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Claims for Patent: 7,851,502

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Claims for Patent: 7,851,502

Title:Pharmaceutical formulations containing an SGLT2 inhibitor
Abstract: Pharmaceutical formulations are provided which are in the form of capsules or tablets for oral use and which include a medicament dapagliflozin or its propylene glycol hydrate ##STR00001## and a pharmaceutical acceptable carrier therefor, which formulation is designed for immediate release.
Inventor(s): Bindra; Dilbir S. (New Brunswick, NJ), Dali; Mandar V. (New Brunswick, NJ), Parab; Prakash V. (New Brunswick, NJ), Patel; Jatin M. (New Brunswick, NJ), Tao; Li (New Brunswick, NJ), Tejwani; Ravindra W. (New Brunswick, NJ), Vatsaraj; Nipa (New Brunswick, NJ), Wu; Yongmei (New Brunswick, NJ)
Assignee: Bristol-Myers Squibb Company (Princeton, NJ)
Application Number:12/053,442
Patent Claims: 1. A pharmaceutical formulation comprising: a) dapagliflozin propylene glycol hydrate, wherein the dapagliflozin propylene glycol hydrate is present in an amount within the range of from about 0.1% to about 15% by weight of tablet or capsule fill; b) microcrystalline cellulose, wherein the microcrystalline cellulose is present in an amount sufficient to make the total weight of the tablet or capsule fill 100%; c) lactose, wherein the lactose is present in an amount within the range of from about 10% to about 30% by weight of tablet or capsule fill; d) crospovidone, wherein the crospovidone is present in an amount within the range of from about 3% to about 10% by weight of tablet or capsule fill; e) silicon dioxide, wherein the silicon dioxide is present in an amount within the range of from about 0.5% to about 4% by weight of tablet or capsule fill; and f) magnesium stearate, wherein the magnesium stearate is present in an amount within the range of from about 0.5% to about 2% by weight of tablet or capsule fill; wherein the pharmaceutical formulation is in a form selected from the group consisting of a tablet, a stock granulation, and a capsule and wherein the pharmaceutical formulation is an immediate release formulation.

2. The formulation as defined in claim 1, wherein said formulation is in the form of a 1.0 mg tablet comprising: a) dapagliflozin propylene glycol hydrate, wherein the dapagliflozin propylene glycol hydrate is present in an amount of 1.23 mg; b) microcrystalline cellulose, wherein the microcrystalline cellulose is present in an amount of about 50 mg to about 90 mg; c) lactose, wherein the lactose is present in an amount of about 10 mg to about 30 mg; d) crospovidone, wherein the crospovidone is present in an amount of about 2 mg to about 10 mg; e) silicon dioxide, wherein the silicon dioxide is present in an amount of about 0.5 mg to about 4.0 mg; f) magnesium stearate, wherein the magnesium stearate is present in an amount of about 0.5 mg to about 2.0 mg; and g) an antioxidant and/or chelating agent, wherein the antioxidant and/or chelating agent is present in an amount of about 0 mg to about 0.5 mg.

3. The formulation as defined in claim 1, wherein said formulation is in the form of a 2.5 mg tablet comprising: a) dapagliflozin propylene glycol hydrate, wherein the dapagliflozin propylene glycol hydrate is present in an amount of 3.075 mg; b) microcrystalline cellulose, wherein the microcrystalline cellulose is present in an amount of about 60 mg to about 115 mg; c) lactose, wherein the lactose is present in an amount of about 12.5 mg to about 38 mg; d) crospovidone, wherein the crospovidone is present in an amount of about 2.5 mg to about 13 mg; e) silicon dioxide, wherein the silicon dioxide is present in an amount of about 0.6 mg to about 5.0 mg; f) magnesium stearate, wherein the magnesium stearate is present in an amount of about 0.6 mg to about 2.5 mg; and g) an antioxidant and/or chelating agent, wherein the antioxidant and/or chelating agent is present in an amount of about 0 mg to about 0.6 mg.

4. The formulation as defined in claim 1, wherein said formulation is in the form of a 5.0 mg tablet comprising: a) dapagliflozin propylene glycol hydrate, wherein the dapagliflozin propylene glycol hydrate is present in an amount of 6.15 mg; b) microcrystalline cellulose, wherein the microcrystalline cellulose is present in an amount of about 60 mg to about 115 mg; c) lactose, wherein the lactose is present in an amount of about 12.5 mg to about 38 mg; d) crospovidone, wherein the crospovidone is present in an amount of about 2.5 mg to about 13 mg; e) silicon dioxide, wherein the silicon dioxide is present in an amount of about 0.6 mg to about 5.0 mg; f) magnesium stearate, wherein the magnesium stearate is present in an amount of about 0.6 mg to about 2.5 mg; and g) an antioxidant and/or chelating agent, wherein the antioxidant and/or chelating agent is present in an amount of about 0 mg to about 0.6 mg.

5. The formulation as defined in claim 1, wherein said formulation is in the form of a 10 mg tablet comprising: a) dapagliflozin propylene glycol hydrate, wherein the dapagliflozin propylene glycol hydrate is present in an amount of 12.3 mg; b) microcrystalline cellulose, wherein the microcrystalline cellulose is present in an amount of about 120 mg to about 230 mg; c) lactose, wherein the lactose is present in an amount of about 25 mg to about 75 mg; d) crospovidone, wherein the crospovidone is present in an amount of about 5 mg to about 25 mg; e) silicon dioxide, wherein the silicon dioxide is present in an amount of about 1.0 mg to about 10 mg; f) magnesium stearate, wherein the magnesium stearate is present in an amount of about 1.0 mg to about 5 mg; and g) an antioxidant and/or chelating agent, wherein the antioxidant and/or chelating agent is present in an amount of about 0 mg to about 1.25 mg.

6. The pharmaceutical formulation as in any one of claims 1-5, wherein the dapagliflozin propylene glycol hydrate is ##STR00018##
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