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Self-modeling curve resolution method applied for the evaluation of dissolution testing data: A case study of meloxicam-mannitol binary systems
Authors:Róbert Rajkó  Parya Reisi Nassab
Institution:a Department of Mechanical and Process Engineering, Faculty of Engineering, University of Szeged, Moszkvai krt. 5-7, H-6725 Szeged, Hungary
b Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Szeged, Eötvös u. 6., H-6720 Szeged, Hungary
Abstract:This paper introduces some chemometric methods, i.e., self-modeling curve resolution (SMCR), multivariate curve resolution-alternating least squares (MCR-ALS) and parallel factor analysis (PARAFAC and PARAFAC2), which are used to evaluate in vitro dissolution testing data detected by a UV-vis spectrophotometer on meloxicam-mannitol binary systems. These systems were chosen because of their relative simplicity to apply as part of the validation process illustrating the effectiveness of the developed and applied chemometric method. The paper illustrates the failure of PARAFAC methods used before for pharmaceutical data evaluations as well, and we suggest application of the feasible band form given by SMCR as a more general procedure.Steps to improve the dissolution behavior of drugs have become among the most interesting aspects of pharmaceutical technology, and our results show that a larger particle size of meloxicam is advantageous for dissolution. Instead of the use of only one characteristic wavelength, appropriate chemometric methods can furnish more information from dissolution testing data, i.e., the individual dissolution rate profiles and the individual spectra for all the components can be obtained without resorting to any separation techniques such as HPLC.
Keywords:Dissolution test  Meloxicam-mannitol binary systems  Chemometrics  Self-modeling curve resolution (SMCR)  Multivariate curve resolution-alternative least squares (MCR-ALS)  Parallel factor analysis (PARAFAC)
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