Abuse resistant opioid drug-ion exchange resin complexes having hybrid coatings

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.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of U.S. patent application Ser. No. 12 / 154,970, filed May 28, 2008, which is an application that claims the benefit under 35 USC 119(e) of U.S. Provisional Patent Application No. 60 / 941,169, filed May 31, 2007, now expired.BACKGROUND OF THE INVENTION[0002]Opioids are commonly prescribed because of their effective analgesic, or pain-relieving, properties. Medications that fall within this class, referred to as prescription narcotics, include morphine sulfate (e.g., Kadian®, Avinza™), codeine salts, oxycodone HCl (e.g., OxyContin™, Percodan™, Percocet™), and related drugs. For example, OxyContin™ tablets are presently commercially available in 10, 20, 40, 80, and 160 milligrams forms. Morphine, for example, is often used before and after surgical procedures to alleviate severe pain. Codeine, on the other hand, is often prescribed for mild pain. In addition to their pain-relieving properties, some of these ...

AI Technical Summary

Benefits of technology

The present invention provides a modified release tablet formulation of an opioid drug bound to an ion exchange resin, coated with a hybrid coating comprising a barrier coating containing a polyvinyl acetate polymer and a plasticizer and an enteric polymer mixed therewith. This formulation provides a desired modified release profile while also providing favorable abuse resistance properties. The invention also provides a solid dose modified release morphine formulation containing a pharmaceutically effective amount of morphine bound to a pharmaceutically acceptable cationic exchange resin complex, which is coated with a cured hybrid modified release coating directly thereon. The hybrid coating comprises a single cured layer comprising a uniform mixture of a barrier forming component containing at least a polyvinylacetate (PVA) polymer system and a plasticizer and enteric coating forming component preferably containing at least a PVA-phthalate and at least one plasticizer. The invention further provides a method of administering an opioid drug for a sustained period, the method comprising administering a formulation of an opioid drug bound to an ion exchange resin, coated with a hybrid coating as described herein.

Problems solved by technology

However, opioid drugs are at times associated with side effects including, e.g., stomach upset and other gastrointestinal effects.

Further, because of the sometimes addictive properties of these drugs and the euphoria which can be associated with taking them, including through routes other than those prescribed, these opioid drugs are particular susceptible to abuse.

These antagonists cannot be easily extracted from the agonist and will cause an aversive effect in a physically dependent patient.

However, these antagonists may have other side effects which may be disadvantageous.

Further, there is no data in the '392 patent of prolonged release of the drug from the coated drug-ion exchange resin complex beyond about 12 hours.

There have been literature-reported drawbacks of using ethyl cellulose based aqueous dispersions as coatings for drug-ion exchange resin complexes.