Influence of the quality of capsule shell on the non-invasive monitoring of medicines using Terizidone as an example

Abstract

The aim of this study is to investigate the influence of hard capsule shells on the possibility of non-invasive monitoring and authentication of medicines presented in capsules dosage form. It is shown that the NIR measurements followed by the chemometric analysis, reflects all macro-components of the analyzed samples, which are the PVC blister, the capsule shell, and the capsule contents. The special variable selection procedure, based on the pure spectra of all components, makes it possible to develop a model that is insensitive to small variations of the capsule shell. The shrinkage of spectral region can greatly affect the results of the classification. Consequently, in case we are interested in the whole remedy, capsules with deviations in shell properties should be rejected as the substandard ones. If we are only interested in the quality of capsules' content, the developed model is effective and applicable in the routine testing. The final model helps to understand and demonstrate the reason for the rejection of substandard samples authentication. It also gives a practical signal to the manufacturer to pay attention to the quality of the capsule shells.

Keywords: Capsule shell quality; DD-SIMCA; Model sensitivity and specificity; Near infrared spectroscopy; Substandard medicines.