Document Type

Thesis

Date of Award

Spring 5-31-2014

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 currently investigated by both industry and academia as a method for manufacturing solid oral dosages with improved bioavailability of poorly-water soluble active pharmaceutical ingredients (APIs) and control drug release of water-soluble APIs. Although HME is traditionally utilizing synthetic polymers to produce such dosages, biopolymers constantly gain ground by virtue of renewability, biocompatibility and in some cases biodegradability. In this work, the possibility of using Keltone, a marine polysaccharide derived from brown seaweed, as a polymeric excipient for pharmaceutical HME is explored. Keltone is insoluble in acidic pH and soluble in basic pH, therefore making it suitable for intestinal drug release. The processability of Keltone by extrusion using water and Eudragit EPO as plasticizers, and Diphenhydramine Hydrochloride and Clotrimazoleas as active pharmaceutical ingredients is assessed. The amount of residual water in the extrudates is determined by thermogravimetric analysis. The thermal transitions of the extrudates are determined by Differential Scanning Calorimetry.

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