JP2022535401A - アルカリホスファターゼ製剤及びその使用 - Google Patents

アルカリホスファターゼ製剤及びその使用 Download PDF

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JP2022535401A
JP2022535401A JP2021571800A JP2021571800A JP2022535401A JP 2022535401 A JP2022535401 A JP 2022535401A JP 2021571800 A JP2021571800 A JP 2021571800A JP 2021571800 A JP2021571800 A JP 2021571800A JP 2022535401 A JP2022535401 A JP 2022535401A
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modified release
release formulation
radiation
formulation
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JP2022535401A5 (https=
JPWO2020247421A5 (https=
Inventor
カレコ、マイケル
ステイプルトン、レイ
ブリストル、アンドリュー
ヒューバート、スティーヴン
フレイレ、クリスティーナ
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シンセティック・バイオロジクス・インコーポレイテッド
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Publication of JP2022535401A5 publication Critical patent/JP2022535401A5/ja
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5084Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/465Hydrolases (3) acting on ester bonds (3.1), e.g. lipases, ribonucleases
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5026Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5036Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5073Microcapsules 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 having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078Microcapsules 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 having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14Hydrolases (3)
    • C12N9/16Hydrolases (3) acting on ester bonds (3.1)
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y201/00Transferases transferring one-carbon groups (2.1)
    • C12Y201/03Carboxy- and carbamoyltransferases (2.1.3)
    • C12Y201/03001Methylmalonyl-CoA carboxytransferase (2.1.3.1)
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y301/00Hydrolases acting on ester bonds (3.1)
    • C12Y301/03Phosphoric monoester hydrolases (3.1.3)
    • C12Y301/03001Alkaline phosphatase (3.1.3.1)

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  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Biomedical Technology (AREA)
  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
JP2021571800A 2019-06-03 2020-06-03 アルカリホスファターゼ製剤及びその使用 Pending JP2022535401A (ja)

Priority Applications (1)

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JP2024206717A JP2025027050A (ja) 2019-06-03 2024-11-27 アルカリホスファターゼ製剤及びその使用

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962856309P 2019-06-03 2019-06-03
US62/856,309 2019-06-03
PCT/US2020/035814 WO2020247421A1 (en) 2019-06-03 2020-06-03 Alkaline phosphatase formulations and uses thereof

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JP2022535401A true JP2022535401A (ja) 2022-08-08
JP2022535401A5 JP2022535401A5 (https=) 2023-06-07
JPWO2020247421A5 JPWO2020247421A5 (https=) 2023-06-07

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JP2024206717A Pending JP2025027050A (ja) 2019-06-03 2024-11-27 アルカリホスファターゼ製剤及びその使用

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US (1) US20220323367A1 (https=)
EP (1) EP3975999A4 (https=)
JP (2) JP2022535401A (https=)
KR (1) KR20220016199A (https=)
CN (2) CN119896726A (https=)
AU (1) AU2020287084B2 (https=)
CA (1) CA3142240A1 (https=)
WO (1) WO2020247421A1 (https=)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20220005560A (ko) 2019-05-06 2022-01-13 신세틱 바이오로직스, 인코퍼레이티드 알칼리성 포스페이트-기반 종양학 치료제
KR20220111693A (ko) 2019-12-09 2022-08-09 알렉시온 파마슈티칼스, 인코포레이티드 알칼리성 포스파타제 폴리펩티드 및 이의 이용 방법
US12083169B2 (en) * 2021-02-12 2024-09-10 Alexion Pharmaceuticals, Inc. Alkaline phosphatase polypeptides and methods of use thereof
WO2023141560A2 (en) * 2022-01-20 2023-07-27 Synthetic Biologics, Inc. Alkaline phosphatase for use in oncology
US20260048103A1 (en) * 2022-08-09 2026-02-19 Theriva Biologics, Inc. Treatment or prevention of gastrointestinal immunotherapy side effects
CN118216620A (zh) * 2024-05-24 2024-06-21 中国农业科学院北京畜牧兽医研究所 牛碱性磷酸酶bIAP作为饲料添加剂用于抵抗产气荚膜梭菌感染肉鸡所致感染症状的应用

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106890326A (zh) * 2015-12-21 2017-06-27 青岛黄海制药有限责任公司 一种含复合磷酸酯酶的肠溶微丸及其制备
WO2018175413A1 (en) * 2017-03-21 2018-09-27 Synthetic Biologics, Inc. Alkaline phosphatase formulations

