Trends in drug characteristics increasingly favor greater degrees of lipophilicity, higher molecular weight, greater physical form complexity and significantly lower aqueous solubility. Consequently, many chemical entities in drug development pipelines have poor water solubility.
Low aqueous solubility severely limits a compound’s bioavailability and therefore also limits the commercial viability of a new product. As a consequence, many active pharmaceutical ingredients that could potentially help cure diseases and improve consumers’ lives never enter the market.
DuPont is committed to addressing the solubilization performance requirements of your APIs with a portfolio of tailored AFFINISOL™ polymers.
AFFINISOL™ hypromellose acetate succinate (AFFINISOL™ HPMCAS) is an excellent polymer for the formation of solid dispersions. It helps in maintaining stable solid dispersions and inhibiting API crystallization in solution, promoting supersaturation of the drug. AFFINISOL™ HPMCAS, either in spray drying or hot-melt extrusion, offers flexibility in acetate and succinate substitution levels, facilitating the optimization of both solubility enhancement and material processing.
AFFINISOL™ High Productivity (HP) HPMCAS is a lower-viscosity HPMCAS designed to further improve the utility of AFFINISOL™ HPMCAS for spray-dried dispersion, hot-melt extrusion and top-spray granulation.
AFFINISOL™ HPMC HME is a readily extrudable hydroxypropyl methylcellulose with processing versatility that requires no plasticizer. It is tailored for solubility enhancement and can offer controlled release formulations produced by HME. While it is capable of being extruded where current HPMC materials fail, it has been designed without modification of the HPMC backbone trusted for safety and performance.
AMBERLITE™ and DUOLITE™ resins can be used to enhance the solubility and disintegration of poorly soluble drugs. In the case of poorly soluble ionizable drugs, the release of drug from a resinate can be faster than the rate of dissolution of the solid form of the drug. Hence, with AMBERLITE™ or DUOLITE™ AP, one can increase the rate at which poorly soluble drugs dissolve.