For a drug substance administered via oral route, it should possess adequately aqueous solubility before passes through the gastrointestinal tract to complete the absorption, and then enters the blood steams for the pharmacological actions.
Lipid-based formulation is proven to be one of the effective approaches to enhance solubility of poorly soluble drugs. At J-Star, our scientists are experienced in this solubilization method, and at the same time, applying it to liquid-filled capsules to simplify the process and stay away from the manufacturing issues of oral dosage forms.
Research studies show that the majority of API candidates in the development pipeline have a BCS Class II rating, which means those APIs need a solubilization strategy to promote the bioavailability to improve their chance of clinical success.
With the ability to develop both Drug Substance (DS) and Drug product (DP) under the same umbrella, our team enjoys a synergism absent in most CROs. The ability to bridge the DS/DP interface is a major competitive advantage, and we are able to shorten development timeline and to improve ruggedness of the DP process.