Methodological study on the consistency evaluation of dissolution of cefditoren pivoxil tablets
Objective To select a prescription through different dissolution conditions to ensure that the self-made sample has the same in vitro dissolution as the original reference formulation.Methods We investigated the dissolution performance of cefditoren pivoxil tablets using the(f2)similarity factor of the US Food and Drug Administration non model dependent method.A sodium chloride hydrochloric acid mixture was used as the dissolution solution,with a volume of 900 mL.The paddle method was used,rotating speed 50 r·min-1,and UV-visible spectrophotometer was used,The measurement wavelength was 272 nm.Finally,we compared the dissolution performance of self-made cefditoren pivoxil tablets with the reference formulation,and determined their dissolution performance and corresponding influencing factors.Results The curve equation for ceftriaxone is A=3.25 × 10-2 C-1.80 × 10-2(R2=0.999 7),with a linear range of 7.5-22.5μg·mL-1,with an average recovery rate of 99.33％.Through the dissolution testing method used,we found that in the in vitro experiment,the difference in dissolution similarity factor of f2 between the self-made sample and the reference formulation we used was very small and met expectations.Conclusion The dissolution test method for cefditoren pivoxil tablets is suitable for the development of this formulation.Prescription formulations selected by comparing similar factors can significantly improve the success rate of bioequivalence.
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