |
| US9884025B2 (en) | 2000-11-15 | 2018-02-06 | Aptalis Pharma S.R.L. | Microspheres of pancreatic enzymes with high stability and production method thereof |
| US10206882B2 (en) | 2007-02-20 | 2019-02-19 | Allergan Pharmaceuticals International Limited | Stable digestive enzyme compositions |
| US10087493B2 (en) | 2008-03-07 | 2018-10-02 | Aptalis Pharma Canada Ulc | Method for detecting infectious parvovirus in pharmaceutical preparations |
| US11364205B2 (en) | 2010-10-01 | 2022-06-21 | Societe Des Produits Nestle S.A. | Stable low digestive enzyme content formulation |
| 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 |
| WO2015019198A3 (fr) * | 2013-07-22 | 2015-05-28 | Aptalis Pharma Ltd. | Compositions pharmaceutiques de pancréatine de puissance élevée |
| CN105392496A (zh) * | 2013-07-22 | 2016-03-09 | 阿普塔利斯制药有限公司 | 高效的胰酶药物组合物 |
| RU2686460C2 (ru) * | 2013-07-22 | 2019-04-26 | Апталис Фарма Лтд. | Высокоэффективные фармацевтические композиции панкреатина |
| US10993996B2 (en) | 2013-08-09 | 2021-05-04 | Allergan Pharmaceuticals International Limited | Digestive enzyme composition suitable for enteral administration |
| EP4314008A4 (fr) * | 2021-03-23 | 2025-07-02 | Kashiv Biosciences Llc | Procédé d'extraction de pancrélipase et évaluation de celui-ci |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2004074470A1 (fr) | 2004-09-02 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Dead |