The Feasibility Study On Construction Of Near Infrared System For Fast Drug Analysis

Fake and counterfeit drugs are serious problems in countries all over the world, and are most severe in developing countries. It not only puts people's lives in danger, but also causes enormous damage to legitimate pharmaceutical companies in terms of profit loss and damage to reputation. With support from the Chinese State Food and Drug Administration (SFDA) a large scale study on the feasibility of using Near Infrared Spectroscopy (NIR) as a quick screening tool for fakes and counterfeits was carried out by the National Institute for the Control of Pharmaceutical and Biological Products of China.In this paper, the tablets of macrolides antibiotics were used as examples for the study on how to build a universal quantitative or qualitative model for quick analysis of a given pharmaceutical product from different manufacturers, then the transferability of these universal models in multiple instruments were evaluated.Three kinds of discriminant analysis models used to identify and verify authentic tablets of macrolides antibiotics were developed and tested. These models can differentiate the same tablets from different manufacturers. Qualitative modeling focuses mainly on spectral signatures from the active ingredients. The study will address selection criteria for calibration sample sets, choice of spectral regions to be used for discriminant analysis, data pre-treatments, and proper threshold setting to effectively differentiate products. Furthermore, in order to test the accuracy and stability of these models, both positive and negative challenge samples were used for validation. Then the rules on how to set up these universal qualitative models were summarized.On the other hand, universal quantitative models were developed for the analysis of "Roxithromycin" and "Erythromycin Ethylsuccinate" from different manufacturers. The two quantitative models were built from 78 batches of "Roxithromycin" samples from 18 different manufacturers with a concentration range of 19.49% to 73.86%, and 66 batches "Erythromycin Ethylsuccinate" samples from 36 manufacturers with a concentration range of 28.12% to 70.87%. Based on the ICH guidelines, the quantitative models were then evaluated in terms of selectivity, linearity, accuracy, precision, robustness and model transferability. Since the study is for a large-scale effort to control fakes and counterfeits in China, the model performance over the multiple instruments was also evaluated.Our results have shown that it is feasible to build a universal quantitative or qualitative model for quick analysis of a given pharmaceutical product from different manufacturers and these models can be transferred directly to different instruments of the same brand without any mathematical pretreatments.