Prediction of the stability of polymeric matrix tablets containing famotidine from the positron annihilation lifetime distributions of their physical mixtures |
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Authors: | Virá g Szente,Ká roly Sü vegh,Tamá s Marek,Romá na Zelkó |
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Affiliation: | 1. Gedeon Richter Plc., Formulation R&D, Gyömr?i Str. 19-21, H-1103 Budapest, Hungary;2. Laboratory of Nuclear Chemistry, Eötvös Loránd University/HAS Chemical Research Center, P.O. Box 32, H-1518 Budapest 112, Hungary;3. Laboratory of Nuclear Chemistry, Chemical Research Center Hungarian Academy of Sciences, Pázmány P. s 1/A, H-1117 Budapest, Hungary;4. University Pharmacy Department of Pharmacy Administration, Semmelweis University, H?gyes Endre Str. 7-9, H-1092 Budapest, Hungary |
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Abstract: | The aim of the present work was to elucidate the impact of the structural changes of polymeric excipients during the course of storage on the drug release stability of tablets containing different polymers. Matrix tablets were formulated with famotidine as a model drug, using polyvinylpyrrolidone and carbopol matrix. Dissolution tests were carried out before and after storing the tablets under stress conditions for different time intervals. Parameters characterizing the release kinetics of matrix tablets, just as difference and similarity factors, were calculated to compare the release profiles as a function of storage time. Positron annihilation lifetime measurements were carried out to track the structural changes of the physical mixtures containing polymers during the course of storage. The changes in the positron lifetime distribution curves of the famotidine-polymer mixtures were in good correlation with the significant changes of release parameters of tablets. Thus the method would be a valuable tool for the screening of possible destabilizing interactions in the preformulation phase. |
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Keywords: | Drug release kinetics Similarity and difference factors Positron annihilation lifetime spectroscopy Famotidine Polymers |
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