JP7576334B2 - 放射性医薬の製造方法及び放射性医薬 - Google Patents

放射性医薬の製造方法及び放射性医薬 Download PDF

Info

Publication number
JP7576334B2
JP7576334B2 JP2021511185A JP2021511185A JP7576334B2 JP 7576334 B2 JP7576334 B2 JP 7576334B2 JP 2021511185 A JP2021511185 A JP 2021511185A JP 2021511185 A JP2021511185 A JP 2021511185A JP 7576334 B2 JP7576334 B2 JP 7576334B2
Authority
JP
Japan
Prior art keywords
radioactive
radiopharmaceutical
producing
stabilizer
component
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
JP2021511185A
Other languages
English (en)
Japanese (ja)
Other versions
JPWO2020202831A1 (https=
Inventor
幸恵 吉井
明栄 張
和紀 河村
寿 鈴木
裕輝 橋本
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
NATIONAL INSTITUTES FOR QUANTUM AND RADIOLOGICALSCIENCE AND TECHNOLOGY
Original Assignee
NATIONAL INSTITUTES FOR QUANTUM AND RADIOLOGICALSCIENCE AND TECHNOLOGY
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 NATIONAL INSTITUTES FOR QUANTUM AND RADIOLOGICALSCIENCE AND TECHNOLOGY filed Critical NATIONAL INSTITUTES FOR QUANTUM AND RADIOLOGICALSCIENCE AND TECHNOLOGY
Publication of JPWO2020202831A1 publication Critical patent/JPWO2020202831A1/ja
Application granted granted Critical
Publication of JP7576334B2 publication Critical patent/JP7576334B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K51/00—Preparations containing radioactive substances for use in therapy or testing in vivo
    • A61K51/02—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by the carrier, i.e. characterised by the agent or material covalently linked or complexing the radioactive nucleus
    • A61K51/04—Organic compounds
    • A61K51/0474—Organic compounds complexes or complex-forming compounds, i.e. wherein a radioactive metal (e.g. 111In3+) is complexed or chelated by, e.g. a N2S2, N3S, NS3, N4 chelating group
    • A61K51/0478—Organic compounds complexes or complex-forming compounds, i.e. wherein a radioactive metal (e.g. 111In3+) is complexed or chelated by, e.g. a N2S2, N3S, NS3, N4 chelating group complexes from non-cyclic ligands, e.g. EDTA, MAG3
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K51/00—Preparations containing radioactive substances for use in therapy or testing in vivo
    • A61K51/12—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by a special physical form, e.g. emulsion, microcapsules, liposomes, characterized by a special physical form, e.g. emulsions, dispersions, microcapsules
    • A61K51/121—Solutions, i.e. homogeneous liquid formulation
    • 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
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

Landscapes

  • 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)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Engineering & Computer Science (AREA)
  • Optics & Photonics (AREA)
  • Physics & Mathematics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
JP2021511185A 2019-03-29 2020-02-14 放射性医薬の製造方法及び放射性医薬 Active JP7576334B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2019068873 2019-03-29
JP2019068873 2019-03-29
PCT/JP2020/005830 WO2020202831A1 (ja) 2019-03-29 2020-02-14 放射性医薬の製造方法及び放射性医薬

Publications (2)

Publication Number Publication Date
JPWO2020202831A1 JPWO2020202831A1 (https=) 2020-10-08
JP7576334B2 true JP7576334B2 (ja) 2024-10-31

Family

ID=72667952

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2021511185A Active JP7576334B2 (ja) 2019-03-29 2020-02-14 放射性医薬の製造方法及び放射性医薬

Country Status (4)

Country Link
US (1) US20220175973A1 (https=)
JP (1) JP7576334B2 (https=)
CN (1) CN113766952B (https=)
WO (1) WO2020202831A1 (https=)

