Correlation studies between thermal and dissolution rate constants of cimetidine drug and tablets |
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Authors: | de Souza F S Basílio I D Oliveira E J Macwdo R O |
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Institution: | (1) Unidade de Desenvolvimento e Ensaio de Medicamentos, Laboratório de Tecnologia Farmacwutica, Universidade Federal da Paraíba, Campus I, Joăo Pessoa, PB 58059-900, Brazil |
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Abstract: | This work developed a methodology that can potentially be applied to the quality control of cimetidine drug substance and
its tablets. The kT obtained at different temperatures (200, 190, 180, 170 and 160°C) were determined by isothermal thermogravimetric
method using the classical Arrhenius equations. The dissolution profiles were obtained using USP 24 (Method 711) and rate
constants (kD) were determined by Kitazawa equations. An evaluation was made to check if there was statistically significant correlation
between the two variables kT and kD. Isothermal TG data were used to determine the reaction order and degradation reaction
rate constants. The results showed that in all temperatures thermal order (kT) was: C<A<B tablets, while dissolution order (kD) was: C<A<B tablets. In conclusion, correlation between kT/kD seems to be a suitable method for detecting possible interactions between cimetidine and excipients in development or manufacturing
changes, particularly for immediate release dosage forms and therefore could be especially useful on quality control.
This revised version was published online in July 2006 with corrections to the Cover Date. |
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Keywords: | dissolution rate constants cimetidine thermal analysis |
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