Formula Screening For Dabigatran Etexilate Mesylate Capsule

Dabigatran etexilate mesylate is the unlisted drugs, with a wide range of applications in clinical practice, currently used for knee replacement surgery or hip replacement surgery, venous thrombosis prophylaxis. However, the formulation of dabigatran etexilate capsule formulation is tartaric acid special pill core multiparticulate formulations, and excipients tartaric have a greater effect on the stability of raw materials, but form an acidic environment in the body, using the excipients is necessary, it requires the use of multiple technologies will tartaric acid particles with the raw material by wrapping the insulating layer separated from the larger preparation difficult. Based on the foreign patent prescription process analysis and original research product testing and analysis, the establishment of tartaric acid, gum arabic, hydroxypropyl methyl cellulose, hydroxypropyl cellulose(SSL), talc(1250), hydroxypropyl methylcellulose fiber Capsule shell as the materials, ethanol(95%) and isopropanol as a solvent, using centrifugal granulator, prepare legal tartaric acid powder layering pellet cores using a fluidized-bag barrier layer, and finally with a fluidized bed contained methanesulfonamide granulating process dabigatran acid ester prepared dabigatran etexilate mesylate capsules meet the quality requirements, quantities of 30,000. And original research product comparison test showed that the test product dissolution profile of the four medium and original development agent similar to the loss on drying and capsule shell dry weight loss and other quality indicators and original research products close, in vitro dissolution behavior, impurity profile of the original research consistent. In line with dabigatran etexilate mesylate capsules quality requirements of the National Center for Drug Evaluation.