Bautista Mercader, Manuel, Tosini, Federico, Schneider, Marcel and Steigmiller, Stefan (2016) Transmission Raman Spectroscopy (TRS): how far can we go with the analysis of capsule based Dry Powder Inhalers? European Pharmaceutical Review, 21 (6). pp. 6-10.

Abstract

During the manufacturing of a pharmaceutical inhalation product (i.e. capsule based Dry Powder Inhaler (DPI)), several analytical tests are typically executed for the control on the product quality before its final release on the market or in a clinical center. Therefore, a rigorous control of the quality (with the adequate qualitative and quantitative analyses) on the raw materials, during and after the bulk manufacturing and after the packaging phase must be performed. Some of these analytical measurements are carried out with techniques that require complex sample preparation with long-time analyses and sample destruction.
For drug product (DP) intended to the clinical studies it is required to perform an additional release step after the primary and secondary packaging phase (Post Packaging Analysis (PPA)) because the final product is blinded before delivery to clinical centers to assure that the clinician and the patient cannot distinguish between different DPs or between DP and Placebo.
Therefore, the application of alternative analytical technologies, which involve shorter analysis running time and no samples destruction, could lead to a cost reduction and faster release of the final DP by maintaining the quality.
Transmission Raman Spectroscopy (TRS) has been evaluated as a Process Analytical Technology (PAT) for the qualitative analysis of capsule based DPIs with low drug substance (DS) concentration spanned between 0.05% and 6%, with the aim to replace the HPLC release identification test.

Item Type:	Article
Date Deposited:	30 May 2017 00:45
Last Modified:	30 May 2017 00:45
URI:	https://oak.novartis.com/id/eprint/30983