Excipient

Excipient is a substance formulated alongside the active ingredient of a medication. Excipients serve various purposes, including long-term stabilization, bulking up solid formulations containing potent active ingredients in small amounts (often referred to as "bulking agents", "fillers", or "diluents"), or enhancing the therapeutic properties of the active ingredient in the final dosage form. They can facilitate drug absorption, reduce viscosity, or enhance solubility.[1][2] Excipients can also aid in the manufacturing process by improving the handling of active substances, facilitating powder flowability, or preventing denaturation and aggregation during the expected shelf life. The selection of excipients depends on factors such as the route of administration, dosage form, and active ingredient.

Pharmaceutical regulations and standards mandate the identification and safety assessment of all ingredients in drugs, including their chemical decomposition products. It is common for a final drug formulation to contain more excipient than active ingredient, and virtually all marketed drugs contain excipients. In some cases, novel excipients can be patented, while in others, the specific formulation involving them is kept as a trade secret to prevent reverse engineering.[citation needed]

  1. ^ Borbás E, Sinkó B, Tsinman O, Tsinman K, Kiserdei É, Démuth B, et al. (November 2016). "Investigation and Mathematical Description of the Real Driving Force of Passive Transport of Drug Molecules from Supersaturated Solutions". Molecular Pharmaceutics. 13 (11): 3816–3826. doi:10.1021/acs.molpharmaceut.6b00613. PMID 27611057.
  2. ^ Hsu T, Mitragotri S (September 2011). "Delivery of siRNA and other macromolecules into skin and cells using a peptide enhancer". Proceedings of the National Academy of Sciences of the United States of America. 108 (38): 15816–21. Bibcode:2011PNAS..10815816H. doi:10.1073/pnas.1016152108. PMC 3179050. PMID 21903933.