HRP20191366T1 - Injekcijski pripravak - Google Patents

Injekcijski pripravak Download PDF

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HRP20191366T1
HRP20191366T1 HRP20191366TT HRP20191366T HRP20191366T1 HR P20191366 T1 HRP20191366 T1 HR P20191366T1 HR P20191366T T HRP20191366T T HR P20191366TT HR P20191366 T HRP20191366 T HR P20191366T HR P20191366 T1 HRP20191366 T1 HR P20191366T1
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salt
preparation according
quinolin
piperazin
benzo
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HRP20191366TT
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Daiki KANEKO
Takakuni Matsuda
Yusuke HOSHIKA
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Otsuka Pharmaceutical Co., Ltd.
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Application filed by Otsuka Pharmaceutical Co., Ltd. filed Critical Otsuka Pharmaceutical Co., Ltd.
Publication of HRP20191366T1 publication Critical patent/HRP20191366T1/hr
Publication of HRP20191366T4 publication Critical patent/HRP20191366T4/hr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • 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
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • 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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • 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
    • 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
    • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Neurology (AREA)
  • Organic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurosurgery (AREA)
  • Dermatology (AREA)
  • Psychiatry (AREA)
  • Dispersion Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (28)

1. Injekcijski pripravak koji sadrži pripravak koji obuhvaća slabo topivi lijek, disperzijsko sredstvo, i sredstvo za suspendiranje, te sredstvo za suspendiranje sadrži polietilen glikol i karboksimetil celulozu ili njihovu sol, pripravak ima viskoznost od 40 Pa·s ili više u barem jednoj točki u rasponu brzine smicanja od 0.01 do 0.02 s-1 i ima viskoznost od 0.2 Pa·s ili manje u barem jednoj točki u rasponu brzine smicanja od 900 do 1,000 s-1, mjereno pomoću reometra kod 5°C, 25°C ili 40°C, pri čemu je slabo topivi lijek aripiprazol ili njegova sol, ili 7-[4-(4-benzo[b]tiofen-4-il-piperazin-1-il)butoksi]-1H-kinolin-2-on ili njegova sol, i pri čemu je slabo topivi lijek sadržan u koncentraciji od 200 do 600 mg/mL.
2. Injekcijski pripravak prema patentnom zahtjevu 1, naznačen time što pripravak ima viskoznost od 40 Pa·s ili više u barem jednoj točki u rasponu brzine smicanja od 0.01 do 0.02 s-1 i ima viskoznost od 0.2 Pa·s ili manje u barem jednoj točki u rasponu brzine smicanja od 900 do 1,000 s-1, mjereno pomoću reometra kod 25°C.
3. Injekcijski pripravak prema patentnom zahtjevu 1 ili 2 naznačen time što sadrži pripravak koji kao disperzijsko sredstvo sadrži barem vodu.
4. Pripravka gela koji sadrži slabo topivi lijek koji je aripiprazol ili njegova sol, ili 7-[4-(4-benzo[b]tiofen-4-il-piperazin-1-il)butoksi]-1H-kinolin-2-on ili njegova sol, vodu, i sredstvo za suspendiranje, naznačen time što sredstvo za suspendiranje sadrži polietilen glikol i karboksimetil celulozu ili njihovu sol, i pri čemu slabo topivi lijek ima prosječni promjer primarnih čestica od 0.5 do 30 µm i sadržan je u koncentraciji od 200 do 600 mg/mL.
5. Injekcijski pripravak prema bilo kojem od zahtjeva 1 do 3 ili pripravak prema patentnom zahtjevu 4, naznačen time što je sredstvo za suspendiranje sadržano u koncentraciji od 0.05 do 150 mg/mL.
6. Injekcijski pripravak prema bilo kojem od zahtjeva 1 do 3 i 5, ili pripravak prema patentnom zahtjevu 4 ili 5, naznačen time što koncentracija polietilen glikola iznosi 0.05 do 2 mg/mL, te koncentracija karboksimetil celuloze ili njihove soli iznosi 0.5 do 50 mg/mL.
7. Injekcijski pripravak prema bilo kojem od zahtjeva 1 do 3, 5 ili 6, ili pripravak prema bilo kojem od patentnih zahtjeva 4 do 6, naznačen time što sredstvo za suspendiranje dodatno sadrži polivinilpirolidon.
