Pharmaceutical resinate compositions and methods of making and using thereof
AssigneeRhodes Pharmaceuticals L.P.
InventorsMohsen Sadatrezaei, Gerard Frunzi
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Abstract
Disclosed herein Eire pharmaceutical compositions having a mixture of at least one active agent, an ion exchange resin, a binder, and a matrix material such that the composition, when administered to a patient in need thereof, provides the patient with a therapeutic effect for at least about 8 hours and related methods. Also disclosed herein are pharmaceutical compositions having a mixture of a drug susceptible to abuse, a non-opioid analgesic and an ion exchange resin, the composition further including at least one gelling agent and related methods.
Claims27
A solid oral pharmaceutical composition comprising:
- a mixture comprising:
- an ion exchange resin;
- at least one active agent capable of forming a complex with the ion exchange resin, wherein the at least one active agent comprises a drug susceptible to abuse;
- a binder;
- and
- a matrix material comprising a polymer having a molecular weight of about 500,000 Da to about 10,000,000 Da,
- wherein the composition, when administered to a patient in need thereof, provides a controlled release of the at least one active agent to the patient with a therapeutic effect for at least about 8 hours,
- wherein the composition releases about 10% to about 45% active agent after 1 hour, about 12.5% to about 55% (by weight) active agent after 2 hours, about 25% to about 65% (by weight) active agent after 4 hours, about 45% to about 85% (by weight) active agent after 6 hours and about 55% to about 95% (by weight) active agent after 8 hours, when measured by in-vitro dissolution in a USP Apparatus 2 (paddle) at about 50 rpm in about 900 ml simulated gastric fluid at about 37° C., and
- wherein recovery of the at least one active agent is less than about 20% based on a syringeability test whereby the composition is subject to dissolution in 10 ml of water with agitation at room temperature for about 2 min and the resultant solution is aspirated with a 21-gauge needle.
Dependencies are inferred from the claim text.