WO2000071079A3 - Protein stabilized pharmacologically active agents, methods for the preparation thereof and methods for the use thereof - Google Patents

Protein stabilized pharmacologically active agents, methods for the preparation thereof and methods for the use thereof Download PDF

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Publication number
WO2000071079A3
WO2000071079A3 PCT/US2000/013954 US0013954W WO0071079A3 WO 2000071079 A3 WO2000071079 A3 WO 2000071079A3 US 0013954 W US0013954 W US 0013954W WO 0071079 A3 WO0071079 A3 WO 0071079A3
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WO
WIPO (PCT)
Prior art keywords
protein
pharmacologically active
agent
particles
methods
Prior art date
Application number
PCT/US2000/013954
Other languages
French (fr)
Other versions
WO2000071079A2 (en
Inventor
Neil P Desai
Chunlin Tao
Andrew Yang
Leslie Louie
Zhiwen Yao
Patrick Soon-Shiong
Shlomo Magdassi
Original Assignee
American Bioscience Inc
Neil P Desai
Chunlin Tao
Andrew Yang
Leslie Louie
Zhiwen Yao
Patrick Soon-Shiong
Shlomo Magdassi
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 claimed from US09/316,642 external-priority patent/US6749868B1/en
Application filed by American Bioscience Inc, Neil P Desai, Chunlin Tao, Andrew Yang, Leslie Louie, Zhiwen Yao, Patrick Soon-Shiong, Shlomo Magdassi filed Critical American Bioscience Inc
Priority to EP00932669A priority Critical patent/EP1178786A4/en
Priority to AU50359/00A priority patent/AU784416B2/en
Priority to CA2371912A priority patent/CA2371912C/en
Publication of WO2000071079A2 publication Critical patent/WO2000071079A2/en
Priority to HK02105870.2A priority patent/HK1045646A1/en
Priority to AU2006202836A priority patent/AU2006202836B2/en
Publication of WO2000071079A3 publication Critical patent/WO2000071079A3/en

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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
    • 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
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/337—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Dispersion Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Biomedical Technology (AREA)
  • Nanotechnology (AREA)
  • Optics & Photonics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

In accordance with the present invention, there are provided compositions and methods useful for the in vivo delivery of substantially water insoluble pharmacologically active agents (such as the anticancer drug paclitaxel) in which the pharmacologically active agent is delivered in the form of suspended particles coated with protein (which acts as a stabilizing agent). In particular, protein and pharmacologically active agent in a biocompatible dispersing medium are subjected to high shear, in the absence of any conventional surfactants, and also in the absence of any polymeric core material for the particles. The procedure yields particles with a diameter of less than about 1 micron. The use of specific composition and preparation conditions (e.g., addition of a polar solvent to the organic phase), and careful election of the proper organic phase and phase fraction, enables the reproducible production of unusually small nanoparticles of less than 200 nm diameter, which can be sterile-filtered. The particulate system produced according to the invention can be converted into a redispersible dry powder comprising nanoparticles of water-insoluble drug coated with a protein, and free protein to which molecules of the pharmacological agent are bound. This results in a unique delivery system, in which part of the pharmacologically active agent is readily bioavailable (in the form of molecules bound to the protein), and part of the agent is present within particles without any polymeric matrix therein.
PCT/US2000/013954 1999-05-21 2000-05-19 Protein stabilized pharmacologically active agents, methods for the preparation thereof and methods for the use thereof WO2000071079A2 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
EP00932669A EP1178786A4 (en) 1999-05-21 2000-05-19 Protein stabilized pharmacologically active agents, methods for the preparation thereof and methods for the use thereof
AU50359/00A AU784416B2 (en) 1999-05-21 2000-05-19 Protein stabilized pharmacologically active agents, methods for the preparation thereof and methods for the use thereof
CA2371912A CA2371912C (en) 1999-05-21 2000-05-19 Protein stabilized pharmacologically active agents, methods for the preparation thereof and methods for the use thereof
HK02105870.2A HK1045646A1 (en) 1999-05-21 2002-08-12 Protein stabilized pharmacologically active agents, methods for the preparation thereof and methods for the use thereof
AU2006202836A AU2006202836B2 (en) 1999-05-21 2006-06-30 Protein stabilized pharmacologically active agents, methods for the preparation thereof and methods for the use thereof