8. Injekcijski pripravak prema patentnom zahtjevu 7, ili pripravak prema patentnom zahtjevu 7, naznačen time što K vrijednost polivinilpirolidona iznosi 12 do 20, i koncentracija polivinilpirolidona iznosi 0.5 do 20 mg/mL, koncentracija polietilen glikola iznosi 0.1 do 100 mg/mL, koncentracija karboksimetil celuloze ili njihove soli iznosi 0.5 do 50 mg/mL, i slabo topivi lijek je sadržan u koncentraciji od 250 do 450 mg/mL.
9. Injekcijski pripravak prema bilo kojem od zahtjeva 1 do 3 i 5 do 8, ili pripravak prema bilo kojem od patentnih zahtjeva 4 do 8, naznačen time što je slabo topivi lijek aripiprazol ili njegova sol.
10. Injekcijski pripravak prema bilo kojem od zahtjeva 1 do 3 i 5 do 8, ili pripravak prema bilo kojem od patentnih zahtjeva 4 do 8, naznačen time što slabo topivi lijek je 7-[4-(4-benzo[b]tiofen-4-il-piperazin-1-il)butoksi]-1H-kinolin-2-on ili njegovu sol.
11. Injekcijski pripravak ili pripravak prema patentnom zahtjevu 10, naznačen time što je 7-[4-(4-benzo[b]tiofen-4-il-piperazin-1-il)butoksi]-1H-kinolin-2-on u obliku dihidrata.
12. Injekcijski pripravak prema bilo kojem od zahtjeva 1 do 3 i 5 do 11, ili pripravak prema bilo kojem od patentnih zahtjeva 4 do 11, naznačen time što slabo topivi lijek ima srednji promjer sekundarnih čestica koji je do ali ne prelazi tri puta srednji promjer primarnih čestica.
13. Pripravak prema bilo kojem od patentnih zahtjeva 4 do 12, naznačen time što ima viskoznost od 40 Pa·s ili veću u barem jednoj točki u rasponu brzine smicanja od 0.01 do 0.02 s-1 i koji ima viskoznost od 0.2 Pa·s ili manju u barem jednoj točki u rasponu brzine smicanja od 900 do 1,000 s-1, mjereno pomoću reometra kod 5°C, 25°C ili 40°C.
14. Pripravak prema patentnom zahtjevu 13, naznačen time što ima viskoznost od 40 Pa·s ili veću u barem jednoj točki u rasponu brzine smicanja od 0.01 do 0.02 s-1 i koji ima viskoznost od 0.2 Pa·s ili manju barem jednoj točki u rasponu brzine smicanja od 900 do 1,000 s-1, mjereno pomoću reometra at 25°C.
15. Injekcijski pripravak naznačen time što sadrži pripravak prema bilo kojem od patentnih zahtjeva 4 do 14.
16. Postupak za dobivanje pripravka gela kako je definirano u bilo kojem od patentnih zahtjeva 4 do 14 koji sadrži aripiprazol ili njegovu sol, ili 7-[4-(4-benzo[b]tiofen-4-il-piperazin-1-il)butoksi]-1H-kinolin-2-on ili njegovu sol, naznačen time što postupak sadrži ostavljanje tekuće smjese da stoji na 5 do 70°C tijekom 5 minuta ili više, te tekuća smjesa sadrži aripiprazol ili njegovu sol, ili 7-[4-(4-benzo[b]tiofen-4-il-piperazin-1-il)butoksi]-1H-kinolin-2-on ili njegovu sol u koncentraciji od 200 do 600 mg/mL, vodu, i sredstvo za suspendiranje, sredstvo za suspendiranje sadrži polietilen glikol i karboksimetil celulozu ili njihovu sol, i aripiprazol ili njegova sol, ili 7-[4-(4-benzo[b]tiofen-4-il-piperazin-1-il)butoksi]-1H-kinolin-2-on ili njegova sol ima srednji promjer primarnih čestica od 0.5 do 30 µm.
