DK1755554T3 - Varmesterilisering af glucocorticosteroider - Google Patents
Varmesterilisering af glucocorticosteroider Download PDFInfo
- Publication number
- DK1755554T3 DK1755554T3 DK05752889.5T DK05752889T DK1755554T3 DK 1755554 T3 DK1755554 T3 DK 1755554T3 DK 05752889 T DK05752889 T DK 05752889T DK 1755554 T3 DK1755554 T3 DK 1755554T3
- Authority
- DK
- Denmark
- Prior art keywords
- glucocorticosteroid
- budesonide
- suspension
- heating
- minutes
- Prior art date
Links
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
- 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
- A61K9/1682—Processes
-
- 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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
-
- 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—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
- A61L2/02—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
-
- 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—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
- A61L2/02—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
- A61L2/04—Heat
-
- 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
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/02—Nasal agents, e.g. decongestants
-
- 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
- A61P11/06—Antiasthmatics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/08—Antiallergic agents
-
- 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
-
- 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
- A61L2103/00—Materials or objects being the target of disinfection or sterilisation
- A61L2103/05—Living organisms or biological materials
Landscapes
- Health & Medical Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Pulmonology (AREA)
- Otolaryngology (AREA)
- Rheumatology (AREA)
- Ophthalmology & Optometry (AREA)
- Pain & Pain Management (AREA)
- Dermatology (AREA)
- Immunology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Steroid Compounds (AREA)
- Dairy Products (AREA)
Claims (16)
1. Fremgangsmåde til steriliseringen af et labilt glucocorticosteroid, omfattende trinnet at påføre fugtig varme til en suspension af et labilt glucocorticosteroid i en steriliserings-effektiv tidsperiode og hvor glucocorticosteroidet er i en koncentration fra omkring 15mg/ml til omkring 150mg/ml.
2. Fremgangsmåde til steriliseringen af et glucocorticosteroid, omfattende trinnet at opvarme en vandig suspension af et glucocorticosteroid, hvor glucocorticosteroidet har en tilstrækkelig lav opløselighed i vand og anvendes i en tilstrækkelig mængde således at mindst 50% af glucocorticosteroidet er i formen afen suspension under opvarmning.
3. Fremgangsmåde ifølge krav 2, hvor mindst 60% af glucocorticosteroidet er i formen afen suspension under opvarmning.
4. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor opvarmning er ved en temperatur på fra omkring 101 °C til omkring 145 °C.
5. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor opvarmning udføres ved autoklavering.
6. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor opvarmning udføres i omkring 2 til omkring 180 minutter.
7. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor suspensionen endvidere omfatter et overfladeaktivt stof.
8. Fremgangsmåde ifølge krav 7, hvor det overfladeaktive stof er til stede i en koncentration fra omkring 0,75 mg/ml til omkring 60 mg/ml.
9. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor glucocorticosteroidet er budesonid eller beclometason dipropionat.
10. Fremgangsmåde ifølge krav 9, hvor glucocorticosteroidet er budesonid, og opvarmningen udføres ved 121 °C i omkring 20-30 minutter eller ved 110 °C i omkring 120 minutter.
11. Fremgangsmåde ifølge krav 9, hvor glucocorticosteroidet er beclometason dipropionat, og opvarmningen udføres ved 121 °C i omkring 20-30 minutter eller ved 110 °C i omkring 120 minutter.
12. Fremgangsmåde ifølge et hvilket som helst af kravene 2 til 11, hvor glucocorticosteroidet er i en koncentration fra omkring 15 mg/ml til omkring 150 mg/ml.
13. Fremgangsmåde til steriliseringen af budesonid, omfattende trinnet at opvarme en vandig suspension af budesonid i en koncentration fra omkring 15 mg/ml til omkring 150 mg/ml ved en temperatur fra omkring 101 °C til omkring 145 °C i omkring 2 til omkring 180 minutter.
14. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, endvidere omfattende trinnet at fortynde suspensionen til en farmaceutisk egnet koncentration.
15. Steril vandig suspension omfattende et glucocorticosteroid opnået ved fremgangsmåden ifølge et hvilket som helst af kravene 1 til 14, hvor partikelstørrelsen af glucocorticosteroidet er således at DvlOO er mindre end 20 pm, Dv90 er mindre end 10 pm og Dv50 er mindre end 5 pm.
