Date of Award

Spring 2015

Document Type

Thesis

Degree Name

Master of Science in Chemical Engineering - (M.S.)

Department

Chemical, Biological and Pharmaceutical Engineering

First Advisor

Costas G. Gogos

Second Advisor

R. P. T. Tomkins

Third Advisor

Laurent Simon

Fourth Advisor

Ecevit Atalay Bilgili

Fifth Advisor

Nicolas Ioannidis

Abstract

Extrusion has been a most important and widely used continuous process in polymer processing for over one hundred and fifty years. However, it has only been recently applied and adopted by the pharmaceutical industry to prepare solid oral dosage formulations with increased bioavailability for the poorly-water soluble drugs and controlled release characteristics for the water-soluble drugs. In pharmaceutical Hot-melt extrusion poorly water soluble drug particulates are mixed with water soluble polymer excipient particulates and fed in the extruder, where the polymer is melted, after which the drug particulates begin to dissolve into the polymer melt. Extrusion-generated mixing accelerates dissolution process. One issue concerning the pharmaceutical industry is the degradation of drugs when they are exposed to relatively high temperatures of the extrusion process (usually 100 °C above ambient). In order to keep drugs from thermally degrading and at the same time achieving complete dissolution, the dissolution kinetics of drugs (APIs) must be specified for any given excipient/API pair, and a variety of extrusion conditions. In this work the Brabender Batch Mixer is utilized to determine such kinetic data at different concentrations and temperatures by connecting the exponential torque decay after the introduction of the API to the API dissolution. The time to complete the decay is then associated with the average residence time needed for complete dissolution.

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