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/316,642 US6749868B1 (en) 1993-02-22 1999-05-21 Protein stabilized pharmacologically active agents, methods for the preparation thereof and methods for the use thereof
US09/316,642 1999-05-21

Publications (2)

Publication Number Publication Date
WO2000071079A2 WO2000071079A2 (en) 2000-11-30
WO2000071079A3 true WO2000071079A3 (en) 2008-03-27

Family

ID=23229970

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2000/013954 WO2000071079A2 (en) 1999-05-21 2000-05-19 Protein stabilized pharmacologically active agents, methods for the preparation thereof and methods for the use thereof

Country Status (5)

Country Link
EP (1) EP1178786A4 (en)
AU (3) AU784416B2 (en)
CA (2) CA2684454A1 (en)
HK (1) HK1045646A1 (en)
WO (1) WO2000071079A2 (en)

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US8853260B2 (en) 1997-06-27 2014-10-07 Abraxis Bioscience, Llc Formulations of pharmacological agents, methods for the preparation thereof and methods for the use thereof
US8911786B2 (en) 2007-03-07 2014-12-16 Abraxis Bioscience, Llc Nanoparticle comprising rapamycin and albumin as anticancer agent
US8927019B2 (en) 2007-06-01 2015-01-06 Abraxis Bioscience, Llc Methods and compositions for treating recurrent cancer
US8999396B2 (en) 2006-12-14 2015-04-07 Abraxis Bioscience, Llc Breast cancer therapy based on hormone receptor status with nanoparticles comprising taxane
US9149455B2 (en) 2012-11-09 2015-10-06 Abraxis Bioscience, Llc Methods of treating melanoma
US9370494B2 (en) 2010-03-26 2016-06-21 Abraxis Bioscience, Llc Methods for treating hepatocellular carcinoma
US9393318B2 (en) 2010-03-29 2016-07-19 Abraxis Bioscience, Llc Methods of treating cancer
US9446003B2 (en) 2009-04-15 2016-09-20 Abraxis Bioscience, Llc Prion free nanoparticle compositions and methods of making thereof
US9511046B2 (en) 2013-01-11 2016-12-06 Abraxis Bioscience, Llc Methods of treating pancreatic cancer
US9585960B2 (en) 2011-12-14 2017-03-07 Abraxis Bioscience, Llc Use of polymeric excipients for lyophilization or freezing of particles

