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Volume 7
Pharmaceutical Regulatory Affairs: Open Access
ISSN: 2167-7689
Pharma Europe 2018
May 07-09, 2018
May 07-09, 2018 | Frankfurt, Germany
15
th
Annual European Pharma Congress
Influence of hot melt extrusion processing parameters on the properties of a pharmaceutical
formulation
Saad Alshahrani
Prince Sattam Bin Abdulaziz University, Saudi Arabia
H
ot melt extrusion (HME) is an old technology that has been recently adapted to be used in the pharmaceutical industry.
HME is a continuous process that is widely used to produce a solid dispersion matrix. The aim of this dissertation is to
evaluate different factors that will affect the pharmaceutical formulation properties that are produced using HME. For HME,
there are different variables that will affect the product quality such as processing parameters, material selection, material
ratio and the presence of gas or moisture. One aim of this study is to find the most significant factor that affects the product
properties using the simplest design of experiment. Material selection and the ratio between the materials will be extensively
evaluated using carbamazepine as a model drug. Moisture content and gas introduced during the process will be assessed
to illustrate the best method to remove them. Process parameters show a significant effect on the product quality. Polymer
selection and the ratio between the polymers show a great impact on drug dissolution and stability studies. Effective degassing
has successfully enhanced the overly product quality features such as dissolution, shape, drug content and stability.
sm.alshahrani@psau.edu.saPharmaceut Reg Affairs 2018, Volume 7
DOI: 10.4172/2167-7689-C1-031