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BR112018070615A2 - formulação em grânulos contendo cloridrato de cariprazina para administração oral. - Google Patents

formulação em grânulos contendo cloridrato de cariprazina para administração oral.

Info

Publication number
BR112018070615A2
BR112018070615A2 BR112018070615A BR112018070615A BR112018070615A2 BR 112018070615 A2 BR112018070615 A2 BR 112018070615A2 BR 112018070615 A BR112018070615 A BR 112018070615A BR 112018070615 A BR112018070615 A BR 112018070615A BR 112018070615 A2 BR112018070615 A2 BR 112018070615A2
Authority
BR
Brazil
Prior art keywords
granular formulation
formulation containing
cariprazine hydrochloride
oral administration
containing cariprazine
Prior art date
Application number
BR112018070615A
Other languages
English (en)
Inventor
Suzuki Akihiro
Ozaki Fuminori
Mii Keiji
Imada Yasushi
Original Assignee
Richter Gedeon Nyrt
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 Richter Gedeon Nyrt filed Critical Richter Gedeon Nyrt
Publication of BR112018070615A2 publication Critical patent/BR112018070615A2/pt

Links

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
    • A61K9/14—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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic 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
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic 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
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Neurology (AREA)
  • Psychiatry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

a invenção refere-se a uma formulação em grânulos que permite que o cloridrato de cariprazina seja armazenado de forma estável. a solução provê uma formulação em grânulos contendo cloridrato de cariprazina, em que a referida formulação em grânulos contém lactose como diluente primário.
BR112018070615A 2016-04-14 2017-04-13 formulação em grânulos contendo cloridrato de cariprazina para administração oral. BR112018070615A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP16165247.4A EP3231418A1 (en) 2016-04-14 2016-04-14 Granule formulation for oral administration
PCT/IB2017/052129 WO2017178999A1 (en) 2016-04-14 2017-04-13 Granule formulation for oral administration

Publications (1)

Publication Number Publication Date
BR112018070615A2 true BR112018070615A2 (pt) 2019-02-05

Family

ID=55802213

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112018070615A BR112018070615A2 (pt) 2016-04-14 2017-04-13 formulação em grânulos contendo cloridrato de cariprazina para administração oral.

Country Status (13)

Country Link
US (1) US20190117647A1 (pt)
EP (2) EP3231418A1 (pt)
JP (1) JP2019511513A (pt)
KR (1) KR20180131579A (pt)
CN (1) CN109069429A (pt)
AU (1) AU2017250640A1 (pt)
BR (1) BR112018070615A2 (pt)
CA (1) CA3020981A1 (pt)
EA (1) EA201892235A1 (pt)
IL (1) IL262204A (pt)
MX (1) MX2018012562A (pt)
TN (1) TN2018000326A1 (pt)
WO (1) WO2017178999A1 (pt)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NZ590852A (en) 2008-07-16 2013-03-28 Richter Gedeon Nyrt Pharmaceutical formulations containing dopamine receptor ligands trans-1{ 4-[2-[4-(2,3-dichlorophenyl)-piperizin-1-yl]-ethyl]-cyclohexyl} -3,3-dimethyl-urea also known as cariprazine
US11274087B2 (en) 2016-07-08 2022-03-15 Richter Gedeon Nyrt. Industrial process for the preparation of cariprazine
US11273156B2 (en) * 2018-11-20 2022-03-15 Aurobindo Pharma Ltd Stable cariprazine formulations for oral use
US11547707B2 (en) 2019-04-10 2023-01-10 Richter Gedeon Nyrt. Carbamoyl cyclohexane derivatives for treating autism spectrum disorder
US11344503B2 (en) 2019-12-13 2022-05-31 Halo Science LLC Cariprazine release formulations

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HU227534B1 (en) 2003-08-04 2011-08-29 Richter Gedeon Nyrt (thio)carbamoyl-cyclohexane derivatives, process for producing them and pharmaceutical compositions containing them
CA2715760C (en) * 2008-02-21 2017-06-13 Mitsubishi Tanabe Pharma Corporation Solid preparation for oral administration of cariprazine hydrochloride
NZ590852A (en) * 2008-07-16 2013-03-28 Richter Gedeon Nyrt Pharmaceutical formulations containing dopamine receptor ligands trans-1{ 4-[2-[4-(2,3-dichlorophenyl)-piperizin-1-yl]-ethyl]-cyclohexyl} -3,3-dimethyl-urea also known as cariprazine

Also Published As

Publication number Publication date
EP3442508A1 (en) 2019-02-20
IL262204A (en) 2018-11-29
KR20180131579A (ko) 2018-12-10
CN109069429A (zh) 2018-12-21
US20190117647A1 (en) 2019-04-25
TN2018000326A1 (en) 2020-01-16
CA3020981A1 (en) 2017-10-19
EP3231418A1 (en) 2017-10-18
AU2017250640A1 (en) 2018-11-08
JP2019511513A (ja) 2019-04-25
MX2018012562A (es) 2019-06-10
WO2017178999A1 (en) 2017-10-19
EA201892235A1 (ru) 2019-03-29

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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06W Patent application suspended after preliminary examination (for patents with searches from other patent authorities) chapter 6.23 patent gazette]
B350 Update of information on the portal [chapter 15.35 patent gazette]
B11B Dismissal acc. art. 36, par 1 of ipl - no reply within 90 days to fullfil the necessary requirements