KR101798951B1 - 벤다무스틴 환형다당류 조성물 - Google Patents

벤다무스틴 환형다당류 조성물 Download PDF

Info

Publication number
KR101798951B1
KR101798951B1 KR1020117022330A KR20117022330A KR101798951B1 KR 101798951 B1 KR101798951 B1 KR 101798951B1 KR 1020117022330 A KR1020117022330 A KR 1020117022330A KR 20117022330 A KR20117022330 A KR 20117022330A KR 101798951 B1 KR101798951 B1 KR 101798951B1
Authority
KR
South Korea
Prior art keywords
composition
sbecd
cyclodextrin
solution
minutes
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
KR1020117022330A
Other languages
English (en)
Korean (ko)
Other versions
KR20120015294A (ko
Inventor
토마츠 포펙
키쇼어 파텔
발레리 알라호프
그레체고로츠 피에트리즈얀스키
Original Assignee
소프트케모 파마 코포레이션
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=42631521&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=KR101798951(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by 소프트케모 파마 코포레이션 filed Critical 소프트케모 파마 코포레이션
Publication of KR20120015294A publication Critical patent/KR20120015294A/ko
Application granted granted Critical
Publication of KR101798951B1 publication Critical patent/KR101798951B1/ko
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
    • 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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof
    • 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
    • A61K9/19—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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oncology (AREA)
  • Hematology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
KR1020117022330A 2009-02-25 2010-02-24 벤다무스틴 환형다당류 조성물 Active KR101798951B1 (ko)

Applications Claiming Priority (11)

Application Number Priority Date Filing Date Title
US20854109P 2009-02-25 2009-02-25
US61/208,541 2009-02-25
US26994409P 2009-07-01 2009-07-01
US61/269,944 2009-07-01
US27136409P 2009-07-20 2009-07-20
US61/271,364 2009-07-20
US27929309P 2009-10-19 2009-10-19
US61/279,293 2009-10-19
PCT/IB2010/000502 WO2010097700A1 (en) 2009-02-25 2010-02-24 Bendamustine cyclopolysaccharide compositions
US12/711,979 US8436032B2 (en) 2009-02-25 2010-02-24 Bendamustine cyclopolysaccharide compositions
US12/711,979 2010-02-24

Publications (2)

Publication Number Publication Date
KR20120015294A KR20120015294A (ko) 2012-02-21
KR101798951B1 true KR101798951B1 (ko) 2017-11-20

Family

ID=42631521

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020117022330A Active KR101798951B1 (ko) 2009-02-25 2010-02-24 벤다무스틴 환형다당류 조성물

Country Status (12)

Country Link
US (2) US8436032B2 (enExample)
EP (2) EP2400987B1 (enExample)
JP (1) JP5654498B2 (enExample)
KR (1) KR101798951B1 (enExample)
CN (2) CN102421451B (enExample)
AU (1) AU2010217297A1 (enExample)
CA (1) CA2753641C (enExample)
ES (2) ES2675620T3 (enExample)
HU (1) HUE038234T2 (enExample)
NO (1) NO2792369T3 (enExample)
RU (2) RU2734236C2 (enExample)
WO (1) WO2010097700A1 (enExample)

