KR102079402B1 - 사이클로스포린 a의 결정형, 이의 제조 방법 및 이의 사용 방법 - Google Patents

사이클로스포린 a의 결정형, 이의 제조 방법 및 이의 사용 방법 Download PDF

Info

Publication number
KR102079402B1
KR102079402B1 KR1020137034444A KR20137034444A KR102079402B1 KR 102079402 B1 KR102079402 B1 KR 102079402B1 KR 1020137034444 A KR1020137034444 A KR 1020137034444A KR 20137034444 A KR20137034444 A KR 20137034444A KR 102079402 B1 KR102079402 B1 KR 102079402B1
Authority
KR
South Korea
Prior art keywords
crystalline form
cyclosporin
eye
crystalline
ophthalmically acceptable
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
Application number
KR1020137034444A
Other languages
English (en)
Korean (ko)
Other versions
KR20140047054A (ko
Inventor
키오마르스 카라미
리차드 에스. 그레이엄
아누라다 브이. 고어
스코트 더블유. 스미스
커 우
Original Assignee
알러간, 인코포레이티드
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=46178866&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=KR102079402(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by 알러간, 인코포레이티드 filed Critical 알러간, 인코포레이티드
Publication of KR20140047054A publication Critical patent/KR20140047054A/ko
Application granted granted Critical
Publication of KR102079402B1 publication Critical patent/KR102079402B1/ko
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K7/00—Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
    • C07K7/64—Cyclic peptides containing only normal peptide links
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K7/00—Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
    • C07K7/64—Cyclic peptides containing only normal peptide links
    • C07K7/645—Cyclosporins; Related peptides
    • 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
    • A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • 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
    • A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • A61K38/13—Cyclosporins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A61P27/04—Artificial tears; Irrigation solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/30—Extraction; Separation; Purification by precipitation
    • C07K1/306—Extraction; Separation; Purification by precipitation by crystallization
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00—Indexing scheme relating to specific properties of organic compounds
    • C07B2200/13—Crystalline forms, e.g. polymorphs

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • Analytical Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
KR1020137034444A 2011-05-27 2012-05-25 사이클로스포린 a의 결정형, 이의 제조 방법 및 이의 사용 방법 Expired - Fee Related KR102079402B1 (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161490887P 2011-05-27 2011-05-27
US61/490,887 2011-05-27
PCT/US2012/039611 WO2012166610A1 (en) 2011-05-27 2012-05-25 A crystalline form of cyclosporine a, methods of preparation, and methods for use thereof

Publications (2)

Publication Number Publication Date
KR20140047054A KR20140047054A (ko) 2014-04-21
KR102079402B1 true KR102079402B1 (ko) 2020-02-19

Family

ID=46178866

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020137034444A Expired - Fee Related KR102079402B1 (ko) 2011-05-27 2012-05-25 사이클로스포린 a의 결정형, 이의 제조 방법 및 이의 사용 방법

Country Status (19)

