JP7493796B2 - 超圧縮医薬製剤 - Google Patents
超圧縮医薬製剤 Download PDFInfo
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- JP7493796B2 JP7493796B2 JP2020523681A JP2020523681A JP7493796B2 JP 7493796 B2 JP7493796 B2 JP 7493796B2 JP 2020523681 A JP2020523681 A JP 2020523681A JP 2020523681 A JP2020523681 A JP 2020523681A JP 7493796 B2 JP7493796 B2 JP 7493796B2
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Classifications
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
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- 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
- A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
- A61K9/1647—Polyesters, e.g. poly(lactide-co-glycolide)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39591—Stabilisation, fragmentation
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- 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
- A61K9/5031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
-
- 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
- A61K9/5089—Processes
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
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- Health & Medical Sciences (AREA)
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- General Health & Medical Sciences (AREA)
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- Animal Behavior & Ethology (AREA)
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- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Endocrinology (AREA)
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- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Steroid Compounds (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Description
(1)水相および有機相分離プロセス、溶融分散および噴霧乾燥を含む相分離法
(2)界面重合、本来の場所での重合および化学蒸着を含む界面反応
(3)流動層スプレーコーティング、静電コーティング、および物理蒸着を含む物理的方法
(4)溶媒蒸発法またはアンチソルベントとともにエマルションを用いる
実施例1
実施例2
実施例3
Claims (7)
- 50,000から350,000 psiの圧力で圧縮されたマイクロ粒子形状のペプチドまたはプロテイン治療薬と化合されたエステル封鎖ラクチドポリマー、エステル封鎖グリコリドポリマー、エステル封鎖ラクチド-グリコリドコポリマー、またはエステル封鎖ポリカプロラクトンポリマー、を含む医薬製剤。
- 請求項1に記載された医薬製剤であって、
ペプチドまたはプロテイン治療薬は、組換えプロテイン、治療のための抗体、免疫毒素、サイトカインおよびECMプロテインからなるグループから選択される医薬製剤。 - 請求項1に記載された医薬製剤であって、
マイクロ粒子は、50K psiから170K psiが付与されて圧縮されている医薬製剤。 - 請求項1に記載された医薬製剤であって、
マイクロ粒子は、100K psiから300K psiが付与されて圧縮されている医薬製剤。 - 請求項1に記載された医薬製剤であって、
マイクロ粒子は、60K psiから170K psiが付与されて圧縮されている医薬製剤。 - 請求項1に記載された医薬製剤であって、
ペプチドまたはプロテイン治療薬は、組換えプロテインである医薬製剤。 - 請求項1に記載された医薬製剤であって、
ペプチドまたはプロテイン治療薬は、ベバシズマブである医薬製剤。
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US201762531264P | 2017-07-11 | 2017-07-11 | |
US62/531,264 | 2017-07-11 | ||
PCT/US2018/041530 WO2019014280A1 (en) | 2017-07-11 | 2018-07-10 | HYDRO-PRESSED PHARMACEUTICAL FORMULATIONS |
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JP7493796B2 true JP7493796B2 (ja) | 2024-06-03 |
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US (1) | US10406102B2 (ja) |
EP (1) | EP3651800B1 (ja) |
JP (1) | JP7493796B2 (ja) |
AU (1) | AU2018300080A1 (ja) |
BR (1) | BR112020000506A2 (ja) |
CA (1) | CA3069159A1 (ja) |
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BR112020000506A2 (pt) | 2020-07-14 |
IL271908A (en) | 2020-02-27 |
EP3651800A4 (en) | 2021-04-14 |
EP3651800A1 (en) | 2020-05-20 |
IL271908B1 (en) | 2023-10-01 |
WO2019014280A1 (en) | 2019-01-17 |
AU2018300080A1 (en) | 2020-02-13 |
US20190015336A1 (en) | 2019-01-17 |
IL271908B2 (en) | 2024-02-01 |
MX2020000376A (es) | 2020-07-14 |
EP3651800C0 (en) | 2024-04-10 |
CN110913907A (zh) | 2020-03-24 |
EP3651800B1 (en) | 2024-04-10 |
CA3069159A1 (en) | 2019-01-17 |
US10406102B2 (en) | 2019-09-10 |
JP2020531571A (ja) | 2020-11-05 |
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