New Analytical Methods For Silicone Elastomers Used in Drug Delivery Systems

Abstract

The modern pharmaceutical industry requires high quality performance and documentation in all the manufacturing steps to meet continually increasing economic and regulatory demands. This includes the need for new advanced analytical methods to ensure high consistency of the incoming raw materials, and of the intermediate and final products. This thesis describes the development of new analytical methods or the refinement of established methods for silicone elastomers with a focus on high selectivity, accuracy and precision. Spectroscopy (NMR, IR MS), chromatography (GC, LC) and thermoanalytical techniques (TGA, DSC, DMTA) have been used to analyse the consistency of the silicone material composition. These methods have also been used to improve the production processes for a controlled drug release product and to ensure that the regulatory demands of the final product are met. The dimethyl silicone elastomer used was cured by a hydrosilylation mechanism where vinyl and hydride siloxane groups add and form an ethylene crosslinking bond. This reaction is catalysed by platinum in the presence of an inhibitor to prevent the material from curing at room temperature.