Propranolol formulations

1 . A composition comprising:

a core comprising a pharmaceutically acceptable propranolol salt disposed on a sugar sphere; and

a coating disposed on the core, the coating comprising about 70:30 to about 85:15 of ethylcellulose:polyvinylpyrrolidone.

2 . The composition of claim 1 , wherein the sugar sphere has a diameter of about 500 to about 710 micrometers.

3 . The composition of claim 1 , wherein the coating comprises 10 wt % to about 17 wt % of the total weight of the coated cores.

4 . The composition of claim 1 , wherein the coating comprises about 12 wt % to about 15 wt % of the total weight of the coated cores.

5 . The composition of claim 1 , wherein the coating comprises ethylcellulose having a viscosity of 5 cps to about 20 cps at 20° C. and polyvinylpyrrolidone having a viscosity of about 5.5 to 8.5 cps at 20° C.

6 . The composition of claim 1 , exhibiting a dissolution profile in a pH 6.8 medium such that:

less than 10 wt % of the propranolol is released at 1 hour;

44 wt % to 64 wt % of the propranolol is released at 6 hours; and

greater than 80 wt % of the propranolol is released at 15 hours.

7 . The composition of claim 1 , exhibiting a dissolution profile in 0.1 M HCl such that:

less than 10 wt % of the propranolol is released at 1 hour;

40 wt % to 60 wt % of the propranolol is released at 6 hours; and

greater than 80 wt % of the propranolol is released at 15 hours.

8 . The composition of claim 1 , wherein the coated core comprises no added organic acid.

9 . A dosage form comprising:

a core comprising a pharmaceutically acceptable propranolol salt disposed on a sugar sphere; and

a coating disposed on the core, the coating comprising polyvinylpyrrolidone and ethylcellulose;

wherein the dosage form comprises one type of controlled-release coated core; and

wherein the average C max of the dosage form is about 120 ng/mL to about 250 ng/mL and the average AUC 0-∞ of the dosage form is about 3000 ng hr/mL to about 4000 ng hr/mL when measured under fasting conditions, or

wherein the average C max of the dosage form is about 80 ng/mL to about 200 ng/mL and the average AUC 0-∞ of the dosage form is about 1600 ng hr/mL to about 4375 ng hr/mL when measure under fed conditions.

10 . The dosage form of claim 9 , wherein the coating comprises about 70:30 to about 85:15 of ethylcellulose:polyvinylpyrrolidone.

11 . The dosage form of claim 9 , wherein the coating comprises about 75:25 to about 80:20 of ethylcellulose:polyvinylpyrrolidone.

12 . The dosage form of claim 9 , wherein the ethylcellulose has a viscosity of 5 cps to about 20 cps at 20° C. and the polyvinylpyrrolidone has a viscosity of about 5.5 to 8.5 cps at 20° C.

13 . The dosage form of claim 9 , exhibiting a dissolution profile in a pH 6.8 medium such that:

less than 10 wt % of the propranolol is released at 1 hour;

44 wt % to 64 wt % of the propranolol is released at 6 hours; and

greater than 80 wt % of the propranolol is released at 15 hours.

14 . The dosage form of claim 9 , exhibiting a dissolution profile in 0.1 M HCl such that:

less than 10 wt % of the propranolol is released at 1 hour;

40 wt % to 60 wt % of the propranolol is released at 6 hours; and

greater than 80 wt % of the propranolol is released at 15 hours.

15 . The dosage form of claim 9 , wherein the coated core comprises no added organic acid.

16 . The dosage form of claim 9 , wherein the dosage form comprises a capsule.

17 . A method of treating a human, comprising administering a pharmaceutically effective amount of the dosage forms of claim 9 to a human in need of treatment for angina, cardiac arrhythmia, or hypertension.

18 . The method of claim 17 , wherein the coating comprises about 70:30 to about 85:15 of ethylcellulose:polyvinylpyrrolidone.

19 . The method of claim 17 , wherein the coated core comprises no added organic acid.

20 . The method of claim 17 , wherein the dosage form comprises a capsule.