dosedumping

Dose dumping, also written as dose-dumping, refers to the rapid release of an active pharmaceutical ingredient from a dosage form, typically an extended-release product, resulting in higher and faster systemic exposure than intended. This phenomenon can undermine the design intent of modified-release formulations and pose safety concerns for patients.

Such dumping may occur when the drug's release mechanism is disrupted by physical alteration of the product, formulation flaws, or interactions with concomitant substances such as alcohol. Other contributing factors can include dissolution changes, coating defects, and certain storage conditions. Dose dumping is a safety concern because it can overwhelm the body's ability to metabolize and excrete the drug, leading to adverse effects or overdose in a short period.

Regulatory and clinical practice treat dose dumping as a risk specific to modified-release formulations. During product development, manufacturers assess the potential for dose dumping through in vitro release testing and sometimes in vivo studies. Post-market pharmacovigilance monitors reports of adverse events that may be compatible with dumping. Abuser-deterrent or advanced-release technologies aim to reduce the likelihood of dose dumping.

Prevention and patient safety rely on appropriate prescription labeling, patient education, and avoidance of alteration of dosage forms, including crushing or chewing, unless explicitly advised. In cases where alcohol or interactions may influence release, warnings and proper use instructions help mitigate risk. See also dose dumping in pharmacology and related pharmacovigilance discussions.