IMPROVED STABILITY FOR INJECTION SOLUTIONS, CONTAINING PEPTID-BASED THROMBIN INHIBITOR AND PROCESS FOR PREPARATION THEREOF

摘要

The present invention is a low-molecular-weight, peptide-based, thrombin inhibitor, or parenteral aqueous solution of 3 and 8 k "z" ttipH in a vial, bottle, cartridge with a stopper or plunger containing bromobutyl rubber. or the pre-filled pack containing the pre-filled syringe "lt". The aqueous solution may contain, in addition to the active ingredient, n trium chloride or (hydroxypropyl) - - cyclodextrin (HPbCD). also the above-mentioned primary packaging preparation slurry process, which includes the addition of thrombin inhibitor in water, adjusting the pH of the solution to 3 and 8 k, addition of trium chloride or HPbCD, sterile filtration of the solution, packing into a primary container and sealing with a rubber stopper or plunger containing bromobutyl rubber.