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The New Jersey Institute of Technology's
Electronic Theses & Dissertations Project

Title: Assessment of a marine polysaccharide for use as excipient in pharmaceutical hot-melt extrusion
Author: Ye, Qing
View Online: njit-etd2014-081
(xi, 48 pages ~ 1.7 MB pdf)
Department: Department of Chemical, Biological and Pharmaceutical Engineering
Degree: Master of Science
Program: Pharmaceutical Engineering
Document Type: Thesis
Advisory Committee: Gogos, Costas G. (Committee chair)
Armenante, Piero M. (Committee member)
Barat, Robert Benedict (Committee member)
Ioannidis, Nicolas (Committee member)
Date: 2014-05
Keywords: Pharmaceutical hot melt extrusion (HME)
Biopolymers
Keltone
Marine polysaccharide
Brown seaweed
Availability: Unrestricted
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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