AU2020328351B2 - Oral pharmaceutical composition - Google Patents

Oral pharmaceutical composition

Info

Publication number
AU2020328351B2
AU2020328351B2 AU2020328351A AU2020328351A AU2020328351B2 AU 2020328351 B2 AU2020328351 B2 AU 2020328351B2 AU 2020328351 A AU2020328351 A AU 2020328351A AU 2020328351 A AU2020328351 A AU 2020328351A AU 2020328351 B2 AU2020328351 B2 AU 2020328351B2
Authority
AU
Australia
Prior art keywords
disorder
salt
sodium
mass
cellulose
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
AU2020328351A
Other languages
English (en)
Other versions
AU2020328351A1 (en
Inventor
Ryuta AONO
Takuya Fujii
Naoki Kamada
Ryohei TOGASHI
Xinyu Wang
Motoyasu YOSHIMURA
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.)
Otsuka Pharmaceutical Co Ltd
Original Assignee
Otsuka Pharmaceutical 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 Otsuka Pharmaceutical Co Ltd filed Critical Otsuka Pharmaceutical Co Ltd
Publication of AU2020328351A1 publication Critical patent/AU2020328351A1/en
Application granted granted Critical
Publication of AU2020328351B2 publication Critical patent/AU2020328351B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0002Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • 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
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/06Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/08Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/06Antimigraine agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/14Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16Anti-Parkinson drugs
    • 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
    • A61P25/20Hypnotics; Sedatives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/22Anxiolytics
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/04Anorexiants; Antiobesity agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Psychiatry (AREA)
  • Hospice & Palliative Care (AREA)
  • Pain & Pain Management (AREA)
  • Inorganic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Anesthesiology (AREA)
  • Diabetes (AREA)
  • Otolaryngology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Psychology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
AU2020328351A 2019-08-13 2020-08-13 Oral pharmaceutical composition Active AU2020328351B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
AUPCT/JP2019/031895 2019-08-13
PCT/JP2019/031895 WO2021029020A1 (ja) 2019-08-13 2019-08-13 経口医薬組成物
PCT/JP2020/030776 WO2021029429A1 (ja) 2019-08-13 2020-08-13 経口医薬組成物

Publications (2)

Publication Number Publication Date
AU2020328351A1 AU2020328351A1 (en) 2022-03-24
AU2020328351B2 true AU2020328351B2 (en) 2026-03-05

Family

ID=74569440

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2020328351A Active AU2020328351B2 (en) 2019-08-13 2020-08-13 Oral pharmaceutical composition
AU2020327792A Active AU2020327792B2 (en) 2019-08-13 2020-08-13 Oral pharmaceutical composition containing heterocyclic compound

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2020327792A Active AU2020327792B2 (en) 2019-08-13 2020-08-13 Oral pharmaceutical composition containing heterocyclic compound

Country Status (15)

Country Link
US (4) US20220273647A1 (https=)
EP (2) EP4015001A4 (https=)
JP (7) JPWO2021029020A1 (https=)
KR (2) KR20220046625A (https=)
CN (2) CN114222562A (https=)
AU (2) AU2020328351B2 (https=)
BR (2) BR112022002433A2 (https=)
CA (2) CA3150751A1 (https=)
IL (2) IL290469B2 (https=)
MX (3) MX2022001758A (https=)
MY (2) MY208261A (https=)
PH (2) PH12022550347A1 (https=)
TW (2) TWI870441B (https=)
WO (3) WO2021029020A1 (https=)
ZA (2) ZA202202319B (https=)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021029020A1 (ja) * 2019-08-13 2021-02-18 大塚製薬株式会社 経口医薬組成物
CN118742293A (zh) * 2022-01-31 2024-10-01 住友精化株式会社 药物控释制剂用组合物和药物控释制剂
JP2023173950A (ja) * 2022-05-27 2023-12-07 同仁医薬化工株式会社 経口液剤
AU2024247059A1 (en) * 2023-03-29 2025-10-30 Merck Sharp & Dohme (Uk) Limited Controlled release pde10a formulations

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006112464A1 (en) * 2005-04-14 2006-10-26 Otsuka Pharmaceutical Co., Ltd. Piperazine-substituted benzothiophenes for treatment of mental disorders
US20140120185A1 (en) * 2011-04-05 2014-05-01 Tsuyoshi Hirose Combinations comprising brexpiprazole or a salt thereof and a second drug for use in the treatment of a cns disorder
US20140234417A1 (en) * 2011-10-14 2014-08-21 Otsuka Pharmaceutical Co., Ltd. Tablet comprising 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1h-quinolin-2-one or a salt thereof

