New morphine capsule prevents alcohol interaction

The results of a new study suggest that the combination of alcohol and an extended-release formulation of morphine does not increase the rate of absorption of the potent narcotic painkiller. The new product, called Kadian, packages morphine sulfate in a polymer-coated, extended-release capsule.

In 2005, the US Food and Drug Administration pulled another extended-release opioid, Palladone (hydromorphone hydrochloride) from the market after a potentially fatal interaction with alcohol was discovered, the authors explain in The Journal of Pain. The regulatory agency has recommended further investigations of extended-release formulations to determine the risk of alcohol-induced “dose-dumping.”

Dr. Franklin Johnson and colleagues at Alpharma Pharmaceuticals, Piscataway, New Jersey—which markets Kadian—conducted an open-label crossover study with 32 healthy men who were moderate drinkers.

The subjects were randomly assigned to Kadian followed by four shots of 80-proof alcohol and water while fasting; a high-fat meal followed by the drug and four shots of alcohol; or Kadian plus water while fasting. The researchers took blood samples to analyze morphine concentrations over the next 48 hours.

Morphine concentrations in the blood did not differ significantly in the men who took Kadian with water or with alcohol, or during fasting or after a full meal, the authors report.

The FDA has reviewed the results of this study, Johnson’s team adds, and agrees that there is no interaction between Kadian and alcohol when they are taken together and the agency has not required any changes or warnings on the drug’s packaging.

They speculate that the extended-release formulation may prevent an interaction. The Kadian shell is made of a combination of polymers - some are pH-sensitive and some are not. This interspersed within a polymer matrix that is not water soluble.

Alcohol is quickly absorbed in the stomach, but the capsule does not dissolve until it moves from the stomach to a higher pH environment in the intestinal tract.

Nevertheless, Johnson and his associates caution that the “consumption of alcohol with any morphine product, whether immediate- or extended-release, is not recommended.”

SOURCE: The Journal of Pain, April 2008.