Patent ID: 7067151

Claim:
A long lag pellet suitable for use in a once-a-day diltiazem formulation comprising a core and a coating layer sufficiently enveloping the core, wherein 1) the core comprises an effective amount of diltiazem or a pharmaceutically acceptable salt and is substantially free of organic acid; and 2) the long lag pellet substantially exhibits the following dissolution profile when measured according to U.S. Pharmacopoeia XXII in a type 2 dissolution apparatus at 37° C. in 0.1N HCl at 100 rpm; a) 0 to 10% of the diltiazem is released after 2 hours; b) 0 to 10% of the diltiazem is released after 4 hours; c) 0 to 15% of the diltiazem is released after 6 hours; d) 0 to 15% of the diltiazem is released after 8 hours; e) 4.5% to 24.5% of the diltiazem is released after 14 hours; f) 41% to 61% of the diltiazem is released after 16 hours; and g) more than 60% of the diltiazem is released after 18 hours.