Patent ID: 6663888
Filing Date: 2003-12-16
Classification: A61K,Y10S

Abstract:
A histamine H2 antagonist pharmaceutical dosage form providing a bi-modal pulsatile release profile comprising:a. immediate release (IR) beads comprising an active-containing core particle; and b. timed pulsatile release (TPR) beads, wherein said TPR beads comprise: i. an active-containing core particle; and ii. a pulse coating comprising a water insoluble polymer and an enteric polymer surrounding said core, said timed pulsatile release (TPR) beads when tested in a USP Type II apparatus at 50 rpm using a 2-stage dissolution medium (first 2 hours in 700 ml 0.1 N HCl at 37Â° C. followed by a dissolution in a pH of 6.8 obtained by the addition of 200 ml of pH modifier) exhibit a dissolution profile substantially corresponding to the following pattern: after 2 hours, 0-25% of the total active is released; after 3 hours, 15-80% of the total active is released; and after 4 hours, not less than 60% of the total active is released, wherein said IR beads provide a therapeutically effective amount of active to treat gastric acid secretions and the TPR beads provide a delayed dose of active which provides a therapeutically effective amount of active to treat midnight GERD.