WO2005123907A2 - Ex-vivo application of solid microparticulate therapeutic agents - Google Patents
Ex-vivo application of solid microparticulate therapeutic agents Download PDFInfo
- Publication number
- WO2005123907A2 WO2005123907A2 PCT/US2005/022992 US2005022992W WO2005123907A2 WO 2005123907 A2 WO2005123907 A2 WO 2005123907A2 US 2005022992 W US2005022992 W US 2005022992W WO 2005123907 A2 WO2005123907 A2 WO 2005123907A2
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- A61K49/00—Preparations for testing in vivo
- A61K49/0002—General or multifunctional contrast agents, e.g. chelated agents
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/69—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
- A61K47/6901—Conjugates being cells, cell fragments, viruses, ghosts, red blood cells or viral vectors
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- A—HUMAN NECESSITIES
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- 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
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Definitions
- the polyhexylcyanoacrylate nanoparticles were prepared by emulsion polymerization and tested in-vitro for antiviral activity in primary human monocytes/macrophages.
- An aqueous solution of saquinavir showed little antiviral activity in HlV-infected macrophages, whereas the nanoparticulate formulation demonstrated significant antiviral activity at one-tenth the solution concentration.
- saquinavir in solution was completely inactive in chronically HlV-infected macrophages, but when bound to nanoparticles it caused a 35% decrease in viral antigen production.
- the drug was entrained in a polymer (polyhexylcyanoacrylate) matrix.
- Antineoplastic agents can include paclitaxel and its derivative compounds, alkaloids, antimetabolites, enzyme inhibitors, alkylating agents and antibiotics.
- Other therapeutic agents include carbamazepine, prednisolone, and nabumetone.
- Therapeutic agents can also include a biologic.
- the biologic can be selected from proteins, polypeptides, carbohydrates, polynucleotides, and nucleic acids. Nucleic acids include, but are not limited to, single or double stranded DNA, RNA generally and cDNA, t- RNA, mRNA, si-RNA and the like.
- the protein can be an antibody selected from polyclonal antibodies and monoclonal antibodies. Diagnostic agents include the x-ray imaging agents and contrast media.
- Sterilization can be performed by any medical sterilization process including heat sterilization or sterilization by gamma irradiation. It can also be sterilized by filtration, either directly as a dispersion having particle sizes under 200 nm, or by sterile filtration of the solutions used in the precipitation process, prior to forming the solid dispersion. Sterilization can also be accomplished by brief application of very high pressure (greater than 2000 atmospheres), or by a combination of high pressure and elevated temperature. The present invention can be practiced with water-soluble compounds.
- Sterilization can be accomplished by heat sterilization, gamma irradiation, filtration (either directly as a dispersion having particle sizes under 200 nm, or by sterile filtration of the solutions used in the precipitation process, prior to forming the solid dispersion), and by application of very high pressure (greater than 2000 atmospheres), or by a combination of high pressure and elevated temperature.
- the subsequent energy-addition step can be carried out more quickly and efficiently when compared to an organic compound in a less friable crystalline morphology.
- the first solution and second solvent are simultaneously subjected to the energy-addition step.
- the energy-addition step can be carried out in any fashion wherein the presuspension or the first solution and second solvent are exposed to cavitation, shearing or impact forces.
- the energy-addition step is an annealing step.
- the energy-addition step involves adding energy through sonication, homogenization, countercurrent flow homogenization, microfluidization, or other methods of providing impact, shear or cavitation forces.
- the sample may be cooled or heated during this stage.
- the energy-addition step is effected by a piston gap homogenizer such as the one sold by Avestin Inc. under the product designation EmulsiFlex-C160.
- the energy-addition step may be accomplished by ultrasonication using an ultrasonic processor such as the Vibra-Cell Ultrasonic Processor (600W), manufactured by Sonics and Materials, Inc.
- the supersaturated solution is treated to precipitate the organic compound in the desired polymorphic form. Treating the supersaturated solution includes aging the solution for a time period until the formation of a crystal or crystals is observed to create a seeding mixture. It is also possible to add energy to the supersaturated solution to cause the organic compound to precipitate out of the solution in the desired polymorph.
- the energy can be added in a variety of ways including the energy addition steps described above. Further energy can be added by heating, or by exposing the pre-suspension to electromagnetic energy, particle beam or electron beam sources.
- Such methods include, but are not limited to, pheresis of peripheral blood; by mobilization of bone marrow cells through G-CSF or GM-CSF, e.g., or by direct removal of marrow cells by spinal, sternal, lumbar, or iliac crest puncture.
- the cells are nurtured in a selective or non-selective growth medium and simultaneously or later contacted with the particulate pharmaceutical composition and incubated for short period of time to allow for cell uptake or adsorption of the particles.
