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Impact of Extrusion Process Parameters on Drug Recovery and Dissolution

This technical paper studies the impact of extrusion process parameters on the performance of solid dispersions of Ritonavir, a poorly soluble antiretroviral drug, and AFFINISOL(TM) HPMC HME, a new grade of HPMC designed for hot melt extrusion.

The formulation with a fixed drug: polymer ratio was extruded at different processing conditions exploring the variables of feed rate, screw speed and temperature for their impact on drug degradation, its physical state and dissolution performance of the resulting solid dispersions.

The broad processing window of AFFINISOL™ HPMC HME allows exploration of the process parameter design space without harming the polymer to study and minimize drug degradation for compounds with sensitivities such as Ritonavir.

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