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J. Manuf. Mater. Process. 2017, 1(1), 9; doi:10.3390/jmmp1010009

Processing Stability and the Significance of Variation in Extrusion Speeds and Temperatures on SSB® 55 Pharma Grade Shellac for Oral Drug Delivery

1
Materials Research Institute, Athlone Institute of Technology, Co., Westmeath N37 HD68, Ireland
2
Centre for Industrial Services and Design (CISD), Department of Mechanical and Polymer Engineering, School of Engineering, Athlone Institute of Technology, Co., Westmeath N37 HD68, Ireland
*
Author to whom correspondence should be addressed.
Received: 18 July 2017 / Revised: 17 August 2017 / Accepted: 30 August 2017 / Published: 6 September 2017
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Abstract

The melt-extrusion process is utilized in the pharmaceutical arena for the manufacturing of a variety of dosage forms and formulations, including solid dispersions. This technology is considered an efficient and continuous dosage form manufacturing method. However, there are potential challenges mainly because, during hot-melt extrusion, polymers are subject to mechanical and thermal degradation. Mechanical degradation may be induced by the shear effects imposed by the rotating screw. Thermal degradation results from high temperatures and includes random scission, scission from the ends of the polymer and unzipping of substitute groups. This paper endeavors to understand the impact of thermal and/or mechanical components of the melt-extrusion process on the stability of a pH sensitive polymer, namely Shellac. Correlation between the screw speeds and processing temperature profile was examined in the context of the overall degradation profile of the polymer. The results suggest that the processing stability of Shellac was reliant on optimization of screw speed (rpm) and process temperature. View Full-Text
Keywords: melt extrusion; process stability; Shellac; oral drug delivery melt extrusion; process stability; Shellac; oral drug delivery
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This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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Gately, N.M.; Kennedy, J.E. Processing Stability and the Significance of Variation in Extrusion Speeds and Temperatures on SSB® 55 Pharma Grade Shellac for Oral Drug Delivery. J. Manuf. Mater. Process. 2017, 1, 9.

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J. Manuf. Mater. Process. EISSN 2504-4494 Published by MDPI AG, Basel, Switzerland RSS E-Mail Table of Contents Alert
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