CA3210098A1 - Microsphere formulations comprising lurasidone and methods for making and using the same - Google Patents

Microsphere formulations comprising lurasidone and methods for making and using the same Download PDF

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Publication number
CA3210098A1
CA3210098A1 CA3210098A CA3210098A CA3210098A1 CA 3210098 A1 CA3210098 A1 CA 3210098A1 CA 3210098 A CA3210098 A CA 3210098A CA 3210098 A CA3210098 A CA 3210098A CA 3210098 A1 CA3210098 A1 CA 3210098A1
Authority
CA
Canada
Prior art keywords
polymer
microsphere
lurasidone
microspheres
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.)
Pending
Application number
CA3210098A
Other languages
English (en)
French (fr)
Inventor
Colin Spencer
Griffin BEYER
Tracy RICHEY
Mark Smith
Nicholas DELUCIA
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.)
Oakwood Laboratories LLC
Original Assignee
Oakwood Laboratories LLC
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 Oakwood Laboratories LLC filed Critical Oakwood Laboratories LLC
Publication of CA3210098A1 publication Critical patent/CA3210098A1/en
Pending legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1641Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647Polyesters, e.g. poly(lactide-co-glycolide)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/496Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5089Processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/18Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/24Antidepressants

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Psychiatry (AREA)
  • Organic Chemistry (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
CA3210098A 2021-02-24 2022-02-24 Microsphere formulations comprising lurasidone and methods for making and using the same Pending CA3210098A1 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US202163152943P 2021-02-24 2021-02-24
US63/152,943 2021-02-24
US202263267403P 2022-02-01 2022-02-01
US63/267,403 2022-02-01
PCT/US2022/070807 WO2022183196A1 (en) 2021-02-24 2022-02-24 Microsphere formulations comprising lurasidone and methods for making and using the same

Publications (1)

Publication Number Publication Date
CA3210098A1 true CA3210098A1 (en) 2022-09-01

Family

ID=82900191

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3210098A Pending CA3210098A1 (en) 2021-02-24 2022-02-24 Microsphere formulations comprising lurasidone and methods for making and using the same

Country Status (9)

Country Link
US (1) US11992559B2 (enExample)
EP (1) EP4297753A4 (enExample)
JP (1) JP2024507528A (enExample)
KR (1) KR20230157365A (enExample)
AU (1) AU2022226584A1 (enExample)
CA (1) CA3210098A1 (enExample)
IL (1) IL304650A (enExample)
MX (1) MX2023009754A (enExample)
WO (1) WO2022183196A1 (enExample)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN119424341A (zh) * 2023-08-02 2025-02-14 珠海市华海康医药科技有限责任公司 一种注射用药物缓释微球及其制备方法