16. Steril vandig budesonid suspension opnået ved fremgangsmåden ifølge et hvilket som helst af kravene 1 til 14, hvor suspensionen omfatter mindre end 0,2 vægtprocent af 1,2-dihydrobudesonid baseret på mængden af budesonid.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GBGB0410995.5A GB0410995D0 (en) | 2004-05-17 | 2004-05-17 | Heat sterilization of glucocorticosteroids |
| PCT/US2005/017292 WO2005115332A2 (en) | 2004-05-17 | 2005-05-17 | Heat sterilization of glucocorticosteroids |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK1755554T3 true DK1755554T3 (da) | 2014-12-15 |
Family
ID=32607464
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK05752889.5T DK1755554T3 (da) | 2004-05-17 | 2005-05-17 | Varmesterilisering af glucocorticosteroider |
| DK14001800.3T DK2805712T4 (da) | 2004-05-17 | 2005-05-17 | Varmesterilisering af glucocorticoidsteroider |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK14001800.3T DK2805712T4 (da) | 2004-05-17 | 2005-05-17 | Varmesterilisering af glucocorticoidsteroider |
Country Status (21)
| Country | Link |
|---|---|
| US (2) | US8791096B2 (da) |
| EP (3) | EP1755554B1 (da) |
| JP (2) | JP5116469B2 (da) |
| KR (1) | KR101148446B1 (da) |
| CN (2) | CN102600491B (da) |
| AU (1) | AU2005247422B8 (da) |
| CA (1) | CA2569549C (da) |
| CY (1) | CY1115948T1 (da) |
| DK (2) | DK1755554T3 (da) |
| ES (2) | ES2670706T5 (da) |
| FI (1) | FI2805712T4 (da) |
| GB (1) | GB0410995D0 (da) |
| HK (1) | HK1252557A1 (da) |
| HU (1) | HUE037567T2 (da) |
| IL (1) | IL179066A (da) |
| LT (1) | LT2805712T (da) |
| MX (1) | MXPA06012874A (da) |
| PL (2) | PL1755554T3 (da) |
| PT (2) | PT1755554E (da) |
| SI (2) | SI2805712T1 (da) |
| WO (1) | WO2005115332A2 (da) |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PE20050941A1 (es) | 2003-12-16 | 2005-11-08 | Nycomed Gmbh | Suspensiones acuosas de ciclesonida para nebulizacion |
| GB0425266D0 (en) * | 2004-11-16 | 2004-12-15 | Norton Healthcare Ltd | Pharmaceutical manufacturing process |
| RU2611665C2 (ru) * | 2011-05-03 | 2017-02-28 | КЬЕЗИ ФАРМАЧЕУТИЧИ С.п.А. | Улучшенный состав суспензии кортикостероида для ингаляционного введения |
| CN111224763B (zh) * | 2013-03-11 | 2022-09-30 | 北京三星通信技术研究有限公司 | 一种下行传输方法和用户终端设备 |
| US9867973B2 (en) | 2013-06-17 | 2018-01-16 | Medline Industries, Inc. | Skin antiseptic applicator and methods of making and using the same |
| US11027032B2 (en) * | 2014-01-08 | 2021-06-08 | Carefusion 2200, Inc. | Systems, methods, and devices for sterilizing antiseptic solutions |
| US9511156B2 (en) | 2014-01-08 | 2016-12-06 | Carefusion 2200, Inc. | Systems, methods, and devices for sterilizing antiseptic solutions |
| CN106310299A (zh) * | 2015-06-30 | 2017-01-11 | 开尔弗森2200有限公司 | 用于使防腐剂溶液灭菌的系统、方法和装置 |
| US9895455B2 (en) | 2015-06-30 | 2018-02-20 | Carefusion 2200, Inc | Systems, methods, and devices for sterilizing antiseptic solutions |
| WO2022098321A1 (en) * | 2020-11-09 | 2022-05-12 | Arven Ilac Sanayi Ve Ticaret Anonim Sirketi | Process for the preparation of sterilised suspensions for the administration by inhalation |
| CN112891328A (zh) * | 2021-04-12 | 2021-06-04 | 上海方予健康医药科技有限公司 | 一种吸入用布地奈德混悬液的制备方法 |
Family Cites Families (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3692430A (en) | 1971-06-18 | 1972-09-19 | John W Timmons | Liquid pumping system |
| US3962430A (en) | 1974-08-07 | 1976-06-08 | Merck & Co., Inc. | Sterilization of solid non-electrolyte medicinal agents employing sodium chloride |
| GB9410222D0 (en) * | 1994-05-21 | 1994-07-06 | Glaxo Wellcome Australia Ltd | Medicaments |
| US5933781A (en) | 1997-01-31 | 1999-08-03 | Qualcomm Incorporated | Pilot based, reversed channel power control |
| 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 |
| US6598603B1 (en) * | 1997-12-31 | 2003-07-29 | Astra Aktiebolag | Method for treating respiratory diseases |
