According to Pharmacopoeia General Principles, additives is defined as "A material other than the active ingredient contained in the Formulation. It is used for the purpose of enhancing usefulness, facilitating formulation, stabilizing formulation, and improving the appearance of medicines.
Additive products include excipient, stabilizers, preservatives, buffers, acidifier, suspending agent, emulsifiers, aromatic agents, solvents, colourants, and thickner.
However, the additives are safe and not directly pharmacological in the dosage of the drug, and do not change the therapeutic effects of the drug or interfere with the testing."
Its purpose is 1) to enhance stability, bioavailability and etc., 2) to preserve or maintain the quality of the drug during use and storage, and 3) to enhance the drug economy by controlling the physical characteristics.
