Claims for Patent: 12,059,424
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Summary for Patent: 12,059,424
| Title: | Pharmaceutical compositions comprising (2S)-N-{(1S)-1-cyano-2-[4-(3-methyl-2-oxo-2,3-dihydro-1,3-benzoxazol-5-yl)phenyl]ethyl}-1,4-oxazepane-2-carboxamide |
| Abstract: | The present disclosure relates to pharmaceutical compositions suitable for oral administration, and more particularly to pharmaceutical compositions, including pharmaceutical tablet compositions, containing (2S)-N-{(1S)-1-cyano-2-[4-(3-methyl-2-oxo-2,3-dihydro-1,3-benzoxazol-5-yl)phenyl]ethyl}-1,4-oxazepane-2-carboxamide (Compound A) or a pharmaceutically acceptable salt thereof. |
| Inventor(s): | Håkan Wikström, Jufang Wu LUDVIGSSON, Thomas Andersson |
| Assignee: | AstraZeneca AB |
| Application Number: | US16/975,292 |
| Patent Claims: |
1. A pharmaceutical composition comprising: (a) from about 3 wt % to about 10 wt % of (2S)-N-{(1S)-1-cyano-2-[4-(3-methyl-2-oxo-2,3-dihydro-1,3-benzoxazol-5-yl)phenyl] ethyl}-1,4-oxazepane-2-carboxamide (Compound A); (b) from about 55 wt % to about 70 wt % microcrystalline cellulose, acting as a pharmaceutical diluent; (c) from about 18 wt % to about 22 wt % dibasic calcium phosphate dihydrate, acting as a compression aid; (d) from about 3.5 wt % to about 4.5 wt % sodium starch glycolate, acting as a pharmaceutical disintegrant; (e) from about 0.05 wt % to about 0.25 wt % silicon dioxide, acting as a pharmaceutical glidant; (f) from about 2.5 wt % to about 4.5 wt % glycerol behenate, acting as a pharmaceutical lubricant; and wherein the weights of the components (a)-(f) add up to 100 wt %. 2. The pharmaceutical composition of claim 1, wherein the composition is in tablet form. 3. The pharmaceutical composition of claim 2, wherein the composition further comprises a tablet coat. 4. The pharmaceutical composition of claim 1, wherein Compound (A) is present at from about 5 mg to about 50 mg in the composition. 5. The pharmaceutical composition of claim 1, wherein Compound (A) is present at from about 10 mg to about 40 mg in the composition. 6. The pharmaceutical composition of claim 1, wherein Compound (A) is present at 10 mg in the composition. 7. The pharmaceutical composition of claim 1, wherein Compound (A) is present at 25 mg in the composition. 8. The pharmaceutical composition of claim 1, wherein Compound (A) is present at 40 mg in the composition. |
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