HRP20100111T1 - Nova formulacija doze - Google Patents

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HRP20100111T1
HRP20100111T1 HR20100111T HRP20100111T HRP20100111T1 HR P20100111 T1 HRP20100111 T1 HR P20100111T1 HR 20100111 T HR20100111 T HR 20100111T HR P20100111 T HRP20100111 T HR P20100111T HR P20100111 T1 HRP20100111 T1 HR P20100111T1
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lower alkyl
tablet composition
hydrogen
composition according
pharmaceutical tablet
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HR20100111T
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A. Ahmed Hashim
Page Susanne
Hargovindas Shah Navnit
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F. Hoffmann - La Roche Ag
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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D413/00Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and oxygen atoms as the only ring hetero atoms
    • C07D413/02Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and oxygen atoms as the only ring hetero atoms containing two hetero rings
    • C07D413/04Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and oxygen atoms as the only ring hetero atoms containing two hetero rings directly linked by a ring-member-to-ring-member bond
    • 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
    • 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
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • 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
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • 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
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445Non condensed piperidines, e.g. piperocaine
    • 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
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/455Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
    • 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
    • A61K9/2031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • A61P25/22Anxiolytics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/24Antidepressants
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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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
    • A61K9/14Particulate 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
    • 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
    • A61K9/1694Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient

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Abstract

Proces za pripremu farmaceutskog tabletnog sastava, naznačen time, da aktivni farmaceutski sastojak ima formulu Igdje jeR niži alkil, niži alkoksi, halogen ili trifluorometilR1 je halogen ili vodik; i kada je p 1, R1 se može pored gornjih supstituenata također uzeti s R za tvorbu -CH=CH-CH=CH-;R2 i R2 su svaki neovisno vodik, halogen, trifluorometil, niži alkoksi ili cijano; i kada je n 1, R2 i R2 mogu pored gornjih supstituenata tvoriti -CH=CH-CH=CH-, nesupstituiran ili supstituiran s jednim ili dva supstituenta izabranih od nižeg alkila ili nižeg alkoksi; R3 i R3 su vodik, niži alkil ili uzeti zajedno s pričvršćenim ugljikovim atomom tvore cikloalkilnu skupinu; R4 je vodik, -N(R5)(CH2)nOH, -N(R5)S(O)2-niži alkil, -N(R5)S(O)2fenil, -N=CH-N(R5)2, -N(R5)C(O)R5, R5 je vodik, C3-6-cikloalkil, benzil, ili niži alkil; R6 je vodik, hidroksi, niži alkil, -(CH2)nCOO-(R5), -N(R5)CO-niži alkil, hidroksi-niži alkil, -(CH2)nCN, -(CH2)nO(CH2)nOH, -CHO ili heterociklički prsten s 5- ili 6- članova koji sadrži 1 do 4 heteroatoma izabranih iz skupine koja se sastoji od kisika, dušika i sumpora i s jednim od ugljikovih atoma u spomenutom prstenu koji je nesupstituiran ili supstituiran s okso skupinom, gdje je heterociklički prsten izravno spojen ili spojen putem alkilenske skupine na ostatak molekule; je ciklički tercijarni amin koji može sadržavati jedan dodatni heteroatom izabran iz skupine koja se sastoji od kisika, dušika ili sumpora, gdje je bilo koji sumpor prisutan u prstenu tio ili se može oksidirati do sulfoksida ili sumpornog dioksida s kojim je spomenuti ciklički tercijarni amin direktno spojen na ostatak molekule ili je pričvršćen putem spojnice -(CH2)nN(R5)-;X je -C(O)N(R5)-, -(CH2)mO-, -(CH2)mN(R5)-, -N(R5)C(O)-, ili -N(R5)(CH2)m-;n, p, i q su svaki neovisno 1 do 4; m je 1 ili 2; i"Niži alkil" označava ravnu ili razgranatu lančanu alkilnu skupinu koja sadrži od 1 do 7 ugljikovih atoma; ili su njihove farmaceutski prihvatljive soli uz dodatak kiseline i poloksameri topivi u vodi zajedno procesirani ekstruzijom vruće taline prije miješanja s drugim sastojkom i gdje se nakon toga sastav tablete može prevući sa sastavom koji sadrži sustav prevlake s filmom za brzo otpuštanje i pročišćenu vodu. Patent sadrži još 13 patentnih zahtjeva.

