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Claims for Patent: 9,155,705

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Claims for Patent: 9,155,705

Title:DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Abstract: The present invention relates to pharmaceutical compositions comprising fixed dose combinations of a DPP-4 inhibitor drug and a partner drug, processes for the preparation thereof, and their use to treat certain diseases.
Inventor(s): Friedl; Thomas (Ochsenhausen, DE), Braun; Michael (Wullenstetten, DE), Egusa; Kenji (Osaka, JP), Fujita; Hikaru (Osaka, JP), Maruyama; Megumi (Hyogo, JP), Nishioka; Takaaki (Kobe, JP)
Assignee: Boehringer Ingelheim International GmbH (Ingelheim am Rhein, DE)
Application Number:12/935,634
Patent Claims: 1. A solid pharmaceutical composition comprising or made from: (a) 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-a- mino-piperidin-1-yl)-xanthine in a dosage range from about 0.5 mg to about 10 mg, (b) metformin hydrochloride, (c) a pharmaceutical excipient, and (d) about 1 mg to 50 mg of L-arginine.

2. The pharmaceutical composition according to claim 1, wherein the 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-a- mino-piperidin-1-yl)-xanthine is present in a dosage strength of 0.5, 1, 2.5, 5, or 10 mg.

3. The pharmaceutical composition according to claim 1, wherein the 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-a- mino-piperidin-1-yl)-xanthine is present in a dosage strength of 2.5 mg.

4. The pharmaceutical composition according to claim 1, wherein metformin hydrochloride is present in a dosage range from about 100 mg to about 1500 mg.

5. The pharmaceutical composition according to claim 1, wherein metformin hydrochloride is present in a dosage strength of 250, 500, 625, 750, 850, or 1000 mg.

6. The pharmaceutical composition according to claim 1, wherein metformin hydrochloride is present in a dosage strength of 500 mg, 850 mg, or 1000 mg.

7. The pharmaceutical composition according to claim 1, wherein the 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-a- mino-piperidin-1-yl)-xanthine and L-arginine are present in a weight ratio from about 1:20 to about 10:1.

8. The pharmaceutical composition according to claim 1, wherein the excipient is selected from the group consisting of one or more fillers; a binder; a lubricant; and a glidant.

9. The pharmaceutical composition according to claim 1, comprising copovidone as binder.

10. The pharmaceutical composition according to claim 9, further comprising corn starch, magnesium stearate, or colloidal anhydrous silica.

11. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition is a tablet selected from a mono-layer tablet, a bi-layer tablet, a press-coated tablet, and a tablet which is film-coated for drug-loading.

12. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition is a tablet comprising a film-coat.

13. A solid pharmaceutical composition comprising or made from 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-a- mino-piperidin-1-yl)-xanthine in a dosage range from about 0.5 mg to about 10 mg, metformin hydrochloride, about 1 mg to 50 mg of L-arginine, a filler, a binder, a glidant, and a lubricant.

14. The pharmaceutical composition according to claim 1, wherein 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-a- mino-piperidin-1-yl)-xanthine has a particle size distribution of X90<200 .mu.m.

15. A pharmaceutical composition according to claim 1 made by a process comprising incorporating the active ingredients and about 1 mg to 50 mg of L-arginine in a pharmaceutical excipient selected from D-mannitol, corn starch, pregelatinized starch, copovidone, magnesium stearate, and colloidal anhydrous silica.

16. The pharmaceutical composition according to claim 1, wherein the pharmaceutical excipient comprises a filler.

17. The pharmaceutical composition according to claim 1, wherein the pharmaceutical excipient comprises a filler and a binder.

18. The pharmaceutical composition according to claim 1, wherein the pharmaceutical excipient comprises a filler, a binder, and a lubricant.

19. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition is a tablet comprising or made from: (a) 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-a- mino-piperidin-1-yl)-xanthine in a dosage range from about 0.5 mg to about 10 mg, (b) metformin hydrochloride, (c) a pharmaceutical excipient, and (d) about 1 mg to 50 mg of L-arginine.

20. The pharmaceutical composition according to claim 19, wherein the pharmaceutical excipient comprises a filler.

21. The pharmaceutical composition according to claim 19, wherein the pharmaceutical excipient comprises a filler and a binder.

22. The pharmaceutical composition according to claim 19, wherein the pharmaceutical excipient comprises a filler, a binder, and lubricant.

23. The pharmaceutical composition according to claim 19, wherein the pharmaceutical excipient comprises a filler, a binder, a lubricant, and a glidant.

24. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition is a tablet comprising or made from: (a) 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-a- mino-piperidin-1-yl)-xanthine in a dosage range from about 0.5 mg to about 10 mg, (b) metformin hydrochloride, (c) a pharmaceutical excipient comprising corn starch, copovidone, magnesium stearate, and colloidal anhydrous silica, and (d) about 1 mg to 50 mg of L-arginine.

25. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition is a tablet comprising or made from: (a) 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-a- mino-piperidin-1-yl)-xanthine in a dosage of about 2.5 mg, (b) about 0.5 mg to about 10 mg of metformin hydrochloride, (c) a pharmaceutical excipient, and (d) about 1 mg to about 25 mg of L-arginine.
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