- a surfactant used to transfer DNA into cells is the SAINTTM reagent from Synvolux Therapeutics B.V. L. J. (Groningen, The Netherlands), which is based on a pyridinium surfactant.
- the ex-vivo cells are nurtured in a cell culture medium or other isolating system known to those skilled in the art.
- the purpose of the culture so described maybe for the purpose of simple storage without loss of cells, or for cell expansion, by appropriate addition of growth factors, cytokines, and nutrients, to encourage cell expansion. Such expansion would minimize the number of times that a patient would have to be prepared for removal of cellular samples.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Epidemiology (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Virology (AREA)
- Tropical Medicine & Parasitology (AREA)
- Pulmonology (AREA)
- Pain & Pain Management (AREA)
- Obesity (AREA)
- Ophthalmology & Optometry (AREA)
- Cell Biology (AREA)
- Endocrinology (AREA)
- Oncology (AREA)
- Immunology (AREA)
- Psychiatry (AREA)
- Anesthesiology (AREA)
- Emergency Medicine (AREA)
- Rheumatology (AREA)
- Urology & Nephrology (AREA)
- Nutrition Science (AREA)
- Psychology (AREA)
- Child & Adolescent Psychology (AREA)
- Cardiology (AREA)
Abstract
Description
Claims
Priority Applications (7)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
BRPI0510271-5A BRPI0510271A (en) | 2004-06-15 | 2005-06-08 | Ex vivo applications microparticulate therapeutic agents |
MXPA06011171A MXPA06011171A (en) | 2004-06-15 | 2005-06-08 | Ex-vivo application of solid microparticulate therapeutic agents. |
AU2005255039A AU2005255039A1 (en) | 2004-06-15 | 2005-06-08 | Ex-vivo application of solid microparticulate therapeutic agents |
CA002565972A CA2565972A1 (en) | 2004-06-15 | 2005-06-08 | Ex-vivo application of solid microparticulate therapeutic agents |
JP2007516856A JP2008502706A (en) | 2004-06-15 | 2005-06-08 | Ex vivo application of solid particulate therapeutic agents |
EP05763705A EP1763576A2 (en) | 2004-06-15 | 2005-06-08 | Ex-vivo application of solid microparticulate therapeutic agents |
IL177780A IL177780A0 (en) | 2004-06-15 | 2006-08-30 | Ex-vivo application of solid microparticulate therapeutic agents |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US57989104P | 2004-06-15 | 2004-06-15 | |
US60/579,891 | 2004-06-15 |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2005123907A2 true WO2005123907A2 (en) | 2005-12-29 |
WO2005123907A3 WO2005123907A3 (en) | 2007-08-23 |
Family
ID=35169714
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2005/022992 WO2005123907A2 (en) | 2004-06-15 | 2005-06-08 | Ex-vivo application of solid microparticulate therapeutic agents |
Country Status (13)
Country | Link |
---|---|
US (1) | US8333959B2 (en) |
EP (1) | EP1763576A2 (en) |
JP (1) | JP2008502706A (en) |
KR (1) | KR20070037444A (en) |
CN (1) | CN101310011A (en) |
AU (1) | AU2005255039A1 (en) |
BR (1) | BRPI0510271A (en) |
CA (1) | CA2565972A1 (en) |
IL (1) | IL177780A0 (en) |
MX (1) | MXPA06011171A (en) |
RU (1) | RU2006144851A (en) |
WO (1) | WO2005123907A2 (en) |
ZA (1) | ZA200610078B (en) |
Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US8333959B2 (en) | 2004-06-15 | 2012-12-18 | Baxter International Inc. | Ex-vivo application of solid microparticulate therapeutic agents |
US8986736B2 (en) | 2003-06-24 | 2015-03-24 | Baxter International Inc. | Method for delivering particulate drugs to tissues |
US9044381B2 (en) | 2003-06-24 | 2015-06-02 | Baxter International Inc. | Method for delivering drugs to the brain |
US9364443B2 (en) | 2008-03-05 | 2016-06-14 | Baxter International, Inc. | Compositions and methods for drug delivery |
JP2017002071A (en) * | 2007-09-26 | 2017-01-05 | アンスロジェネシス コーポレーション | Angiogenic cells from human placental perfusate |
US10952965B2 (en) | 2009-05-15 | 2021-03-23 | Baxter International Inc. | Compositions and methods for drug delivery |
Families Citing this family (18)
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US20070166386A1 (en) * | 2006-01-13 | 2007-07-19 | Chinea Vanessa I | Nanoparticle formation of pharmaceutical ingredients |
