JP7814375B2 - ケタミンを含むマイクロスフェア製剤ならびにその製造及び使用方法 - Google Patents

ケタミンを含むマイクロスフェア製剤ならびにその製造及び使用方法

Info

Publication number
JP7814375B2
JP7814375B2 JP2023511830A JP2023511830A JP7814375B2 JP 7814375 B2 JP7814375 B2 JP 7814375B2 JP 2023511830 A JP2023511830 A JP 2023511830A JP 2023511830 A JP2023511830 A JP 2023511830A JP 7814375 B2 JP7814375 B2 JP 7814375B2
Authority
JP
Japan
Prior art keywords
polymer
ketamine
microsphere
microspheres
esketamine
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
JP2023511830A
Other languages
English (en)
Japanese (ja)
Other versions
JP2023538901A (ja
JP2023538901A5 (https=
Inventor
ガラスカ、レイチェル
カート、ケルシー
リッチー、トレイシー
Original Assignee
オークウッド ラボラトリーズ，エル．エル．シー．
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 オークウッド ラボラトリーズ，エル．エル．シー． filed Critical オークウッド ラボラトリーズ，エル．エル．シー．
Publication of JP2023538901A publication Critical patent/JP2023538901A/ja
Publication of JP2023538901A5 publication Critical patent/JP2023538901A5/ja
Application granted granted Critical
Publication of JP7814375B2 publication Critical patent/JP7814375B2/ja
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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647—Polyesters, e.g. poly(lactide-co-glycolide)
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/24—Antidepressants
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Pain & Pain Management (AREA)
  • Psychiatry (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Dermatology (AREA)
JP2023511830A 2020-08-18 2021-08-17 ケタミンを含むマイクロスフェア製剤ならびにその製造及び使用方法 Active JP7814375B2 (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US202063067068P 2020-08-18 2020-08-18
US63/067,068 2020-08-18
US202163149911P 2021-02-16 2021-02-16
US63/149,911 2021-02-16
PCT/US2021/046220 WO2022040130A1 (en) 2020-08-18 2021-08-17 Microsphere formulations comprising ketamine and methods for making and using the same

Publications (3)

Publication Number Publication Date
JP2023538901A JP2023538901A (ja) 2023-09-12
JP2023538901A5 JP2023538901A5 (https=) 2024-08-15
JP7814375B2 true JP7814375B2 (ja) 2026-02-16

Family

ID=80270269

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2023511830A Active JP7814375B2 (ja) 2020-08-18 2021-08-17 ケタミンを含むマイクロスフェア製剤ならびにその製造及び使用方法

Country Status (10)

Country Link
US (1) US12233165B2 (https=)
EP (1) EP4199917B1 (https=)
JP (1) JP7814375B2 (https=)
KR (1) KR20230052915A (https=)
CN (1) CN115942935B (https=)
AU (1) AU2021329820A1 (https=)
CA (1) CA3191160A1 (https=)
IL (1) IL300547A (https=)
TW (1) TWI906350B (https=)
WO (1) WO2022040130A1 (https=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2907692T3 (es) 2017-12-29 2022-04-26 Celon Pharma Sa Composición de ketamina de polvo seco para su administración por vía pulmonar en la depresión resistente al tratamiento
EP4611729A1 (en) * 2022-10-31 2025-09-10 Oakwood Laboratories, LLC Mixed release profile polymer microsphere formulations comprising octreotide and methods for making and using the same

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002020269A (ja) 2000-06-28 2002-01-23 Dong Kook Pharmaceut Co 多重エマルジョン法による徐放出性微粒球の製造方法
WO2019126108A1 (en) 2017-12-22 2019-06-27 Janssen Pharmaceutica Nv Esketamine for the treatment of depression

