NO327380B1 - Fremgangsmate for sterilisering av farmasoytika - Google Patents
Fremgangsmate for sterilisering av farmasoytika Download PDFInfo
- Publication number
- NO327380B1 NO327380B1 NO20032361A NO20032361A NO327380B1 NO 327380 B1 NO327380 B1 NO 327380B1 NO 20032361 A NO20032361 A NO 20032361A NO 20032361 A NO20032361 A NO 20032361A NO 327380 B1 NO327380 B1 NO 327380B1
- Authority
- NO
- Norway
- Prior art keywords
- temperature
- preparation
- stated
- seconds
- suspension
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims abstract description 64
- 230000001954 sterilising effect Effects 0.000 title claims abstract description 48
- 238000004659 sterilization and disinfection Methods 0.000 title claims description 37
- 239000003814 drug Substances 0.000 title claims description 21
- 239000000725 suspension Substances 0.000 claims abstract description 33
- 238000010438 heat treatment Methods 0.000 claims abstract description 12
- 238000001816 cooling Methods 0.000 claims abstract description 3
- 238000009472 formulation Methods 0.000 claims description 43
- 239000000203 mixture Substances 0.000 claims description 43
- 238000002360 preparation method Methods 0.000 claims description 32
- VOVIALXJUBGFJZ-KWVAZRHASA-N Budesonide Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@@H]2[C@@H]1[C@@H]1C[C@H]3OC(CCC)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@@H]2O VOVIALXJUBGFJZ-KWVAZRHASA-N 0.000 claims description 30
- 229960004436 budesonide Drugs 0.000 claims description 30
- 239000000825 pharmaceutical preparation Substances 0.000 claims description 19
- 229940079593 drug Drugs 0.000 claims description 13
- 239000004094 surface-active agent Substances 0.000 claims description 13
- 239000003862 glucocorticoid Substances 0.000 claims description 10
- 238000003860 storage Methods 0.000 claims description 9
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 8
- 239000012141 concentrate Substances 0.000 claims description 7
- 239000003755 preservative agent Substances 0.000 claims description 4
- 239000002904 solvent Substances 0.000 claims description 4
- 238000010924 continuous production Methods 0.000 claims description 3
- 230000000813 microbial effect Effects 0.000 claims description 3
- 239000011521 glass Substances 0.000 claims description 2
- 239000002184 metal Substances 0.000 claims description 2
- 238000007789 sealing Methods 0.000 claims description 2
- 238000007865 diluting Methods 0.000 claims 1
- 239000000463 material Substances 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract description 4
- 239000002245 particle Substances 0.000 description 17
- 230000006378 damage Effects 0.000 description 9
- 239000000047 product Substances 0.000 description 9
- 238000006386 neutralization reaction Methods 0.000 description 6
- 229950008882 polysorbate Drugs 0.000 description 6
- 229920000136 polysorbate Polymers 0.000 description 6
- 238000004519 manufacturing process Methods 0.000 description 5
- 238000002156 mixing Methods 0.000 description 5
- 230000015556 catabolic process Effects 0.000 description 4
- 238000006731 degradation reaction Methods 0.000 description 4
- 230000036512 infertility Effects 0.000 description 4
- 239000008267 milk Substances 0.000 description 4
- 210000004080 milk Anatomy 0.000 description 4
- 235000013336 milk Nutrition 0.000 description 4
- 239000000243 solution Substances 0.000 description 4
- 239000007788 liquid Substances 0.000 description 3
- 238000005259 measurement Methods 0.000 description 3
- 238000012545 processing Methods 0.000 description 3
- 238000012360 testing method Methods 0.000 description 3
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 description 2
- 239000004480 active ingredient Substances 0.000 description 2
- 239000013543 active substance Substances 0.000 description 2
- 230000002411 adverse Effects 0.000 description 2
- 238000005054 agglomeration Methods 0.000 description 2