Families Citing this family (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2734236C2 (ru) 2009-02-25 2020-10-13 Софткемо Фарма Корп. Композиции бендамустина и циклополисахарида
EP3158991B1 (en) * 2010-01-28 2021-03-17 Eagle Pharmaceuticals, Inc. Formulations of bendamustine
WO2011103150A2 (en) * 2010-02-18 2011-08-25 Cephalon, Inc. Lyophilized preparations of bendamustine
US20110207764A1 (en) * 2010-02-23 2011-08-25 Valery Alakhov Cyclopolysaccharide compositions
US8383663B2 (en) 2010-07-19 2013-02-26 Supratek Pharma Inc. Bendamustine anionic-catioinic cyclopolysaccharide compositions
EA028413B1 (ru) * 2011-09-18 2017-11-30 Эро-Селтик С.А. Фармацевтические композиции
AR092790A1 (es) 2012-02-01 2015-05-06 Euro Celtique Sa Derivados bencimidazolicos del acido hidroxamico
ES2718902T3 (es) 2012-03-20 2019-07-05 Eagle Pharmaceuticals Inc Composición líquida destinada a ser utilizada en un método de tratamiento de condiciones en respuesta a la bendamustina en pacientes que requieren volúmenes reducidos para administración
HUE064884T2 (hu) 2012-03-20 2024-04-28 Eagle Pharmaceuticals Inc Bendamusztin kiszerelések
US20230241218A1 (en) * 2012-07-10 2023-08-03 Eagle Pharmaceuticals, Inc. Formulations of bendamustine
JP2016501876A (ja) * 2012-11-30 2016-01-21 ザ リージェンツ オブ ザ ユニバーシティ オブ カリフォルニア ステロイドの抗痙攣活性
CN109953954A (zh) * 2013-08-27 2019-07-02 V·沃道里斯 苯达莫司汀医药组合物
GB201409485D0 (en) 2014-05-28 2014-07-09 Euro Celtique Sa Pharmaceutical composition
GB201409488D0 (en) 2014-05-28 2014-07-09 Euro Celtique Sa Pharmaceutical composition
GB201409471D0 (en) 2014-05-28 2014-07-09 Euro Celtique Sa Pharmaceutical composition
AU2016426574B2 (en) 2016-10-11 2023-07-13 Euro-Celtique S.A. Hodgkin lymphoma therapy
GB201709405D0 (en) 2017-06-13 2017-07-26 Euro Celtique Sa Compounds for treating ovarian cancer
GB201709402D0 (en) 2017-06-13 2017-07-26 Euro Celtique Sa Compounds for treating t-pll
GB201709403D0 (en) 2017-06-13 2017-07-26 Euro Celtique Sa Compounds for treating sarcoma
GB201709406D0 (en) 2017-06-13 2017-07-26 Euro-Cletique S A Compounds for treating TNBC
US20200246312A1 (en) * 2017-10-05 2020-08-06 Tube Pharmaceuticals Gmbh Oral bendamustine formulations
US11730815B2 (en) * 2018-11-26 2023-08-22 Good Health, Llc Stable liquid pharmaceutical compositions comprising bendamustine
WO2020128913A1 (en) 2018-12-18 2020-06-25 Mundipharma International Corporation Limited Compounds for treating multiple myeloma
CN111557904A (zh) * 2020-04-09 2020-08-21 比卡生物科技（广州）有限公司 苯达莫司汀组合物及其用途
EP4134068A4 (en) * 2020-04-09 2024-02-07 Bika Biotechnology (Guangzhou) Co., Ltd. Bendamustine composition and use thereof
US20240148696A1 (en) 2022-10-25 2024-05-09 Softkemo Pharma Inc. Lyophilized bendamustine-cyclodextrin composition

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060159713A1 (en) 2005-01-14 2006-07-20 Cephalon, Inc. Bendamustine pharmaceutical compositions
WO2008063910A2 (en) 2006-11-08 2008-05-29 Novavax, Inc. Method of preparing solid dosage forms of multi-phasic pharmaceutical compositions

