Preparation and evaluation of dabigatran etexilate solid self-microemulsion dispersible tablets
LIU Xiao-qing
ZHENG Chun-li
DING Ya-fei
ZHANG Ya-jie
CHAI Fu-juan
CHEN Min
Abstract：Objective:To prepare dabigatran etexilate self-microemulsion dispersible tablets and investigate their qualities in vitro.Methods:The tablets were prepared by direct powder compression method.Solid adsorbent materials which can completely release drug within 45 min were screened,and the formulation of dispersible tablets was optimized by single factor experiments.Results:Microcrystalline cellulose (MCC) KG 802 was selected as a suitable solid adsorbent,which can effectively absorb the dabigatran etexilate self-microemulsion and form solid adsorption mixture (Mix).The final formulation was determined as follows:Mix 25％,disintegrating agent PVPP 25％,a suitable amount of lubricant composed of 4％ micropowder silica gel and 0.5％ magnesium stearate,and the remaining was MCC 102 as the filler.The hardness,friability,uniform dispersion and disintegration time of the tablets met the requirements.In vitro study showed that the dispersible tablets could disperse in distilled water to form microemulsion with an average particle size of 200 ～230 nm,which was comparable to the particle size of liquid dabigatran etexilate self-microemulsion.Conclusion:The self-microemulsion dispersible tablets can keep the characteristics of liquid self-microemulsion and is expected to improve the bioavailability of dabigatran etexilate,which may expand the applications of self-microemulsifying drug delivery system.
Keywords：dabigatran etexilateself-microemulsionsolid self-microemulsiondispersible tabletsquality evaluation
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 1942-1947 )