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006528644A (ja) 2003-07-24 2006-12-21 ブラッコ・イメージング・ソシエタ・ペル・アチオニ 安定な放射性医薬品組成物およびその製法
WO2009141965A1 (ja) 2008-05-22 2009-11-26 旭化成メディカル株式会社 濾過方法
JP2012514007A (ja) 2008-12-31 2012-06-21 アビド・ラジオファーマシューティカルス・インコーポレイテッド トシラート前駆体からの１８ｆ−放射性標識スチリルピリジンおよびその安定性医薬組成物の合成
JP2012524064A (ja) 2009-04-15 2012-10-11 ランセウス メディカル イメージング， インコーポレイテッド アスコルビン酸による放射性医薬組成物の安定化
JP2014129316A (ja) 2012-12-27 2014-07-10 Nihon Medi Physics Co Ltd 放射性医薬及び医薬キット
JP2015081242A (ja) 2013-10-23 2015-04-27 日本メジフィジックス株式会社 放射性医薬組成物の製造方法
JP2015516457A (ja) 2012-05-18 2015-06-11 エム・ウント・カー・メディカル・インヴェント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツングＭ ＆ Ｋ Ｍｅｄｉｃａｌ Ｉｎｖｅｎｔ Ｇｍｂｈ 放射性医薬品の製造用キット及び製造方法
JP2016515517A (ja) 2013-03-15 2016-05-30 オークウッド ラボラトリーズ，エル．エル．シー． 徐放性ミクロスフェア及びその製造方法
JP2016528233A (ja) 2013-08-08 2016-09-15 シーエスエル、リミテッド 混入物除去方法

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999008709A1 (fr) * 1997-08-14 1999-02-25 Daiichi Radioisotope Laboratories, Ltd. Medicament radioactif stable
WO2007056205A2 (en) * 2005-11-04 2007-05-18 Eastman Chemical Company Carboxyalkylcellulose esters for administration of poorly soluble pharmaceutically active agents
US20100196272A1 (en) * 2009-01-30 2010-08-05 Neoprobe Corporation Compositions for radiolabeling diethylenetriaminepentaacetic acid (dtpa)-dextran
AR079687A1 (es) * 2009-12-23 2012-02-15 Bayer Schering Pharma Ag Formulaciones adecuadas para el diagnostico por imagenes con pet
WO2011147762A2 (en) * 2010-05-25 2011-12-01 Bayer Pharma Aktiengesellschaft Stabilized radiopharmaceutical composition
WO2013173004A2 (en) * 2012-04-10 2013-11-21 Lantheus Medical Imaging, Inc. Radiopharmaceutical synthesis methods
JP6472493B2 (ja) * 2017-08-01 2019-02-20 日本メジフィジックス株式会社 放射性医薬組成物

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006528644A (ja) 2003-07-24 2006-12-21 ブラッコ・イメージング・ソシエタ・ペル・アチオニ 安定な放射性医薬品組成物およびその製法
WO2009141965A1 (ja) 2008-05-22 2009-11-26 旭化成メディカル株式会社 濾過方法
JP2012514007A (ja) 2008-12-31 2012-06-21 アビド・ラジオファーマシューティカルス・インコーポレイテッド トシラート前駆体からの１８ｆ−放射性標識スチリルピリジンおよびその安定性医薬組成物の合成
JP2012524064A (ja) 2009-04-15 2012-10-11 ランセウス メディカル イメージング， インコーポレイテッド アスコルビン酸による放射性医薬組成物の安定化
JP2015516457A (ja) 2012-05-18 2015-06-11 エム・ウント・カー・メディカル・インヴェント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツングＭ ＆ Ｋ Ｍｅｄｉｃａｌ Ｉｎｖｅｎｔ Ｇｍｂｈ 放射性医薬品の製造用キット及び製造方法
JP2014129316A (ja) 2012-12-27 2014-07-10 Nihon Medi Physics Co Ltd 放射性医薬及び医薬キット
JP2016515517A (ja) 2013-03-15 2016-05-30 オークウッド ラボラトリーズ，エル．エル．シー． 徐放性ミクロスフェア及びその製造方法
JP2016528233A (ja) 2013-08-08 2016-09-15 シーエスエル、リミテッド 混入物除去方法
JP2015081242A (ja) 2013-10-23 2015-04-27 日本メジフィジックス株式会社 放射性医薬組成物の製造方法