Family Cites Families (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0720859B2 (ja) * 1985-02-07 1995-03-08 武田薬品工業株式会社 マイクロカプセルの製造法
US6902743B1 (en) * 1995-05-22 2005-06-07 The United States Of America As Represented By The Secretary Of The Army Therapeutic treatment and prevention of infections with a bioactive material(s) encapuslated within a biodegradable-bio-compatable polymeric matrix
US5945126A (en) 1997-02-13 1999-08-31 Oakwood Laboratories L.L.C. Continuous microsphere process
US6270802B1 (en) 1998-10-28 2001-08-07 Oakwood Laboratories L.L.C. Method and apparatus for formulating microspheres and microcapsules
US6291013B1 (en) * 1999-05-03 2001-09-18 Southern Biosystems, Inc. Emulsion-based processes for making microparticles
AU6510400A (en) 1999-08-04 2001-03-05 Oakwood Laboratories L.L.C. Slow release microspheres
US6479007B1 (en) 1999-09-16 2002-11-12 University Technology Corporation Apparatus and method for controlling pore size in polymeric membranes and thin films
EP1387671A1 (en) * 2001-05-03 2004-02-11 MASSACHUSETTS EYE & EAR INFIRMARY Implantable drug delivery device and use thereof
US7771742B2 (en) 2004-04-30 2010-08-10 Allergan, Inc. Sustained release intraocular implants containing tyrosine kinase inhibitors and related methods
WO2005107714A2 (en) 2004-05-05 2005-11-17 Alkermes Controlled Therapeutics, Inc. Method of forming microparticles that include a bisphosphonate and a polymer
KR101271263B1 (ko) 2005-09-28 2013-06-07 아우리스 메디칼 아게 내이 장애 치료용 약학 조성물
CA2635374C (en) 2006-01-11 2015-12-08 Hyperbranch Medical Technology, Inc. Crosslinked gels comprising polyalkyleneimines, and their uses as medical devices
US20070292521A1 (en) * 2006-06-20 2007-12-20 Schwitzer Co., Ltd Oral Encapsulated Preparation for Aquatic Animals
US20110027331A1 (en) 2009-07-29 2011-02-03 Warsaw Orthopedic, Inc. An implantable drug depot having a reversible phase transition material for treatment of pain and/or inflammation
WO2013119183A1 (en) 2012-02-06 2013-08-15 Nanyang Technological University Methods of manufacturing core-shell microparticles, and microparticles formed thereof
WO2013138322A1 (en) * 2012-03-12 2013-09-19 Janssen Pharmaceutica Nv Esketamine for the treatment of treatment-refractory or treatment-resistant depression
WO2017075136A1 (en) 2015-10-27 2017-05-04 Purdue Research Foundation Polymer-based therapeutics for inductive browning of fat
SG11202001206YA (en) 2017-09-14 2020-03-30 Agency Science Tech & Res Emulsions, methods and uses thereof
EP3968979A4 (en) 2019-05-15 2023-03-01 Bexson Biomedical, Inc. KETAMINE FORMULATION FOR SUBCUTANEOUS INJECTION
EP3993898B1 (en) 2019-07-01 2025-10-15 Oakwood Laboratories, Llc System and method for making microspheres and emulsions
US20220401366A1 (en) * 2019-11-15 2022-12-22 Consegna Pharma, Inc. Long acting nmda antagonists
PH12022550775A1 (en) 2019-12-20 2023-08-23 Alar Pharmaceuticals Inc Long-acting injectable formulations of ketamine pamoate salts
US20210361578A1 (en) 2020-04-03 2021-11-25 University Of Iowa Research Foundation Mek1/2 inhibitor-loaded microparticle formulation

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002020269A (ja) 2000-06-28 2002-01-23 Dong Kook Pharmaceut Co 多重エマルジョン法による徐放出性微粒球の製造方法
WO2019126108A1 (en) 2017-12-22 2019-06-27 Janssen Pharmaceutica Nv Esketamine for the treatment of depression

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
HAN, F. Y., et al.，Novel Polymeric Bioerodable Microparticles for Prolonged-Release Intrathecal Delivery of Analgesic Agents for Relief of Intractable Cancer-Related Pain，Journal of Pharmaceutical Sciences，2015年，Vol.104，pp.2334-2344
ZHU, M., et al.，Bioerodable Ketamine-Loaded Microparticles Fabricated Using Dissolvable Hydrogel Template Technology，Journal of Pharmaceutical Sciences，Vol.108，2019年，pp.1220-1226

Also Published As

Publication number Publication date
TWI906350B (zh) 2025-12-01
TW202227044A (zh) 2022-07-16
CA3191160A1 (en) 2022-02-24
EP4199917C0 (en) 2026-01-07
EP4199917A4 (en) 2024-10-30
US12233165B2 (en) 2025-02-25
EP4199917B1 (en) 2026-01-07
WO2022040130A1 (en) 2022-02-24
US20220054420A1 (en) 2022-02-24
CN115942935A (zh) 2023-04-07
JP2023538901A (ja) 2023-09-12
EP4199917A1 (en) 2023-06-28
IL300547A (en) 2023-04-01
AU2021329820A1 (en) 2023-03-09
CN115942935B (zh) 2025-09-05
KR20230052915A (ko) 2023-04-20

Similar Documents

Publication Publication Date Title
JP6678571B2 (ja) 高薬物含有ブプレノルフィンマイクロスフェア及びその製造方法
JP7814375B2 (ja) ケタミンを含むマイクロスフェア製剤ならびにその製造及び使用方法
US9636308B2 (en) High drug load buprenorphine microspheres and method of producing same
WO2022198167A1 (en) Microsphere formulations comprising naltrexone and methods for making and using the same
US11992559B2 (en) Microsphere formulations comprising lurasidone and methods for making and using the same
US20240216280A1 (en) Microsphere formulations comprising nalmefene andmethods for making and using the same
ES3061392T3 (en) Microsphere formulations comprising ketamine and methods for making and using the same
US20240342115A1 (en) Microsphere formulations comprising ketamine and methods formaking and using the same
US20230225993A1 (en) Microsphere formulations comprising ketamine and methods for making and using the same
WO2023133554A2 (en) Microsphere formulations comprising ketamine and methods for making and using the same
JP2026507990A (ja) オクトレオチドを含む混合放出プロファイルポリマーミクロスフェア製剤ならびにその製造方法及び使用方法
US20240000772A1 (en) Microsphere formulations comprising naltrexone and methods for making and using the same
KR20230154222A (ko) Btk 억제제를 포함하는 마이크로스피어 제제 및 이의 제조 및 사용 방법
US20230404922A1 (en) Microsphere formulations comprising btk inhibitors and methods for making and using the same
WO2024163997A1 (en) Microsphere formulations comprising naltrexone and methods for making and using the same
WO2025117624A1 (en) Microsphere formulations comprising brexpiprazole and methods for making and using the same
WO2023097204A1 (en) Microsphere formulations comprising asenapine and methods for making and using the same

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20240806

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20240806

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20250711

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20250722

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20251021

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: 20260130

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20260203

R150 Certificate of patent or registration of utility model

Ref document number: 7814375

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150