Abuse-resistant drug formulations
AssigneeKashiv Biosciences, LLC
InventorsHarpreet Kaur Sandhu, Siva Ram Kiran Vaka, Ashish Chatterji, Dipen Desai, Wantanee Phuapradit, Navnit H. Shah
Life of this patent
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Abstract
Disclosed are abuse resistant oral pharmaceutical compositions that reduce the likelihood of improper administration of drugs that are susceptible to abuse. The oral pharmaceutical formulations contain abuse deterrent agents that cause discomfort to the user when administered in an improper manner and make the extraction of an active ingredient more difficult. Methods of making and using the compositions are also disclosed.
Claims20
An abuse-resistant liquid pharmaceutical composition comprising an immediate release unit dose of a mixture of an effective amount of at least one pharmaceutically active agent susceptible to abuse, an organic vehicle, a surfactant, a co-solvent, and a viscosity-building polymer;
- wherein the organic vehicle, surfactant, and co-solvent co-elute with the pharmaceutically active agent when exposed to a solvent;
- wherein the organic vehicle is a C6-C18 fatty acid, a C6-C18 fatty acid mono-, di- or tri-glyceride, a C6-C18 fatty acid propylene glycol mono- or di-ester, a C6-C18 fatty acid polyethylene glycol ester, a vegetable oil, or a mixture of two or more thereof, and is present in an amount of about 50% to about 90% by weight, based on the total weight of the composition;
- wherein the surfactant is dioctyl sodium sulfosuccinate, sodium lauryl sulfate, PEG-32 glyceryl laurate, PEG-32 glyceryl palmitostearate, PEG-35 castor oil, PEG-8 glyceryl caprylate/caprate, PEG-6 glyceryl caprylate/caprate, PEG-40 hydrogenated castor oil, Macrogol 15 hydroxystearate, an ethylene oxide/propylene oxide block copolymer, polyoxyethylene 20 sorbitan monolaurate, polyoxyethylene 20 sorbitan monooleate, sorbitan monolaurate, sorbitan monooleate, tocopherol PEG succinate, polyoxyl 40 stearate, or a mixture of two or more thereof, and is present in an amount of about 2% to about 40% by weight, based on the total weight of the composition;
- wherein the viscosity-building polymer is PEG-2M, PEG-5M, PEG-7M, PEG-14M, PEG-23M, PEG-45M, PEG-90M, or a combination of two or more thereof, and is present in an amount of about 0.5% to about 20% by weight, based on the total weight of the composition, so that it does not slow an immediate release of the pharmaceutically active agent from a single unit-dose administration, but slows the immediate release of the pharmaceutically active agent from a multiple unit-dose administration.
A method of rendering abuse resistant a pharmaceutically active agent susceptible to abuse, comprising preparing an immediate-release liquid pharmaceutical composition by mixing an effective amount of the pharmaceutically active agent, an organic vehicle, a surfactant, a co-solvent, and a viscosity-building polymer;
- wherein the organic vehicle, surfactant, and co-solvent co-elute with the pharmaceutically active agent when exposed to a solvent,
- wherein the organic vehicle is a C6-C18 fatty acid, a C6-C18 fatty acid mono-, di- or tri-glyceride, a C6-C18 fatty acid propylene glycol mono- or di-ester, a C6-C18 fatty acid polyethylene glycol ester, a vegetable oil, or a mixture of two or more thereof, and is present in an amount of about 50% to about 90% by weight, based on the total weight of the composition;
- wherein the surfactant is dioctyl sodium sulfosuccinate, sodium lauryl sulfate, PEG-32 glyceryl laurate, PEG-32 glyceryl palmitostearate, PEG-35 castor oil, PEG-8 glyceryl caprylate/caprate, PEG-6 glyceryl caprylate/caprate, PEG-40 hydrogenated castor oil, Macrogol 15 hydroxystearate, an ethylene oxide/propylene oxide block copolymer, polyoxyethylene 20 sorbitan monolaurate, polyoxyethylene 20 sorbitan monooleate, sorbitan monolaurate, sorbitan monooleate, tocopherol PEG succinate, polyoxyl 40 stearate, or a mixture of two or more thereof, and is present in an amount of about 2% to about 40%, by weight, based on the total weight of the composition;
- wherein the viscosity-building polymer is PEG-2M, PEG-5M, PEG-7M, PEG-14M, PEG-23M, PEG-45M, PEG-90M, or a combination of two or more thereof, and is present in an amount of about 0.5% to about 20% by weight, based on the total weight of the composition, so that it does not slow an immediate release of the pharmaceutically active agent from a single unit-dose administration, but slows the immediate release of the pharmaceutically active agent from a multiple unit-dose administration.
A method of deterring abuse of a pharmaceutically active agent susceptible to abuse, comprising administering the pharmaceutically active agent to a subject in need thereof, wherein the pharmaceutically active agent is formulated in a liquid pharmaceutical composition that comprises a mixture of an immediate release unit of a mixture of an effective amount of the pharmaceutically active agent, an organic vehicle, a surfactant, a co-solvent, and a viscosity-building polymer;
- wherein the organic vehicle, surfactant, and co-solvent co-elute with the pharmaceutically active agent when exposed to a solvent,
- wherein the organic vehicle is a C6-C18 fatty acid, a C6-C18 fatty acid mono-, di- or tri-glyceride, a C6-C18 fatty acid propylene glycol mono- or di-ester, a C6-C18 fatty acid polyethylene glycol ester, a vegetable oil, or a mixture of two or more thereof, and is present in an amount of about 50% to about 90% by weight, based on the total weight of the composition;
- wherein the surfactant is dioctyl sodium sulfosuccinate, sodium lauryl sulfate, PEG-32 glyceryl laurate, PEG-32 glyceryl palmitostearate, PEG-35 castor oil, PEG-8 glyceryl caprylate/caprate, PEG-6 glyceryl caprylate/caprate, PEG-40 hydrogenated castor oil, Macrogol 15 hydroxystearate, an ethylene oxide/propylene oxide block copolymer, polyoxyethylene 20 sorbitan monolaurate, polyoxyethylene 20 sorbitan monooleate, sorbitan monolaurate, sorbitan monooleate, tocopherol PEG succinate, polyoxyl 40 stearate, or a mixture of two or more thereof, and is present in an amount of about 2% to about 40%, by weight, based on the total weight of the composition;
- wherein the viscosity-building polymer is PEG-2M, PEG-5M, PEG-7M, PEG-14M, PEG-23M, PEG-45M, PEG-90M, or a combination of two or more thereof, and is present in an amount of about 0.5% to about 20% by weight, based on the total weight of the composition, so that it does not slow an immediate release of the pharmaceutically active agent from a single unit-dose administration, but slows the immediate release of the pharmaceutically active agent from a multiple unit-dose administration.
Dependencies are inferred from the claim text.