JP6996713B2 - チモシンベータ４を含む眼科用製剤の製造方法 - Google Patents

チモシンベータ４を含む眼科用製剤の製造方法 Download PDF

Info

Publication number
JP6996713B2
JP6996713B2 JP2018511451A JP2018511451A JP6996713B2 JP 6996713 B2 JP6996713 B2 JP 6996713B2 JP 2018511451 A JP2018511451 A JP 2018511451A JP 2018511451 A JP2018511451 A JP 2018511451A JP 6996713 B2 JP6996713 B2 JP 6996713B2
Authority
JP
Japan
Prior art keywords
thymosin
container
composition containing
inert gas
ophthalmic preparation
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
JP2018511451A
Other languages
English (en)
Japanese (ja)
Other versions
JP2018531905A5 (enExample
JP2018531905A (ja
Inventor
イ・シヨン
カン・シヌク
ソン・ジヘ
オム・テフム
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.)
HLB Therapeutics Co Ltd
Original Assignee
HLB Therapeutics Co Ltd
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 HLB Therapeutics Co Ltd filed Critical HLB Therapeutics Co Ltd
Publication of JP2018531905A publication Critical patent/JP2018531905A/ja
Publication of JP2018531905A5 publication Critical patent/JP2018531905A5/ja
Application granted granted Critical
Publication of JP6996713B2 publication Critical patent/JP6996713B2/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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/2292—Thymosin; Related peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1468—Containers characterised by specific material properties
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K9/0048—Eye, e.g. artificial tears
    • 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
    • A61P27/06—Antiglaucoma agents or miotics
    • C—CHEMISTRY; METALLURGY
    • C01—INORGANIC CHEMISTRY
    • C01B—NON-METALLIC ELEMENTS; COMPOUNDS THEREOF; METALLOIDS OR COMPOUNDS THEREOF NOT COVERED BY SUBCLASS C01C
    • C01B23/00—Noble gases; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • A61J1/12—Bag-type containers with means for holding samples of contents

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Endocrinology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
JP2018511451A 2015-10-06 2015-12-18 チモシンベータ４を含む眼科用製剤の製造方法 Active JP6996713B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
KR20150140489 2015-10-06
KR10-2015-0140489 2015-10-06
PCT/KR2015/013981 WO2017061663A1 (ko) 2015-10-06 2015-12-18 티모신 베타 4를 포함하는 안약의 제조방법

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2020109496A Division JP2020183391A (ja) 2015-10-06 2020-06-25 チモシンベータ４を含む眼科用製剤の製造方法

Publications (3)

Publication Number Publication Date
JP2018531905A JP2018531905A (ja) 2018-11-01
JP2018531905A5 JP2018531905A5 (enExample) 2021-10-21
JP6996713B2 true JP6996713B2 (ja) 2022-02-04

Family

ID=58487995

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2018511451A Active JP6996713B2 (ja) 2015-10-06 2015-12-18 チモシンベータ４を含む眼科用製剤の製造方法
JP2020109496A Pending JP2020183391A (ja) 2015-10-06 2020-06-25 チモシンベータ４を含む眼科用製剤の製造方法

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2020109496A Pending JP2020183391A (ja) 2015-10-06 2020-06-25 チモシンベータ４を含む眼科用製剤の製造方法

Country Status (6)

Country Link
US (1) US10744088B2 (enExample)
EP (1) EP3342398A4 (enExample)
JP (2) JP6996713B2 (enExample)
KR (1) KR102487614B1 (enExample)
HK (1) HK1256595A1 (enExample)
WO (1) WO2017061663A1 (enExample)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20210251970A1 (en) 2018-10-10 2021-08-19 Presbyopia Therapies Inc Compositions and methods for storage stable ophthalmic drugs
CA3114204A1 (en) * 2018-10-10 2020-04-16 Presbyopia Therapies, Inc. Compositions and methods for the treatment of presbyopia
CN112107678B (zh) * 2020-09-30 2022-11-18 辰欣药业股份有限公司 一种含有胸腺法新的冻干组合物及其制备方法
US12180206B2 (en) 2021-11-17 2024-12-31 Lenz Therapeutics Operations, Inc. Aceclidine derivatives, compositions thereof and methods of use thereof
US12414942B1 (en) 2024-03-15 2025-09-16 Lenz Therapeutics Operations, Inc. Compositions, methods, and systems for treating presbyopia

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008108927A2 (en) 2007-03-06 2008-09-12 Regenerx Biopharmaceuticals, Inc. Methods and compositions for stabilizing polypeptides

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4150744A (en) * 1976-02-27 1979-04-24 Smith & Nephew Pharmaceuticals Ltd. Packaging
US6271216B1 (en) * 1989-07-24 2001-08-07 Allergan Stable solution of hyaluronate in a balanced salt medium
KR19980703582A (ko) * 1995-04-04 1998-11-05 가와구치 시게키 염산 프로카테롤 수용액 제제를 보지하는 패키지 및 염산 프로카테롤 수용액 제제
CA2338928A1 (en) 1998-07-30 2000-02-10 Hynda K. Kleinman Thymosin .beta.4 promotes wound repair
MXPA01003729A (es) * 1998-10-14 2002-05-06 Kyowa Hakko Kogyo Kk Metodo para estabilizar una solucion acuosa de derivados de pirazoloacridona.
MX2007001181A (es) * 2004-07-30 2007-03-21 Otsuka Pharma Co Ltd Botella comprimible y envase con gotero oftalmico que usa el mismo.
CN1748704B (zh) * 2004-09-15 2011-05-04 尼普洛株式会社 注射用水溶液制剂及其稳定化方法
CA2612522A1 (en) * 2005-06-17 2006-12-28 Regenerx Biopharmaceuticals, Inc. Lkktet and/or lkktnt peptide compositions and methods
ES2288118B1 (es) * 2006-05-10 2008-11-01 Bcn Peptides, S.A. Procedimiento para sintetizar timosinas.
MX2009010977A (es) 2007-04-11 2010-02-12 Biomarin Pharm Inc Metodos de administracion de tetrahidrobiopterina, composiciones asociadas y metodos de medicion.
JP5990880B2 (ja) * 2011-08-31 2016-09-14 東レ株式会社 有用タンパク質組成物およびその製造方法