- 230000002776 aggregation Effects 0.000 description 2
- 230000001580 bacterial effect Effects 0.000 description 2
- 239000008364 bulk solution Substances 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 239000000356 contaminant Substances 0.000 description 2
- 230000006866 deterioration Effects 0.000 description 2
- 239000013583 drug formulation Substances 0.000 description 2
- 238000005429 filling process Methods 0.000 description 2
- 239000013020 final formulation Substances 0.000 description 2
- 229940126601 medicinal product Drugs 0.000 description 2
- 239000006199 nebulizer Substances 0.000 description 2
- 238000004806 packaging method and process Methods 0.000 description 2
- 230000000704 physical effect Effects 0.000 description 2
- 239000011148 porous material Substances 0.000 description 2
- 238000005086 pumping Methods 0.000 description 2
- 238000013094 purity test Methods 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 241000894006 Bacteria Species 0.000 description 1
- 239000008186 active pharmaceutical agent Substances 0.000 description 1
- 229960005070 ascorbic acid Drugs 0.000 description 1
- 235000010323 ascorbic acid Nutrition 0.000 description 1
- 239000011668 ascorbic acid Substances 0.000 description 1
- 208000006673 asthma Diseases 0.000 description 1
- 230000004071 biological effect Effects 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 239000007795 chemical reaction product Substances 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 230000034994 death Effects 0.000 description 1
- 231100000517 death Toxicity 0.000 description 1
- 238000000354 decomposition reaction Methods 0.000 description 1
- 239000006185 dispersion Substances 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 229940088679 drug related substance Drugs 0.000 description 1
- 238000011049 filling Methods 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 230000001771 impaired effect Effects 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 238000002372 labelling Methods 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 238000002663 nebulization Methods 0.000 description 1
- 239000007971 pharmaceutical suspension Substances 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 238000003672 processing method Methods 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
- 238000011272 standard treatment Methods 0.000 description 1
- 239000008223 sterile water Substances 0.000 description 1
- 238000013190 sterility testing Methods 0.000 description 1
Classifications
-
- 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
- A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
- A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
- A61L2/0023—Heat
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07J—STEROIDS
- C07J5/00—Normal steroids containing carbon, hydrogen, halogen or oxygen, substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane and substituted in position 21 by only one singly bound oxygen atom, i.e. only one oxygen bound to position 21 by a single bond
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Molecular Biology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Biomedical Technology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
- Food Preservation Except Freezing, Refrigeration, And Drying (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB0028763A GB0028763D0 (en) | 2000-11-24 | 2000-11-24 | Sterilisation of pharmaceuticals |
| GB0111745A GB0111745D0 (en) | 2000-11-24 | 2001-05-14 | Sterilization of pharmaceuticals |
| PCT/GB2001/005208 WO2002041925A1 (fr) | 2000-11-24 | 2001-11-26 | Sterilisation de produits pharmaceutiques |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| NO20032361D0 NO20032361D0 (no) | 2003-05-26 |
| NO20032361L NO20032361L (no) | 2003-07-24 |
| NO327380B1 true NO327380B1 (no) | 2009-06-22 |
Family
ID=26245330
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| NO20032361A NO327380B1 (no) | 2000-11-24 | 2003-05-26 | Fremgangsmate for sterilisering av farmasoytika |
