Controlled release agent

A controlled release agent is not a biological molecule or therapeutic target; rather, it is a pharmaceutical technology or substance, such as a polymer or lipid, used to regulate the delivery of a drug over time. These agents are designed to maintain therapeutic drug concentrations in the systemic circulation, reducing the frequency of administration and minimizing side effects associated with peak-and-trough plasma levels (Uhrich, S. M., et al., 1999, Chemical Reviews). Common materials used as controlled release agents include hydroxypropyl methylcellulose (HPMC), polylactic-co-glycolic acid (PLGA), and various hydrogels. Because these substances serve as delivery vehicles or excipients rather than sites of drug action like receptors or enzymes, they do not fulfill the criteria for a therapeutic target. Consequently, 'Controlled release agent' is classified as an incorrect entry for a target molecule (FDA, 2017, Guidance for Industry: Modified Release Solid Oral Dosage Forms).

Other names

Sustained-release agentExtended-release agentModified-release excipientControlled-release drug delivery systemPolymer matrix

Controlled release agents function by physically or chemically modulating the rate at which an active pharmaceutical ingredient is released from a dosage form, typically through mechanisms such as diffusion through a polymer membrane, erosion of a matrix, or osmotic pressure (Langer, R., 1990, Science).