JP5661912B2 - 安定なボルテゾミブ製剤 - Google Patents
安定なボルテゾミブ製剤 Download PDFInfo
- Publication number
- JP5661912B2 JP5661912B2 JP2013500229A JP2013500229A JP5661912B2 JP 5661912 B2 JP5661912 B2 JP 5661912B2 JP 2013500229 A JP2013500229 A JP 2013500229A JP 2013500229 A JP2013500229 A JP 2013500229A JP 5661912 B2 JP5661912 B2 JP 5661912B2
- Authority
- JP
- Japan
- Prior art keywords
- bortezomib
- solvent system
- pharmaceutical composition
- less
- formulation
- 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.)
- Expired - Fee Related
Links
Classifications
-
- 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
- A61K31/69—Boron compounds
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
-
- 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
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/4965—Non-condensed pyrazines
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/05—Dipeptides
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
-
- 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
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- 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
Description
Claims (7)
- ボルテゾミブを含む液状製剤を含む薬学組成物であって、
前記液状製剤は注射用であって水の総含有量が15体積%以下である溶媒系であり、
前記溶媒系の非水成分はプロピレングリコールからなり、
前記ボルテゾミブは少なくとも1 mg/mlの濃度で存在し、
前記液状製剤は、前記液状製剤を環境条件において少なくとも3ヶ月以上貯蔵した場合にボルテゾミブの減成が10重量%未満のレベルである、
薬学組成物。 - 前記溶媒系が100体積%のプロピレングリコールを含む、請求項1に記載の薬学組成物。
- ボルテゾミブを含む液状製剤を含む薬学組成物であって、
前記液状製剤は注射用であって水の総含有量が15体積%以下である溶媒系であり、
前記溶媒系の非水成分は、25体積%以下の量のエタノール、およびプロピレングリコールからなり、
前記ボルテゾミブは少なくとも1 mg/mlの濃度で存在し、
前記液状製剤は、前記液状製剤を環境条件において少なくとも3ヶ月以上貯蔵した場合にボルテゾミブの減成が10重量%未満のレベルである、
薬学組成物。 - 前記溶媒系が20体積%以下の量のエタノールを含む、請求項3に記載の薬学組成物。
- 前記溶媒系がエタノールおよびプロピレングリコールからなる、請求項3または4に記載の薬学組成物。
- 前記溶媒系が10体積%以下の量の水を含む、請求項1に記載の薬学組成物。
- 請求項1〜6のいずれかに記載の薬学組成物を含む容器であって、バイアル、アンプル、静注用バッグ、又は注射器であり、任意で複数回使用容器としての構成を有する、容器。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US31508010P | 2010-03-18 | 2010-03-18 | |
US61/315,080 | 2010-03-18 | ||
PCT/US2011/029003 WO2011116286A2 (en) | 2010-03-18 | 2011-03-18 | Stable bortezomib formulations |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2013522320A JP2013522320A (ja) | 2013-06-13 |
JP5661912B2 true JP5661912B2 (ja) | 2015-01-28 |
Family
ID=44647709
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2013500229A Expired - Fee Related JP5661912B2 (ja) | 2010-03-18 | 2011-03-18 | 安定なボルテゾミブ製剤 |
Country Status (8)
Country | Link |
---|---|
US (1) | US9061037B2 (ja) |
EP (1) | EP2547333B1 (ja) |
JP (1) | JP5661912B2 (ja) |
KR (1) | KR101530942B1 (ja) |
AU (1) | AU2011227083B2 (ja) |
NZ (1) | NZ602392A (ja) |
RU (1) | RU2529800C2 (ja) |
WO (1) | WO2011116286A2 (ja) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11805323B2 (en) | 2021-04-01 | 2023-10-31 | Brillnics Singapore Pte. Ltd. | Solid-state imaging device, method for driving solid-state imaging device, and electronic apparatus |
Families Citing this family (22)
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US8263578B2 (en) | 2010-03-18 | 2012-09-11 | Innopharma, Inc. | Stable bortezomib formulations |
JP5661912B2 (ja) | 2010-03-18 | 2015-01-28 | イノファーマ,インコーポレイテッド | 安定なボルテゾミブ製剤 |
EP2624818B1 (en) | 2010-10-05 | 2017-04-05 | Fresenius Kabi USA, LLC | Bortezomib formulations stabilised with boric acid |
CA2866135A1 (en) * | 2012-03-02 | 2014-09-06 | Dr. Reddy's Laboratories Limited | Pharmaceutical compositions comprising boronic acid compounds |
CA2784240C (en) * | 2012-03-27 | 2014-07-08 | Innopharma, Inc. | Stable bortezomib formulations |
WO2015025000A1 (en) * | 2013-08-23 | 2015-02-26 | Synthon B.V. | Pharmaceutical compositions comprising bortezomib |
US10167311B2 (en) | 2014-02-03 | 2019-01-01 | Ohio State Innovation Foundation | Boronic acid esters and pharmaceutical formulations thereof |
