Date of Award

Spring 2014

Document Type

Thesis

Degree Name

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

Department

Chemical, Biological and Pharmaceutical Engineering

First Advisor

Costas G. Gogos

Second Advisor

Piero M. Armenante

Third Advisor

Robert Benedict Barat

Fourth Advisor

Nicolas Ioannidis

Abstract

Pharmaceutical Hot Melt Extrusion (HME) is essentially a special case of polymer compounding. The elementary steps involved in traditional plastics melt processing are handling of particulates, melting, dispersive and distributive mixing, devolatilization and stripping, and finally pressurization and pumping. However, for pharmaceutical HME, the dissolution of the API (Active Pharmaceutical Ingredient) is an additional and very important elementary step, along with the melting of the polymeric excipient that precedes it, and mixing which accelerates the dissolution process. A major concern in pharmaceutical HME is the thermal degradation of the API. To avoid overexposure of API to heat while ensuring complete dissolution of the API in the production of solid solution, the dissolution kinetics of the API must be known. This work employs a non- dissolving, surrogate material in an attempt to deconvolute the phenomena of distribution, dispersion and dissolution of the API inside a molten polymeric matrix using a Brabender batch mixer, in order to determine the dissolution kinetics of the API.

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