Effect of Active Pharmaceutical Ingredient Particle Size on the in vitro and in vivo Equivalence of Nifedipine Sustained-Release Tablets(Ⅰ)
OBJECTIVE To study the effect of different particle size of nifedipine on the in vitro and in vivo equivalence of its sustained-release tablets(Ⅰ),and confirm the appropriate range.METHODS The effect of API with different particle size on the dissolution of nifedipine sustained-release tablets(Ⅰ)was evaluated by experimental design and dissolution similarity factors(f2),and the in vitro dissolution and in vivo bioequivalence of the commercial products with the reference preparations were compared.RESULTS The dissolution of the industrial products prepared by micronizing the API to Dv90 ≤20 μm is similar to the reference preparations in four dissolution media in vitro,and both are bioequivalent in vivo.CONCLUSION The particle size of API is the key factor affecting the release and equivalence of nifedipine sustained-release tablets(Ⅰ).
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