IN VITRO CEFIXIME DISSOLUTION IN PHARMACOPEIA-RECOMMENDED MEDIUM AND SIMULATED GASTROINTESTINAL FLUIDS: A COMPARATIVE STUDY.
Objectives: The objective of this study was compare in vitro dissolution of cefixime in a pharmacopeial-recommended medium and in simulated gastrointestinal fluids.
Methods: Prior to dissolution testing, the drug content in the tested materials were determined by UV spectrophotometer. The dissolution media used in this study were that recommended by the United stated pharmacopeia as well as 4 different media that mimics gastric and intestinal fluids in fed and fasted states. The tested materials included the pure drug and two 200-mg capsules brands (original and test).
Results: The pharmacopeial medium showed no difference in both extent and rate of the drug dissolution between the tested materials. In the contrary, the difference was significant when the simulated fluids were used. Moreover, it was found that the simulated intestinal fluid of fed state showed 21-32% decrement in the drug dissolution compared to that of the corresponding fasted-state simulated fluid. Indeed, this finding was in agreement with those of in vivo bioavailability studies published in the literature.
Conclusion: The simulated intestinal fluid is much more valid as a medium for in vitro testing of cefixime capsule than the one recommended by the USP pharmacopeia.
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