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ME01941B - Formulacije DPP IV inhibitora - Google Patents

Formulacije DPP IV inhibitora

Info

Publication number
ME01941B
ME01941B MEP-2014-136A MEP13614A ME01941B ME 01941 B ME01941 B ME 01941B ME P13614 A MEP13614 A ME P13614A ME 01941 B ME01941 B ME 01941B
Authority
ME
Montenegro
Prior art keywords
methyl
pharmaceutical composition
composition according
amino
butyn
Prior art date
Application number
MEP-2014-136A
Other languages
English (en)
Inventor
Anja Kohlrausch
Patrick Romer
Gerd Seiffert
Original Assignee
Boehringer Ingelheim Int
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=ME01941(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 filed Critical Boehringer Ingelheim Int
Publication of ME01941B publication Critical patent/ME01941B/me

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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
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    • 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 (20)

1. Farmaceutska kompozicija koja kao aktivni sastojak sadrži jedinjenje sa amino grupom koje je DPP IV inhibitor ili njegovu so, prvi razređivač, drugi razređivač, sredstvo za vezivanje, sredstvo za raspadanje i lubrikans; pri čemu je DPP IV inhibitor prisutan u količini od 0.5 mg. 1 mg, 2.5 mg, 5 mg ili 10 mg; i pri čemu su razređivači izabrani između eritritola, nisko supstituisane hidroksipropil celuloze, manitola, preželatiniziranog skroba i ksilitola;sredstvo za vezivanje je izabrano između kopovidona (kopolimerizati vinilpirolidona sa drugim derivatima vinila), hidroksipropil metil celuloze (HPMC), hidroksipropil celuloze (HPC), polivinilpirolidona (povidona), preželatiniziranog skroba, i nisko supstituisane hidroksipropil celuloze (L-HPC);sredstvo za raspadanje je izabrano između kukuruznog skroba, krospovidona, nisko supstituisane hidroksipropil celuloze (L-HPC), i preželatiniziranog skroba; i lubrikans je izabran između talka, polietilenglikola, kalcijum behenata, kalcijum stearata, hidrogenovanog ricinusovog ulja i magnezijum stearata.
2. Farmaceutska kompozicija prema zahtjevu 1 koja sadrži dodatno sredstvo za raspadanje.
3. Farmaceutska kompozicija prema zahtjevima 1 ili 2 koja sadrži dodatno sredstvo za kliženje.
4. Farmaceutska kompozicija prema zahtjevu 1, pri čemu je prvi razređivač manitol, a drugi razređivač je preželatinizirani skrob.
5. Farmaceutska kompozicija prema zahtjevu 1, pri čemu je sredstvo za vezivanje kopovidon (kopolimerizati vinilpirolidona sa drugim derivatima vinila), hidroksipropil metil celuloza (HPMC), hidroksipropil celuloza (HPC), ili polivinilpirolidon (povidon).
6. Farmaceutska kompozicija prema zahtjevu 1, pri čemu je sredstvo za raspadanje kukuruzni skrob.
7. Farmaceutska kompozicija prema zahtjevu 2, pri čemu je dodatno sredstvo za raspadanje krospovidon.
8. Farmaceutska kompozicija prema zahtjevu 3, pri čemu je opciono sredstvo za kliženje koliodni silicijum dioksid.
9. Farmaceutska kompozicija prema zahtjevu 1, pri čemu je prvi razređivač manitol, drugi razređivač je preželatinizirani skrob, sredstvo za vezivanje je kopovidon, sredstvo za raspadanje je kukuruzni skrob, a lubrikans je magnezijum stearat.
10. Farmaceutska kompozicija prema zahtjevu 1 koja sadrži 0-5-20 % aktivnog sastojka, 40-88 % razređivača 1, 3-40 % razređivača 2, 1-5 % sredstva za vezivanje, 5-15 % sredstva za raspadanje, i 0.1-4 % lubrikansa.
11. Farmaceutska kompozicija prema zahtjevu 1 koja sadrži 0.5-7 % aktivnog sastojka, 50-75 % razređivača 1, 5-15 % razređivača 2, 2-4 % sredstva za vezivanje, 8-12 % sredstva za raspadanje, i 0.5-2 % lubrikansa.
12. Farmaceutska kompozicija prema zahtjevu 1 u dozirnom obliku kapsule, tablete ili film obložene tablete.
13. Farmaceutska kompozicija prema zahtjevu 12 koja sadrži 2-4 % film-obloge.
14. Farmaceutska kompozicija prema zahtjevu 13, pri čemu film-obloga sadrži agens za formiranje filma, plastifikator, sredstvo za kliženje i opciono jedan ili više pigmenata.
15. Farmaceutska kompozicija prema zahtjevu 14, pri čemu film-obloga sadrži hidroksipropilmetil celulozu (HPMC), polietilen glikol (PEG), talk, titanijum dioksid i gvožđe oksid.
16. Postupak za dobijanje farmaceutske kompozicije prema zahtjevu 1 koji sadrži a. rastvaranje veziva u rastvaraču da bi se dobila tečnost za granulaciju; b. mješanje DPP-IV inhibitora, razređivača i sredstva za raspadanje da bi se dobio premiks; c. vlaženje premiksa sa tečnosti za granulaciju, a zatim granulisanje navlaženog premiksa; d. opciono prosejavanje granulisanog premiksa kroz sito sa veličinom otvora od najmanje 1.0 mm; e. sušenje granulata na oko 40-75°C sve dok se ne ostvari željeni gubitak vrednosti sušenjem u opsegu od 1-5 %; f. prosejavanje osušenog granulata kroz sito sa veličinom otvora od najmanje 0.6 mm; g. dodavanje lubrikansa granulatu radi finalnog mješanja.
17. Postupak prema zahtjevu 16, koji dalje sadrži h. komprimovanje finalne smješe u jezgra tableta; i. pripremanje suspenzije za oblaganje; j. prevlačenje jezgra tableta sa suspenzijom za oblaganje do dobijanja težine od oko 2-4 % radi dobijanja film tableta.
18. Postupak prema zahtjevu 16, pri čemu se dio ekscipijenasa dodaje ekstragranularno pre finalnog mješanja u koraku g.
19. Postupak prema zahtjevu 16, pri čemu se granulat dobijen u koracima a-e dobija u jednokomornom procesu granulacije sa visokim smicanjem i pratećim sušenjem u jednokomornom granulatoru.
20. Kompozicija prema zahtjevu 1 ili postupak prema zahtjevu 16, pri čemu je DPP IV inhibitor izabran između sledećih: • 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]naftiridin-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-aminopropil)- 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, • 1-[(4,6-dimetil-pirimidin-2-il)metil]-3-metil-7-(2-butin-1-il)-8-((R)-3-amino-piperidin-1-il)- ksantin, • 1-[(hinoksalin-6-il)metil]-3-metil-7-(2-butin-1-il)-8-((R)-3-amino-piperidin-1-il)-ksantin, i njegova so.
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