BRPI9711856B8 - métodos para preparação de um agente ativo, substancialmente insolúvel em água e composição para liberação in vivo de um agente ativo - Google Patents

métodos para preparação de um agente ativo, substancialmente insolúvel em água e composição para liberação in vivo de um agente ativo

Info

Publication number
BRPI9711856B8
BRPI9711856B8 BRPI9711856A BR9711856A BRPI9711856B8 BR PI9711856 B8 BRPI9711856 B8 BR PI9711856B8 BR PI9711856 A BRPI9711856 A BR PI9711856A BR 9711856 A BR9711856 A BR 9711856A BR PI9711856 B8 BRPI9711856 B8 BR PI9711856B8
Authority
BR
Brazil
Prior art keywords
active agent
pharmacologically active
preparing
composition
methods
Prior art date
Application number
BRPI9711856A
Other languages
English (en)
Other versions
BRPI9711856B1 (pt
BR9711856A (pt
Inventor
Yang Andrew
Tao Chunlin
Louie Leslie
P Desai Neil
Soon-Shiong Patrick
Magdassi Shlomo
Zheng Tianli
Yao Zhiwen
Original Assignee
Abraxis Bioscience Inc
Abraxis Bioscience Llc
American Bioscience Inc
Vivorx Pharmaceuticals Inc
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=24895164&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BRPI9711856(B8) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Abraxis Bioscience Inc, Abraxis Bioscience Llc, American Bioscience Inc, Vivorx Pharmaceuticals Inc filed Critical Abraxis Bioscience Inc
Publication of BR9711856A publication Critical patent/BR9711856A/pt
Publication of BRPI9711856B1 publication Critical patent/BRPI9711856B1/pt
Publication of BRPI9711856B8 publication Critical patent/BRPI9711856B8/pt

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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/51—Nanocapsules; Nanoparticles
    • A61K9/5107—Excipients; Inactive ingredients
    • A61K9/513—Organic macromolecular compounds; Dendrimers
    • A61K9/5169—Proteins, e.g. albumin, gelatin
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/40—Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/51—Nanocapsules; Nanoparticles
    • A61K9/5192—Processes
    • 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
    • A61P35/00—Antineoplastic agents
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B82—NANOTECHNOLOGY
    • B82Y—SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
    • B82Y5/00—Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
    • 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
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S977/00—Nanotechnology
    • Y10S977/902—Specified use of nanostructure
    • Y10S977/904—Specified use of nanostructure for medical, immunological, body treatment, or diagnosis
    • Y10S977/906—Drug delivery
    • Y10S977/907—Liposome
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S977/00—Nanotechnology
    • Y10S977/902—Specified use of nanostructure
    • Y10S977/904—Specified use of nanostructure for medical, immunological, body treatment, or diagnosis
    • Y10S977/915—Therapeutic or pharmaceutical composition
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S977/00—Nanotechnology
    • Y10S977/902—Specified use of nanostructure
    • Y10S977/904—Specified use of nanostructure for medical, immunological, body treatment, or diagnosis
    • Y10S977/927—Diagnostic contrast agent

Abstract

patente de invenção: "agentes farmacologicamente ativos estabilizados com proteína, processos para a sua preparação e processos para o seu uso". de acordo com a presente invenção são providos composições e processos para liberação in vivo de agentes farmacologicamente ativos substancialmente insolúveis em água (tais como paclitaxel de drogas anticâncer) nos quais o agente farmacologicamente ativo é liberado na forma de partículas suspensas revestidas com proteína (que agem como um agente estabilizador) . em particular, a proteína e o agente farmacologicamente ativo em um meio dispersante biocompatível são submetidos a alto cisalhamento, na ausência de qualquer tensoativo convencional e também na ausência de qualquer material de núcleo polimérico para as partículas. o procedimento produz partículas com diâmetro menor do que 1 mícron. o uso de composição e de preparação específicas (por exemplo, adição de um solvente polar à fase orgânica) e uma seleção cuidadosa da fase orgânica apropriada permite a produção reproduzível de nanopartículas especialmente pequenas de menos do que 200 nm de diâmetro, as quais podem ser filtradas sob condições estéreis. o sistema de partícula produzido de acordo com a presente invenção pode ser convertido em um pó seco redispersável compreendendo nanopartículas de droga insolúvel em água revestidas com proteína e uma proteína livre à qual as moléculas do referido agente farmacologicamente ativo está associado. isto resulta em um sistema único de liberação no qual parte do agente farmacologicamente ativo está rapidamente biodisponível (na forma de moléculas ligadas a uma proteína) e parte do agente está presente dentro de partículas sem qualquer matriz polimérica.
BRPI9711856A 1996-10-01 1997-09-24 métodos para preparação de um agente ativo, substancialmente insolúvel em água e composição para liberação in vivo de um agente ativo BRPI9711856B8 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08/720,756 US5916596A (en) 1993-02-22 1996-10-01 Protein stabilized pharmacologically active agents, methods for the preparation thereof and methods for the use thereof
PCT/US1997/017157 WO1998014174A1 (en) 1996-10-01 1997-09-24 Protein stabilized pharmacologically active agents, methods for the preparation thereof and methods for the use thereof

Publications (3)

Publication Number Publication Date
BR9711856A BR9711856A (pt) 2001-11-06
BRPI9711856B1 BRPI9711856B1 (pt) 2016-07-12
BRPI9711856B8 true BRPI9711856B8 (pt) 2021-05-25

Family

ID=24895164

Family Applications (2)

Application Number Title Priority Date Filing Date
BRPI9711856A BRPI9711856B8 (pt) 1996-10-01 1997-09-24 métodos para preparação de um agente ativo, substancialmente insolúvel em água e composição para liberação in vivo de um agente ativo
BRPI9715297A BRPI9715297B8 (pt) 1996-10-01 1997-09-24 composição compreendendo partículas de agente farmacologicamente ativo, uso da mesma, cateter intravenoso, frasco selado e emulsão compreendendo um agente farmacologicamente ativo

Family Applications After (1)

Application Number Title Priority Date Filing Date
BRPI9715297A BRPI9715297B8 (pt) 1996-10-01 1997-09-24 composição compreendendo partículas de agente farmacologicamente ativo, uso da mesma, cateter intravenoso, frasco selado e emulsão compreendendo um agente farmacologicamente ativo

Country Status (19)

Country Link
US (1) US5916596A (pt)
EP (3) EP1944019B1 (pt)
JP (2) JP4837809B2 (pt)
CN (2) CN1157185C (pt)
AT (1) ATE427739T1 (pt)
AU (1) AU718753B2 (pt)
BR (2) BRPI9711856B8 (pt)
CA (2) CA2512487C (pt)
DE (2) DE122009000065I1 (pt)
DK (1) DK0961612T4 (pt)
ES (2) ES2323559T5 (pt)
FR (1) FR09C0050I2 (pt)
HK (1) HK1024866A1 (pt)
LU (1) LU91613I2 (pt)
NL (1) NL300417I1 (pt)
NO (1) NO328689B1 (pt)
NZ (1) NZ335133A (pt)
PT (1) PT961612E (pt)
WO (1) WO1998014174A1 (pt)

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