Family Cites Families (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2799241A (en) 1949-01-21 1957-07-16 Wisconsin Alumni Res Found Means for applying coatings to tablets or the like
US3173876A (en) 1960-05-27 1965-03-16 John C Zobrist Cleaning methods and compositions
NL271831A (https=) 1960-11-29
US3276586A (en) 1963-08-30 1966-10-04 Rosaen Filter Co Indicating means for fluid filters
US3546142A (en) 1967-01-19 1970-12-08 Amicon Corp Polyelectrolyte structures
US3541006A (en) 1968-07-03 1970-11-17 Amicon Corp Ultrafiltration process
US3541005A (en) 1969-02-05 1970-11-17 Amicon Corp Continuous ultrafiltration of macromolecular solutions
US3865108A (en) 1971-05-17 1975-02-11 Ortho Pharma Corp Expandable drug delivery device
US3916899A (en) 1973-04-25 1975-11-04 Alza Corp Osmotic dispensing device with maximum and minimum sizes for the passageway
US4002173A (en) 1974-07-23 1977-01-11 International Paper Company Diester crosslinked polyglucan hydrogels and reticulated sponges thereof
GB1478759A (en) 1974-11-18 1977-07-06 Alza Corp Process for forming outlet passageways in pills using a laser
US4207893A (en) 1977-08-29 1980-06-17 Alza Corporation Device using hydrophilic polymer for delivering drug to biological environment
JP4315393B2 (ja) 2005-04-14 2009-08-19 大塚製薬株式会社 複素環化合物
JP4540700B2 (ja) * 2006-10-13 2010-09-08 大塚製薬株式会社 医薬
TWI632921B (zh) * 2011-10-19 2018-08-21 大塚製藥股份有限公司 口服溶液
AR090775A1 (es) * 2012-04-23 2014-12-03 Otsuka Pharma Co Ltd Preparado inyectable
EP2911670A1 (en) * 2012-10-25 2015-09-02 Otsuka Pharmaceutical Co., Ltd. Prophylactic and/or therapeutic agent for behavioral and psychological symptoms associated with neurodegenerative disease or impulsive symptoms associated with mental disease containing brexpiprazole or salt thereof
CN106667969A (zh) * 2017-02-23 2017-05-17 佛山市弘泰药物研发有限公司 一种依匹哌唑缓释胶囊及其制备方法
JP6886654B2 (ja) 2017-04-11 2021-06-16 学校法人帝京大学 抗カンジダ活性組成物
WO2021029020A1 (ja) * 2019-08-13 2021-02-18 大塚製薬株式会社 経口医薬組成物

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006112464A1 (en) * 2005-04-14 2006-10-26 Otsuka Pharmaceutical Co., Ltd. Piperazine-substituted benzothiophenes for treatment of mental disorders
US20140120185A1 (en) * 2011-04-05 2014-05-01 Tsuyoshi Hirose Combinations comprising brexpiprazole or a salt thereof and a second drug for use in the treatment of a cns disorder
US20140234417A1 (en) * 2011-10-14 2014-08-21 Otsuka Pharmaceutical Co., Ltd. Tablet comprising 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1h-quinolin-2-one or a salt thereof

Also Published As

Publication number Publication date
CN114222575A (zh) 2022-03-22
MX2022001758A (es) 2022-05-13
JPWO2021029020A1 (https=) 2021-02-18
PH12022550349B1 (en) 2024-03-06
BR112022002433A2 (pt) 2022-12-13
MY208261A (en) 2025-04-29
MY208267A (en) 2025-04-29
JPWO2021029429A1 (https=) 2021-02-18
AU2020327792A1 (en) 2022-03-24
TW202120090A (zh) 2021-06-01
CA3150751A1 (en) 2021-02-18
PH12022550347A1 (en) 2022-12-12
KR20220046625A (ko) 2022-04-14
AU2020328351A1 (en) 2022-03-24
JP2022180531A (ja) 2022-12-06
WO2021029430A1 (ja) 2021-02-18
JPWO2021029430A1 (https=) 2021-02-18
EP4015002A4 (en) 2023-06-07
AU2020327792B2 (en) 2026-03-05
TWI870441B (zh) 2025-01-21
CA3150827A1 (en) 2021-02-18
IL290472A (en) 2022-04-01
IL290469B2 (en) 2025-08-01
TW202120091A (zh) 2021-06-01
IL290469B1 (en) 2025-04-01
CN114222562A (zh) 2022-03-22
WO2021029429A1 (ja) 2021-02-18
BR112022002436A2 (pt) 2022-12-13
TW202517267A (zh) 2025-05-01
MX2025006039A (es) 2025-07-01
EP4015001A4 (en) 2023-06-14
JP7148733B2 (ja) 2022-10-05
JP2025072595A (ja) 2025-05-09
TWI870442B (zh) 2025-01-21
MX2022001759A (es) 2022-05-13
JP2022132411A (ja) 2022-09-08
EP4015002A1 (en) 2022-06-22
JP2025074104A (ja) 2025-05-13
IL290469A (en) 2022-04-01
WO2021029020A1 (ja) 2021-02-18
ZA202202319B (en) 2024-06-26
TW202517266A (zh) 2025-05-01
US20250057835A1 (en) 2025-02-20
KR20220046624A (ko) 2022-04-14
EP4015001A1 (en) 2022-06-22
US20220273647A1 (en) 2022-09-01
US20250127776A1 (en) 2025-04-24
US20220280418A1 (en) 2022-09-08
JP7110495B2 (ja) 2022-08-01
ZA202202320B (en) 2024-06-26
PH12022550349A1 (en) 2022-12-12
JP7635187B2 (ja) 2025-02-25

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