Ion Mobility Spectrometry For Determination Of Active Drug In Blinded Dosage Forms

By: D.E. Peterson, G.C. Eden, C.R. Apodaca, D.P. Argyres, and A.L. Kennedy

Clinical trials are an important part of the drug product development process. While the physical attributes of commercially available tablets and capsules may be useful for identification of drug products, the unique appearance of these dosage forms can be problematic in clinical trials, especially when the studies collect subjective data. To minimize the introduction of bias into clinical trials, drug products are generally blinded in such a way as to conceal or hide the drug treatment from both study participants and clinical investigators.

Significant identification responsibility falls on those who manufacture, handle, package, or label blinded products for clinical trials. Testing procedures ensure that the correct product is provided to study subjects. Techniques commonly used to differentiate blinded active drug versus placebo include infrared spectroscopy, colorimetric identification, thin layer chromatography (TLC), high performance liquid chromatography (HPLC), and gas chromatography. 2 Procedures can be time consuming and costly, both in equipment and reagents. Development and validation of analytical methods is particularly expensive with experimental medications since no compendial methods exist. The objective of the current study was to investigate the potential applicability of ion mobility spectrometry (IMS) as a rapid technique to identify the presence or absence of active drug in blinded tablet samples.

SOURCE: Smiths Detection