US8784846B2 (en) * | 2007-07-30 | 2014-07-22 | Loma Linda University Medical Center | Systems and methods for particle radiation enhanced delivery of therapy |
AU2008282215B2 (en) * | 2007-07-30 | 2014-05-29 | Loma Linda University Medical Center | Systems and methods for particle radiation enhanced delivery of therapy |
EP2044934A1 (en) * | 2007-10-01 | 2009-04-08 | Institut National De La Sante Et De La Recherche Medicale (Inserm) | Dispersion of poloxamer-protein particles, methods of manufacturing and uses thereof |
ES2405258T3 (en) * | 2008-02-13 | 2013-05-30 | Erytech Pharma | Formulation and procedure for the prevention and treatment of skeletal manifestation of Gaucher disease |
US20110206740A1 (en) * | 2008-04-29 | 2011-08-25 | Karp Jeffrey M | Cell Membrane Engineering |
US20100042072A1 (en) * | 2008-08-13 | 2010-02-18 | Searete Llc, A Limited Liability Corporation Of The State Of Delaware | Biological targeting compositions and methods of using the same |
US8211656B2 (en) | 2008-08-13 | 2012-07-03 | The Invention Science Fund I, Llc | Biological targeting compositions and methods of using the same |
US20100040546A1 (en) * | 2008-08-13 | 2010-02-18 | Searete Llc, A Limited Liability Corporation Of The State Of Delaware | Biological targeting compositions and methods of using the same |
JP6034695B2 (en) | 2009-10-01 | 2016-11-30 | ローマ リンダ ユニヴァーシティ メディカル センター | Ion-induced impact ionization detector and its use |
WO2011047277A2 (en) | 2009-10-15 | 2011-04-21 | The Brigham And Women's Hospital, Inc. | Release of agents from cells |
NZ702800A (en) * | 2010-06-25 | 2017-03-31 | Shire Human Genetic Therapies | Methods and compositions for cns delivery of heparan n-sulfatase |
CN101926998B (en) * | 2010-09-10 | 2013-09-04 | 中国科学院水生生物研究所 | Expression of embryo type globin induced by adrenoreceptor agonist and application thereof |
US9717827B2 (en) | 2012-09-12 | 2017-08-01 | The Regents Of The University Of California | Immunomodulatory materials for implantable medical devices |
US20150296770A1 (en) * | 2012-10-15 | 2015-10-22 | Mark Frings PITTENGER | Apparatus for extracorporeal cellular therapy of lung or other organ |
AU2014348683B2 (en) | 2013-11-18 | 2020-11-05 | Rubius Therapeutics, Inc. | Synthetic membrane-receiver complexes |
CN107812197B (en) * | 2014-09-20 | 2018-09-18 | 中国药科大学 | A kind of inflammation targeted neutrophil leucocyte delivery system and its application |
RU2633502C2 (en) * | 2016-03-31 | 2017-10-12 | Федеральное государственное бюджетное научное учреждение "Научно-исследовательский институт фундаментальной и клинической иммунологии" (НИИФКИ) | Method for incorporation of biologically active micro- and nanoparticles in neutrophils |
Citations (10)
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US8986736B2 (en) | 2003-06-24 | 2015-03-24 | Baxter International Inc. | Method for delivering particulate drugs to tissues |
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US8333959B2 (en) | 2004-06-15 | 2012-12-18 | Baxter International Inc. | Ex-vivo application of solid microparticulate therapeutic agents |
JP2017002071A (en) * | 2007-09-26 | 2017-01-05 | アンスロジェネシス コーポレーション | Angiogenic cells from human placental perfusate |
US9364443B2 (en) | 2008-03-05 | 2016-06-14 | Baxter International, Inc. | Compositions and methods for drug delivery |
US10952965B2 (en) | 2009-05-15 | 2021-03-23 | Baxter International Inc. | Compositions and methods for drug delivery |
Also Published As
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WO2005123907A3 (en) | 2007-08-23 |
IL177780A0 (en) | 2006-12-31 |
CN101310011A (en) | 2008-11-19 |
MXPA06011171A (en) | 2007-01-25 |
ZA200610078B (en) | 2008-06-25 |
US20050276861A1 (en) | 2005-12-15 |
CA2565972A1 (en) | 2005-12-29 |
US8333959B2 (en) | 2012-12-18 |
RU2006144851A (en) | 2008-06-20 |
JP2008502706A (en) | 2008-01-31 |
KR20070037444A (en) | 2007-04-04 |
AU2005255039A1 (en) | 2005-12-29 |
EP1763576A2 (en) | 2007-03-21 |
BRPI0510271A (en) | 2007-10-30 |
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