ME02459B - Rastvor za oralno ordiniranje - Google Patents

Rastvor za oralno ordiniranje

Info

Publication number
ME02459B
ME02459B MEP-2016-143A MEP2016143A ME02459B ME 02459 B ME02459 B ME 02459B ME P2016143 A MEP2016143 A ME P2016143A ME 02459 B ME02459 B ME 02459B
Authority
ME
Montenegro
Prior art keywords
acid
solution according
solution
oral administration
lactic
Prior art date
Application number
MEP-2016-143A
Other languages
German (de)
English (en)
French (fr)
Inventor
Ayako Okamoto
Original Assignee
Otsuka Pharma 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 Pharma Co Ltd filed Critical Otsuka Pharma Co Ltd
Publication of ME02459B publication Critical patent/ME02459B/me

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/191Carboxylic acids, e.g. valproic acid having two or more hydroxy groups, e.g. gluconic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/194Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • 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
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/66Phosphorus compounds
    • A61K31/661Phosphorus acids or esters thereof not having P—C bonds, e.g. fosfosal, dichlorvos, malathion or mevinphos
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/06Organic 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
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • 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
    • A61P25/28Drugs 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
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Psychiatry (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Hospice & Palliative Care (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (14)

1. Rastvor za oralno ordiniranje, koji ima pH 2.5 - 4.5, naznačen time, što sadrži 7-[4-(4-benzo[b]tiofen-4-il-piperazin-1-il)butoksi]-1H-hinolin-2-on, ili neku njegovu so, i najmanje jedno jedinjenje koje se bira iz grupe koju čine: mlečna kiselina, fosforna kiselina, glikolna kiselina, jabučna kiselina, vinska kiselina, limunska kiselina, ćilibarna kiselina i sirćetna kiselina.
2. Rastvor prema Zahtevu 1, naznačen time, što sadrži još i glicin.
3. Rastvor prema Zahtevu 1 ili 2, naznačen time, što najmanje jedno jedinjenje koje se bira iz grupe koju čine: mlečna kiselina, fosforna kiselina, glikolna kiselina, jabučna kiselina, vinska kiselina, limunska kiselina, ćilibarna kiselina i sirćetna kiselina, predstavlja mlečna kiselina.
4. Rastvor prema bilo kom od Zahteva 1 do 3, naznačen time, što sadrži još i najmanje jedan agens za poboljšavanje i/ili maskiranje arome.
5. Rastvor prema Zahtevu 4, naznačen time, što ovaj agens za poboljšavanje i/ili maskiranje arome predstavlja Sukraloza.
6. Rastvor prema bilo kom od Zahteva 1 to 5, naznačen time, što sadrži još i neki agens za solubilizaciju.
7. Rastvor prema Zahtevu 6, naznačen time, što ovaj agens za solubilizaciju predstavlja propilenglikol i/ili glicerin.
8. Rastvor prema bilo kom od Zahteva 1 do 7, naznačen time, što sadrži još i neki prezervativ i neki stabilizator.
9. Rastvor prema bilo kom od Zahteva 2 do 8, naznačen time, što je sadržaj glicina od 5 - 20 mg/mL
10. Rastvor prema bilo kom od Zahteva 3 to 9, naznačen time, što je sadržaj mlečne kiseline od 5 - 20 mg/mL
11. Rastvor prema bilo kom od Zahteva 3 to 9, naznačen time, što je maseni odnos glicin:mlečna kiselina 1:(0.5 – 2).
12. Rastvor prema bilo kom od Zahteva 7 to 11, naznačen time, što je agens za solubilizaciju komponovan od propilenglikola i glicerina, a maseni odnos propilenglikol:glicerin je 1:3.
13. Rastvor prema bilo kom od Zahteva 1 to 12, naznačen time, što ima pH od 3.0 - 3.4.
14. Upotreba kompozicije za oralno ordiniranje, koja sadrži 7-[4-(4-benzo[b]tiofen-4-il-piperazin-1-il)butoksi]-1H-hinolin-2-on, ili neku njegovu so, i najmanje jedno jedinjenje koje se bira iz grupe koju čine: mlečna kiselina, fosforna kiselina, glikolna kiselina, jabučna kiselina, vinska kiselina, limunska kiselina, ćilibarna kiselina i sirćetna kiselina, a ima pH 2.5 - 4.5, u nekom postupku za tretiranje centralnih neuroloških bolesti.
MEP-2016-143A 2011-10-19 2012-10-19 Rastvor za oralno ordiniranje ME02459B (me)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161548859P 2011-10-19 2011-10-19
EP12784753.1A EP2768508B1 (en) 2011-10-19 2012-10-19 Solution for oral administration
PCT/JP2012/077668 WO2013058411A1 (en) 2011-10-19 2012-10-19 Solution for oral administration

