Pharmaceutical Composition Containing Glimepiride and Metformin Hydrochloride

Abstract

Pharmaceutical compositions of the active substances glimepiride with metformin or its salts such as hydrochloride, succinate, fumarate, etc. are useful to control blood glucose in patients with type 2 diabetes. To prove the effectiveness of the combination, clinical studies were conducted that demonstrated the existence of not only an additive effect, but also a synergistic effect of the two drugs compared with monotherapy using only one of the drugs used in combination. In consequence, the combination may be used as an effective and safe therapy to control blood glucose in patients with type 2 diabetes, using different proportions of the active substances in combinations suitable for the needs of different patients.

1 - 11 . (canceled) 
     
     
         12 . A solid pharmaceutical composition, comprising a synergistic combination of glimepiride and metformin hydrochloride, wherein the weight ratio of glimepiride and metformin hydrochloride is about 1/250, wherein the combination of glimepiride and metformin hydrochloride reduces blood glucose levels in a patient with type 2 diabetes greater than either glimepiride or metformin hydrochloride alone, and wherein the composition further comprises 18 mg to 36 mg of povidone, 3 mg to 6 mg of magnesium stearate, and 1.8 mg to 3.6 mg of colloidal silicon dioxide. 
     
     
         13 . The solid pharmaceutical composition according to  claim 12 , comprising 1,000 mg metformin hydrochloride and 4 mg glimepiride. 
     
     
         14 . The solid pharmaceutical composition according to  claim 12 , comprising 500 mg metformin hydrochloride and 2 mg glimepiride. 
     
     
         15 . A method of controlling blood glucose levels in a patient with type 2 diabetes, comprising administering the composition of  claim 12  to said patient. 
     
     
         16 . The method according to  claim 15 , comprising administering a composition wherein glimepiride and metformin hydrochloride are present in amounts of 2 mg glimepiride and 500 mg metformin hydrochloride or 4 mg glimepiride and 1,000 mg metformin hydrochloride. 
     
     
         17 . The method according to  claim 15 , comprising administering a composition wherein glimepiride and metformin hydrochloride are present in amounts of 2 mg glimepiride and 500 mg metformin hydrochloride. 
     
     
         18 . The method according to  claim 15 , comprising administering a composition wherein glimepiride and metformin hydrochloride are present in amounts of 4 mg glimepiride and 1,000 mg metformin hydrochloride. 
     
     
         19 . The solid pharmaceutical composition according to  claim 12 , wherein the combination of glimepiride and metformin hydrochloride reduces blood glucose levels in a patient with type 2 diabetes greater than the additive effect of glimepiride and metformin hydrochloride alone. 
     
     
         20 . The method according to  claim 15 , wherein the combination of glimepiride and metformin hydrochloride reduces blood glucose levels in a patient with type 2 diabetes greater than the additive effect of glimepiride and metformin hydrochloride alone. 
     
     
         21 . The solid pharmaceutical composition according to  claim 12 , wherein the combination of glimepiride and metformin hydrochloride reduces glycosylated hemoglobin levels in a patient with type 2 diabetes greater than either glimepiride or metformin hydrochloride alone. 
     
     
         22 . The method according to  claim 15 , wherein the combination of glimepiride and metformin hydrochloride reduces glycosylated hemoglobin levels in a patient with type 2 diabetes greater than either glimepiride or metformin hydrochloride alone. 
     
     
         23 . The solid pharmaceutical composition according to  claim 21 , wherein the combination of glimepiride and metformin hydrochloride reduces glycosylated hemoglobin levels in a patient with type 2 diabetes greater than the additive effect of glimepiride and metformin hydrochloride alone. 
     
     
         24 . The method according to  claim 22 , wherein the combination of glimepiride and metformin hydrochloride reduces glycosylated hemoglobin levels in a patient with type 2 diabetes greater than the additive effect of glimepiride and metformin hydrochloride alone. 
     
     
         25 . The solid pharmaceutical composition according to  claim 12 , further comprising microcrystalline cellulose and croscarmellose sodium. 
     
     
         26 . The solid pharmaceutical composition according to  claim 25 , further comprising opadry clear. 
     
     
         27 . The solid pharmaceutical composition according to  claim 12 , further comprising 18 mg of povidone, 3 mg of magnesium stearate, and 1.8 mg of colloidal silicon dioxide. 
     
     
         28 . The solid pharmaceutical composition according to  claim 12 , further comprising 36 mg of povidone, 6 mg of magnesium stearate, and 3.6 mg of colloidal silicon dioxide. 
     
     
         29 . The solid pharmaceutical composition according to  claim 13 , further comprising 36 mg of povidone, 6 mg of magnesium stearate, and 3.6 mg of colloidal silicon dioxide. 
     
     
         30 . The solid pharmaceutical composition according to  claim 14 , further comprising 18 mg of povidone, 3 mg of magnesium stearate, and 1.8 mg of colloidal silicon dioxide. 
     
     
         31 . The method according to  claim 18 , wherein the composition further comprises 36 mg of povidone, 6 mg of magnesium stearate, and 3.6 mg of colloidal silicon dioxide.