17. Postupak prema patentnom zahtjevu 16 naznačen time što sadrži: mikronizaciju aripiprazola ili njegove soli, ili 7-[4-(4-benzo[b]tiofen-4-il-piperazin-1-il)butoksi]-1H-kinolin-2-ona ili njegove soli na srednji promjer primarnih čestica od 0.5 do 30 µm u tekućoj smjesi koja sadrži aripiprazol ili njegovu sol, ili 7-[4-(4-benzo[b]tiofen-4-il-piperazin-1-il)butoksi]-1H-kinolin-2-on ili njegovu sol u koncentraciji od 200 do 600 mg/mL, water, i a sredstvo za suspendiranje, te sredstvo za suspendiranje sadrži polietilen glikol i karboksimetil celulozu ili njihovu sol; i ostavljanje mikronizirane tekuće smjese da stoji na 5 do 70°C tijekom 5 minuta ili više.
18. Postupak za proizvodnju napunjene štrcaljke koja je napunjena s pripravkom gela prema bilo kojem od patentnih zahtjeva 4 do 14 koji sadrži aripiprazol ili njegovu sol, ili 7-[4-(4-benzo[b]tiofen-4-il-piperazin-1-il)butoksi]-1H-kinolin-2-on ili njegovu sol, te je postupak naznačen time što obuhvaća: punjenje u špricu tekuće smjese koja sadrži aripiprazol ili njegovu sol, ili 7-[4-(4-benzo[b]tiofen-4-il-piperazin-1-il)butoksi]-1H-kinolin-2-on ili njegovu sol u koncentraciji od 200 do 600 mg/mL, vodu, i sredstvo za suspendiranje, pri čemu sredstvo za suspendiranje sadrži polietilen glikol i karboksimetil celulozu ili njihovu sol, i pri čemu aripiprazol ili njegova sol, ili 7-[4-(4-benzo[b]tiofen-4-il-piperazin-1-il)butoksi]-1H-kinolin-2-on ili njegova sol ima prosječni promjer primarnih čestica od 0.5 do 30 µm; i ostavljanje tekuće smjese da stoji na 5 do 70°C tijekom 5 minuta ili više.
19. Postupak prema patentnom zahtjevu 18 naznačen time što obuhvaća: mikronizaciju aripiprazola ili njegove soli, ili 7-[4-(4-benzo[b]tiofen-4-il-piperazin-1-il)butoksi]-1H-kinolin-2-ona ili njegove soli do srednjeg promjera primarnih čestica od 0.5 do 30 µm u tekućoj smjesi koja sadrži aripiprazol ili njegovu sol, ili 7-[4-(4-benzo[b]tiofen-4-il-piperazin-1-il)butoksi]-1H-kinolin-2-on ili njegovu sol u koncentraciji od 200 do 600 mg/mL, vodu, te sredstvo za suspendiranje, pri čemu sredstvo za suspendiranje sadrži polietilen glikol i karboksimetil celulozu ili njihovu sol; i punjenje praškaste tekuće smjese u štrcaljku i ostavljanje praškaste tekuće smjese da stoji na 5 do 70°C tijekom 5 minuta ili više.
20. Injekcijski pripravak prema bilo kojem od patentnih zahtjeva 1 do 3, zahtjeva 5 do 12 i 15 koji sadrži pripravak koji obuhvaća: slabo topivi lijek koji je aripiprazol ili njegova sol, ili 7-[4-(4-benzo[b]tiofen-4-il-piperazin-1-il)butoksi]-1H-kinolin-2-on ili njegova sol, vodu, i sredstvo za suspendiranje, pri čemu sredstvo za suspendiranje sadrži polietilen glikol i karboksimetil celulozu ili njihovu sol, i pri čemu slabo topivi lijek ima prosječni promjer primarnih čestica od 1 do 10 µm i sadržan je u koncentraciji od 200 do 400 mg/mL, pripravak je obliku gela kada se ostavi stajati, te prelazi u koloidnu fazu kada je podvrgnut udarcu, i koji je pripravak s produljenim otpuštanjem i pogodan je za davanje jednom mjesečno.
21. Injekcijski pripravak prema zahtjevu 20 naznačen time što slabo topivi lijek ima prosječni promjer primarnih čestica od 2 do 7 µm.
