RU2003108821A - Способ получения наночастиц паклитаксела и альбумина - Google Patents

Способ получения наночастиц паклитаксела и альбумина

Info

Publication number
RU2003108821A
RU2003108821A RU2003108821/15A RU2003108821A RU2003108821A RU 2003108821 A RU2003108821 A RU 2003108821A RU 2003108821/15 A RU2003108821/15 A RU 2003108821/15A RU 2003108821 A RU2003108821 A RU 2003108821A RU 2003108821 A RU2003108821 A RU 2003108821A
Authority
RU
Russia
Prior art keywords
albumin
acid
paclitaxel
sterile
nanoparticles
Prior art date
Application number
RU2003108821/15A
Other languages
English (en)
Inventor
Маурицио ДЗЕНОНИ (IT)
Маурицио ДЗЕНОНИ
Симоне МАСКИО (IT)
Симоне МАСКИО
Original Assignee
Акс Добфар С.П.А. (It)
Акс Добфар С.П.А.
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 Акс Добфар С.П.А. (It), Акс Добфар С.П.А. filed Critical Акс Добфар С.П.А. (It)
Publication of RU2003108821A publication Critical patent/RU2003108821A/ru

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
    • A61K9/19—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
    • 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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • A61K9/14—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
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1658—Proteins, e.g. albumin, gelatin
    • 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
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5052—Proteins, e.g. albumin
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Nanotechnology (AREA)
  • Optics & Photonics (AREA)
  • Physics & Mathematics (AREA)
  • Biomedical Technology (AREA)
  • Dermatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (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)
  • Epoxy Compounds (AREA)

Claims (6)

1. Способ получения стерильного лиофилизированного порошка, включающего наночастицы паклитаксела и человеческого сывороточного альбумина, где водную смесь, содержащую паклитаксел и альбумин, при температуре от 0 до 40°С подвергают обработке гомогенизацией при высоком давлении от 9000 до 40000 фунт/дюйм2 с получением наноэмульсии, которую замораживают при температуре от –20 до –80°С и окончательно лиофилизируют нагреванием до температуры от +20 до +35°С, отличающийся тем, что указанную водную смесь получают в стерильных условиях растворением от 2 до 3% (масс./об.) указанного альбумина в стерильной воде с последующим добавлением к указанному раствору альбумина от 2 до 4% (об./об.) стерильного хлороформа, а затем паклитаксела в форме стерильного порошка в количестве от 5,4 до 20,0 мас.% от массы альбумина, присутствующего в растворе.
2. Способ по п.1, отличающийся тем, что количество паклитаксела в стерильной порошкообразной форме, добавляемое к указанному раствору альбумина, составляет от 5,6 до 19,4 мас.% от массы альбумина.
3. Способ по п.1 или 2, отличающийся тем, что к указанному раствору альбумина перед добавлением паклитаксела добавляют по меньшей мере одну биологически совместимую кислоту в количестве, достаточном для получения рН повторно растворенной водной смеси для инъекции наночастиц в порошкообразной форме от 5,4 до 5,8.
4. Способ по п.3, отличающийся тем, что количество указанной кислоты является таким, чтобы довести рН указанного повторно растворенного водного раствора до величины от 5,5 до 5,7.
5. Способ по п.3 или 4, отличающийся тем, что указанную кислоту выбирают из группы, включающей HCl, лимонную кислоту, фосфорную кислоту, уксусную кислоту, биологически совместимые органические и неорганические кислоты.
6. Способ по п.5, отличающийся тем, что указанной кислотой является лимонная кислота.
RU2003108821/15A 2002-03-29 2003-03-28 Способ получения наночастиц паклитаксела и альбумина RU2003108821A (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITMI2002A000681 2002-03-29
IT2002MI000681A ITMI20020681A1 (it) 2002-03-29 2002-03-29 Procedimento per la produzione di nanoparticelle di paclitaxel ed albumina

Publications (1)

Publication Number Publication Date
RU2003108821A true RU2003108821A (ru) 2004-11-10

Family

ID=11449619

Family Applications (1)

Application Number Title Priority Date Filing Date
RU2003108821/15A RU2003108821A (ru) 2002-03-29 2003-03-28 Способ получения наночастиц паклитаксела и альбумина

Country Status (15)

Country Link
US (2) US20030185894A1 (ru)
EP (1) EP1348431A1 (ru)
JP (2) JP4794115B2 (ru)
KR (1) KR20030078722A (ru)
CN (2) CN1911446A (ru)
AU (1) AU2003200920A1 (ru)
BR (1) BR0300846A (ru)
CA (1) CA2423915A1 (ru)
IL (1) IL154762A0 (ru)
IT (1) ITMI20020681A1 (ru)
MX (1) MXPA03002543A (ru)
NO (1) NO334407B1 (ru)
NZ (1) NZ524605A (ru)
RU (1) RU2003108821A (ru)
ZA (1) ZA200302040B (ru)

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Also Published As

Publication number Publication date
ZA200302040B (en) 2003-09-17
JP2011132253A (ja) 2011-07-07
ITMI20020681A1 (it) 2003-09-29
JP4794115B2 (ja) 2011-10-19
AU2003200920A1 (en) 2003-10-16
NO20031448L (no) 2003-09-30
NZ524605A (en) 2004-03-26
MXPA03002543A (es) 2005-08-26
IL154762A0 (en) 2003-10-31
JP2003300878A (ja) 2003-10-21
CN1911446A (zh) 2007-02-14
CA2423915A1 (en) 2003-09-29
US20030185894A1 (en) 2003-10-02
ITMI20020681A0 (it) 2002-03-29
NO20031448D0 (no) 2003-03-28
CN1259902C (zh) 2006-06-21
EP1348431A1 (en) 2003-10-01
US20060121119A1 (en) 2006-06-08
CN1448128A (zh) 2003-10-15
KR20030078722A (ko) 2003-10-08
BR0300846A (pt) 2004-08-17
NO334407B1 (no) 2014-02-24

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