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4537776A (en) 1983-06-21 1985-08-27 The Procter & Gamble Company Penetrating topical pharmaceutical compositions containing N-(2-hydroxyethyl) pyrrolidone
PT1355919E (pt) 2000-12-12 2011-03-02 Medimmune Llc Moléculas com semivida longa, composições que as contêm e suas utilizações
US7048914B2 (en) 2002-12-12 2006-05-23 Zoltan Laboratories Placental alkaline phosphatase to control diabetes
ES2280891T3 (es) * 2003-12-04 2007-09-16 F. Hoffmann-La Roche Ag Metodo para obtener polinucleotidos circulares mutados y/o quimericos.
CA2554683C (en) * 2004-02-04 2014-06-10 Pharmaaware Sepsis B.V. Use of alkaline phosphatase for the detoxification of lps present at mucosal barriers
WO2008001341A1 (en) * 2006-06-27 2008-01-03 Biovail Laboratories International Srl Multiparticulate osmotic delivery system
US9023352B2 (en) 2007-02-20 2015-05-05 Tufts University Methods, compositions and kits for treating a subject using a recombinant heteromultimeric neutralizing binding protein
EP1985697A1 (en) * 2007-04-27 2008-10-29 AM-Pharma B.V. Modified phosphatases
WO2010025267A2 (en) 2008-08-29 2010-03-04 The General Hospital Corporation Methods of modulating gastrointestinal tract flora levels with alkaline phosphatase
EP2570120B1 (en) * 2010-06-08 2017-10-25 Kobe Gakuin Educational Foundation Coated particle and method for producing coated particle
KR101243938B1 (ko) * 2010-10-19 2013-03-19 이희엽 타크롤리무스를 유효성분으로 함유하는 서방형 펠렛
US20130251701A1 (en) 2010-10-22 2013-09-26 Zoltan Kiss Consulting Alkaline phosphatase to correct insulin resistance, hyperinsulinemia, and dyslipidemia
CN102743339B (zh) * 2012-07-20 2015-01-14 苏州大学 一种碱性磷酸酶纳微颗粒及其制备方法
CA2899925A1 (en) 2013-02-04 2014-08-07 Seres Therapeutics, Inc. Compositions and methods for inhibition of pathogenic bacterial growth
EP3125870A4 (en) 2014-04-04 2017-12-13 Alba Therapeutics Corporation Methods of treating celiac disease with larazotide
RU2016138847A (ru) 2014-04-07 2018-05-07 Хэлф Ресерч, Инк. Композиции и способы, относящиеся к покоящимся предрасположенным к старению клеткам (DSPC)
AU2017297718B2 (en) * 2016-07-11 2023-06-08 Contera Pharma A/S Pulsatile drug delivery system for treating morning akinesia
WO2019183208A1 (en) 2018-03-20 2019-09-26 Synthetic Biologics, Inc. Intestinal alkaline phosphatase formulations

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106890326A (zh) * 2015-12-21 2017-06-27 青岛黄海制药有限责任公司 一种含复合磷酸酯酶的肠溶微丸及其制备
WO2018175413A1 (en) * 2017-03-21 2018-09-27 Synthetic Biologics, Inc. Alkaline phosphatase formulations

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
REBECCA M. RENTEA ET AL.: ""Radiation-induced changes in intestinal and tissue-nonspecific alkaline phosphatase: implications", THE AMERICAN JOURNAL OF SURGERY, vol. 212, no. 4, JPN6024009282, October 2016 (2016-10-01), pages 602 - 608, XP029761276, ISSN: 0005380251, DOI: 10.1016/j.amjsurg.2016.06.005 *

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Publication number Publication date
AU2020287084A1 (en) 2021-12-02
AU2020287084A2 (en) 2023-06-29
WO2020247421A1 (en) 2020-12-10
EP3975999A1 (en) 2022-04-06
CN119896726A (zh) 2025-04-29
KR20220016199A (ko) 2022-02-08
EP3975999A4 (en) 2023-07-19
CN114222561A (zh) 2022-03-22
JP2025027050A (ja) 2025-02-26
AU2020287084B2 (en) 2025-12-18
US20220323367A1 (en) 2022-10-13
CA3142240A1 (en) 2020-12-10

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