Publications (1)

Publication Number Publication Date
ME02459B true ME02459B (me) 2017-02-20

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US (8) US20140303183A1 (me)
EP (1) EP2768508B1 (me)
JP (1) JP6077534B2 (me)
KR (1) KR101856283B1 (me)
CN (2) CN107823131A (me)
AR (1) AR088372A1 (me)
AU (2) AU2012326978B2 (me)
BR (1) BR112014009330A2 (me)
CA (1) CA2851999C (me)
CL (1) CL2014000967A1 (me)
CO (1) CO6950486A2 (me)
CY (1) CY1117794T1 (me)
DK (1) DK2768508T3 (me)
EA (2) EA201490812A1 (me)
ES (1) ES2583137T3 (me)
HR (1) HRP20160989T1 (me)
HU (1) HUE028869T2 (me)
IL (1) IL231988A (me)
IN (1) IN2014DN02987A (me)
JO (1) JO3190B1 (me)
LT (1) LT2768508T (me)
ME (1) ME02459B (me)
MX (1) MX347309B (me)
MY (1) MY169096A (me)
PH (1) PH12014500816A1 (me)
PL (1) PL2768508T3 (me)
PT (1) PT2768508T (me)
RS (1) RS54967B1 (me)
SG (1) SG11201401273SA (me)
SI (1) SI2768508T1 (me)
SM (1) SMT201600341B (me)
TW (2) TWI679977B (me)
UA (1) UA111506C2 (me)
WO (1) WO2013058411A1 (me)
ZA (1) ZA201402669B (me)

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US20170182036A1 (en) 2017-06-29
US20210236483A1 (en) 2021-08-05
TWI632921B (zh) 2018-08-21
AU2012326978B2 (en) 2017-08-31
MY169096A (en) 2019-02-18
CL2014000967A1 (es) 2014-10-03
EA201490812A1 (ru) 2014-09-30
EP2768508B1 (en) 2016-07-06
US20180271858A1 (en) 2018-09-27
HUE028869T2 (en) 2017-01-30
PL2768508T3 (pl) 2016-12-30
EP2768508A1 (en) 2014-08-27
TW201737916A (zh) 2017-11-01
TWI679977B (zh) 2019-12-21
KR101856283B1 (ko) 2018-05-09
TW201330873A (zh) 2013-08-01
CY1117794T1 (el) 2017-05-17
BR112014009330A2 (pt) 2017-04-11
NZ623523A (en) 2015-12-24
ZA201402669B (en) 2015-09-30
CO6950486A2 (es) 2014-05-20
JO3190B1 (ar) 2018-03-08
DK2768508T3 (en) 2016-08-29
JP2014530801A (ja) 2014-11-20
SG11201401273SA (en) 2014-05-29
LT2768508T (lt) 2016-09-12
PH12014500816A1 (en) 2014-05-19
SI2768508T1 (sl) 2016-09-30
RS54967B1 (sr) 2016-11-30
US20200171023A1 (en) 2020-06-04
CA2851999A1 (en) 2013-04-25
CN103889426A (zh) 2014-06-25
ES2583137T3 (es) 2016-09-19
AR088372A1 (es) 2014-05-28
AU2017213570A1 (en) 2017-08-31
US20240009186A1 (en) 2024-01-11
CA2851999C (en) 2020-01-07
WO2013058411A1 (en) 2013-04-25
MX347309B (es) 2017-04-21
HRP20160989T1 (hr) 2016-10-07
AU2012326978A1 (en) 2014-05-22
CN107823131A (zh) 2018-03-23
JP6077534B2 (ja) 2017-02-08
MX2014004529A (es) 2014-08-01
KR20140083032A (ko) 2014-07-03
UA111506C2 (uk) 2016-05-10
IL231988A0 (en) 2014-05-28
SMT201600341B (it) 2016-11-10
US20250099460A1 (en) 2025-03-27
EA202190445A2 (ru) 2021-08-31
IN2014DN02987A (me) 2015-05-08
IL231988A (en) 2017-09-28
US20140303183A1 (en) 2014-10-09
US20160213665A1 (en) 2016-07-28
HK1196773A1 (zh) 2014-12-24
PT2768508T (pt) 2016-08-17

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