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Budapest, Hungary

Kormany R.,EGIS Pharmaceuticals Plc. | Fekete J.,Budapest University of Technology and Economics | Guillarme D.,University of Geneva | Fekete S.,University of Geneva
Journal of Pharmaceutical and Biomedical Analysis | Year: 2014

The goal of this study was to evaluate the accuracy of simulated robustness testing using commercial modelling software (DryLab) and state-of-the-art stationary phases. For this purpose, a mixture of amlodipine and its seven related impurities was analyzed on short narrow bore columns (50. ×. 2.1. mm, packed with sub-2. μm particles) providing short analysis times. The performance of commercial modelling software for robustness testing was systematically compared to experimental measurements and DoE based predictions. We have demonstrated that the reliability of predictions was good, since the predicted retention times and resolutions were in good agreement with the experimental ones at the edges of the design space. In average, the retention time relative errors were <1.0%, while the predicted critical resolution errors were comprised between 6.9 and 17.2%. Because the simulated robustness testing requires significantly less experimental work than the DoE based predictions, we think that robustness could now be investigated in the early stage of method development.Moreover, the column interchangeability, which is also an important part of robustness testing, was investigated considering five different C8 and C18 columns packed with sub-2. μm particles. Again, thanks to modelling software, we proved that the separation was feasible on all columns within the same analysis time (less than 4. min), by proper adjustments of variables. © 2013 Elsevier B.V.


Vajna B.,Budapest University of Technology and Economics | Farkas I.,Budapest University of Technology and Economics | Szabo A.,Budapest University of Technology and Economics | Zsigmond Z.,EGIS Pharmaceuticals Plc. | Marosi G.,Budapest University of Technology and Economics
Journal of Pharmaceutical and Biomedical Analysis | Year: 2010

Raman imaging method was used to characterize the effect of different manufacturing technologies on properties of the produced tablets, such as compound distribution, polymorphism, strength, and estimated active pharmaceutical ingredient (API) content. The obtained chemical maps were evaluated based on their visual appearance and on the statistical properties of the component scores obtained by direct classical least squares (DCLS) modelling. It is demonstrated that changes in the distribution of the API and excipients can be detected with chemical imaging and these differences are in close relationship with the applied granulation method and with the mechanical properties of the analyzed tablet. It is also shown that the chemical images used for characterizing the component distribution can also be processed for obtaining a cautious estimation to the mass fractions of the components. © 2009 Elsevier B.V. All rights reserved.


Vajna B.,Budapest University of Technology and Economics | Farkas A.,Budapest University of Technology and Economics | Pataki H.,Budapest University of Technology and Economics | Zsigmond Z.,EGIS Pharmaceuticals Plc. | And 2 more authors.
Analytica Chimica Acta | Year: 2012

Chemical imaging is a rapidly emerging analytical method in pharmaceutical technology. Due to the numerous chemometric solutions available, characterization of pharmaceutical samples with unknown components present has also become possible. This study compares the performance of current state-of-the-art curve resolution methods (multivariate curve resolution-alternating least squares, positive matrix factorization, simplex identification via split augmented Lagrangian and self-modelling mixture analysis) in the estimation of pure component spectra from Raman maps of differently manufactured pharmaceutical tablets. The batches of different technologies differ in the homogeneity level of the active ingredient, thus, the curve resolution methods are tested under different conditions. An empirical approach is shown to determine the number of components present in a sample. The chemometric algorithms are compared regarding the number of detected components, the quality of the resolved spectra and the accuracy of scores (spectral concentrations) compared to those calculated with classical least squares, using the true pure component (reference) spectra. It is demonstrated that using appropriate multivariate methods, Raman chemical imaging can be a useful tool in the non-invasive characterization of unknown (e.g. illegal or counterfeit) pharmaceutical products. © 2011 Elsevier B.V.


Patent
Egis Pharmaceuticals Plc | Date: 2015-04-09

Disclosed are gel compositions suitable for the topical administration of an active compound having poor solubility and skin penetration, for example, of a COX-2 inhibitor compounds, processes of preparation thereof and methods of use thereof for the treatment of indications treatable by the active compound.


Patent
Egis Pharmaceuticals Plc | Date: 2014-02-13

Disclosed are gel compositions suitable for the topical administration of an active compound having poor solubility and skin penetration, for example, of a COX-2 inhibitor compounds, processes of preparation thereof and methods of use thereof for the treatment of indications treatable by the active compound.

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