The influence of apparent viscosity of AFFINISOL™ HPMC HME on hot melt extrusion processability and drug release from amorphous solid dispersions

AFFINISOL™ HPMC HME of varied viscosity was successfully processed with Itraconazole into homogenous amorphous solid dispersions. The use of two viscosity grades blended to a final target did not influence the homogeneity or amorphicity of the resulting dispersion, nor was the dissolution rate different compared to the directly synthesized reference. Thus, the apparent viscosity of the polymer was the dominant factor regarding HME processability and formulation dissolution performance. This demonstrates that multiple viscosity grades can be incorporated into a formulation to achieve a target dissolution profile without risk of one component dominating performance.


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