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
CHEN, Jianqing et al.，Synthsis, stabilization and formulation of [177Lu]Lu-AMBA, a systemic radiotherapeutic agent for gas，Appl Radiat Isot，2008年，Vol.66，pp.497-505
MOHSIN, Farheen et al.，Comparison of stabilizers, myo-inositol and D-mannitol for 99mTc-DMSA(III)，J Chem Soc Pak，2008年，Vol.30, No.6，pp.907-912，特に、Summary
SCOTT, Peter, J. H. et al.，Studies into radiolytic decomposition of fluorine-18 labeled radiopharmaceuticals for positron emiss，Appl Radiat Isot，2009年，Vol.67, No.1，pp.88-94
TAKAAT, H. M. et al.，Synthesis of 99mTc-radiolabeled uridine as a potential tumor imaging agent，Radiochemistry，2018年，Vol.60, No.1，pp.51-57

Also Published As

Publication number Publication date
CN113766952A (zh) 2021-12-07
WO2020202831A1 (ja) 2020-10-08
US20220175973A1 (en) 2022-06-09
JPWO2020202831A1 (https=) 2020-10-08
CN113766952B (zh) 2023-09-08

Similar Documents

Publication Publication Date Title
KR100941210B1 (ko) 백금 유도체를 포함하는 제약 제제
JP5289060B2 (ja) Ｐａｒｐインヒビターとの組合せ療法
JP6401317B2 (ja) がんを治療するためのシステム、方法、および製剤
EP3068762B1 (en) Metal complexes and methods of treatment
EP3766521B1 (en) Pharmaceutical composition containing 211at-labeled amino acid derivative, and method for producing said pharmaceutical composition
JP2016530285A (ja) 癌の撮像及び治療のためのハロゲン化化合物、及びその使用方法
EA010834B1 (ru) Пиридилзамещённые порфириновые соединения и способы их применения
JP7336805B2 (ja) フルオロ置換ポルフィリン化合物、該化合物を含む医薬組成物、並びに該化合物を調製及び使用する方法
JP7529305B2 (ja) アスタチン溶液及びその製造方法
JP7576334B2 (ja) 放射性医薬の製造方法及び放射性医薬
JP6085810B2 (ja) 放射性医薬及び医薬キット
JP2025015727A (ja) ｐ－ボロノフェニルアラニンを含有する注射液剤
JP6656484B2 (ja) 放射性抗腫瘍剤
JP2015524795A (ja) 癌治療
EP4104833B1 (en) Ascorbic acid and quinone compound for cancer treatment
JPH07504153A (ja) ３−ヒドロキシ−４−ピロンのガリウム錯体の医薬組成物
JPS6054320A (ja) 腎疾患治療剤
WO2023063154A1 (ja) 放射性ｐｅｔ診断用トレーサー組成物、その中間体、その製造方法
JP2023009974A (ja) ホウ素とヨウ素を含有する化合物又はその塩並びにそれらの用途
HK40040536A (en) Astatine solution and method for producing same
Kuykendall III et al. Radioprotectant Activity of 5‐Diethylsulfonamoylsalicylatocopper (II) in Gamma Irradiated Mice

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20210927

RD01 Notification of change of attorney

Free format text: JAPANESE INTERMEDIATE CODE: A7426

Effective date: 20211117

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A821

Effective date: 20211117

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20220916

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20231003

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20231204

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20240117

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20240423

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20240624

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20240805

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20241001

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20241011

R150 Certificate of patent or registration of utility model

Ref document number: 7576334

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150