WO1999065469A3 - Processes to generate submicron particles of water-insoluble compounds - Google Patents

Processes to generate submicron particles of water-insoluble compounds Download PDF

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Publication number
WO1999065469A3
WO1999065469A3 PCT/US1999/013755 US9913755W WO9965469A3 WO 1999065469 A3 WO1999065469 A3 WO 1999065469A3 US 9913755 W US9913755 W US 9913755W WO 9965469 A3 WO9965469 A3 WO 9965469A3
Authority
WO
WIPO (PCT)
Prior art keywords
water
submicron particles
insoluble compounds
processes
generate submicron
Prior art date
Application number
PCT/US1999/013755
Other languages
French (fr)
Other versions
WO1999065469A2 (en
Inventor
Gary W Pace
G Michael Vachon
K Awadhesh Mishra
Inge B Henriksen
Val Krukonis
Anthony Godinas
Original Assignee
Rtp Pharma 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
Priority to IL14027699A priority Critical patent/IL140276A0/en
Application filed by Rtp Pharma Inc filed Critical Rtp Pharma Inc
Priority to CA002335472A priority patent/CA2335472C/en
Priority to AU46938/99A priority patent/AU755993C/en
Priority to JP2000554349A priority patent/JP4693238B2/en
Priority to EP99930387A priority patent/EP1089714B1/en
Priority to DE69905716T priority patent/DE69905716T2/en
Priority to AT99930387T priority patent/ATE233549T1/en
Publication of WO1999065469A2 publication Critical patent/WO1999065469A2/en
Publication of WO1999065469A3 publication Critical patent/WO1999065469A3/en
Priority to IL140276A priority patent/IL140276A/en
Priority to SE0004620A priority patent/SE521255C2/en
Priority to HK02100959.7A priority patent/HK1039566A1/en
Priority to AU2003203459A priority patent/AU2003203459A1/en

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
    • A61K9/1688—Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
    • 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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • 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
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • 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
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • 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
    • A61K9/5005—Wall or coating material
    • A61K9/5015—Organic compounds, e.g. fats, sugars
    • 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
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F23/00—Mixing according to the phases to be mixed, e.g. dispersing or emulsifying
    • B01F23/50—Mixing liquids with solids
    • B01F23/51—Methods thereof
    • B01F23/511—Methods thereof characterised by the composition of the liquids or solids
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F25/00—Flow mixers; Mixers for falling materials, e.g. solid particles
    • B01F25/20—Jet mixers, i.e. mixers using high-speed fluid streams
    • B01F25/28—Jet mixers, i.e. mixers using high-speed fluid streams characterised by the specific design of the jet injector
    • B01F25/281—Jet mixers, i.e. mixers using high-speed fluid streams characterised by the specific design of the jet injector the jet injector being of the explosive rapid expansion of supercritical solutions [RESS] or fluid injection of molecular spray [FIMS] type, i.e. the liquid is jetted in an environment (gas or liquid) by nozzles, in conditions of significant pressure drop, with the possible generation of shock waves
    • 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
    • B01J3/00—Processes of utilising sub-atmospheric or super-atmospheric pressure to effect chemical or physical change of matter; Apparatus therefor
    • B01J3/008—Processes carried out under supercritical conditions
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F2101/00—Mixing characterised by the nature of the mixed materials or by the application field
    • B01F2101/22—Mixing of ingredients for pharmaceutical or medical compositions
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F23/00—Mixing according to the phases to be mixed, e.g. dispersing or emulsifying
    • B01F23/04—Specific aggregation state of one or more of the phases to be mixed
    • B01F23/043—Mixing fluids or with fluids in a supercritical state, in supercritical conditions or variable density fluids
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F23/00—Mixing according to the phases to be mixed, e.g. dispersing or emulsifying
    • B01F23/50—Mixing liquids with solids
    • B01F23/56—Mixing liquids with solids by introducing solids in liquids, e.g. dispersing or dissolving
    • 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
    • Y10S977/70—Nanostructure
    • Y10S977/773—Nanoparticle, i.e. structure having three dimensions of 100 nm or less
    • 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
    • Y10S977/70—Nanostructure
    • Y10S977/788—Of specified organic or carbon-based composition
    • Y10S977/797—Lipid particle
    • Y10S977/798—Lipid particle having internalized material
    • Y10S977/799—Containing biological material
    • Y10S977/801—Drug
    • 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