Claims (14)

1. Proces za pripremu farmaceutskog tabletnog sastava, naznačen time, da aktivni farmaceutski sastojak ima formulu I [image] gdje je R niži alkil, niži alkoksi, halogen ili trifluorometil R1 je halogen ili vodik; i kada je p 1, R1 se može pored gornjih supstituenata također uzeti s R za tvorbu -CH=CH-CH=CH-; R2 i R2 su svaki neovisno vodik, halogen, trifluorometil, niži alkoksi ili cijano; i kada je n 1, R2 i R2 mogu pored gornjih supstituenata tvoriti -CH=CH-CH=CH-, nesupstituiran ili supstituiran s jednim ili dva supstituenta izabranih od nižeg alkila ili nižeg alkoksi; R3 i R3 su vodik, niži alkil ili uzeti zajedno s pričvršćenim ugljikovim atomom tvore cikloalkilnu skupinu; R4 je vodik, -N(R5)(CH2)nOH, -N(R5)S(O)2-niži alkil, -N(R5)S(O)2fenil, -N=CH—N(R5)2, -N(R5)C(O)R5, [image] R5 je vodik, C3-6-cikloalkil, benzil, ili niži alkil; R6 je vodik, hidroksi, niži alkil, -(CH2)nCOO-(R5), -N(R5)CO-niži alkil, hidroksi-niži alkil, -(CH2)nCN, -(CH2)nO(CH2)nOH, -CHO ili heterociklički prsten s 5- ili 6- članova koji sadrži 1 do 4 heteroatoma izabranih iz skupine koja se sastoji od kisika, dušika i sumpora i s jednim od ugljikovih atoma u spomenutom prstenu koji je nesupstituiran ili supstituiran s okso skupinom, gdje je heterociklički prsten izravno spojen ili spojen putem alkilenske skupine na ostatak molekule; [image] je ciklički tercijarni amin koji može sadržavati jedan dodatni heteroatom izabran iz skupine koja se sastoji od kisika, dušika ili sumpora, gdje je bilo koji sumpor prisutan u prstenu tio ili se može oksidirati do sulfoksida ili sumpornog dioksida s kojim je spomenuti ciklički tercijarni amin direktno spojen na ostatak molekule ili je pričvršćen putem spojnice -(CH2)nN(R5)-; X je -C(O)N(R5)-, -(CH2)mO-, -(CH2)mN(R5)-, -N(R5)C(O)-, ili -N(R5)(CH2)m-; n, p, i q su svaki neovisno 1 do 4; m je 1 ili 2; i "Niži alkil" označava ravnu ili razgranatu lančanu alkilnu skupinu koja sadrži od 1 do 7 ugljikovih atoma; ili su njihove farmaceutski prihvatljive soli uz dodatak kiseline i poloksameri topivi u vodi zajedno procesirani ekstruzijom vruće taline prije miješanja s drugim sastojkom i gdje se nakon toga sastav tablete može prevući sa sastavom koji sadrži sustav prevlake s filmom za brzo otpuštanje i pročišćenu vodu.
2. Proces za pripremu farmaceutskog tabletnog sastava prema zahtjevu 1, naznačen time, da sadrži slijedeće korake 1). pripremu smjese aktivnog farmaceutskog sastava s Poloksamerom topivim u vodi, 2). pripremu vrućih rastaljenih ekstrudata primjenom smjese u prahu iz koraka 1, 3). prolazak ekstrudiranog materijala kroz mašinu za prosijavanje da bi se dobio mljeveni materijal. Može biti potrebno više od jednog koraka prosijavanja da bi se dobio materijal u željenom rasponu veličine čestica, 4). pripremu smjese mljevenog ekstrudata iz koraka 3 u prvom koraku s punjenjem(ima) i sredstvom za rastvaranje, 5). priprema konačne smjese miješanjem smjese iz koraka 4 uz pomoćno sredstvo za procesiranje i glidante, 6). kompresiranje konačne smjese pripremljene u koraku 5 u tablete.
3. Farmaceutski tabletni sastav pripremljen prema zahtjevima 1 ili 2, naznačen time, da sadrži [image]
4. Farmaceustki tabletni sastav prema zahtjevu 3, naznačen time, da tableta sadrži 400 mg aktivnog sastojka formule I.
5. Farmaceutski tabletni sastav prema zahtjevu 3, naznačen time, da je aktivni sastojak 2-(3,5-bis-trifluorometil-fenil)-N-metil-N-(6-morfolin-4-il-4-o-tolil-piridin-3-il)-izobutiramid.
6. Farmaceutski tabletni sastav prema zahtjevu 3, naznačen time, da je poloksamer topiv u vodi blok kopolimer od etilen oksida (POE) ili propilen oksida (POP).
7. Farmaceutski tabletni sastav prema zahtjevu 6, naznačen time, da je poloksamer topiv u vodi Lutrol F68.
8. Farmaceutski tabletni sastav prema zahtjevu 3, naznačen time, da je punilo smjesa kukuruznog škroba, mikrokristalne celuloze i šećernog alkohola.
9. Farmaceutski tabletni sastav prema zahtjevu 8, naznačen time, da je punilo "pure-Cote" ili "Pure-Bind" ili "Pure-Dent" ili "Pure Gel" ili "Pure-Set" ili "Melojel" ili "Meritena" ili "Payge155" ili "perfectamylD6PH" ili "Purity 21" ili "Purity 826" ili "Tablet White" i "Avicel" ili "Vivapur" ili "Vivacel" ili "Emcocel" i "Parteck M 200".
10. Farmaceutski tabletni sastav prema zahtjevu 3, naznačen time, da je pomoćno sredstvo za procesiranje koloidalni silikonski dioksid.
11. Farmaceustki tabletni sastav prema zahtjevu 10, naznačen time, da je pomoćno sredstvo za procesiranje "Aerosil 380" ili "Cab-O-Sil".
12. Farmaceutski tabletni sastav prema zahtjevu 3, naznačen time, da je sredstvo za rastvaranje "polyplasdone XL".
13. Farmaceutski tabletni sastav prema zahtjevu 3, naznačen time, da je glidant magnezijev stearat.
14. Farmaceutski tabletni sastav prema zahtjevu 3, naznačen time, da sadrži - 2-(3,5-Bis-trifluorometil-fenil)-N-metil-N-(6-morfolin-4-il-4-o-tolil-piridin-3-il)-izobutiramid klorovodik 400.00 mg - "Lutrol F68" 133.35 mg - Mikrokristalna Celuloza (Avicel PH 102) 162.65 mg - "Parteck 200" (Mannitol) 30.00 mg - "Polyplasdone XL" 16.00 mg - Koloidalni Silikonski Dioksid (Aorosil 380) 16.00 mg - Kukuruzni škrob 30.00 mg - kukuruzni škrob 30.00 mg - Magnezijev Stearat 12.00 mg - "Opadry Yellow" 03K 12429 25.00 mg - Pročišćena Voda 131.25 ml
HR20100111T 2005-09-23 2010-03-02 Nova formulacija doze HRP20100111T1 (hr)