WO2016059592A1 (en) * | 2014-10-16 | 2016-04-21 | Piramal Enterprises Limited | Stable injectable composition of peptide drugs and process for its preparation |
US20170239335A1 (en) * | 2014-10-16 | 2017-08-24 | Piramal Enterprises Limited | Stable injectable composition of pharmaceutically active agents and process for its preparation |
WO2016059590A1 (en) * | 2014-10-16 | 2016-04-21 | Piramal Enterprises Limited | Stable injectable composition of small molecule drugs and process for its preparation |
EP3031811A1 (en) | 2014-12-09 | 2016-06-15 | Teva Pharmaceuticals Ltd. | Malic acid esters of bortezomib |
WO2016110870A1 (en) * | 2015-01-07 | 2016-07-14 | Emcure Pharmaceuticals Limited | Pharmaceutical composition of bortezomid |
AU2016255738B2 (en) * | 2015-04-29 | 2020-10-15 | Nanosilical Devices S.r.l. | Bortezomib-based delivery system |
EP3120837A1 (de) | 2015-07-22 | 2017-01-25 | Stada Arzneimittel Ag | Verfahren zur herstellung einer bortezomibester-lösung |
EP3120836A1 (de) | 2015-07-22 | 2017-01-25 | Stada Arzneimittel Ag | Gebrauchsfertige bortezomib-lösung |
CN107224569A (zh) * | 2016-03-26 | 2017-10-03 | 复旦大学 | 一种硼替佐米水溶性药用组合物及其制备方法和用途 |
JP6706988B2 (ja) * | 2016-07-20 | 2020-06-10 | 日本化薬株式会社 | ボルテゾミブを含有する医薬組成物 |
KR101807462B1 (ko) * | 2017-03-09 | 2017-12-08 | 씨제이헬스케어 주식회사 | 보르테조밉을 포함하는 안정한 제제 및 이의 제조방법 |
WO2019097413A1 (en) * | 2017-11-15 | 2019-05-23 | Intas Pharmaceuticals Ltd. | Stable non-aqueous pharmaceutical compositions |
US10988489B2 (en) * | 2018-11-27 | 2021-04-27 | Clark Atlanta University | Organoboranes useful as electrolytes for lithium batteries |
US20220133757A1 (en) * | 2020-11-02 | 2022-05-05 | Spes Pharmaceuticals Inc. | Aqueous compositions of bortezomib |
EP4134083A1 (en) | 2021-08-12 | 2023-02-15 | Extrovis AG | Pharmaceutical compositions of bortezomib |
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JP2000336041A (ja) * | 1999-03-19 | 2000-12-05 | Wakamoto Pharmaceut Co Ltd | プロピレングリコールを含有することを特徴とするウリナスタチン含有水性製剤 |
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US8263578B2 (en) * | 2010-03-18 | 2012-09-11 | Innopharma, Inc. | Stable bortezomib formulations |
JP5661912B2 (ja) | 2010-03-18 | 2015-01-28 | イノファーマ,インコーポレイテッド | 安定なボルテゾミブ製剤 |
-
2011
- 2011-03-18 JP JP2013500229A patent/JP5661912B2/ja not_active Expired - Fee Related
- 2011-03-18 RU RU2012144316/15A patent/RU2529800C2/ru not_active IP Right Cessation
- 2011-03-18 WO PCT/US2011/029003 patent/WO2011116286A2/en active Application Filing
- 2011-03-18 EP EP11757060.6A patent/EP2547333B1/en not_active Not-in-force
- 2011-03-18 KR KR1020127027272A patent/KR101530942B1/ko not_active IP Right Cessation
- 2011-03-18 US US13/051,102 patent/US9061037B2/en not_active Expired - Fee Related
- 2011-03-18 NZ NZ602392A patent/NZ602392A/en not_active IP Right Cessation
- 2011-03-18 AU AU2011227083A patent/AU2011227083B2/en not_active Ceased
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11805323B2 (en) | 2021-04-01 | 2023-10-31 | Brillnics Singapore Pte. Ltd. | Solid-state imaging device, method for driving solid-state imaging device, and electronic apparatus |
Also Published As
Publication number | Publication date |
---|---|
KR101530942B1 (ko) | 2015-06-23 |
WO2011116286A4 (en) | 2012-05-10 |
EP2547333A4 (en) | 2014-04-30 |
US9061037B2 (en) | 2015-06-23 |
US20110230441A1 (en) | 2011-09-22 |
EP2547333B1 (en) | 2017-08-23 |
RU2012144316A (ru) | 2014-04-27 |
EP2547333A2 (en) | 2013-01-23 |
WO2011116286A2 (en) | 2011-09-22 |
NZ602392A (en) | 2014-03-28 |
KR20130010902A (ko) | 2013-01-29 |
AU2011227083A1 (en) | 2012-10-04 |
JP2013522320A (ja) | 2013-06-13 |
AU2011227083B2 (en) | 2013-07-18 |
WO2011116286A3 (en) | 2012-03-22 |
RU2529800C2 (ru) | 2014-09-27 |
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