Dissolution properties of drug products containing olmesartan medoxomil

Abstract

A pharmaceutical tablet containing olmesartan medoxomil and amlodipine besylate, which has improved dissolvability. The composition contains (A) olmesartan medoxomil and (B) amlodipine besylate as active ingredients and (C) a calcium-containing additive. A method for treating or preventing hypertension by administering the pharmaceutical tablet to a patient.

1 . A pharmaceutical tablet prepared from a pharmaceutical composition consisting of (A) olmesartan medoxomil and (B) amlodipine besylate as the only active drug ingredients and (C) one or more pharmaceutically acceptable calcium-containing excipients selected from the group consisting of carmellose calcium, calcium silicate, calcium carbonate, calcium ascorbate and calcium chloride, and said calcium-containing excipient in said pharmaceutical composition is in an amount of from 5 to 20 weight percent of said pharmaceutical composition, and wherein said tablet is prepared by direct tableting. 
     
     
         2 . The pharmaceutical tablet according to  claim 1 , wherein said calcium-containing excipient is carmellose calcium. 
     
     
         3 . The pharmaceutical tablet according to  claim 1  which is coated. 
     
     
         4 . The pharmaceutical tablet according to  claim 3 , wherein said calcium-containing excipient is included in the coating. 
     
     
         5 . The pharmaceutical tablet according to  claim 1 , wherein said calcium-containing excipient in said pharmaceutical composition is in an amount of 10 weight percent of said pharmaceutical composition. 
     
     
         6 . The pharmaceutical tablet according to  claim 2 , wherein said calcium-containing excipient in said pharmaceutical composition is in an amount of 10 weight percent of said pharmaceutical composition. 
     
     
         7 . The pharmaceutical tablet according to  claim 1 , wherein olmesartan medoxomil is in an amount of 10 to 40 mg and amlodipine besylate is in an amount of 5 to 10 mg based on a free form base. 
     
     
         8 . The pharmaceutical tablet according to  claim 1 , wherein the calcium-containing excipient is calcium ascorbate. 
     
     
         9 . The pharmaceutical tablet according to  claim 1 , wherein the calcium-containing excipient is calcium chloride. 
     
     
         10 . A method for treating or preventing hypertension comprising administering the pharmaceutical tablet according to  claim 1  to a patient. 
     
     
         11 . A method for treating or preventing hypertension comprising administering the pharmaceutical tablet according to  claim 2  to a patient. 
     
     
         12 . A method for treating or preventing hypertension comprising administering the pharmaceutical tablet according to  claim 3  to a patient. 
     
     
         13 . A method for treating or preventing hypertension comprising administering the pharmaceutical tablet according to  claim 4  to a patient. 
     
     
         14 . A method for treating or preventing hypertension comprising administering the pharmaceutical tablet according to  claim 5  to a patient. 
     
     
         15 . A method for treating or preventing hypertension comprising administering the pharmaceutical tablet according to  claim 6  to a patient. 
     
     
         16 . A method for treating or preventing hypertension comprising administering the pharmaceutical tablet according to  claim 7  to a patient. 
     
     
         17 . A method for treating or preventing hypertension comprising administering the pharmaceutical tablet according to  claim 8  to a patient. 
     
     
         18 . A method for treating or preventing hypertension comprising administering the pharmaceutical tablet according to  claim 9  to a patient.