Family Cites Families (30)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS60100516A (ja) 1983-11-04 1985-06-04 Takeda Chem Ind Ltd 徐放型マイクロカプセルの製造法
US5288502A (en) 1991-10-16 1994-02-22 The University Of Texas System Preparation and uses of multi-phase microspheres
EP0724432B1 (en) 1993-10-22 2002-09-18 Genentech, Inc. Methods and compositions for microencapsulation of antigens for use as vaccines
ATE288270T1 (de) 1993-11-19 2005-02-15 Janssen Pharmaceutica Nv Mikroverkapselte 1,2-benzazole
PT1615959E (pt) 2003-04-10 2013-08-29 Evonik Corp Um método para a produção de micropartículas à base de emulsão
WO2005009356A2 (en) 2003-07-15 2005-02-03 Pr Pharmaceuticals, Inc. Method for the preparation of controlled release formulations
JP2008518881A (ja) 2003-07-18 2008-06-05 オークウッド ラボラトリーズ,エル.エル.シー. 高分子組成物中の高分子の分子量低下、不純物形成およびゲル化の防止
AU2004259209A1 (en) 2003-07-23 2005-02-03 Pr Pharmaceuticals, Inc. Controlled release compositions
WO2006134864A1 (ja) 2005-06-13 2006-12-21 Dainippon Sumitomo Pharma Co., Ltd. 可溶化型製剤
US8158152B2 (en) 2005-11-18 2012-04-17 Scidose Llc Lyophilization process and products obtained thereby
US8202524B2 (en) 2006-08-31 2012-06-19 Sk Chemicals Co., Ltd. Method for producing microspheres loaded with drugs and microspheres loaded with drugs produced thereby
CA2709712C (en) 2007-12-20 2016-05-10 Surmodics Pharmaceuticals, Inc. Process for preparing microparticles having a low residual solvent volume
KR20120035183A (ko) 2009-06-10 2012-04-13 선오비온 파마슈티컬스 인코포레이티드 히스타민 h3 역 작용제 및 길항제, 및 이의 사용 방법
AU2010339689B2 (en) 2010-01-07 2015-02-19 Alkermes Pharma Ireland Limited Quaternary ammonium salt prodrugs
US10335366B2 (en) * 2010-05-31 2019-07-02 Laboratorios Farmacéuticos Rovi, S.A. Risperidone or paliperidone implant formulation
CN107595771A (zh) 2010-10-18 2018-01-19 大日本住友制药株式会社 注射用缓释制剂
SG190009A1 (en) 2010-11-24 2013-06-28 Univ Nanyang Tech Method for encapsulating particles
AU2011348085B2 (en) 2010-12-23 2016-12-08 Alkermes Pharma Ireland Limited Multi- API loading prodrugs
WO2013142205A1 (en) 2012-03-19 2013-09-26 Alkermes Pharma Ireland Limited Pharmaceutical compositions comprising benzyl alcohol
WO2014076712A2 (en) 2012-11-14 2014-05-22 Hetero Research Foundation Lurasidone hydrochloride solid dispersion
US9393211B2 (en) 2013-03-15 2016-07-19 Oakwood Laboratories LLC High drug load buprenorphine microspheres and method of producing same
US9956177B2 (en) 2013-03-15 2018-05-01 Oakwood Laboratories LLC Sustained release microspheres and method of producing same
US9636308B2 (en) 2013-03-15 2017-05-02 Oakwood Laboratories LLC High drug load buprenorphine microspheres and method of producing same
RU2658004C2 (ru) * 2013-06-20 2018-06-19 Фарматен С.А. Получение полилактидно-полигликолидных микрочастиц, характеризующихся сигмоидальным профилем высвобождения
CA3148303C (en) * 2013-12-03 2024-02-27 Intra-Cellular Therapies, Inc. Heterocycle fused gamma-carboline compounds for use in treatment of bipolar disorders
US20150157628A1 (en) 2013-12-11 2015-06-11 Saravanan Kannusamy Pharmaceutical compositions of Lurasidone and Process for preparation thereof
EP3242653A1 (en) 2015-01-05 2017-11-15 Boston Scientific Scimed Inc. Biodegradable drug eluting microsphere for the treatment of solid tumors
WO2017059106A1 (en) 2015-09-30 2017-04-06 Indivior Uk Limited Psychiatric treatment for patients with gene polymorphisms
WO2017119928A1 (en) 2016-01-08 2017-07-13 Abon Pharmaceuticals, Llc Long acting injectable formulations
WO2018015915A1 (en) * 2016-07-22 2018-01-25 Cadila Healthcare Limited A parenteral controlled release composition of an atypical antipsychotic agent

Also Published As

Publication number Publication date
IL304650A (en) 2023-09-01
JP2024507528A (ja) 2024-02-20
US20220265562A1 (en) 2022-08-25
AU2022226584A1 (en) 2023-08-17
EP4297753A1 (en) 2024-01-03
MX2023009754A (es) 2023-08-30
EP4297753A4 (en) 2025-01-01
US11992559B2 (en) 2024-05-28
WO2022183196A1 (en) 2022-09-01
KR20230157365A (ko) 2023-11-16

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