dose dumping

Dose dumping is the nightmare scenario for a modified-release product: instead of trickling out over many hours, the whole built-in store of drug is released in one rush. A dose engineered to last all day suddenly hits the body at once, and because such products often contain several times an immediate-release dose, the result can be acute overdose.

It usually happens when the release-controlling barrier is defeated. Crushing or chewing an extended-release tablet, a manufacturing flaw in a coating, or — notoriously — taking certain controlled-release products with alcohol (which can dissolve the rate-controlling polymer) can all let the dose escape early. Food effects and individual physiology can play a part too.

Because of this hazard, modified-release products are tested for alcohol-induced dose dumping during development, labelled to be swallowed whole, and never to be split unless explicitly scored. Reservoir-type designs that store the dose behind a single membrane are especially vulnerable; matrix systems, with drug spread throughout, tend to fail more gently.