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008108927A2 (en) 2007-03-06 2008-09-12 Regenerx Biopharmaceuticals, Inc. Methods and compositions for stabilizing polypeptides

Also Published As

Publication number Publication date
HK1256595A1 (en) 2019-09-27
EP3342398A1 (en) 2018-07-04
JP2020183391A (ja) 2020-11-12
KR20170041109A (ko) 2017-04-14
EP3342398A4 (en) 2019-03-20
US20180228729A1 (en) 2018-08-16
JP2018531905A (ja) 2018-11-01
KR102487614B1 (ko) 2023-01-12
WO2017061663A1 (ko) 2017-04-13
US10744088B2 (en) 2020-08-18

Similar Documents

Publication Publication Date Title
JP2020183391A (ja) チモシンベータ４を含む眼科用製剤の製造方法
TWI849355B (zh) 含阿托平之水性組成物及其用途
EP0838221B1 (en) Lyophilized hgf preparations
US20250222070A1 (en) Stable peptide compositions
US10071136B2 (en) Stable liquid formulations of recombinant fusion proteins
KR101587412B1 (ko) 사이클로스포린 및 트레할로스를 포함하는 안과용 조성물
US20190038746A1 (en) Recombinant fusion protein formulation
EP3643784A1 (en) Recombinant human-basic fibroblast growth factor (rh-bfgf) and pharmaceutical composition comprising rh-bfgf
KR20090118030A (ko) Ｈｇｆ 제제
RU2555332C2 (ru) Композиция, способ и набор для альфа-1 ингибитора протеазы
EP2478010B1 (en) Partial peptide of lacritin
EP3715451A2 (en) Composition for promoting goblet cell proliferation or mucin secretion comprising thymosin beta 4 or derivative thereof as active ingredient
KR101838759B1 (ko) 점안제
US20220017602A1 (en) Ocular compositions and methods
ES2771849T3 (es) Derivados de azúcares que comprenden restos que contienen azufre, métodos para prepararlos y métodos para emplearlos en el tratamiento de MPS IIIC
JP6910072B2 (ja) チモシンベータ４およびクエン酸を活性成分として含む角膜損傷予防／治療用組成物
US20250161403A1 (en) Peptides and methods of use thereof in treating ocular disorders
US20100316592A1 (en) AQUEOUS PREPARATION COMPRISING eMIP AS ACTIVE INGREDIENT
WO2016169455A1 (zh) 神经生长因子组合物和注射粉剂
KR20170021667A (ko) 티모신 β4를 유효성분으로 포함하는 신경영양성각막염 치료용 조성물

Legal Events

Date Code Title Description
A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20181102

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20190708

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20190716

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20191015

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20200225

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20200625

C60 Trial request (containing other claim documents, opposition documents)

Free format text: JAPANESE INTERMEDIATE CODE: C60

Effective date: 20200625

C11 Written invitation by the commissioner to file amendments

Free format text: JAPANESE INTERMEDIATE CODE: C11

Effective date: 20200707

A911 Transfer to examiner for re-examination before appeal (zenchi)

Free format text: JAPANESE INTERMEDIATE CODE: A911

Effective date: 20200806

C21 Notice of transfer of a case for reconsideration by examiners before appeal proceedings

Free format text: JAPANESE INTERMEDIATE CODE: C21

Effective date: 20200811

A912 Re-examination (zenchi) completed and case transferred to appeal board

Free format text: JAPANESE INTERMEDIATE CODE: A912

Effective date: 20200911

C211 Notice of termination of reconsideration by examiners before appeal proceedings

Free format text: JAPANESE INTERMEDIATE CODE: C211

Effective date: 20200915

C22 Notice of designation (change) of administrative judge

Free format text: JAPANESE INTERMEDIATE CODE: C22

Effective date: 20210406

C13 Notice of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: C13

Effective date: 20210601

C28A Non-patent document cited

Free format text: JAPANESE INTERMEDIATE CODE: C2838

Effective date: 20210601

A524 Written submission of copy of amendment under article 19 pct

Free format text: JAPANESE INTERMEDIATE CODE: A524

Effective date: 20210831

C876 Explanation why request for accelerated appeal examination is justified

Free format text: JAPANESE INTERMEDIATE CODE: C876

Effective date: 20210831

C305 Report on accelerated appeal examination

Free format text: JAPANESE INTERMEDIATE CODE: C305

Effective date: 20210908

C23 Notice of termination of proceedings

Free format text: JAPANESE INTERMEDIATE CODE: C23

Effective date: 20211005

C03 Trial/appeal decision taken

Free format text: JAPANESE INTERMEDIATE CODE: C03

Effective date: 20211109

C30A Notification sent

Free format text: JAPANESE INTERMEDIATE CODE: C3012

Effective date: 20211109

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20211208

R150 Certificate of patent or registration of utility model

Ref document number: 6996713

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250