Family Cites Families (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DD159289A1 (de) * 1981-06-01 1983-03-02 Uwe Olthoff Verfahren zur herstellung stabiler injektionsloesungen von n-lostverbindungen
US6407079B1 (en) 1985-07-03 2002-06-18 Janssen Pharmaceutica N.V. Pharmaceutical compositions containing drugs which are instable or sparingly soluble in water and methods for their preparation
US5068226A (en) * 1987-12-07 1991-11-26 Cyclex, Inc. Pharmaceutical preparations containing cyclodextrins and their use in iontophoretic therapies
US5602112A (en) 1992-06-19 1997-02-11 Supergen, Inc. Pharmaceutical formulation
DK0814778T3 (da) * 1995-03-10 2001-09-17 Roche Diagnostics Gmbh Polypeptidholdige farmaceutiske administrationsformer i form af mikropartikler og fremgangsmåde til fremstilling deraf
DE59607089D1 (de) * 1995-03-10 2001-07-19 Roche Diagnostics Gmbh Polypeptid-enthaltende pharmazeutische darreichungsformen in form von mikropartikeln und verfahren zu deren herstellung
US6624141B1 (en) 1999-03-17 2003-09-23 The Regents Of The University Of Michigan Protamine fragment compositions and methods of use
DE10204792A1 (de) * 2002-02-06 2003-08-14 Merck Patent Gmbh Lyophilisierte Zubereitung enthaltend Immuncytokine
KR101121675B1 (ko) 2002-04-19 2012-03-13 노파르티스 아게 신규 생체적합물질, 그의 제조방법 및 용도
BR0317888A (pt) * 2002-12-31 2005-12-06 Altus Pharmaceuticals Inc Cristais do hormÈnio do crescimento humano e processos para preparação dos mesmos
JP2007517069A (ja) * 2003-12-31 2007-06-28 サイデックス・インコーポレイテッド スルホアルキルエーテルγ−シクロデキストリンおよびコルチコステロイドを含む吸入製剤
JP2007530654A (ja) * 2004-03-30 2007-11-01 ファイザー・プロダクツ・インク シグナル伝達阻害剤の組合せ
MXPA06014215A (es) * 2004-06-07 2007-05-04 Nastech Pharm Co Formulaciones intranasales de interferon beta libres de estabilizadores que son proteinas o polipeptidos.
AU2005268929A1 (en) * 2004-08-03 2006-02-09 Royal College Of Surgeons In Ireland Phenytoin formulations, and uses thereof in wound healing
JP2008519032A (ja) * 2004-11-03 2008-06-05 キュラジェン コーポレイション Ｆｇｆ−２０の調合物、生成方法および使用
MX2007005361A (es) * 2004-11-05 2008-01-11 Cephalon Inc Tratamientos para cancer.
US20060128653A1 (en) * 2004-12-10 2006-06-15 Chunlin Tang Pharmaceutical formulation of decitabine
UA94036C2 (ru) * 2005-01-14 2011-04-11 Сефалон, Инк. Фармацевтическая композиция бендамустина, предназначенная для лиофилизации
US9295722B2 (en) * 2005-01-28 2016-03-29 The Scripps Research Institute Bacterial glycolipid activation of CD1d-restricted NKT cells
US8158152B2 (en) * 2005-11-18 2012-04-17 Scidose Llc Lyophilization process and products obtained thereby
CN1846685A (zh) 2006-01-25 2006-10-18 济南帅华医药科技有限公司 含苯达莫司汀和其增效剂的缓释注射剂
US8425459B2 (en) * 2006-11-20 2013-04-23 Lutonix, Inc. Medical device rapid drug releasing coatings comprising a therapeutic agent and a contrast agent
US8372834B2 (en) * 2007-03-02 2013-02-12 University Of Wollongong Compositions and methods for delivery of anti-cancer agents
CN101219113A (zh) 2008-01-28 2008-07-16 济南帅华医药科技有限公司 含苯达莫司汀的复方抗癌缓释注射剂
RU2734236C2 (ru) 2009-02-25 2020-10-13 Софткемо Фарма Корп. Композиции бендамустина и циклополисахарида
CN101606934B (zh) * 2009-07-27 2011-09-28 江苏奥赛康药业有限公司 盐酸苯达莫司汀组合物

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060159713A1 (en) 2005-01-14 2006-07-20 Cephalon, Inc. Bendamustine pharmaceutical compositions
WO2008063910A2 (en) 2006-11-08 2008-05-29 Novavax, Inc. Method of preparing solid dosage forms of multi-phasic pharmaceutical compositions

Also Published As

Publication number Publication date
ES2675620T3 (es) 2018-07-11
WO2010097700A1 (en) 2010-09-02
EP2400987B1 (en) 2014-09-03
JP5654498B2 (ja) 2015-01-14
RU2591804C2 (ru) 2016-07-20
JP2012519657A (ja) 2012-08-30
AU2010217297A1 (en) 2011-10-20
NO2792369T3 (enExample) 2018-09-15
US8703964B2 (en) 2014-04-22
EP2400987A1 (en) 2012-01-04
US20130190372A1 (en) 2013-07-25
RU2011138844A (ru) 2013-04-10
ES2525257T3 (es) 2014-12-19
CA2753641C (en) 2014-09-16
CN102421451A (zh) 2012-04-18
EP2792369B1 (en) 2018-04-18
HUE038234T2 (hu) 2018-10-29
RU2016124871A3 (enExample) 2019-11-11
US20100216858A1 (en) 2010-08-26
EP2400987A4 (en) 2012-08-22
EP2792369A1 (en) 2014-10-22
CA2753641A1 (en) 2010-09-02
RU2016124871A (ru) 2018-12-04
KR20120015294A (ko) 2012-02-21
US8436032B2 (en) 2013-05-07
RU2734236C2 (ru) 2020-10-13
CN102421451B (zh) 2013-11-06
CN102935080A (zh) 2013-02-20

