High throughput screening methods are frequently identifying physically complex new chemical entities (NCEs) that are lipophilic with higher molecular weights. This has resulted in approximately 40% of NCEs in drug development pipelines having poor water solubility. More recent reports indicate this number has grown substantially to nearly 90%*. Many of these Active Pharmaceutical Ingredients (APIs) fall into the Biopharmaceutics Classification System (BCS) Class II displaying low solubility but having high biological permeability. For such APIs the low aqueous solubility severely limits the compound’s oral bioavailability and thus commercial viability. Therefore, formulation scientists are consistently in need of functional excipients and enabling technologies capable of increasing the API solubility in order to achieve therapeutically relevant and reproducible concentrations within the blood and thus a successful drug product.
At Dow, we are committed to addressing the pipeline challenges associated with poorly soluble drug compounds. To help the pharmaceutical industry advance treatment options for patients around the world, Dow Pharma Solutions utilizes an array of technologies including high-throughput polymer synthesis, API polymer performance screening, laboratory-scale product development, and structure-property optimization to match the polymer with the API for exceptional performance. In addition, Dow Pharma Solutions operates a cGMP (Current Good Manufacturing Practices) market-development production plant to support clinical development of optimized polymers.
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