September 23, 2009
Medicinal Products Susceptible To ‘Dose Dumping’ Should Be Fully Tested
Controlled release pills and capsules that show a tendency in the standard laboratory test toward "dose dumping" "” releasing their medicine in a faster and potentially unsafe manner in patients who have consumed alcohol "” should be withheld from the market until proven safe with testing in people. That's the conclusion of a review of existing studies in the September-October issue of ACS' Molecular Pharmaceutics, a bi-monthly journal.
In the article, Hans Lennernäs analyzed the gastrointestinal factors that may contribute to dose dumping when a vulnerable formulation interacts with alcohol present in the stomach. However, these factors are highly variable and depend on individual drinking behavior, whether food is present in the stomach, and other circumstances. That makes it "almost impossible" to predict whether a patient will experience an overdose as a result of dose dumping.
On the Net:
- "Ethanol-Drug Absorption Interaction: Potential for a Significant Effect on the Plasma Pharmacokinetics of Ethanol Vulnerable Formulations"
- American Chemical Society