BRPI0417264A - processos para a preparação de uma batelada de um ingrediente farmacêutico ativo, um recipiente compreendendo criogránulos de um produto alérgeno, e um criogránulo de um produto alérgeno - Google Patents
processos para a preparação de uma batelada de um ingrediente farmacêutico ativo, um recipiente compreendendo criogránulos de um produto alérgeno, e um criogránulo de um produto alérgenoInfo
- Publication number
- BRPI0417264A BRPI0417264A BRPI0417264-7A BRPI0417264A BRPI0417264A BR PI0417264 A BRPI0417264 A BR PI0417264A BR PI0417264 A BRPI0417264 A BR PI0417264A BR PI0417264 A BRPI0417264 A BR PI0417264A
- Authority
- BR
- Brazil
- Prior art keywords
- allergen product
- container
- cryogranes
- processes
- active pharmaceutical
- Prior art date
Links
- 239000013566 allergen Substances 0.000 title abstract 7
- 239000008186 active pharmaceutical agent Substances 0.000 title abstract 3
- 238000000034 method Methods 0.000 title abstract 3
- 238000002360 preparation method Methods 0.000 title abstract 2
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 abstract 2
- 239000007788 liquid Substances 0.000 abstract 2
- 230000015572 biosynthetic process Effects 0.000 abstract 1
- 238000004108 freeze drying Methods 0.000 abstract 1
- 239000008187 granular material Substances 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 229910052757 nitrogen Inorganic materials 0.000 abstract 1
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J2/00—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic
- B01J2/02—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic by dividing the liquid material into drops, e.g. by spraying, and solidifying the drops
- B01J2/06—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic by dividing the liquid material into drops, e.g. by spraying, and solidifying the drops in a liquid medium
-
- 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
- A61K9/1688—Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
-
- 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
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B5/00—Drying solid materials or objects by processes not involving the application of heat
- F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
- F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
- F26B5/065—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing the product to be freeze-dried being sprayed, dispersed or pulverised
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Organic Chemistry (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Mechanical Engineering (AREA)
- Molecular Biology (AREA)
- General Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Pulmonology (AREA)
- General Chemical & Material Sciences (AREA)
- Immunology (AREA)
- Medicinal Preparation (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Abstract
"PROCESSOS PARA A PREPARAçãO DE UMA BATELADA DE UM INGREDIENTE FARMACêUTICO ATIVO, UM RECIPIENTE COMPREENDENDO CRIOGRáNULOS DE UM PRODUTO ALéRGENO, E UM CRIOGRáNULO DE UM PRODUTO ALéRGENO". A presente invenção refere-se a um processo para a preparação de uma batelada de um ingrediente farmacêutico ativo, por exemplo, um produto alérgeno. A invenção também diz respeito a um recipiente que compreende criogrânulos de uma composição líquida de um produto alérgeno, e a um criogrânulo de um produto alérgeno. Os processos caracterizam a formação de criogrânulos usando um recipiente tendo um meio criogênico (por exemplo, nitrogênio líquido) e armazenamento dos grânulos no mesmo recipiente. Os criogrânulos obtidos podem ser armazenados e manipulados sem secagem por congelamento anterior.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DKPA200301896 | 2003-12-19 | ||
