Abuse resistant opioid drug-ion exchange resin complexes having hybrid coatings
AssigneeTris Pharma, Inc.
InventorsKetan Mehta, Yu-Hsing Tu, Alivia Chaudhuri, Ashok Perumal
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Abstract
A sustained release formulation for opioid drugs is described. The formulation contains an opioid-ion exchange resin complex having a hybrid coating. The hybrid coating contains a cured polyvinylacetate polymer and a pH-dependent enteric coating layer mixed therein. Also provided are methods of making and using same.
Claims25
A solid oral dose tablet, powder or granular formulation having modified release characteristics comprising at least one hybrid coated opioid-ion exchange resin complex and pharmaceutically acceptable excipients, said at least one hybrid coated opioid-ion exchange resin complex comprising:
- a pharmaceutically effective amount of an opioid bound to a pharmaceutically acceptable ion exchange resin;
- and
- a cured hybrid modified release coating layer over the opioid-ion exchange resin complex, said hybrid coating comprising:
- a pH-independent, high tensile strength, water insoluble, water-permeable, diffusion barrier coating forming component comprising about 70% to about 90% w/w polyvinylacetate (PVA) and about 3 to about 10% w/w of a plasticizer;
- and
- an enteric coating forming component having pH-dependent solubility in an aqueous system which is non-reactive with said barrier coating forming component, said enteric coating forming component comprising polyvinylacetate phthalate,
- wherein said barrier coating forming component and said enteric coating forming component are present in a weight ratio of about 20:1 to about 3:1.
Dependencies are inferred from the claim text.