Abuse resistant forms of extended release morphine, method of use and method of making
AssigneeOHEMO Life Sciences Inc.
InventorsManish S. Shah, Ray J. DiFalco
Life of this patent
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Abstract
An abuse resistant oral pharmaceutical composition, comprising: a barrier layer, comprising a first polymer; a diffusion layer, comprising a second polymer, substantially covering the barrier layer, wherein the diffusion layer is bonded to the barrier layer and comprises a drug that is substantially homogeneously distributed within the second polymer and diffuses from the diffusion layer within the gastrointestinal (GI) tract; and optionally an expansion layer comprising an expandable polymer, wherein the expansion layer is substantially covered by the barrier layer. Methods of making the same and methods of using the same are also provided.
Claims24
An oral, extended release pharmaceutical composition in the form of a layered tablet configured to deter abuse, comprising:
- an expansion layer comprising an expandable polymer that forms a gel when exposed to a liquid comprising water and/or alcohol, wherein the expandable polymer is selected from the group consisting of:
- methylcellulose, sodium carboxymethylcellulose, methylhydroxyethylcellulose, hydroxypropylmethylcellulose, alginic acid, tragacanth, and combinations thereof;
- a barrier layer substantially covering the expansion layer, wherein the barrier layer comprises a first polymer selected from the group consisting of:
- acrylic or methacrylic polymers, acrylic or methacrylic copolymers, and mixtures thereof, wherein when the pharmaceutical composition is administered in intact form, the first polymer of the barrier layer is substantially undissolved in the gastrointestinal (GI) tract;
- and
- a diffusion layer covering the barrier layer, the diffusion layer comprising a drug comprising morphine or a pharmaceutically acceptable salt thereof in a pharmaceutically effective amount and a second polymer selected from the group consisting of:
- acrylic or methacrylic polymers, acrylic or methacrylic copolymers, and mixtures thereof, wherein the drug is substantially homogeneously distributed within the second polymer and diffuses from the diffusion layer within the GI tract, wherein the pharmaceutical composition does not comprise a drug that is not an opioid agonist or a central nervous system stimulant, and wherein the diffusion layer is the only drug-containing layer in the pharmaceutical composition,
- wherein the diffusion layer is bonded to the barrier layer by curing the layers together,
- wherein the second polymer is present in an amount sufficient to release at least 50% of the amount of drug after 8 hours after administration in intact form,
- wherein the first polymer and second polymer each comprise the same polymer, and
- wherein when the pharmaceutical composition is crushed to produce particles having a particle size in a range of 500 mesh to 8 mesh, the relative surface area of the diffusion layer increases by no more than 50%.
An oral, extended release pharmaceutical composition in the form of a layered tablet configured to deter abuse, comprising:
- an expansion layer comprising an expandable polymer that forms a gel when exposed to a liquid comprising water and/or alcohol, wherein the expandable polymer is selected from the group consisting of:
- methylcellulose, sodium carboxymethylcellulose, methylhydroxyethylcellulose, hydroxypropyl methylcellulose, alginic acid, tragacanth, and combinations thereof;
- a barrier layer substantially covering the expansion layer, wherein the barrier layer comprises a first polymer, wherein the first polymer is a copolymer of ethyl acrylate and methyl methacrylate, wherein when the pharmaceutical composition is administered in intact form, the first polymer of the barrier layer is substantially undissolved in the gastrointestinal (GI) tract;
- and
- a diffusion layer covering the barrier layer, the diffusion layer comprising a drug comprising morphine or a pharmaceutically acceptable salt thereof in a pharmaceutically effective amount and a second polymer, wherein the second polymer is a copolymer of ethyl acrylate and methyl methacrylate, wherein the drug is substantially homogeneously distributed within the second polymer and diffuses from the diffusion layer within the GI tract, wherein the pharmaceutical composition does not comprise a drug that is not an opioid agonist or a central nervous system stimulant, and wherein the diffusion layer is the only drug-containing layer in the pharmaceutical composition,
- wherein the diffusion layer is bonded to the barrier layer by curing the layers together,
- wherein the second polymer is present in an amount sufficient to release at least 50% of the amount of drug after 8 hours after administration in intact form,
- wherein when the pharmaceutical composition is crushed to produce particles having a particle size in a range of 500 mesh to 8 mesh, the relative surface area of the diffusion layer increases by no more than 50%.
Dependencies are inferred from the claim text.