| US53167903P | 2003-12-23 | 2003-12-23 | |
| PCT/DK2004/000878 WO2005058474A1 (en) | 2003-12-19 | 2004-12-17 | Cryogranulation and storage method for active pharmaceutical agents |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| BRPI0417264A true BRPI0417264A (pt) | 2007-03-06 |
Family
ID=34702154
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BRPI0417264-7A BRPI0417264A (pt) | 2003-12-19 | 2004-12-17 | processos para a preparação de uma batelada de um ingrediente farmacêutico ativo, um recipiente compreendendo criogránulos de um produto alérgeno, e um criogránulo de um produto alérgeno |
Country Status (9)
| Country | Link |
|---|---|
| US (3) | US20050232930A1 (pt) |
| EP (2) | EP2272502A1 (pt) |
| JP (1) | JP5795852B2 (pt) |
| AU (1) | AU2004298719B8 (pt) |
| BR (1) | BRPI0417264A (pt) |
| IL (1) | IL176116A0 (pt) |
| MX (1) | MXPA06006896A (pt) |
| RU (1) | RU2006126051A (pt) |
| WO (1) | WO2005058474A1 (pt) |
Families Citing this family (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20060210590A1 (en) | 2005-02-03 | 2006-09-21 | Alk-Abello A/S | Minor allergen control to increase safety of immunotherapy |
| EP1798504A1 (en) * | 2005-12-19 | 2007-06-20 | Koninklijke Philips Electronics N.V. | Method of making dried particles |
| EP1870649A1 (en) | 2006-06-20 | 2007-12-26 | Octapharma AG | Lyophilisation targetting defined residual moisture by limited desorption energy levels |
| WO2010099966A2 (de) * | 2009-03-06 | 2010-09-10 | Linde Aktiengesellschaft | Verfahren zur herstellung von kosmetika |
| EP2496253B1 (en) | 2009-11-02 | 2019-01-09 | MannKind Corporation | Apparatus and method for cryogranulating a pharmaceutical composition |
| WO2011124667A2 (de) | 2010-04-09 | 2011-10-13 | Qiagen Gmbh | Verfahren zur herstellung von im wesentlichen kugelförmigen lyophilisaten |
| EP2575832B1 (en) | 2010-06-03 | 2017-07-26 | ALK-Abelló A/S | Pharmaceutical product comprising mite allergen extract(s) and a method for the manufacture thereof |
| US8549768B2 (en) * | 2011-03-11 | 2013-10-08 | Linde Aktiengesellschaft | Methods for freeze drying |
| US20130008191A1 (en) * | 2011-07-07 | 2013-01-10 | Suchak Naresh J | Methods for freezing and thawing proteins |
| ES2786506T3 (es) * | 2012-08-01 | 2020-10-13 | Zahra Tavakoli | Composiciones congeladas fluidas que comprenden un agente terapéutico |
| US11207241B2 (en) | 2013-03-15 | 2021-12-28 | Phd Preventative Health Care And Diagnostics, Inc. | Prefilled medication device, method of making and using the same |
| KR102385900B1 (ko) | 2013-09-19 | 2022-04-11 | 알로베이트, 엘엘씨 | 구강점막으로 알레르겐을 전달하기 위한 치약 |
| PT3638044T (pt) | 2017-06-15 | 2024-06-12 | Dsm Ip Assets Bv | Péletes de enzima congeladas |
Family Cites Families (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS5242846B2 (pt) | 1974-04-03 | 1977-10-27 | ||
| JPS6451032A (en) * | 1987-08-22 | 1989-02-27 | Minoru Hosoya | Method for raising hen |
| US4848094A (en) | 1988-04-29 | 1989-07-18 | Union Carbide Corporation | Droplet freezing method and apparatus |
| JPH02187583A (ja) * | 1989-01-13 | 1990-07-23 | Yasuto Ozaki | 携帯用冷却装置 |
| US5275016A (en) | 1992-04-24 | 1994-01-04 | Abaxis, Inc. | Cryogenic apparatus |
| JPH06323712A (ja) * | 1993-04-20 | 1994-11-25 | E I Du Pont De Nemours & Co | 霧化した極低温液滴の閉じ込め帯域を用いて凍結粒子を製造する方法および装置 |
| IL120202A (en) * | 1996-03-07 | 2001-03-19 | Akzo Nobel Nv | Container with freeze-dried vaccine components |
