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Ethno Pharmacological Relevance:  Acetylharpagide is a monomeric compound extracted from  Ajuga decumbens , widely used for remedying infectious and inflammatory diseases in Southern China.   Aim of the Study:  The present study designed and investigated the formulation of colon-targeted acetylharpagide tablets according to the dual controlled release mechanisms of time-delay and pH-sensitivity.   Materials and Methods:  The core tablets of acetylharpagide were coated with the material used in time-delay systems such as ethyl cellulose and suitable channeling agent, followed by pH-dependent polymers, polyacrylic resin II and III in a combination of 1:4. Furthermore, the release and absorption performance of colon-targets tables were evaluated  in vitro  and  in vivo . In the  in vitro  tests, the optimized formulation was not released in simulated gastric fluid in 2 h; the release was <5% at pH 6.8 simulated intestinal fluids for 4 h; the drug was completely released within 5 h at pH 7.6 simulated colon fluid. In the  in vivo  tests, pharmacokinetic characteristics of the colon-targeted tablets were investigated in dogs.   Results:  The results indicated that the acetylharpagide tablets with the technology of colon-targeting caused delayed T max , prolonged absorption time, lower C max , and AUCINF_obs. Meanwhile, the apparent volume of distribution (Vz_F_bs) of the colon-target tablets was higher than the reference.   Conclusions:  These results suggested that colon-targeted acetylharpagide tablets deliver the drug to the colon. The  in vitro  performance of colon-targeted acetylharpagide tablet was appropriately correlated with its performance  in vivo .

Preparation of Colon-Targeted Acetylharpagide Tablets and its Release Properties in vivo and in vitro