Modified Release Drug Product

The term modified-release drug product is used to describe products that alter the timing and/or the rate of release of the drug substance. A modified-release dosage form is defined

as one for which the drug-release characteristics of time course and/or location are chosen to accomplish therapeutic or convenience objectives not offered by conventional dosage forms such as solutions, ointments, or promptly dissolving dosage forms as presently recognized.

Several types of modified-release drug products are recognized:


1. Extended-release drug products. A dosage form that allows at least a twofold reduction in dosage frequency as compared to that drug presented as an immediate-release (conventional) dosage form. Examples of extended-release dosage forms include controlled-release, sustained-release, and long-acting drug products.