DK2395984T3 - Farmaceutisk sammensætning omfattende linagliptin og en sglt2-inhibitor og anvendelse deraf - Google Patents
Farmaceutisk sammensætning omfattende linagliptin og en sglt2-inhibitor og anvendelse deraf Download PDFInfo
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- DK2395984T3 DK2395984T3 DK10703474.6T DK10703474T DK2395984T3 DK 2395984 T3 DK2395984 T3 DK 2395984T3 DK 10703474 T DK10703474 T DK 10703474T DK 2395984 T3 DK2395984 T3 DK 2395984T3
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Claims (15)
- Γ /Λ I L. IΝ I Γχ ΓΧ ΓΛ V1. Fast farmaceutisk doseringsform omfattende linagliptin, som et første aktivt farmaceutisk indholdsstof i en mængde af 5 mg, og l-chlor-4-(p-D-glucopyranos-l-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzen, som et andet farmaceutisk indholdsstof i en mængde af 10 mg eller 25 mg og én eller flere excipienser, hvor betegnelsen "linagliptin" som anvendes her, henviser til linagliptin og farmaceutisk acceptable salte deraf, herunder hydrater og solvater deraf og krystalformer deraf og hvor definitionen "l-chlor-4-0-D-glucopyranos-l-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzen" også omfatter hydrater deraf, solvater og polymorfe former deraf.
- 2. Fast farmaceutisk doseringsform ifølge krav 1 omfattende linagliptin, som et første aktivt farmaceutisk indholdsstof i en mængde af 5 mg, og l-chlor-4-0-D-glucopyranos-l-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzen, som et andet farmaceutisk indholdsstof i en mængde af 10 mg.
- 3. Fast farmaceutisk doseringsform ifølge krav 1 omfattende linagliptin, som et første aktivt farmaceutisk indholdsstof i en mængde af 5 mg, og l-chlor-4-(p-D-glucopyranos-l-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzen, som et andet farmaceutisk indholdsstof i en mængde af 25 mg.
- 4. Fast farmaceutisk doseringsform ifølge et hvilket som helst af kravene 1 til 3, hvor det første aktive indholdsstof har en partikelstørrelsesfordeling af X90 < 200 pm.
- 5. Fast farmaceutisk doseringsform ifølge ét eller flere af de foregående krav, hvor det andet aktive indholdsstof har en partikelstørrelsesfordeling af 1 pm < X90 < 200 pm.
- 6. Fast farmaceutisk doseringsform ifølge ét eller flere af de foregående krav, hvor én eller flere excipienser omfatter ét eller flere fortyndingsmidler og ét eller flere bindemidler.
- 7. Fast farmaceutisk doseringsform ifølge ét eller flere af de foregående krav, hvor én eller flere excipienser omfatter ét eller flere fortyndingsmidler, ét eller flere bindemidler og ét eller flere sprængemidler.
- 8. Fast farmaceutisk doseringsform ifølge ét eller flere af de tidligere krav omfattendehvor procentdelen er på vægtbasis af den totale sammensætning.
- 9. Fast farmaceutisk doseringsform ifølge ét eller flere af de foregående krav omfattendehvor procentdelen er på vægtbasis af den totale sammensætning.
- 10. Fast farmaceutisk doseringsform ifølge ét eller flere af de foregående krav, hvor ét eller flere fortyndingsmidler er valgt fra gruppen bestående af cellulose, dibasisk calci-umphosphat, erythritol, mannitol, stivelse, prægelantineret stivelse og xylitol, herunder derivater og hydrater af de førnævnte stoffer.
- 11. Fast farmaceutisk doseringsform ifølge ét eller flere af de foregående krav, hvor ét eller flere bindemidler er valgt fra gruppen bestående af copovidon, hydroxypropylmethyl-cellulose (FIPMC), hydroxypropylcellulose (FIPC), en polyvinylpyrrolidon, prægelatineret stivelse, lav-substitueret hydroxypropylcellulose (L-FIPC), herunder derivater og hydrater af de førnævnte stoffer.
- 12. Fast farmaceutisk doseringsform ifølge ét eller flere af de foregående krav, hvor ét eller flere sprængemidler er valgt fra gruppen bestående af crospovidon, lav-substitueret hydroxypropylcellulose (L-FIPC) og stivelser, såsom naturlige stivelser, i særdeleshed majsstivelse, og prægelatineret stivelse, herunder derivater og hydrater af de førnævnte stoffer.
