Determination method for in vitro disintegrating time of oral disintegrating tablets of Chinese herbal drug / 第二军医大学学报

ABSTRACT

Objective: To develop methods for determining the disintegration time of oral disintegrating tablets (ODTs) of Chinese herbal drug, and to select the evaluation method with good reproducibility, resolving power, and in vivo and in vitro correlation. Methods: Several placebo ODTs and Chinese herbal drug ODTs were prepared. Their in vitro disintegration time was determined by self-developed method and routine methods, and the results were compared with the oral disintegration time. The reproducibility, resolving power, and the correlation between in vivo and in vitro of those methods were evaluated. Results = Different determination methods obtained different disintegration results of the same tablet. Graduated cylinder and improved disintegration apparatus both had shortcomings and their determination results were very different from that of the oral disintegration time. Our self-developed disintegration device could better determine the disintegration ability of the ODTs, and the result was closer to the oral disintegration time, with clear end point of disintegration and better reproducibility, resolving power, and the in vivo and in vitro correlation compared with other methods. Conclusion: Our self-developed device is suitable to determine in vitro disintegration time of ODTs, and may serve as a reference for quality control of ODTs.