Country Status (20)
| Country | Link |
|---|---|
| US (1) | US6863865B2 (fr) |
| EP (1) | EP1337279B1 (fr) |
| JP (1) | JP4048114B2 (fr) |
| AT (1) | ATE330638T1 (fr) |
| AU (1) | AU2002223896B9 (fr) |
| BR (1) | BR0115584A (fr) |
| CA (1) | CA2429574C (fr) |
| CY (1) | CY1105266T1 (fr) |
| CZ (1) | CZ301049B6 (fr) |
| DE (1) | DE60121023T2 (fr) |
| DK (1) | DK1337279T3 (fr) |
| ES (1) | ES2266310T3 (fr) |
| GB (1) | GB2374013C (fr) |
| HK (1) | HK1057492A1 (fr) |
| HU (1) | HUP0302630A3 (fr) |
| IL (1) | IL155935A0 (fr) |
| IS (1) | IS2528B (fr) |
| NO (1) | NO327380B1 (fr) |
| NZ (1) | NZ526118A (fr) |
| WO (1) | WO2002041925A1 (fr) |
Families Citing this family (30)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SE9704186D0 (sv) * | 1997-11-14 | 1997-11-14 | Astra Ab | New composition of matter |
| EP1337279B1 (fr) * | 2000-11-24 | 2006-06-21 | Breath Limited | Sterilisation de suspensions de glucocorticosteriodes |
| DK1476201T3 (da) | 2002-02-19 | 2009-03-30 | Resolution Chemicals Ltd | Solvent-baseret sterilisering af steroider |
| NZ537945A (en) | 2002-07-02 | 2007-08-31 | Altana Pharma Ag | Ciclesonide-containing sterile aqueous suspension |
| RU2327450C2 (ru) * | 2002-08-29 | 2008-06-27 | Сипла Лимитед | Фармацевтические продукты и композиции, содержащие специфические антихолинергические средства, агонисты бета-2 и кортикостероиды |
| SE524496C2 (sv) * | 2002-12-13 | 2004-08-17 | Tetra Laval Holdings & Finance | Styrning av steriliseringsanordning |
| EP1454636A1 (fr) * | 2003-03-04 | 2004-09-08 | Dompé S.P.A. | Stérilisation de médicaments glucocorticostéroides particulaires pour application pulmonaire |
| PE20050941A1 (es) * | 2003-12-16 | 2005-11-08 | Nycomed Gmbh | Suspensiones acuosas de ciclesonida para nebulizacion |
| US20070020299A1 (en) * | 2003-12-31 | 2007-01-25 | Pipkin James D | Inhalant formulation containing sulfoalkyl ether cyclodextrin and corticosteroid |
| US20070020298A1 (en) * | 2003-12-31 | 2007-01-25 | Pipkin James D | Inhalant formulation containing sulfoalkyl ether gamma-cyclodextrin and corticosteroid |
| DE602005026225D1 (de) | 2004-03-12 | 2011-03-24 | Cipla Ltd | Sterilisationsprozess für Steroide |
| EP1730751B1 (fr) * | 2004-03-12 | 2009-10-21 | The Provost, Fellows And Scholars Of The College Of The Holy And Undivided Trinity Of Queen Elizabeth Near Dublin | Milieu magnetoresistant |
| GB0410995D0 (en) * | 2004-05-17 | 2004-06-23 | Norton Healthcare Ltd | Heat sterilization of glucocorticosteroids |
| ITSA20040012A1 (it) * | 2004-09-07 | 2004-12-07 | Genetec S P A | Processo di sterilizzazione di un glucocorticosteroide. |
| GB0425266D0 (en) * | 2004-11-16 | 2004-12-15 | Norton Healthcare Ltd | Pharmaceutical manufacturing process |
| ES2388287T3 (es) * | 2005-01-20 | 2012-10-11 | Eratech S.R.L. | Procedimiento para la preparación de suspensiones concentradas de fármacos y kit correspondiente |
| TWI353855B (en) * | 2005-05-26 | 2011-12-11 | Shionogi & Co | Method for preparing an aqueous solution of doripe |
| US20070197486A1 (en) * | 2005-12-20 | 2007-08-23 | Verus Pharmaceuticals, Inc. | Methods and systems for the delivery of corticosteroids |
| US20070249572A1 (en) * | 2005-12-20 | 2007-10-25 | Verus Pharmaceuticals, Inc. | Systems and methods for the delivery of corticosteroids |
| US20070160542A1 (en) * | 2005-12-20 | 2007-07-12 | Verus Pharmaceuticals, Inc. | Methods and systems for the delivery of corticosteroids having an enhanced pharmacokinetic profile |
| US20070185066A1 (en) * | 2005-12-20 | 2007-08-09 | Verus Pharmaceuticals, Inc. | Systems and methods for the delivery of corticosteroids |
| EP1988880A2 (fr) * | 2006-02-15 | 2008-11-12 | Tika Läkemedel AB | Mélange de corticostéroïdes stable |
| GB0604141D0 (en) * | 2006-03-01 | 2006-04-12 | Arrow Int Ltd | Nebulizer formulation |
| GB0700380D0 (en) * | 2007-01-09 | 2007-02-14 | Breath Ltd | Storage Of Ampoules |
