Timed, sustained release systems for propranolol
First Claim
1. A method for the treatment of hypertension comprising administering to a patient in need thereof a pharmaceutical formulation comprising:
- a) a core particle comprising propranolol or a pharmaceutically acceptable salt thereof;
b) a first layer disposed over the core particle comprising a first water insoluble polymer; and
c) a second layer disposed over the first layer comprising a mixture of a second water insoluble polymer and an enteric polymer, wherein the second layer provides a lag time in propranolol blood plasma concentration of from about 2 to about 6 hours;
wherein the pharmaceutical formulation comprises about 80 mg, about 120 mg, or about 160 mg of propranolol or a pharmaceutically acceptable salt thereof, andwherein the pharmaceutical formulation provides a maximum blood plasma concentration (Cmax) between about 10 and about 14 hours following administration.
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Accused Products
Abstract
A unit dosage form, such as a capsule or the like for delivering drugs into the body in a circadian release fashion, is comprising of one or more populations of propranolol-containing particles (beads, pellets, granules, etc.). Each bead population exhibits a pre-designed rapid or sustained release profile with or without a predetermined lag time of 3 to 5 hours. Such a circadian rhythm release cardiovascular drug delivery system is designed to provide a plasma concentration—time profile, which varies according to physiological need during the day, i.e., mimicking the circadian rhythm and severity/manifestation of a cardiovascular disease, predicted based on pharmaco-kinetic and pharmaco-dynamic considerations and in vitro/in vivo correlations.
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Citations
12 Claims
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1. A method for the treatment of hypertension comprising administering to a patient in need thereof a pharmaceutical formulation comprising:
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a) a core particle comprising propranolol or a pharmaceutically acceptable salt thereof; b) a first layer disposed over the core particle comprising a first water insoluble polymer; and c) a second layer disposed over the first layer comprising a mixture of a second water insoluble polymer and an enteric polymer, wherein the second layer provides a lag time in propranolol blood plasma concentration of from about 2 to about 6 hours; wherein the pharmaceutical formulation comprises about 80 mg, about 120 mg, or about 160 mg of propranolol or a pharmaceutically acceptable salt thereof, and wherein the pharmaceutical formulation provides a maximum blood plasma concentration (Cmax) between about 10 and about 14 hours following administration. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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Specification