BR112012011603A2 - aparelho e método para criogranular composição farmacêutica - Google Patents

aparelho e método para criogranular composição farmacêutica

Info

Publication number
BR112012011603A2
BR112012011603A2 BR112012011603A BR112012011603A BR112012011603A2 BR 112012011603 A2 BR112012011603 A2 BR 112012011603A2 BR 112012011603 A BR112012011603 A BR 112012011603A BR 112012011603 A BR112012011603 A BR 112012011603A BR 112012011603 A2 BR112012011603 A2 BR 112012011603A2
Authority
BR
Brazil
Prior art keywords
pharmaceutical
cryo
manufacture
fluid medium
pharmaceutical composition
Prior art date
Application number
BR112012011603A
Other languages
English (en)
Other versions
BR112012011603B8 (pt
BR112012011603B1 (pt
Inventor
Amoro Edwin
Vanackere Karel
a white Michael
Original Assignee
Mannkind Corp
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 Mannkind Corp filed Critical Mannkind Corp
Publication of BR112012011603A2 publication Critical patent/BR112012011603A2/pt
Publication of BR112012011603B1 publication Critical patent/BR112012011603B1/pt
Publication of BR112012011603B8 publication Critical patent/BR112012011603B8/pt

Links

Classifications

    • 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
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • 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
    • B01J19/00—Chemical, physical or physico-chemical processes in general; Their relevant apparatus
    • B01J19/24—Stationary reactors without moving elements inside
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/28—Insulins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • 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
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • 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
    • B01J19/00—Chemical, physical or physico-chemical processes in general; Their relevant apparatus
    • B01J19/24—Stationary reactors without moving elements inside
    • B01J19/2415—Tubular reactors
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

aparelho e método para criogranular composição farmacêutica. são apresentados sistemas de criogranulação com conjuntos de dispensador aparfeiçoados para uso na fabricação de bolinhas congeladas de substâncias farmacêuticas em um meio fluido. são também apresentados métodos para criogranular a substância farmacêutica no meio fluido. em modalidades específicas, o conjunto de dispensador é usado como suspensões ou pastas semi-fluidas de composições farmacêuticas que incluem substâncias biodegradáveis, tais como proteínas, peptídeos e ácidos nucléicos. em determinadas modalidades, a substância farmacêutica pode ser absorvida em quaisquer partículas condutoras farmaceuticamente aceitáveis adequadas para a fabricação de pós farmacêuticos. em uma modalidade, o condutor farmacêutico pode consistir em micro-partículas á base de dicetopiperazina, por exemplo. o conjunto de dispensador aperfeiçoa as características físicas das crio-bolinhas formadas e reduz ao mínimo a perda de produtos durante o processamento.
BR112012011603A 2009-11-02 2010-11-02 sistema de criogranulação, conjunto de dispensador, método para criogranular uma composição farmacêutica e método para criopeletizar BR112012011603B8 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US25738509P 2009-11-02 2009-11-02
US61/257,385 2009-11-02
PCT/US2010/055085 WO2011053959A1 (en) 2009-11-02 2010-11-02 Apparatus and method for cryogranulating a pharmaceutical composition

Publications (3)

Publication Number Publication Date
BR112012011603A2 true BR112012011603A2 (pt) 2018-04-17
BR112012011603B1 BR112012011603B1 (pt) 2021-03-30
BR112012011603B8 BR112012011603B8 (pt) 2021-07-27

Family

ID=43922628

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112012011603A BR112012011603B8 (pt) 2009-11-02 2010-11-02 sistema de criogranulação, conjunto de dispensador, método para criogranular uma composição farmacêutica e método para criopeletizar

Country Status (14)

Country Link
US (7) US8590320B2 (pt)
EP (2) EP3533517A1 (pt)
JP (2) JP5960599B2 (pt)
KR (2) KR101822208B1 (pt)
CN (2) CN104027312B (pt)
AU (1) AU2010313173B2 (pt)
BR (1) BR112012011603B8 (pt)
CA (3) CA3107195C (pt)
HK (2) HK1173647A1 (pt)
IL (2) IL219303A0 (pt)
MX (2) MX357798B (pt)
RU (2) RU2638794C2 (pt)
SG (1) SG10201406835XA (pt)
WO (1) WO2011053959A1 (pt)

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Also Published As

Publication number Publication date
EP3533517A1 (en) 2019-09-04
IL238630A0 (en) 2015-06-30
SG10201406835XA (en) 2014-11-27
US11077063B2 (en) 2021-08-03
CN104027312A (zh) 2014-09-10
RU2012118253A (ru) 2013-12-10
CN102596238B (zh) 2014-06-18
MX357798B (es) 2018-07-25
MX2012005090A (es) 2012-06-19
RU2563122C2 (ru) 2015-09-20
CA3107195C (en) 2023-02-14
US10500159B2 (en) 2019-12-10
US20140044790A1 (en) 2014-02-13
CA2779613A1 (en) 2011-05-05
US20110100028A1 (en) 2011-05-05
CA2976705C (en) 2021-03-16
IL238630A (en) 2017-02-28
US20200069590A1 (en) 2020-03-05
US8590320B2 (en) 2013-11-26
EP2496253A1 (en) 2012-09-12
EP2496253B1 (en) 2019-01-09
WO2011053959A1 (en) 2011-05-05
JP2013509276A (ja) 2013-03-14
AU2010313173A1 (en) 2012-05-17
US20210322320A1 (en) 2021-10-21
CA2976705A1 (en) 2011-05-05
US20240074976A1 (en) 2024-03-07
IL219303A0 (en) 2012-06-28
KR101822208B1 (ko) 2018-01-25
US20180338920A1 (en) 2018-11-29
RU2014145428A (ru) 2015-06-20
KR101931069B1 (ko) 2018-12-19
AU2010313173B2 (en) 2015-02-12
CN104027312B (zh) 2018-11-02
US20170119673A1 (en) 2017-05-04
EP2496253A4 (en) 2013-04-03
US10052285B2 (en) 2018-08-21
CA2779613C (en) 2017-10-10
KR20120120154A (ko) 2012-11-01
JP2016128400A (ja) 2016-07-14
JP6228175B2 (ja) 2017-11-08
RU2638794C2 (ru) 2017-12-15
US11839688B2 (en) 2023-12-12
JP5960599B2 (ja) 2016-08-02
BR112012011603B8 (pt) 2021-07-27
BR112012011603B1 (pt) 2021-03-30
KR20180011336A (ko) 2018-01-31
US9566243B2 (en) 2017-02-14
HK1201748A1 (en) 2015-09-11
HK1173647A1 (en) 2013-05-24
CN102596238A (zh) 2012-07-18
CA3107195A1 (en) 2011-05-05

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