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- W2130536643 abstract "A therapeutical non-equivalence case between two carbamazepine pediatric suspensions was investigated for suspected differences either in carbamazepine raw materials used or in vitro dissolution rate, for which compendia methods do no exist. There were not significant differences in surface tension between the products neither in intrinsic dissolution coefficients between the correspondent carbamazepine substances, while DSC results show a slightly increased fraction of the more soluble beta polymorph carbamazepine used in the reference product. The increased dissolution rate for the last one may be more realistically explained by a higher surface area, from Malvern Size particle distribuition result. A dissolution procedure using paddle method 50 rpm and 900 mL of water is suggested, for the minimum possible sample 1 mL of 2% carbamazepine suspension normally collectable. Though not yet totally performed in sink conditions, the method showed a good discriminating power, still more if NaCl 15% in water as medium is used, to block the effect of surfactant present in both the formulations. Moreover, dissolution results fitted by Weibull function with the aid of a non linear program Comstat (Sidec, Brussels), based on a Steepest Descent algorithm, allowed to calculated U (form of the curve) and Td (time) parameters that are very useful in the general case of ultra fast dissolution kinetcs, like suspension-formulated drug products, not only to compare several curves but mainly to extrapolate percent dissolved times not obtained in experimental data, making essier the establishment of compendia specifications." @default.
- W2130536643 created "2016-06-24" @default.
- W2130536643 creator A5031298339 @default.
- W2130536643 date "2005-01-01" @default.
- W2130536643 modified "2023-10-15" @default.
- W2130536643 title "Estudo de uma inequivalência terapêutica entre duas suspensões de carbamazepina e desenvolvimento de método de dissolução biorrelevante" @default.
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- W2130536643 hasPublicationYear "2005" @default.
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