Synopsis

Excipients are typically the major components in a drug product. Many formulations contain only a small percentage of the active drug molecules. Pharmaceutical excipients or additives are compounds added to the finished drug products to serve a specific function.
Injectable products require a unique formulation strategy. The formulated product must be sterile, pyrogen-free, and, in the case of solution, free of particulate matter. No coloring agent may be added solely for the purpose of coloring the parenteral preparation. The formulation should preferably be isotonic, and depending on the route of administration, certain excipients are not allowed. The injected drug by-passes natural defense barriers; hence, for any given drug, the risk of an adverse event may be greater or the effects difficult to reverse if administered as an injection rather than a non-parenteral route. For this reason ultra-high purity grades of excipients are available for parenteral administration. Sterility requirements demand that an excipient is able to withstand terminal sterilization or aseptic processing. These factors limit the choice of excipients available in the market. With the new products for Clariant the choice of excipients have increased for parenteral formulations and in the presentation we will discuss the new product range.