Controlled release dosage forms

Abstract

The invention provides stable controlled release monolithic coating compositions for use in coating pharmaceutical oral dosage forms comprising a polyglycol having a melting point greater than 55° C. and an aqueous dispersion of a neutral ester copolymer lacking functional groups.

1 . A controlled release oral dosage form comprising:
 a. an immediate release core, comprising about 1000 mg of metformin hydrochloride; and   b. a controlled release coating surrounding said core, wherein said dosage form provides a T max  of said metformin hydrochloride of from about 6 hours to about 12 hours after administration to a patient.   
     
     
         2 . The controlled release oral dosage form according to  claim 1 , wherein said T max  is about 9 hours. 
     
     
         3 . A controlled release oral dosage form comprising:
 a. an immediate release core, comprising about 1000 mg of metformin hydrochloride; and   b. a controlled release coating surrounding said core, wherein said dosage form provides a C max  of said metformin hydrochloride of about 1252±321 ng/mL after administration to a patient.   
     
     
         4 . The controlled release oral dosage form according to  claim 3 , wherein said C max  is about 1210 ng/mL. 
     
     
         5 . A controlled release oral dosage form comprising:
 a. an immediate release core, comprising about 1000 mg of metformin hydrochloride; and   b. a controlled release coating surrounding said core, wherein said dosage form provides a AUC(0 to t) of said metformin hydrochloride of about 11644±2808 (ng)(hr)/mL after administration to a patient.   
     
     
         6 . The controlled release oral dosage form according to  claim 5 , wherein said AUC(0 to t) is about 11313 (ng)(hr)/mL. 
     
     
         7 . A controlled release oral dosage form comprising:
 a. an immediate release core, comprising about 1000 mg of metformin hydrochloride; and   b. a controlled release coating surrounding said core, wherein said dosage form provides a AUC(0 to infiniti) of said metformin hydrochloride of about 11812±2822 (ng)(hr)/mL after administration to a patient.   
     
     
         8 . The controlled release oral dosage form according to  claim 7 , wherein said AUC(0 to infiniti) is about 11482 (ng)(hr)/mL. 
     
     
         9 . The controlled release oral dosage form according to  claim 1 , wherein said dosage form further provides a C max  of said metformin hydrochloride of about 1252±321 ng/mL. 
     
     
         10 . The controlled release oral dosage form according to  claim 1 , wherein said dosage form further provides an AUC(0 to t) of said metformin hydrochloride of about 11644±2808 (ng)(hr)/mL. 
     
     
         11 . The controlled release oral dosage form according to  claim 1 , wherein said dosage form further provides an AUC(0 to infiniti) of said metformin hydrochloride of about 11812±2822 (ng)(hr)/mL. 
     
     
         12 . The controlled release oral dosage form according to  claim 1 , wherein said dosage form further provides a C max  of said metformin of about 1252±321 ng/mL and an AUC(0 to t) of said metformin hydrochloride of about 11644±2808 (ng)(hr)/mL. 
     
     
         13 . The controlled release oral dosage form according to  claim 1 , wherein said dosage form further provides a C max  of said metformin of about 1252±321 ng/mL and an AUC(0 to infiniti) of said metformin of about 11812±2822 (ng)(hr)/mL.