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ME01170B - Formulacije dpp iv inhibitora - Google Patents

Formulacije dpp iv inhibitora

Info

Publication number
ME01170B
ME01170B MEP-2010-172A MEP17210A ME01170B ME 01170 B ME01170 B ME 01170B ME P17210 A MEP17210 A ME P17210A ME 01170 B ME01170 B ME 01170B
Authority
ME
Montenegro
Prior art keywords
methyl
amino
xanthine
piperidin
butyn
Prior art date
Application number
MEP-2010-172A
Other languages
English (en)
French (fr)
Inventor
Anja Kohlrausch
Patrick Romer
Gerd Seiffert
Original Assignee
Boehringer Ingelheim Int
Boehringer Ingelheim Pharma
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=36972901&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ME01170(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Boehringer Ingelheim Int, Boehringer Ingelheim Pharma filed Critical Boehringer Ingelheim Int
Publication of ME01170B publication Critical patent/ME01170B/me

Links

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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    • 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
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/517—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine
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Claims (14)

1.Farmaceutska kompozicija koja sadrži kao aktivni sastojak jedinjenje DPP IV inhibitora sa amino grupom odabranom od ·1-[(4-metil-hinazolin-2-il)metil]-3-metil-7-(2-butin-1-il)-8-(3-(R)-amino-piperidin-1-il)-ksantin, ·1-[([1,5]nafthiridin-2-il)metil]-3-metil-7-(2-butin-1-il)-8-((R)-3-amino-piperidin-1-il)-ksantin, ·1-[(hinazolin-2-il)metil]-3-metil-7-(2-butin-1-il)-8-((R)-3-amino-piperidin-1-il)-ksantin, ·2-((R)-3-amino-piperidin-1-il)-3-(but-2-inil)-5-(4-metil-hinazolin-2-ilmetil)-3,5-dihidro-imidazo[4,5-d]piridazin-4-on, ·1-[(4-metil-hinazolin-2-il)metil]-3-metil-7-(2-butin-1-il)-8-[(2-amino-2-metil-propil)-metilamino]-ksantin, ·1-[(3-cijano-hinolin-2-il)metil]-3-metil-7-(2-butin-1-il)-8-((R)-3-amino-piperidin-1-il)-ksantin, ·1-(2-cijano-benzil)-3-metil-7-(2-butin-1-il)-8-((R)-3-amino-piperidin-1-il)-ksantin, ·1-[(4-metil-hinazolin-2-il)metil]-3-metil-7-(2-butin-1-il)-8-[(S)-(2-amino-propil)-metilamino]-ksantin, ·1-[(3-cijano-piridin-2-il)metil]-3-metil-7-(2-butin-1-il)-8-((R)-3-amino-piperidin-1-il)-ksantin, ·1-[(4-metil-pirimidin-2-il)metil]-3-metil-7-(2-butin-1-il)-8-((R)-3-amino-piperidin-1-il)-ksantin, i ·1-[(4,6-dimetil-pirimidin-2-il)metil]-3-metil-7-(2-butin-1-il)-8-((R)-3-amino-piridin-1-il)-ksantin, ·1-[(hinoksalin-6-il)metil]-3-metil-7-(2-butin-1-il)-8-((R)-3-amino-piperidin-1-il)-ksantin, ili njihove soli, prvi razblaživač koji je manitol, drugi razblaživač koji je preželatinizovani skrob, vezivnu supstancu koja je kopovidon, dezintegrant koji je kukuruzni skrob, i lubrikant koji je magnezijum stearat.
2.Farmaceutska kompozicija prema zahtevu 1, koja sadrži 0.5-20% aktivnog sastojka, 40-88% razblaživača 1, 3-40% razblaživača 2, 1-5% vezivne supstance, 5-15% dezintegranta, i 0.1-4% lubrikanta