- 13. Fast farmaceutisk doseringsform ifølge ét eller flere af de foregående krav, hvor ét eller flere smøremidler er valgt fra gruppen bestående af talk, polyethylenglycol, i særdeleshed polyethylenglycol med en molekylvægt i et område fra omkring 4400 til omkring 9000, hydrogeneret ricinusolie, fedtsyrer og salte af fedtsyrer, i særdeleshed calcium-, magnesium-, natrium- eller kaliumsalte deraf, for eksempel calciumbehenat, calciumstearat, na-triumstearylfumarat eller magnesiumstearat.
- 14. Fast farmaceutisk doseringsform ifølge ét eller flere af de foregående krav, k e n detegnet ved, at det er en kapsel, en tablet eller en film-coatet tablet.
- 15. Farmaceutisk doseringsform ifølge ét eller flere af de foregående krav, k e n d e t egnet ved, at det er en et-lags tablet hvor de to aktive farmaceutiske indholdsstoffer er til stede i det ene lag.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US15230609P | 2009-02-13 | 2009-02-13 | |
| PCT/EP2010/051735 WO2010092124A1 (en) | 2009-02-13 | 2010-02-11 | Pharmaceutical composition comprising linagliptin and optionally a sglt2 inhibitor, and uses thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2395984T3 true DK2395984T3 (da) | 2016-12-19 |
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| CL2008003653A1 (es) | 2008-01-17 | 2010-03-05 | Mitsubishi Tanabe Pharma Corp | Uso de un inhibidor de sglt derivado de glucopiranosilo y un inhibidor de dppiv seleccionado para tratar la diabetes; y composicion farmaceutica. |
| UA105362C2 (en) | 2008-04-02 | 2014-05-12 | Бьорингер Ингельхайм Интернациональ Гмбх | 1-heterocyclyl-1, 5-dihydro-pyrazolo [3, 4-d] pyrimidin-4-one derivatives and their use as pde9a modulators |
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| AU2009270936B2 (en) | 2008-07-15 | 2014-12-18 | Theracos, Inc. | Deuterated benzylbenzene derivatives and methods of use |
| BRPI0916997A2 (pt) | 2008-08-06 | 2020-12-15 | Boehringer Ingelheim International Gmbh | Inibidor de dpp-4 e seu uso |
| UY32030A (es) | 2008-08-06 | 2010-03-26 | Boehringer Ingelheim Int | "tratamiento para diabetes en pacientes inapropiados para terapia con metformina" |
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| AR074990A1 (es) | 2009-01-07 | 2011-03-02 | Boehringer Ingelheim Int | Tratamiento de diabetes en pacientes con un control glucemico inadecuado a pesar de la terapia con metformina |
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| KR101921934B1 (ko) * | 2009-02-13 | 2018-11-26 | 베링거 인겔하임 인터내셔날 게엠베하 | 글루코피라노실 디페닐메탄 유도체를 포함하는 약제학적 조성물, 이들의 약제학적 용량형, 이들의 제조방법 및 환자에서의 개선된 당 조절을 위한 이들의 용도 |
| MX2011008416A (es) * | 2009-02-13 | 2011-09-08 | Boehringer Ingelheim Int | Medicaciones antidiabeticas que comprenden un inhibidor de dpp-4 (linagliptina) opcionalmente en combinacion con otros antidiabeticos. |
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| AU2010303123B2 (en) | 2009-09-30 | 2014-02-27 | Boehringer Ingelheim International Gmbh | Method for the preparation of a crystalline form of 1-chloro-4- (Beta-D-glucopyranos-1-yl)-2-(4-((S)-tetrahydrofuran-3-yloxy)benzyl)benzene |
| IN2012DN02751A (da) | 2009-09-30 | 2015-09-18 | Boehringer Ingelheim Int | |
| US10610489B2 (en) * | 2009-10-02 | 2020-04-07 | Boehringer Ingelheim International Gmbh | Pharmaceutical composition, pharmaceutical dosage form, process for their preparation, methods for treating and uses thereof |
| KR102668834B1 (ko) | 2009-11-27 | 2024-05-24 | 베링거 인겔하임 인터내셔날 게엠베하 | 리나글립틴과 같은 ｄｐｐ－ｉｖ 억제제를 사용한 유전자형 검사된 당뇨병 환자의 치료 |
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