Risks in the pharmaceutical supply chain are not solely related to the active pharmaceutical ingredients (API). On average, excipients used in formulating medicines comprise 80% of each product and include a broad range of substances such as antiadherents, binders, coatings, disintegrants, diluents, flavors, colorings, preservatives, and sweeteners. Pharmaceutical excipients aid in the manufacturing process to protect, support, or enhance stability and bioavailability, and also make the product acceptable to the patient. They may also assist in product identification and augment the overall safety or function of the product during storage or use. Excipients represent an annual market value of approximately $4 billion worldwide, accounting for 0.5% of the total pharmaceutical market, according to industry experts…
Tag: <span>excipients</span>
Polysorbate-80, or polysorbitan mono-oleate, a non-ionic surfactant commercially referred to as Tween-80, is commonly employed as an excipient in the biopharmaceutical industry due to its low toxicity as well as its ability to solubilize hydrophobic molecules. Thus, polysorbate-80 is employed as a stabilizer in order to control the formation of protein aggregates and larger particulates in biopharmaceutical drug substance and drug product formulations. Guidelines published by The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and the United States Pharmacopeia (USP) classify excipients such as polysorbate-80 as major components in biopharmaceutical formulations and specify that these types of compounds be quantified using a validated analytical method…