3.Farmaceutska kompozicija prema zahtevu 1, koja sadrži 0.5-7% aktivnog sastojka, 50-75% razblaživača 1, 5-15% razblaživača 2, 2-4% vezivne supstance, 8-12% dezintegranta, i 0.5-2% lubrikanta
4.Farmacetska kompozicija prema zahtevu 1, u doznom obliku kapsule, tablete ili teblete presvučene tankim slojem.
5.Farmaceutska kompozicija prema zahtevu 4, koja sadrži 2-4% tankog sloja obloge.
6.Farmaceutska kompozicija prema zahtevu 4, pri čemu tanak sloj obloge sadrži agens za formiranje tankog sloja, plastikator, glidant i opciono jedan ili više pigmenata.
7.Farmaceutska kompozicija prema zahtevu 6, pri čemu tanak sloj obloge sadrži hidroksipropilmetilcelulozu (HPMC), polietilen glikol (PEG), talk, titanijum dioksid i oksid gvožđa.
8.Postupak za dobijanje farmaceutske kompozicije prema zahtevu 1, koji obuhvata a.rastvaranje vezivne supstance u rastvaraču kako bi se dobila tečnost za granulaciju; b.mešanje DPP-IV inhibitora, razblaživača, i dezintegranta kako bi se dobila pred-smeša; c.vlaženje pred-smeše sa granulacionom tečnošću, a potom granulisanje navlažene pred-smeše; d.opciono prosejavanje granulisane pred-smeše kroz sito sa veličinom otvora najmanje 1.0 mm; e.sušenje granulata na oko 40-75°C, dok se ne postigne željeni gubitak na osušenoj vrednosti u opsegu od 1-5%; f. prosejavanje osušenih granula kroz sito sa veličinom otvora najmanje 06. mm; g.dodavanje lubrikanta granulama za finalno mešanje.
9.Postupak prema zahtevu 8, dalje obuhvata h.kompresiju finalne smeše u tablete; i. pripremanje suspenzije za oblaganje; j. oblaganje tablete sa suspenzijom za oblaganje do postignute težine od oko 2-4% kako bi se dobile tablete obložene tankim slojem.
10.Postupak prema zahtevu 8, pri čemu deo ekscipijenata je dodato ekstragranulaciji koja prethodi finalnom mešanju u koraku g.
11.Postupak prema zahtevu 8, pri čemu granula dobijena pri koracima a-e je dobijena u postupku granulacije sa jednom posudom sa visokim smicanjem, a potom osušena u granulatoru sa jednom posudom.
12.Dozni oblik dobijen sa farmaceutskom kompozicijom prema zahtevu 1, koji sadrži aktivni sastojak u dozi od 0.5 mg, 1 mg, 2.5 mg, 5 mg ili 10 mg.
13.Farmaceutska kompozicija prema zahtevu 1, pri čemu DPP IV inhibitor je 1-[(4-metil-hinazolin-2-il)metil]-3-metil-7-(2-butin-1-il)-8-(3-(R)-amino-piperidin-1-il)-ksantin.
14.Postupak prema zahtevu 8 ili 9, pri čemu DPP IV inhibitor je 1-[(4-metil-hinazolin-2-il)metil]-3-metil-7-(2-butin-1-il)-8-(3-(R)-amino-piperidin-1-il)-ksantin.
MEP-2010-172A 2006-05-04 2007-04-30 Formulacije dpp iv inhibitora ME01170B (me)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP06009201A EP1852108A1 (en) 2006-05-04 2006-05-04 DPP IV inhibitor formulations
EP07728658A EP2023902B8 (en) 2006-05-04 2007-04-30 Dpp iv inhibitor formulations
PCT/EP2007/054204 WO2007128724A1 (en) 2006-05-04 2007-04-30 Dpp iv inhibitor formulations

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ME01170B true ME01170B (me) 2013-03-20

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MEP-2014-136A ME01941B (me) 2006-05-04 2007-04-30 Formulacije DPP IV inhibitora

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