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Application Number Priority Date Filing Date Title
US71979305P 2005-09-23 2005-09-23
PCT/EP2006/066310 WO2007039420A1 (en) 2005-09-23 2006-09-13 Novel dosage formulation

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HRP20100111T1 true HRP20100111T1 (hr) 2010-04-30

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US (3) US20070071813A1 (hr)
EP (1) EP1928427B1 (hr)
JP (2) JP5523706B2 (hr)
KR (1) KR20080043852A (hr)
CN (2) CN103893145A (hr)
AR (1) AR056198A1 (hr)
AT (1) ATE453384T1 (hr)
AU (1) AU2006298898B2 (hr)
BR (1) BRPI0616108A2 (hr)
CA (1) CA2623237C (hr)
DE (1) DE602006011485D1 (hr)
DK (1) DK1928427T3 (hr)
ES (1) ES2335922T3 (hr)
HK (1) HK1198914A1 (hr)
HR (1) HRP20100111T1 (hr)
IL (1) IL189929A (hr)
MY (1) MY143784A (hr)
NO (1) NO340473B1 (hr)
NZ (1) NZ566419A (hr)
PL (1) PL1928427T3 (hr)
PT (1) PT1928427E (hr)
RU (1) RU2431473C2 (hr)
SI (1) SI1928427T1 (hr)
TW (1) TWI375572B (hr)
WO (1) WO2007039420A1 (hr)
ZA (1) ZA200802272B (hr)

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