| PL194804B1 (pl) | 1998-03-16 | 2007-07-31 | Alk Abello As | Zrekombinowany alergen, sposób przygotowywania zrekombinowanego alergenu, kompozycja farmaceutyczna oraz zastosowanie zrekombinowanego alergenu do przygotowywania leku do wywoływania odpowiedzi immunologicznej u osobnika i do przygotowywania leku do leczenia, zapobiegania lub osłabiania reakcji alergicznych |
| CA2338766A1 (en) * | 1998-07-31 | 2000-02-10 | Eli Lilly And Company | Cryogranulation of activated protein c |
| SE9903236D0 (sv) * | 1999-09-10 | 1999-09-10 | Astra Ab | Method to obtain microparticles |
| US6284283B1 (en) * | 1999-10-21 | 2001-09-04 | Alkermes Controlled Therapeutics, Inc. | Method of producing sub-micron particles of biologically active agents and uses thereof |
| CA2397404C (en) | 2000-01-14 | 2008-12-02 | Brown University Research Foundation | Micronized freeze-dried particles |
| US6565888B1 (en) * | 2000-08-23 | 2003-05-20 | Alkermes Controlled Therapeutics, Inc. | Methods and compositions for the targeted delivery of biologically active agents |
| ATE414773T1 (de) | 2000-11-16 | 2008-12-15 | Alk Abello As | Mutante allergene |
| AUPR750501A0 (en) | 2001-09-05 | 2001-09-27 | Gauci, Mark | Products comprising quantum of bioparticles and method for production thereof |
| CN1668737A (zh) | 2002-05-16 | 2005-09-14 | 阿尔克-阿贝洛有限公司 | 重组Bet.V.1过敏原突变体及其方法和制备 |
| GB0218821D0 (en) * | 2002-08-13 | 2002-09-18 | Glaxosmithkline Biolog Sa | Novel compositions |
| US8012505B2 (en) * | 2003-02-28 | 2011-09-06 | Alk-Abello A/S | Dosage form having a saccharide matrix |
-
2004
- 2004-12-17 RU RU2006126051/15A patent/RU2006126051A/ru not_active Application Discontinuation
- 2004-12-17 MX MXPA06006896A patent/MXPA06006896A/es active IP Right Grant
- 2004-12-17 AU AU2004298719A patent/AU2004298719B8/en not_active Ceased
- 2004-12-17 WO PCT/DK2004/000878 patent/WO2005058474A1/en not_active Ceased
- 2004-12-17 EP EP10176523A patent/EP2272502A1/en not_active Withdrawn
- 2004-12-17 BR BRPI0417264-7A patent/BRPI0417264A/pt not_active Application Discontinuation
- 2004-12-17 EP EP04803030A patent/EP1697033B1/en not_active Expired - Lifetime
- 2004-12-20 US US11/014,959 patent/US20050232930A1/en not_active Abandoned
-
2006
- 2006-06-04 IL IL176116A patent/IL176116A0/en unknown
-
2010
- 2010-11-12 US US12/945,812 patent/US8459046B2/en not_active Expired - Fee Related
- 2010-11-12 US US12/945,814 patent/US8551491B2/en not_active Expired - Fee Related
- 2010-11-15 JP JP2010254955A patent/JP5795852B2/ja not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| CA2548249C (en) | 2013-02-12 |
| JP2011105719A (ja) | 2011-06-02 |
| MXPA06006896A (es) | 2006-09-04 |
| IL176116A0 (en) | 2006-10-05 |
| HK1096895A1 (en) | 2007-06-15 |
| US8459046B2 (en) | 2013-06-11 |
| US20110104216A1 (en) | 2011-05-05 |
| EP1697033A1 (en) | 2006-09-06 |
| RU2006126051A (ru) | 2008-01-27 |
| WO2005058474A9 (en) | 2006-08-03 |
| AU2004298719B8 (en) | 2011-04-07 |
| US20050232930A1 (en) | 2005-10-20 |
| JP5795852B2 (ja) | 2015-10-14 |
| EP1697033B1 (en) | 2011-04-13 |
| US8551491B2 (en) | 2013-10-08 |
| WO2005058474A1 (en) | 2005-06-30 |
| CA2548249A1 (en) | 2005-06-30 |
| AU2004298719A1 (en) | 2005-06-30 |
| AU2004298719B2 (en) | 2011-03-24 |
| EP2272502A1 (en) | 2011-01-12 |
| US20110100030A1 (en) | 2011-05-05 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| B06F | Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette] | ||
| B11E | Dismissal acc. art. 34 of ipl - requirements for examination incomplete | ||
| B11T | Dismissal of application maintained [chapter 11.20 patent gazette] |