Controlled extended drug release technology
First Claim
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1. A formulation, comprising:
- (a) a central compartment containing a homogeneous blend of one or more therapeutic agents, a gas generator and optionally oils, antioxidants and surface active agents;
(b) one or more tableting, extrusion and coating aids;
(c) one or more layers of coat surrounding the central compartment, the coat comprising one or more thermoplastic water insoluble cellulose ethers and esters and one or more acrylic polymers; and
(d) wherein release of therapeutic agent from said formulation is characterized by a dissolution profile in which 0.5% to 50% of the therapeutic agent is released within three hours, and greater than 50% is released in 24 hours; and
wherein the formulation is a hydrodynamically buoyant dosage form.
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Abstract
A controlled extended drug release technology for the controlled extended release of hydrophobic or hydrophilic drugs or therapeutically active agents consisting of a homogeneous blend of one or more therapeutic agents, gas generators and surrounded by one or more layers of coat made of thermoplastic water insoluble cellulose derivatives, acrylic polymers, superdisintegrants and optionally an oil, antioxidants and electrolytes. The technology platform is capable of releasing therapeutic agents via zero, first or pseudo first order release.
226 Citations
19 Claims
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1. A formulation, comprising:
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(a) a central compartment containing a homogeneous blend of one or more therapeutic agents, a gas generator and optionally oils, antioxidants and surface active agents; (b) one or more tableting, extrusion and coating aids; (c) one or more layers of coat surrounding the central compartment, the coat comprising one or more thermoplastic water insoluble cellulose ethers and esters and one or more acrylic polymers; and (d) wherein release of therapeutic agent from said formulation is characterized by a dissolution profile in which 0.5% to 50% of the therapeutic agent is released within three hours, and greater than 50% is released in 24 hours; and wherein the formulation is a hydrodynamically buoyant dosage form. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18)
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19. A formulation, comprising:
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(a) a central compartment containing a homogeneous blend of one or more therapeutic agents, a gas generator and optionally oils, antioxidants and surface active agents; (b) a coat surrounding the central compartment, comprising one or more thermoplastic water insoluble cellulose ethers and esters and one or more acrylic polymers and a superdisintegrant; and (c) a loading dose top coat comprising a loading dose of a therapeutic agent; wherein release of therapeutic agent from said formulation is characterized by a dissolution profile in which 0.5% to 50% of the therapeutic agent is released within three hours, and greater than 50% is released in 24 hours; and wherein the formulation is a hydrodynamically buoyant dosage form.
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Specification