| US9056841B2 (en) | 2009-03-19 | 2015-06-16 | The Johns Hopkins University | PSMA-targeting compounds and uses thereof |
| US20180009767A9 (en) | 2009-03-19 | 2018-01-11 | The Johns Hopkins University | Psma targeted fluorescent agents for image guided surgery |
| US8273725B2 (en) * | 2009-09-10 | 2012-09-25 | Genzyme Corporation | Stable hyaluronan/steroid formulation |
| CN103616442B (zh) * | 2013-10-31 | 2015-08-19 | 中国计量学院 | 一种家畜血液中布地奈德异构体的定量检测方法 |
| WO2018232280A1 (fr) | 2017-06-15 | 2018-12-20 | The Johns Hopkins University | Agents fluorescents ciblés par psma pour chirurgie guidée par image |
| CN113133993A (zh) * | 2021-04-23 | 2021-07-20 | 海门普适医药有限公司 | 无菌吸入用混悬制剂及其制备方法 |
Family Cites Families (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4695454A (en) * | 1985-04-01 | 1987-09-22 | New York Blood Center, Inc. | Process for preparing hepatitis B surface antigen containing particles in novel forms which are highly immunogenic |
| DE4240103A1 (de) * | 1992-05-26 | 1993-12-02 | Behringwerke Ag | Verfahren zur Inaktivierung von Viren in Präparationen von Proteinen |
| US6250379B1 (en) * | 1994-05-17 | 2001-06-26 | Hde Metallwerk Gmbh | High-speed capillary tube heat exchanger |
| US5583960A (en) * | 1994-06-01 | 1996-12-10 | David Reznik | Electroheating apparatus and methods |
| AU3965795A (en) * | 1994-10-31 | 1996-05-23 | Abbott Laboratories | Method and system for sterilizing heat sensitive drugs |
| US5603894A (en) * | 1994-10-31 | 1997-02-18 | Abbott Laboratories | Method of sterilizing a pharmaceutical composition |
| ATE184102T1 (de) * | 1995-01-10 | 1999-09-15 | Hde Metallwerk Gmbh | Hochleistungs-kapillarwärmeaustauscher |
| US5565947A (en) * | 1995-10-30 | 1996-10-15 | Eastman Kodak Company | Framing apparatus for a camera |
| SE9704186D0 (sv) * | 1997-11-14 | 1997-11-14 | Astra Ab | New composition of matter |
| US6066292A (en) | 1997-12-19 | 2000-05-23 | Bayer Corporation | Sterilization process for pharmaceutical suspensions |
| CN1245955C (zh) | 1998-05-29 | 2006-03-22 | 斯凯伊药品加拿大公司 | 热保护微粒组合物及其最终蒸汽灭菌的方法 |
| EP1165148A1 (fr) * | 1999-03-30 | 2002-01-02 | Gambro Lundia AB | Procede et appareil de sterilisation d'un fluide sensible a la chaleur |
| EP1337279B1 (fr) * | 2000-11-24 | 2006-06-21 | Breath Limited | Sterilisation de suspensions de glucocorticosteriodes |
-
2001
- 2001-11-26 EP EP01997317A patent/EP1337279B1/fr not_active Expired - Lifetime
- 2001-11-26 DE DE60121023T patent/DE60121023T2/de not_active Expired - Lifetime
- 2001-11-26 JP JP2002544102A patent/JP4048114B2/ja not_active Expired - Fee Related
- 2001-11-26 WO PCT/GB2001/005208 patent/WO2002041925A1/fr active IP Right Grant
- 2001-11-26 CZ CZ20031446A patent/CZ301049B6/cs not_active IP Right Cessation
- 2001-11-26 BR BR0115584-9A patent/BR0115584A/pt not_active IP Right Cessation
- 2001-11-26 ES ES01997317T patent/ES2266310T3/es not_active Expired - Lifetime
- 2001-11-26 DK DK01997317T patent/DK1337279T3/da active
- 2001-11-26 NZ NZ526118A patent/NZ526118A/en not_active IP Right Cessation
- 2001-11-26 IL IL15593501A patent/IL155935A0/xx active IP Right Grant
- 2001-11-26 AU AU2002223896A patent/AU2002223896B9/en not_active Ceased
- 2001-11-26 CA CA002429574A patent/CA2429574C/fr not_active Expired - Fee Related
- 2001-11-26 GB GB0215020A patent/GB2374013C/en not_active Expired - Fee Related
- 2001-11-26 AT AT01997317T patent/ATE330638T1/de active
- 2001-11-26 HU HU0302630A patent/HUP0302630A3/hu unknown
-
2002
- 2002-09-30 US US10/259,781 patent/US6863865B2/en not_active Expired - Lifetime
-
2003
- 2003-05-15 IS IS6817A patent/IS2528B/is unknown
- 2003-05-26 NO NO20032361A patent/NO327380B1/no not_active IP Right Cessation
-
2004
- 2004-01-21 HK HK04100471A patent/HK1057492A1/xx not_active IP Right Cessation
-
2006
- 2006-09-06 CY CY20061101272T patent/CY1105266T1/el unknown
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MM1K | Lapsed by not paying the annual fees |