Country Link
US (4) US8772245B2 (https=)
EP (2) EP3521302A1 (https=)
JP (1) JP6163482B2 (https=)
KR (1) KR102079402B1 (https=)
CN (1) CN103649108B (https=)
AR (1) AR086586A1 (https=)
AU (4) AU2012262513B2 (https=)
BR (1) BR112013030554B1 (https=)
CA (1) CA2836946C (https=)
CL (1) CL2013003400A1 (https=)
IL (2) IL229475A0 (https=)
MX (1) MX362271B (https=)
MY (1) MY180581A (https=)
RU (1) RU2602062C2 (https=)
SG (1) SG10201607344UA (https=)
TW (1) TWI554522B (https=)
UA (1) UA113627C2 (https=)
WO (1) WO2012166610A1 (https=)
ZA (1) ZA201308665B (https=)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP6363506B2 (ja) * 2011-11-15 2018-07-25 アラーガン、インコーポレイテッドＡｌｌｅｒｇａｎ，Ｉｎｃｏｒｐｏｒａｔｅｄ シクロスポリンａ２型の懸濁剤
ES2666191T3 (es) * 2011-11-15 2018-05-03 Allergan, Inc. Un proceso para la cristalización de la forma 2 de la ciclosporina A
RU2630970C2 (ru) * 2011-11-15 2017-09-15 Аллерган, Инк. Автоклавируемые взвеси циклоспорина а формы 2
RU2639393C2 (ru) * 2011-11-15 2017-12-21 Аллерган, Инк. Состав пролонгированного действия циклоспорина формы 2
JP2015519368A (ja) 2012-06-01 2015-07-09 アラーガン インコーポレイテッドＡｌｌｅｒｇａｎ，Ｉｎｃｏｒｐｏｒａｔｅｄ シクロスポリンａ類似体
GB201222455D0 (en) * 2012-12-13 2013-01-30 Perioc Ltd Novel pharmaceutical formulations and their use in the treatment of periodontaldisease
US10524661B2 (en) * 2013-06-12 2020-01-07 Proactive Live, Inc. Sleep monitoring and stimulation
MY196111A (en) 2014-07-18 2023-03-15 Allergan Inc Suspension Compositions of Cyclosporin a for Subconjunctival and Periocular Injection
US9914755B2 (en) 2015-01-08 2018-03-13 Allergan, Inc. Cyclosporin derivatives wherein the MeBmt sidechain has been cyclized
US10443292B2 (en) * 2016-04-25 2019-10-15 Magna Closures, Inc. Non-contact obstacle detection system for motor vehicles
KR102287226B1 (ko) 2017-05-17 2021-08-11 주식회사 유유제약 신규한 펩타이드 및 이를 유효성분으로 포함하는 안구질환 치료용 약학 조성물
US11613558B2 (en) 2018-11-14 2023-03-28 Yuyu Pharma, Inc. Peptides and pharmaceutical compositions for treating eye diseases
WO2021224901A2 (en) * 2021-08-20 2021-11-11 Sun Pharmaceutical Industries Limited Stable cyclosporine ophthalmic formulation and manufacturing process thereof
EP4585605A1 (en) * 2022-10-20 2025-07-16 Chugai Seiyaku Kabushiki Kaisha Method for producing cyclic peptide crystals
KR20250160895A (ko) 2023-03-20 2025-11-14 추가이 세이야쿠 가부시키가이샤 고리형 펩타이드의 공결정을 제조하는 방법

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100188305B1 (ko) * 1987-12-21 1999-06-01 더블류. 하링, 지. 보이롤 신규의 시클로스포린 결정 형태, 이것의 제조 방법 및 이것을 함유한 약학 조성물 및 그 용도
WO2008137617A1 (en) 2007-05-04 2008-11-13 Allergan, Inc. Use of cyclosporines in the treatment of patients with intraocular lenses

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB9105705D0 (en) * 1991-03-18 1991-05-01 Sandoz Ltd Improvements in or relating to organic compounds
US5474979A (en) 1994-05-17 1995-12-12 Allergan, Inc. Nonirritating emulsions for sensitive tissue
US6254860B1 (en) 1999-04-13 2001-07-03 Allergan Sales, Inc. Ocular treatment using cyclosporin-A derivatives
US6656504B1 (en) * 1999-09-09 2003-12-02 Elan Pharma International Ltd. Nanoparticulate compositions comprising amorphous cyclosporine and methods of making and using such compositions
JP2011508776A (ja) * 2008-01-04 2011-03-17 アルコン ファーマシューティカルズ リミテッド 安定な水性シクロスポリン組成物

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100188305B1 (ko) * 1987-12-21 1999-06-01 더블류. 하링, 지. 보이롤 신규의 시클로스포린 결정 형태, 이것의 제조 방법 및 이것을 함유한 약학 조성물 및 그 용도
WO2008137617A1 (en) 2007-05-04 2008-11-13 Allergan, Inc. Use of cyclosporines in the treatment of patients with intraocular lenses

