×

Timed, pulsatile release systems

  • US 10,500,161 B2
  • Filed: 07/17/2018
  • Issued: 12/10/2019
  • Est. Priority Date: 05/02/2005
  • Status: Active Grant
First Claim
Patent Images

1. A multiparticulate drug delivery formulation comprising a first and a second population of timed, pulsatile release (TPR) beads, wherein at least one of the first and the second population of TPR beads comprises:

  • i. a core particle comprising an active pharmaceutical ingredient or a pharmaceutically acceptable salt thereof; and

    ii. an outer lag-time coating comprising a water-insoluble polymer in combination with at least one enteric polymer,wherein;

    the first population of TPR beads provides a lag time of at least about 3 hours before onset of drug release and the second population of TPR beads provides a lag time of at least about 6 hours before onset of drug release,when tested for dissolution using Apparatus 1 (Baskets@ 100 rpm) or 2 (Paddles @ 50 rpm) and a two-stage dissolution medium (first two hours in 700 mL of 0.1 N HCl and thereafter in 900 mL of phosphate buffer at pH 6.8).

View all claims
  • 3 Assignments
Timeline View
Assignment View
    ×
    ×