| EP0938896A1 (en) | 1998-01-15 | 1999-09-01 | Novartis AG | Autoclavable pharmaceutical compositions containing a chelating agent |
| US6241969B1 (en) * | 1998-06-26 | 2001-06-05 | Elan Corporation Plc | Aqueous compositions containing corticosteroids for nasal and pulmonary delivery |
| IT1303692B1 (it) | 1998-11-03 | 2001-02-23 | Chiesi Farma Spa | Procedimento per la preparazione di sospensioni di particelle difarmaci da somministrare per inalazione. |
| US6267989B1 (en) | 1999-03-08 | 2001-07-31 | Klan Pharma International Ltd. | Methods for preventing crystal growth and particle aggregation in nanoparticulate compositions |
| WO2002041925A1 (en) * | 2000-11-24 | 2002-05-30 | Breath Limited | Sterilisation of pharmaceuticals |
| NL1016981C2 (nl) | 2000-12-22 | 2002-06-25 | Nutricia Nv | Pasteuriseren of steriliseren. |
| DE10145361A1 (de) | 2001-09-14 | 2003-04-03 | Pari Gmbh | Verfahren zur Herstellung von flüssigen, sterilen Zubereitungen zur Inhalation |
| US7112340B2 (en) * | 2001-10-19 | 2006-09-26 | Baxter International Inc. | Compositions of and method for preparing stable particles in a frozen aqueous matrix |
| MXPA04012756A (es) | 2002-07-02 | 2005-03-23 | Altana Pharma Ag | Suspension acuosa esteril que contiene ciclesonida. |
| EP1454636A1 (en) * | 2003-03-04 | 2004-09-08 | Dompé S.P.A. | Sterilization of glucocorticoid drug particles for pulmonary delivery |
| ATE497787T1 (de) | 2004-03-12 | 2011-02-15 | Cipla Ltd | Sterilisationsprozess für steroide |
-
2004
- 2004-05-17 GB GBGB0410995.5A patent/GB0410995D0/en not_active Ceased
-
2005
- 2005-05-17 EP EP05752889.5A patent/EP1755554B1/en not_active Revoked
- 2005-05-17 ES ES14001800T patent/ES2670706T5/es not_active Expired - Lifetime
- 2005-05-17 SI SI200532207T patent/SI2805712T1/en unknown
- 2005-05-17 JP JP2007527389A patent/JP5116469B2/ja not_active Expired - Lifetime
- 2005-05-17 LT LTEP14001800.3T patent/LT2805712T/lt unknown
- 2005-05-17 PT PT57528895T patent/PT1755554E/pt unknown
- 2005-05-17 PL PL05752889T patent/PL1755554T3/pl unknown
- 2005-05-17 PT PT140018003T patent/PT2805712T/pt unknown
- 2005-05-17 CN CN201210068425.7A patent/CN102600491B/zh not_active Expired - Lifetime
- 2005-05-17 WO PCT/US2005/017292 patent/WO2005115332A2/en not_active Ceased
- 2005-05-17 AU AU2005247422A patent/AU2005247422B8/en not_active Expired
- 2005-05-17 FI FIEP14001800.3T patent/FI2805712T4/fi active
- 2005-05-17 MX MXPA06012874A patent/MXPA06012874A/es active IP Right Grant
- 2005-05-17 US US10/594,861 patent/US8791096B2/en active Active
- 2005-05-17 DK DK05752889.5T patent/DK1755554T3/da active
- 2005-05-17 SI SI200531916T patent/SI1755554T1/sl unknown
- 2005-05-17 CN CN2005800159892A patent/CN1988886B/zh not_active Expired - Lifetime
- 2005-05-17 HU HUE14001800A patent/HUE037567T2/hu unknown
- 2005-05-17 CA CA2569549A patent/CA2569549C/en not_active Expired - Lifetime
- 2005-05-17 EP EP17195406.8A patent/EP3299013A1/en active Pending
- 2005-05-17 PL PL14001800.3T patent/PL2805712T5/pl unknown
- 2005-05-17 ES ES05752889.5T patent/ES2525877T3/es not_active Expired - Lifetime
- 2005-05-17 DK DK14001800.3T patent/DK2805712T4/da active
- 2005-05-17 KR KR1020067023275A patent/KR101148446B1/ko not_active Expired - Lifetime
- 2005-05-17 EP EP14001800.3A patent/EP2805712B2/en not_active Expired - Lifetime
-
2006
- 2006-11-06 IL IL179066A patent/IL179066A/en active IP Right Grant
-
2012
- 2012-08-31 JP JP2012191294A patent/JP5473029B2/ja not_active Expired - Lifetime
-
2014
- 2014-06-20 US US14/310,825 patent/US10314785B2/en not_active Expired - Lifetime
- 2014-12-08 CY CY20141101076T patent/CY1115948T1/el unknown
-
2018
- 2018-09-14 HK HK18111870.2A patent/HK1252557A1/en unknown
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