CONTROLLED RELEASE DOSAGE FORMS
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.