excipieni

Excipients are inactive substances formulated alongside the active pharmaceutical ingredient in a drug product. They do not have therapeutic effects themselves but serve to facilitate manufacturing, storage, dosage form performance, and patient acceptability. Excipients are chosen for compatibility with the active ingredient and with each other, and they are generally considered pharmacologically inert at the doses used. Their presence can influence the stability, release profile, taste, appearance, and handling of the medicine.

Common classes of excipients include diluents or fillers such as lactose and microcrystalline cellulose, which add bulk to dosage forms; binders like povidone, which help hold tablets together; disintegrants such as croscarmellose sodium, which promote breakup of a tablet in the digestive tract; and lubricants such as magnesium stearate, which reduce friction during manufacture. Additional categories cover film coatings (for taste masking or controlled release), preservatives and antioxidants to preserve stability, as well as flavors, colorants, and sweeteners to improve acceptability. Excipients also include solvents, surfactants, emulsifiers, and stabilizers tailored to specific formulations.

Regulatory and quality considerations address the inert nature of excipients, requiring them to meet pharmacopeial specifications and supplier qualifications. Safety reviews for allergenicity, drug–excipient interactions, and compatibility with the active ingredient are standard. Manufacturing uses good manufacturing practices, and sterile products require sterile excipients and controlled processes.