Abstract

Submicron particles of water-insoluble compounds, particularly drugs, are prepared by simultaneously stabilizing microparticulate suspensions of same with surface modifier molecules by rapid expansion into an aqueous medium from a compressed solution of the compound and surface modifiers in a liquefied gas and optionally homogenizing the aqueous suspension thus formed with a high pressure homogenizer.
PCT/US1999/013755 1998-06-19 1999-06-18 Processes to generate submicron particles of water-insoluble compounds WO1999065469A2 (en)

Priority Applications (11)

Application Number Priority Date Filing Date Title
DE69905716T DE69905716T2 (en) 1998-06-19 1999-06-18 NEW PROCESS FOR PRODUCING PARTICLES OF WATER-INSOLUBLE COMPONENTS IN THE SIZE RANGE UP TO 2000 NM
CA002335472A CA2335472C (en) 1998-06-19 1999-06-18 Processes to generate submicron particles of water-insoluble compounds
AU46938/99A AU755993C (en) 1998-06-19 1999-06-18 Processes to generate submicron particles of water-insoluble compounds
JP2000554349A JP4693238B2 (en) 1998-06-19 1999-06-18 Method for producing submicron particles of water insoluble compounds
EP99930387A EP1089714B1 (en) 1998-06-19 1999-06-18 Processes to generate particles of water-insoluble compounds of up to 2000 nm in size
IL14027699A IL140276A0 (en) 1998-06-19 1999-06-18 Processes to generate submicron particles of water-insoluble compounds
AT99930387T ATE233549T1 (en) 1998-06-19 1999-06-18 NEW PROCESS FOR PRODUCING PARTICLES OF WATER-INSOLUBLE COMPONENTS IN THE SIZE RANGE UP TO 2000 NM
IL140276A IL140276A (en) 1998-06-19 2000-12-13 Processes to generate suspensions of water-insoluble biologically active compounds containing particles of sizes of up to two microns
SE0004620A SE521255C2 (en) 1998-06-19 2000-12-14 Process for the preparation of submicron particles of water-insoluble compounds
HK02100959.7A HK1039566A1 (en) 1998-06-19 2002-02-07 Process to generate submicron particles of water-insoluble compounds
AU2003203459A AU2003203459A1 (en) 1998-06-19 2003-04-01 Processes to generate submicron particles of water-insoluble compounds

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US8985298P 1998-06-19 1998-06-19
US60/089,852 1998-06-19

Publications (2)

Publication Number Publication Date
WO1999065469A2 WO1999065469A2 (en) 1999-12-23
WO1999065469A3 true WO1999065469A3 (en) 2000-03-02

Family

ID=22219900

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1999/013755 WO1999065469A2 (en) 1998-06-19 1999-06-18 Processes to generate submicron particles of water-insoluble compounds

Country Status (14)

Country Link
US (1) US6177103B1 (en)
EP (1) EP1089714B1 (en)
JP (2) JP4693238B2 (en)
KR (1) KR100622047B1 (en)
CN (1) CN1160059C (en)
AT (1) ATE233549T1 (en)
AU (2) AU755993C (en)
CA (1) CA2335472C (en)
DE (1) DE69905716T2 (en)
ES (1) ES2194477T3 (en)
HK (1) HK1039566A1 (en)
IL (2) IL140276A0 (en)
SE (1) SE521255C2 (en)
WO (1) WO1999065469A2 (en)

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US8722091B2 (en) 2001-09-26 2014-05-13 Baxter International Inc. Preparation of submicron sized nanoparticles via dispersion lyophilization

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