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US20030199425A1 (en) * 1997-06-27 2003-10-23 Desai Neil P. Compositions and methods for treatment of hyperplasia
RU2002113659A (en) * 1999-10-27 2004-01-27 Бейкер Нортон Фармасьютикалз, Инк. (Us) METHOD AND COMPOSITIONS FOR ORAL DOSAGE OF TAXANS TO SICK PEOPLE
US9700866B2 (en) 2000-12-22 2017-07-11 Baxter International Inc. Surfactant systems for delivery of organic compounds
US8067032B2 (en) 2000-12-22 2011-11-29 Baxter International Inc. Method for preparing submicron particles of antineoplastic agents
CA2461349C (en) 2001-09-26 2011-11-29 Baxter International Inc. Preparation of submicron sized nanoparticles via dispersion and solvent or liquid phase removal
US20060003012A9 (en) 2001-09-26 2006-01-05 Sean Brynjelsen Preparation of submicron solid particle suspensions by sonication of multiphase systems
ES2625340T3 (en) 2001-10-15 2017-07-19 Crititech, Inc. Compositions and methods for the administration of poorly water soluble drugs and treatment methods
ITMI20020680A1 (en) * 2002-03-29 2003-09-29 Acs Dobfar Spa IMPROVED ANTI-TUMOR COMPOSITION BASED ON PACLITAXEL AND METHOD FOR ITS OBTAINING
NZ518997A (en) * 2002-05-16 2004-12-24 Interag Injection formulation for parenteral administration of biodegradable implant for sustained release of active agent
SI21222A (en) * 2002-05-28 2003-12-31 Krka, Tovarna Zdravil, D.D., Novo Mesto Method for preparation of nanoparticles
GB0216700D0 (en) 2002-07-18 2002-08-28 Astrazeneca Ab Process
DK1585548T3 (en) 2002-12-09 2018-09-03 Abraxis Bioscience Llc COMPOSITIONS AND PROCEDURES FOR THE DELIVERY OF PHARMACOLOGICAL AGENTS
GB0302673D0 (en) 2003-02-06 2003-03-12 Astrazeneca Ab Pharmaceutical formulations
IL160095A0 (en) * 2004-01-28 2004-06-20 Yissum Res Dev Co Formulations for poorly soluble drugs
EP1834624A4 (en) * 2005-01-07 2011-05-04 Eisai R&D Man Co Ltd Medicinal composition and process for producing the same
EP2301531B1 (en) 2005-02-18 2018-06-06 Abraxis BioScience, LLC Combinations and modes of administration of therapeutic agents and combination therapy
US8735394B2 (en) 2005-02-18 2014-05-27 Abraxis Bioscience, Llc Combinations and modes of administration of therapeutic agents and combination therapy
BRPI0612071A2 (en) * 2005-06-14 2010-10-19 Baxter Int pharmaceutical formulations to minimize drug interactions
KR101420445B1 (en) * 2005-08-31 2014-07-16 아브락시스 바이오사이언스, 엘엘씨 Compositions comprising poorly water soluble pharmaceutical agents and antimicrobial agents
JP2009512682A (en) * 2005-10-21 2009-03-26 パナセア バイオテック リミテッド Pharmaceutical composition comprising at least one anticancer drug and at least one polymer
US8980323B2 (en) 2006-08-29 2015-03-17 Fujifilm Corporation Hydrophilic matrix containing poorly water-soluble compound and method for producing the same
FR2924024B1 (en) * 2007-11-27 2012-08-17 Centre Nat Rech Scient NANOPARTICLES OF THERAPEUTIC ACTIVE INGREDIENTS OF LOW AQUEOUS SOLUBILITY
KR20100048751A (en) * 2008-10-31 2010-05-11 주식회사 동성바이오레인 Capsulated functional dual core aerosol composition and the method for their manufacture
US8226967B2 (en) 2008-11-27 2012-07-24 Basf Se Surface active proteins as excipients in solid pharmaceutical formulations
JP5936112B2 (en) 2009-02-11 2016-06-15 アルブミディクス アクティーゼルスカブ Albumin variants and complexes
CN105567699A (en) 2009-10-30 2016-05-11 诺维信生物制药丹麦公司 Albumin variants
KR20130028727A (en) 2010-03-29 2013-03-19 아브락시스 바이오사이언스, 엘엘씨 Methods of enhancing drug delivery and effectiveness of therapeutic agents
NZ604031A (en) 2010-06-04 2015-05-29 Abraxis Bioscience Llc Methods of treatment of pancreatic cancer
BR112014018679A2 (en) 2012-03-16 2017-07-04 Novozymes Biopharma Dk As albumin variants
MX2015005363A (en) 2012-11-08 2015-11-06 Novozymes Biopharma Dk As Albumin variants.
PT106738B (en) * 2013-01-09 2015-06-08 Hovione Farmaciencia Sa METHOD FOR THE CONTROL OF OSTWALD DIFUSIONAL DEGRADATION PHENOMENON (OSTWALD RIPENING) IN THE PROCESSING OF PARTICLES OF A PHARMACEUTICAL INGREDIENT
EP3318124A3 (en) 2013-02-16 2018-05-30 Albumedix A/S Pharmacokinetic animal model
US10744110B2 (en) 2013-03-12 2020-08-18 Abraxis Bioscience, Llc Methods of treating lung cancer
SG11201507234UA (en) 2013-03-14 2015-10-29 Abraxis Bioscience Llc Methods of treating bladder cancer
CN104548116A (en) * 2013-10-11 2015-04-29 程树海 Preparation method of stable protein drug-loaded microparticle system
CN104434808A (en) 2014-07-03 2015-03-25 石药集团中奇制药技术（石家庄）有限公司 Therapeutic nanoparticles and preparation method thereof
US10705070B1 (en) 2015-03-05 2020-07-07 Abraxis Bioscience, Llc Methods of assessing suitability of use of pharmaceutical compositions of albumin and poorly water soluble drug
US10527604B1 (en) 2015-03-05 2020-01-07 Abraxis Bioscience, Llc Methods of assessing suitability of use of pharmaceutical compositions of albumin and paclitaxel
KR20230165356A (en) 2015-06-29 2023-12-05 아브락시스 바이오사이언스, 엘엘씨 Methods of treating epithelioid cell tumors
WO2017029407A1 (en) 2015-08-20 2017-02-23 Albumedix A/S Albumin variants and conjugates
CN110337590A (en) 2016-11-04 2019-10-15 奥胡斯大学 The identification and treatment of tumour characterized by neonatal Fc receptor is overexpressed
DE102016125666A1 (en) * 2016-12-23 2018-06-28 Michael Denck HSA Galenik
CN110753541A (en) * 2017-04-24 2020-02-04 Zy治疗公司 Pharmaceutical compositions for in vivo delivery, process for preparing substantially water insoluble pharmacologically active agents
CA3094453A1 (en) 2018-03-20 2019-09-26 Abraxis Bioscience, Llc Methods of treating central nervous system disorders via administration of nanoparticles of an mtor inhibitor and an albumin
AU2020375810A1 (en) 2019-10-28 2022-05-12 Abraxis Bioscience, Llc Pharmaceutical compositions of albumin and rapamycin
WO2021119439A1 (en) * 2019-12-11 2021-06-17 The Regents Of The University Of Michigan Compositions and methods for systemic delivery of bcl-2 and bcl-xl antagonists

