47 results about "Dabigatran Etexilate Mesylate" patented technology

The invention discloses a pharmaceutical composition containing dabigatran etexilate and a preparation method thereof. The pharmaceutical composition includes a pharmaceutical active ingredient and an amphoteric polymer; wherein, the pharmaceutical active ingredient is dabigatran etexilate and / or dabigatran etexilate mesylate, and the amphoteric polymer is polyvinyl caprolactam-polymer Vinyl acetate-polyethylene glycol graft copolymer; and the mass ratio of the active pharmaceutical ingredient and the amphoteric polymer is 1:0.23-1:3. The pharmaceutical composition can not only improve the bioavailability of the active ingredients of the drug, but also reduce the variability of absorption while providing a more stable concentration of dabigatran in plasma, thereby reducing adverse side effects and reducing the possibility of GIT bleeding. In addition, due to enhanced absorption, there was a significant reduction in unabsorbed DEM in the gastrointestinal tract, which further alleviated GIT hemorrhage.

The invention discloses a multi-layer tablet containing dabigatran etexilate mesylate. The multi-layer tablet comprises a tablet core and a coating film; the tablet core comprises at least one drug-containing layer containing dabigatran etexilate mesylate and at least one organic acid layer. The multi-layer tablet is capable of increasing the solubility in vivo and the absorption rate in vivo, and also capable of effectively controlling the release time in vivo, and further is low in batch difference, and therefore, the safety of drug use is improved. Meanwhile, the multi-layer tablet is used for solving the problem that other substances are generated due to crystal transformation in the production and storage processes, and the production quality is improved and the storage time is prolonged. In addition, the multi-layer tablet further has the characteristics of convenience for swallowing, simple production process and high reproducibility.

The present invention provides crystalline form of intermediates of Formula 2A,The present invention also provides process for the preparation of dabigatran etexilate mesylate; polymorph of intermediates thereof; particularly processes for the preparation of crystalline form of intermediates. The present invention also relates to the use of crystalline intermediates for the preparation of dabigatran etexilate mesylate.

The invention discloses a methane sulfonic acid pradaxa pellet and a preparation method and belongs to the technical field of medicals. The structure of the pellet comprises a pellet core, an isolating layer and a drug-containing layer, wherein the isolating layer is wrapped on the outer layer of the pellet core; the drug-containing layer is wrapped on the outer layer of the isolating layer; glycine and hydroxypropyl methylcellulose are contained in the pellet core; hydroxypropyl methylcellulose phthalic ester and talcum powder are contained in the isolating layer; methane sulfonic acid pradaxa, methyl methacrylate and talcum powder are contained in the drug-containing layer. The surface of the isolating layer of the pellet prepared according to the invention is round and smooth; no so-called satellite particle exists; the completeness of the isolating layer is not influenced, so that the active ingredients and the glycine can be effectively isolated in space and the stability of the active ingredients of the preparation in a storage process can be guaranteed. The methane sulfonic acid pradaxa pellet prepared according to the invention has the effects of preventing and treating cerebral ischemia and systemic embolism diseases.