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, Dow implemented Design of Experiment (DoE) techniques to createAFFINISOL™ HPMCAS with flexibility in acetate and succinate substitution levels for the optimization of solubility enhancement.
Solutions for Spray-Dried Dispersion
AFFINISOL™ HPMCAS Polymers
AFFINISOL™ Hypromellose Acetate Succinate (HPMCAS) is a soluble polymer that can help optimize solubility enhancement by maintaining stable solid dispersions and inhibiting API crystallization.
AFFINISOL™ High Productivity HPMCAS Developmental Polymer
For increased productivity in the spray drying process, Dow offers a developmental polymer which facilitates higher solids content in the spray solution for increased throughput in spray-drying while maintaining the solubility enhancement of standard HPMCAS.