Claims for Patent: 12,178,819

Summary for Patent: 12,178,819

Title:	DPP IV inhibitor formulations
Abstract:	The present invention relates to pharmaceutical compositions of DPP IV inhibitors with an amino group, their preparation and their use to treat diabetes mellitus.
Inventor(s):	Anja Kohlrausch, Patrick Romer, Gerd Seiffert
Assignee:	Boehringer Ingelheim International GmbH
Application Number:	US17/319,325
Patent Claims:	1. A pharmaceutical composition comprising as an active ingredient a DPP IV inhibitor compound of formula in an amount of 5 mg, or a salt thereof, a first diluent, a second diluent, a binder, a disintegrant and a lubricant, wherein the first diluent is mannitol and the second diluent is pregelatinized starch wherein the pharmaceutical composition comprises: 0.5-20% by weight of active ingredient 40-88% by weight of first diluent, 3-40% by weight of second diluent, 1-5% by weight of binder, 5-15% by weight of disintegrant, and 0.1-4% by weight of lubricant. 2. The pharmaceutical composition of claim 1, wherein the lubricant is talc, polyethylene glycol, calcium behenate, calcium stearate, hydrogenated castor oil, or magnesium stearate. 3. The pharmaceutical composition of claim 1, wherein the binder is copovidone, hydroxypropyl methylcellulose (HPMC), hydroxypropylcellulose (HPC), or polyvinylpyrrolidone (Povidone). 4. The pharmaceutical composition of claim 1, wherein the disintegrant is corn starch. 5. The pharmaceutical composition of claim 1, wherein the first diluent is mannitol, the second diluent is pregelatinized starch, the binder is copovidone, the disintegrant is corn starch, and the lubricant is magnesium stearate. 6. The pharmaceutical composition of claim 1 further comprising an additional disintegrant. 7. The pharmaceutical composition of claim 6, wherein the additional disintegrant is crospovidone. 8. The pharmaceutical composition of claim 1 further comprising a glidant. 9. The pharmaceutical composition of claim 8, wherein the glidant is colloidal silicon dioxide. 10. The pharmaceutical composition of claim 1 comprising 0.5-7% active ingredient 50-75% diluent 1, 5-15% diluent 2, 2-4% binder, 8-12% disintegrant, and 0.5-2% lubricant. 11. The pharmaceutical composition according to claim 1 in the dosage form of a capsule, a tablet, or a film-coated tablet. 12. The pharmaceutical composition of claim 11 comprising 2-4% film coat. 13. The pharmaceutical composition of claim 11, wherein the film coat comprises a film-forming agent, a plasticizer, a glidant and optionally one or more pigments. 14. The pharmaceutical composition of claim 13, wherein the film coat comprises hydroxypropylmethylcellulose (HPMC), polyethylene glycol (PEG), talc, titanium dioxide and iron oxide. 15. The pharmaceutical composition of claim 1, wherein the binder is copovidone, hydroxypropyl methylcellulose (HPMC), hydroxypropylcellulose (HPC), polyvinylpyrrolidon (povidone), pregelatinized starch, or low-substituted hydroxypropylcellulose (L-HPC). 16. The pharmaceutical composition of claim 1, wherein the disintegrant is corn starch, crospovidone, low-substituted hydroxypropylcellulose (L-HPC), or pregelatinized starch. 17. The pharmaceutical composition of claim 1, wherein the lubricant is talc, polyethyleneglycol, calcium behenate, calcium stearate, hydrogenated castor oil, or magnesium stearate. 18. The pharmaceutical composition of claim 1, wherein the binder is copovidone, hydroxypropyl methylcellulose (HPMC), hydroxypropylcellulose (HPC), polyvinylpyrrolidon (povidone), pregelatinized starch, or low-substituted hydroxypropylcellulose (L-HPC); the disintegrant is corn starch, crospovidone, low-substituted hydroxypropylcellulose (L-HPC), or pregelatinized starch; and lubricant is talc, polyethyleneglycol, calcium behenate, calcium stearate, hydrogenated castor oil, or magnesium stearate. 19. The pharmaceutical composition of claim 1, wherein the DPP IV inhibitor compound is present in an amount 0.5-7.0% based on the total weight of DPP IV inhibitor, first diluent, second diluent, binder, disintegrant and lubricant. 20. The pharmaceutical composition of claim 1, in the dosage form of a tablet, or a film-coated tablet.