22. Injekcijski pripravak prema bilo kojem od patentnih zahtjeva 1 do 3, zahtjeva 5 do 12 i 15 koji sadrži pripravak koji obuhvaća slabo topivi lijek koji je aripiprazol ili njegova sol, ili 7-[4-(4-benzo[b]tiofen-4-il-piperazin-1-il)butoksi]-1H-kinolin-2-on ili njegovu sol, vodu, te sredstvo za suspendiranje, pri čemu sredstvo za suspendiranje sadrži polietilen glikol i karboksimetil celulozu ili njegovu sol, i pri čemu slabo topivi lijek ima prosječni promjer primarnih čestica od 4 do 30 µm i sadržan je u koncentraciji od 300 do 600 mg/mL, pripravak je u obliku gela kada se ostavi stajati, te prelazi u koloidnu fazu kada je podvrgnut udarcu, i koji je pripravak s produljenim otpuštanjem i pogodan je za davanje jednom svaka dva do tri mjeseca.
23. Injekcijski pripravak prema zahtjevu 22 naznačen time što slabo topivi lijek ima prosječni promjer primarnih čestica od 5 do 20 µm.
24. Pripravak gela kako je definirano u bilo kojem od patentnih zahtjeva 4 do 14, naznačen time što sadrži aripiprazol ili njegovu sol, a pripravak je dobiven postupkom prema patentnom zahtjevu 16 ili 17.
25. Napunjena štrcaljka koja je napunjena gel pripravkom kao što je definirano u bilo kojem od patentnih zahtjeva 4 do 14 i 24, koji sadrži aripiprazol ili njegovu sol, ili 7-[4-(4-benzo[b]tiofen-4-il-piperazin-1-il)butoksi]-1H-kinolin-2-on ili njegovu sol, naznačena time što je štrcaljka dobivena pomoću postupka prema zahtjevu 18 ili 19.
26. Komplet naznačen time što sadrži napunjenu štrcaljku prema zahtjevu 25.
27. Injekcijski pripravak prema bilo kojem od zahtjeva 1 do 3, 5 do 12, 15 i 20 do 23, naznačen time što je za uporabu u postupku za liječenje ili prevenciju recidiva šizofrenije, bipolarnog poremećaja ili depresije.
28. Injekcijski pripravak prema zahtjevu 27 naznačen time što se injekcijski pripravak primjenjuje intramuskularno ili potkožno.
HRP20191366TT 2012-04-23 2013-04-23 Injekcijski pripravak HRP20191366T4 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201261636938P 2012-04-23 2012-04-23
US201361792089P 2013-03-15 2013-03-15
EP13728542.5A EP2841054B2 (en) 2012-04-23 2013-04-23 Injectable preparation
PCT/JP2013/062683 WO2013162048A1 (en) 2012-04-23 2013-04-23 Injectable preparation

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HRP20191366T1 true HRP20191366T1 (hr) 2019-12-27
HRP20191366T4 HRP20191366T4 (hr) 2022-08-19

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US (8) US20150093442A1 (hr)
EP (2) EP3539534A1 (hr)
JP (6) JP6234996B2 (hr)
KR (3) KR20210116702A (hr)
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AR (1) AR090776A1 (hr)
AU (5) AU2013253374B2 (hr)
BR (1) BR112014026307B1 (hr)
CA (2) CA2869889C (hr)
CO (1) CO7151500A2 (hr)
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EA (1) EA026619B1 (hr)
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HK (2) HK1206988A1 (hr)
HR (1) HRP20191366T4 (hr)
HU (1) HUE045979T2 (hr)
IL (1) IL235299B (hr)
JO (2) JOP20200109A1 (hr)
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NZ (1) NZ630335A (hr)
PH (2) PH12014502379B1 (hr)
PL (1) PL2841054T5 (hr)
PT (1) PT2841054T (hr)
SG (3) SG10201913425VA (hr)
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TW (4) TWI713826B (hr)
UA (1) UA115444C2 (hr)
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JOP20200109A1 (ar) 2012-04-23 2017-06-16 Otsuka Pharma Co Ltd مستحضر قابل للحقن
AR090775A1 (es) * 2012-04-23 2014-12-03 Otsuka Pharma Co Ltd Preparado inyectable
TWI562991B (en) * 2012-04-23 2016-12-21 Otsuka Pharma Co Ltd Dihydrate of benzothiophene compound or of a salt thereof, and process for producing the same
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