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Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8853260B2 (en) 1997-06-27 2014-10-07 Abraxis Bioscience, Llc Formulations of pharmacological agents, methods for the preparation thereof and methods for the use thereof
US8999396B2 (en) 2006-12-14 2015-04-07 Abraxis Bioscience, Llc Breast cancer therapy based on hormone receptor status with nanoparticles comprising taxane
US8911786B2 (en) 2007-03-07 2014-12-16 Abraxis Bioscience, Llc Nanoparticle comprising rapamycin and albumin as anticancer agent
US8927019B2 (en) 2007-06-01 2015-01-06 Abraxis Bioscience, Llc Methods and compositions for treating recurrent cancer
US9446003B2 (en) 2009-04-15 2016-09-20 Abraxis Bioscience, Llc Prion free nanoparticle compositions and methods of making thereof
US9370494B2 (en) 2010-03-26 2016-06-21 Abraxis Bioscience, Llc Methods for treating hepatocellular carcinoma
US9393318B2 (en) 2010-03-29 2016-07-19 Abraxis Bioscience, Llc Methods of treating cancer
US9597409B2 (en) 2010-03-29 2017-03-21 Abraxis Bioscience, Llc Methods of treating cancer
US9585960B2 (en) 2011-12-14 2017-03-07 Abraxis Bioscience, Llc Use of polymeric excipients for lyophilization or freezing of particles
US9149455B2 (en) 2012-11-09 2015-10-06 Abraxis Bioscience, Llc Methods of treating melanoma
US9511046B2 (en) 2013-01-11 2016-12-06 Abraxis Bioscience, Llc Methods of treating pancreatic cancer

Also Published As

Publication number Publication date
CA2371912A1 (en) 2000-11-30
EP1178786A4 (en) 2006-03-01
AU2009217409A1 (en) 2009-10-08
AU784416B2 (en) 2006-03-30
CA2371912C (en) 2010-02-16
WO2000071079A2 (en) 2000-11-30
AU2006202836A1 (en) 2006-07-27
AU2006202836B2 (en) 2009-10-08
EP1178786A1 (en) 2002-02-13
HK1045646A1 (en) 2002-12-06
CA2684454A1 (en) 2000-11-18
AU5035900A (en) 2000-12-12

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