Similar Documents

Publication Publication Date Title
KR101798951B1 (ko) 벤다무스틴 환형다당류 조성물
US20220265829A1 (en) Formulations of bendamustine
KR101922752B1 (ko) 사이클로덱스트린 및 소수성 약물을 포함하는 주사용 약제학적 조성물을 보존하는 방법
JP5380549B2 (ja) ボリコナゾール含有の薬物製剤及びその調製方法
KR20090084925A (ko) 피모벤단과 사이클로덱스트린의 복합물을 포함하는 액상 제제
KR101807903B1 (ko) 음이온-양이온성 환형다당류 조성물인 벤다무스틴
US20110207764A1 (en) Cyclopolysaccharide compositions
US11730815B2 (en) Stable liquid pharmaceutical compositions comprising bendamustine
KR20210102886A (ko) Bcl-2 억제제의 사이클로덱스트린 기반 제형
WO2021090183A1 (en) Liquid melphalan composition
KR20090050070A (ko) 항종양제를 포함하는 수성 제제
HK1168556A (en) Bendamustine cyclopolysaccharide compositions
US20240148696A1 (en) Lyophilized bendamustine-cyclodextrin composition

Legal Events

Date Code Title Description
PA0105 International application

St.27 status event code: A-0-1-A10-A15-nap-PA0105

T11-X000 Administrative time limit extension requested

St.27 status event code: U-3-3-T10-T11-oth-X000

P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

P13-X000 Application amended

St.27 status event code: A-2-2-P10-P13-nap-X000

P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

P13-X000 Application amended

St.27 status event code: A-2-2-P10-P13-nap-X000

PG1501 Laying open of application

St.27 status event code: A-1-1-Q10-Q12-nap-PG1501

R18-X000 Changes to party contact information recorded

St.27 status event code: A-3-3-R10-R18-oth-X000

A201 Request for examination
PA0201 Request for examination

St.27 status event code: A-1-2-D10-D11-exm-PA0201

R18-X000 Changes to party contact information recorded

St.27 status event code: A-3-3-R10-R18-oth-X000

P22-X000 Classification modified

St.27 status event code: A-2-2-P10-P22-nap-X000

E902 Notification of reason for refusal
PE0902 Notice of grounds for rejection

St.27 status event code: A-1-2-D10-D21-exm-PE0902

T11-X000 Administrative time limit extension requested

St.27 status event code: U-3-3-T10-T11-oth-X000

T11-X000 Administrative time limit extension requested

St.27 status event code: U-3-3-T10-T11-oth-X000

T11-X000 Administrative time limit extension requested

St.27 status event code: U-3-3-T10-T11-oth-X000

T11-X000 Administrative time limit extension requested

St.27 status event code: U-3-3-T10-T11-oth-X000

E13-X000 Pre-grant limitation requested

St.27 status event code: A-2-3-E10-E13-lim-X000

P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

P13-X000 Application amended

St.27 status event code: A-2-2-P10-P13-nap-X000

E701 Decision to grant or registration of patent right
PE0701 Decision of registration

St.27 status event code: A-1-2-D10-D22-exm-PE0701

PN2301 Change of applicant

St.27 status event code: A-3-3-R10-R11-asn-PN2301

R19-X000 Request for party data change rejected

St.27 status event code: A-3-3-R10-R19-oth-X000

PN2301 Change of applicant

St.27 status event code: A-3-3-R10-R13-asn-PN2301

St.27 status event code: A-3-3-R10-R11-asn-PN2301

PR0701 Registration of establishment

St.27 status event code: A-2-4-F10-F11-exm-PR0701

PR1002 Payment of registration fee

St.27 status event code: A-2-2-U10-U12-oth-PR1002

Fee payment year number: 1

PG1601 Publication of registration

St.27 status event code: A-4-4-Q10-Q13-nap-PG1601

PR1001 Payment of annual fee

St.27 status event code: A-4-4-U10-U11-oth-PR1001

Fee payment year number: 4

PR1001 Payment of annual fee

St.27 status event code: A-4-4-U10-U11-oth-PR1001

Fee payment year number: 5

PR1001 Payment of annual fee

St.27 status event code: A-4-4-U10-U11-oth-PR1001

Fee payment year number: 6

PR1001 Payment of annual fee

St.27 status event code: A-4-4-U10-U11-oth-PR1001

Fee payment year number: 7

PR1001 Payment of annual fee

St.27 status event code: A-4-4-U10-U11-oth-PR1001

Fee payment year number: 8

R18-X000 Changes to party contact information recorded

St.27 status event code: A-5-5-R10-R18-oth-X000

PR1001 Payment of annual fee

St.27 status event code: A-4-4-U10-U11-oth-PR1001

Fee payment year number: 9