The use of Spray-Dried Dispersions (SDD) is a growing formulation technology for pharmaceutical applications because SDD is capable of improving the solubility and preventing nucleation of poorly soluble drug compound classified Class II and Class IV under the Biopharmaceutics Classification System.
Hypromellose acetate succinate (HPMCAS) is a leading excipient for the formation of SDD due to its high glass transition temperature, solubility in organic solvents and amphiphilic nature. However, not all active pharmaceutical ingredients (APIs) can achieve a desirable balance between peak drug concentration and sustainment of supersaturated drug concentration in SDD formulations using commercially available HPMCAS grades.
To meet this need, we implemented Design of Experiment (DoE) techniques to create AFFINISOL™ HPMCAS with flexibility in acetate and succinate substitution levels for the optimization of solubility enhancement.
Low-viscosity METHOCEL™ Premium grades are common excipients with proven use in spray-drying processes.
AFFINISOL™ HPMC HME 15LV features a broad range of solvent solubility. In cases where other HPMCs are not suitable due to limited solubility in particular solvent systems, this grade is worth consideration.
Characteristics of AFFINISOL™ HPMCAS are high glass transition temperature, solubility in organic solvents and amphiphilic nature. It helps optimize solubility enhancement by maintaining stable solid dispersions and inhibiting API crystallization. The range of available AFFINISOL™ HPMCAS grades 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 low-viscosity HPMCAS designed to further improve the utility of AFFINISOL™ HPMCAS for spray-dried dispersion.