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Claims for Patent: 9,198,925

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Claims for Patent: 9,198,925

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. (Bridgewater, NJ), Parab; Prakash V. (New Brunswick, NJ), Patel; Jatin M. (New Brunswick, NJ), Tao; Li (New Brunswick, NJ), Tejwani; Ravindra W. (Monmouth Junction, NJ), Vatsaraj; Nipa (New Brunswick, NJ), Wu; Yongmei (New Brunswick, NJ)
Assignee: AstraZeneca AB (Sodertalje, SE)
Application Number:14/267,984
Patent Claims: 1. A method for treating or delaying the progression or onset of Type I and Type II diabetes, impaired glucose tolerance, insulin resistance, nephropathy, retinopathy, neuropathy, cataracts, hyperglycemia, hyperinsulinemia, hypercholesterolemia, dyslipidemia, elevated blood levels of free fatty acids or glycerol, hyperlipidemia, hypertriglyceridemia, obesity, wound healing, tissue ischemia, atherosclerosis, hypertension, or Syndrome X (Metabolic Syndrome) comprising administering to a mammalian subject or patient in need of such treatment a therapeutically effective amount of a pharmaceutical formulation comprising dapagliflozin propylene glycol hydrate and a pharmaceutically acceptable carrier, wherein the dapagliflozin propylene glycol hydrate formulation is in a form selected from the group consisting of a tablet, a stock granulation, and a capsule, wherein the dapagliflozin propylene glycol hydrate is present in an amount to provide a daily dose within the range of from about 0.1 to about 750 mg per day in single or divided doses or multiple doses, which is administered 1 to 4 times, and wherein the dapagliflozin propylene glycol hydrate is present in an amount within the range from 0.1-70% of the tablet, stock granulation, or capsule.

2. The method according to claim 1, wherein the dapagliflozin propylene glycol hydrate is ##STR00018##

3. A method for treating or delaying the progression or onset of Type II diabetes comprising administering to a mammalian subject or patient in need of such treatment a therapeutically effective amount of a pharmaceutical formulation comprising dapagliflozin propylene glycol hydrate and a pharmaceutically acceptable carrier, wherein the dapagliflozin propylene glycol hydrate formulation is in a form selected from the group consisting of a tablet, a stock granulation, and a capsule, wherein the dapagliflozin propylene glycol hydrate is present in an amount to provide a daily dose within the range of from about 0.1 to about 750 mg per day in single or divided doses or multiple doses, which is administered 1 to 4 times, and wherein the dapagliflozin propylene glycol hydrate is present in an amount within the range from 0.1-70% of the tablet, stock granulation, or capsule.

4. The method according to claim 3, wherein the dapagliflozin propylene glycol hydrate is ##STR00019##

5. A method for treating or delaying the progression or onset of Type I and Type II diabetes, impaired glucose tolerance, insulin resistance, nephropathy, retinopathy, neuropathy, cataracts, hyperglycemia, hyperinsulinemia, hypercholesterolemia, dyslipidemia, elevated blood levels of free fatty acids or glycerol, hyperlipidemia, hypertriglyceridemia, obesity, wound healing, tissue ischemia, atherosclerosis, hypertension, or Syndrome X (Metabolic Syndrome) comprising administering to a mammalian subject or patient in need of such treatment a therapeutically effective amount of a pharmaceutical formulation comprising dapagliflozin propylene glycol hydrate, a pharmaceutically acceptable carrier and one or more agents selected from the group consisting of anti-diabetic agents, anti-hyperglycemic agents, hypolipidemic or lipid lowering agents, anti-obesity agents, anti-hypertensive agents, and appetite suppressants, wherein the dapagliflozin propylene glycol hydrate formulation is in a form selected from the group consisting of a tablet, a stock granulation, and a capsule, wherein the dapagliflozin propylene glycol hydrate is present in an amount to provide a daily dose within the range of from about 0.1 to about 750 mg per day in single or divided doses or multiple doses, which is administered 1 to 4 times, and wherein the dapagliflozin propylene glycol hydrate is present in an amount within the range from 0.1-70% of the tablet, stock granulation, or capsule.

6. The method according to claim 5, wherein the dapagliflozin propylene glycol hydrate is ##STR00020##

7. A method for treating or delaying the progression or onset of type II diabetes comprising administering to a mammalian subject or patient in need of such treatment a therapeutically effective amount of a pharmaceutical formulation comprising dapagliflozin propylene glycol hydrate, a pharmaceutically acceptable carrier and one or more agents selected from the group consisting of anti-diabetic agents, anti-hyperglycemic agents, hypolipidemic or lipid lowering agents, anti-obesity agents, anti-hypertensive agents, and appetite suppressants, wherein the dapagliflozin propylene glycol hydrate formulation is in a form selected from the group consisting of a tablet, a stock granulation, and a capsule, wherein the dapagliflozin propylene glycol hydrate is present in an amount to provide a daily dose within the range of from about 0.1 to about 750 mg per day in single or divided doses or multiple doses, which is administered 1 to 4 times, and wherein the dapagliflozin propylene glycol hydrate is present in an amount within the range from 0.1-70% of the tablet, stock granulation, or capsule.

8. The method according to claim 7, wherein the dapagliflozin propylene glycol hydrate is ##STR00021##

9. The method of claim 7, wherein the agents(s) is an anti-diabetic agent(s).

10. The method of claim 9, wherein the anti-diabetic agent(s) is selected from the group consisting of a biguanide, a glucosidase inhibitor, an insulin, a meglitinide, a sulfonylurea, a biguanide/glyburide combination, a thiazolidinedione, a PPAR-alpha agonist, a PPAR-gamma agonist, a PPAR alpha/gamma dual agonist, a glycogen phosphorylase inhibitor, an inhibitor of fatty acid binding proteinz, a glucagon-like peptide-1 agonist, and a dipeptidyl peptidase IV inhibitor.

11. The method of claim 10, wherein the anti-diabetic agent(s) is selected from the group consisting of a biguanide, a glucagon-like peptide-1 agonist, and a dipeptidyl peptidase IV inhibitor.

12. The method of claim 11, wherein the anti-diabetic agent(s) is metformin.

13. The method of claim 11, wherein the anti-diabetic agent(s) is saxagliptin.

14. The method of claim 11, wherein the anti-diabetic agents are metformin and saxagliptin.

15. The method of claim 5, wherein the agents(s) is an anti-obesity agent(s).

16. The method of claim 15, wherein the anti-obesity agent(s) is phentermine.
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