Abstract

Solid oral modified-release dosage forms (SOMRDFs) are pharmaceutical technologies that alter the rate and/or onset of drug release compared with immediate-release (IR) formulations. This has been a significant advance, as many IR formulations fail to reach or maintain therapeutic plasma concentrations for the required duration to treat diseases, primarily due to the problematic biopharmaceutical and pharmacokinetic characteristics of many active ingredients. Types of SOMRDFs are described by regulatory entities in the USA as extended-release and delayed release. However, research in the literature and other regulatory entities does not apply consistent criteria regarding the terms used to name these types of formulations. This review shows that the terminology used for SOMRDFs is frequently not associated with specific characteristics of dissolution profiles. The use of confusing terms in the brand names of products with SOMRDFs in Colombia was also identified. This significant conceptual misunderstanding could lead to errors in the prescribing and use of these technologies and could mislead future researchers investigating this field. The purpose of this review is to minimise future misinterpretations when referring to or researching any type of modified release technology by proposing harmonised terms for describing SOMRDFs.

Key words: biopharmaceutical, modified release, harmonization, extended release, delayed release.