Patent ID: 9480681
Filing Date: 2016-11-01
CPC Classification: A61K,A61P

Claim Text:
1. A controlled release matrix tablet formulation consisting of: i. a tablet core; and ii. optionally a non-functional or aesthetic coating, wherein the tablet core is a mixture comprising: a. micronized nisoldipine with a mean particle size in the range of about 5 μm to about 25 μm; b. about 1 wt % to about 60 wt % of one or more hydrophilic pH independent release controlling polymers; c. about 0.1 wt % to about 25 wt % of an enteric agent selected from the group consisting of cellulose acetate phthalate, hydroxypropyl cellulose phthalate, hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose acetate succinate, polyvinyl acetate phthalate, acrylic acid polymers and copolymers, methacrylic polymers and copolymers, alginates, alkali-soluble acrylic resins, methacrylate-methacrylic acid copolymers, polyvinyl acetate phthalate, styrol maleic acid copolymers, and combinations thereof; and d. tableting excipients selected from the group consisting of diluents, fillers, binders, surfactants, solubilizers, lubricants, glidants and combinations thereof wherein the controlled release matrix tablet releases about 10% to about 16% of the nisoldipine after two hours, about 16.9% to about 25.4% after 4 hours, and about 48.5% to about 56.2% after 8 hours of in vitro testing using a USP Type II dissolution apparatus operated at 50 rpms and with 900 ml of 0.03 N HCl with 0.5% sodium lauryl sulfate.