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BIBR 1048 MS tartaric acid solution is an oral solution formulation of dabigatran etexilate mesylate (BIBR 1048 MS), developed by Boehringer Ingelheim. The active ingredient, dabigatran etexilate, is an orally bioavailable double prodrug of dabigatran (BIBR 953 ZW), which acts as a potent, competitive, and reversible direct thrombin inhibitor. By binding to the active site of thrombin, it inhibits both free and clot-bound thrombin, preventing the conversion of fibrinogen to fibrin and thereby inhibiting thrombus formation. The mesylate salt form and the tartaric acid solution formulation were designed to enhance gastrointestinal absorption by creating an acidic microenvironment, overcoming the high polarity and low oral bioavailability of the active moiety dabigatran. This specific solution formulation has been utilized as a reference treatment in Phase 1 crossover bioavailability studies and was also developed as a pediatric oral solution for the treatment and prevention of venous thromboembolism.
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