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 alérgeno

Info

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
Application number
BRPI0417264-7A
Other languages
English (en)
Inventor
Martin Richter-Friis
Signe Kolmos Andersen
Original Assignee
Alk Abello As
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Alk Abello As filed Critical Alk Abello As
Publication of BRPI0417264A publication Critical patent/BRPI0417264A/pt

Links

Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01JCHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J2/00Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic
    • B01J2/02Processes 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
    • B01J2/06Processes 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • A61K9/1688Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/08Antiallergic agents
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26DRYING
    • F26BDRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B5/00Drying solid materials or objects by processes not involving the application of heat
    • F26B5/04Drying 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
    • F26B5/06Drying 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
    • F26B5/065Drying 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers 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.
BRPI0417264-7A 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 BRPI0417264A (pt)

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)

* Cited by examiner, † Cited by third party
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)

* Cited by examiner, † Cited by third party
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

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]