Hydrophilic abuse deterrent delivery system
OwnerJason Vaughn, Michael Crowley +4inventors
InventorsJason Vaughn, Michael Crowley, Feng Zhang, John Koleng, Justin Keen, Justin Hughey
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Abstract
Disclosed herein are oral dosage forms of therapeutic agents that are resistant to abuse and methods of their formulation. In particular, oral dosage forms that are resistant to dissolution in aqueous solutions of ethanol are described.
Claims47
A monolithic solidified oral dosage form prepared by a thermal process comprising a therapeutic agent and a hydrophilic polymer wherein the oral dosage form releases at least 80% of the therapeutic agent after 2 hours of stirring in a 0.1 N HCl solution and 16 hours stirring in a pH 6.8 phosphate buffer solution using a USP Type II paddle apparatus at 75 rpm and 37° C., and wherein the oral dosage form releases less than 40% of the therapeutic agent after 5 minutes of shaking at 240 cycles/min in a 0.1 N HCl solution followed by 3 hours of shaking on an orbital shaker at 240 cycles/min in an acidic aqueous solution of 40% ethanol at 25° C.
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An oral dosage form comprising:
- an opioid therapeutic agent;
- and
- at least one hydrophilic polymer;
- wherein the oral dosage form releases at least 80% of the opioid therapeutic agent after 2 hours of stirring in a 0.1 N HCl solution and 16 hours stirring in a pH 6.8 phosphate buffer solution using a USP Type II paddle apparatus at 75 rpm and 37° C., and wherein the oral dosage form releases less than 40% of the opioid therapeutic agent after 5 minutes of shaking at 240 cycles/min in a 0.1 N HCl solution followed by 3 hours of shaking on an orbital shaker at 240 cycles/min in an acidic aqueous solution of 40% ethanol at 25° C.
43-72. (canceled)
A method of providing a therapeutic agent to a patient comprising providing the patient with a monolithic solidified oral dosage form prepared by a thermal process, the oral dosage form comprising the therapeutic agent and a hydrophilic polymer, wherein the oral dosage form releases at least 80% of the therapeutic agent after 2 hours of stirring in a 0.1 N HCl solution and 16 hours stirring in a pH 6.8 phosphate buffer solution using a USP Type II paddle apparatus at 75 rpm and 37° C., and wherein the oral dosage form releases less than 40% of the therapeutic agent after 5 minutes of shaking at 240 cycles/min in a 0.1 N HCl solution followed by 3 hours of shaking on an orbital shaker at 240 cycles/min in an acidic aqueous solution of 40% ethanol at 25° C.
74-112. (canceled)
A method of formulating a monolithic solidified oral dosage form, comprising:
- forming a mixture of hydrophilic polymer with a therapeutic agent;
- melting the mixture;
- permitting the mixture to solidify, releases at least 80% of the therapeutic agent after 2 hours of stirring in a 0.1 HCl solution and 16 hours stirring in a pH 6.8 phosphate buffer solution using a USP Type II paddle apparatus at 75 rpm and 37° C., and wherein the oral dosage form releases less than 40% of the therapeutic agent after 5 minutes of shaking at 240 cycles/min in a 0.1 N HCl solution followed by 3 hours of shaking on an orbital shaker at 240 cycles/min in an acidic aqueous solution of 40% ethanol at 25° C.
114-155. (canceled)
Dependencies are inferred from the claim text.