Also Published As

Publication number Publication date
CN103649108A (zh) 2014-03-19
UA113627C2 (xx) 2017-02-27
MY180581A (en) 2020-12-02
TWI554522B (zh) 2016-10-21
NZ719272A (en) 2017-10-27
EP3521302A1 (en) 2019-08-07
BR112013030554B1 (pt) 2020-12-15
MX2013013855A (es) 2014-02-17
EP2714720A1 (en) 2014-04-09
US20160083432A1 (en) 2016-03-24
IL290158A (en) 2022-03-01
JP6163482B2 (ja) 2017-07-12
SG10201607344UA (en) 2016-10-28
RU2602062C2 (ru) 2016-11-10
AU2012262513A1 (en) 2013-12-12
US8772245B2 (en) 2014-07-08
US9206228B2 (en) 2015-12-08
MX362271B (es) 2019-01-10
RU2013155033A (ru) 2015-07-20
US20140315827A1 (en) 2014-10-23
WO2012166610A1 (en) 2012-12-06
US20130023482A1 (en) 2013-01-24
ZA201308665B (en) 2014-07-30
AR086586A1 (es) 2014-01-08
AU2019204192A1 (en) 2019-07-04
BR112013030554A2 (pt) 2016-09-06
EP2714720B1 (en) 2018-12-26
US20210269484A1 (en) 2021-09-02
TW201311730A (zh) 2013-03-16
CA2836946A1 (en) 2012-12-06
AU2017265008A1 (en) 2017-12-07
AU2016203990A1 (en) 2016-06-30
NZ618213A (en) 2016-05-27
JP2014515372A (ja) 2014-06-30
AU2019204192B2 (en) 2021-02-04
CA2836946C (en) 2017-08-01
AU2012262513B2 (en) 2016-03-17
CN103649108B (zh) 2017-03-29
KR20140047054A (ko) 2014-04-21
CL2013003400A1 (es) 2014-08-18
IL229475A0 (en) 2014-01-30

Similar Documents

Publication Publication Date Title
KR102079402B1 (ko) 사이클로스포린 a의 결정형, 이의 제조 방법 및 이의 사용 방법
RU2639393C2 (ru) Состав пролонгированного действия циклоспорина формы 2
JP2020040968A (ja) シクロスポリンａ２型の懸濁剤
US20060166879A1 (en) Treatment of conditions associated with the presence of macromolecular aggregates, particularly ophthalmic disorders
JP6267003B2 (ja) ジクアホソルまたはその塩およびレバミピドまたはその塩を組み合わせたことを特徴とする涙液分泌促進剤
JPWO2006137426A1 (ja) 角結膜疾患の予防又は治療剤
EP4159225A1 (en) Novel pharmaceutical composition for treating dry eye syndrome
CN116419918A (zh) 4-(7-羟基-2-异丙基-4-氧代-4h-喹唑啉-3-基)-苄腈的结晶形式及其配制品
NZ719272B2 (en) A crystalline form of cyclosporine a, methods of preparation, and methods for use thereof
NZ618213B2 (en) A crystalline form of cyclosporine a, methods of preparation, and methods for use thereof
HK1193117A (en) A crystalline form of cyclosporine a, methods of preparation, and methods for use thereof
HK1193117B (en) A crystalline form of cyclosporine a, methods of preparation, and methods for use thereof
CN120112515A (zh) Trpv1拮抗剂的结晶多晶型形式及其制剂

Legal Events

Date Code Title Description
PA0105 International application

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

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

R17-X000 Change to representative recorded

St.27 status event code: A-3-3-R10-R17-oth-X000

A201 Request for examination
AMND Amendment
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

PA0201 Request for examination

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

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

AMND Amendment
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

E601 Decision to refuse application
PE0601 Decision on rejection of patent

St.27 status event code: N-2-6-B10-B15-exm-PE0601

X091 Application refused [patent]
T11-X000 Administrative time limit extension requested

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

T13-X000 Administrative time limit extension granted

St.27 status event code: U-3-3-T10-T13-oth-X000

T11-X000 Administrative time limit extension requested

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

T13-X000 Administrative time limit extension granted

St.27 status event code: U-3-3-T10-T13-oth-X000

AMND Amendment
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

PX0901 Re-examination

St.27 status event code: A-2-3-E10-E12-rex-PX0901

PX0701 Decision of registration after re-examination

St.27 status event code: A-3-4-F10-F13-rex-PX0701

X701 Decision to grant (after re-examination)
GRNT Written decision to grant
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

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: 4

PR1001 Payment of annual fee

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

Fee payment year number: 5

PC1903 Unpaid annual fee

St.27 status event code: A-4-4-U10-U13-oth-PC1903

Not in force date: 20250214

Payment event data comment text: Termination Category : DEFAULT_OF_REGISTRATION_FEE

H13 Ip right lapsed

Free format text: ST27 STATUS EVENT CODE: N-4-6-H10-H13-OTH-PC1903 (AS PROVIDED BY THE NATIONAL OFFICE); TERMINATION CATEGORY : DEFAULT_OF_REGISTRATION_FEE

Effective date: 20250214

PC1903 Unpaid annual fee

St.27 status event code: N-4-6-H10-H13-oth-PC1903

Ip right cessation event data comment text: Termination Category : DEFAULT_OF_REGISTRATION_FEE

Not in force date: 20250214