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|Title:||Pharmaceutical formulations of bivalirudin and processes of making the same|
|Abstract:||Pharmaceutical batch(es) or pharmaceutical formulation(s) comprising bivalirudin as the active ingredient, and a method of preparing the pharmaceutical batch(es) or pharmaceutical formulation(s). The pharmaceutical batch(es) or pharmaceutical formulation(s) may have a maximum impurity level of Asp.sup.9-bivalirudin that does not exceed about 0.6%. Also, the pharmaceutical batch(es) or pharmaceutical formulation(s) may have a reconstitution time that does not exceed about 42 seconds. The method of preparing the pharmaceutical batch(es) or pharmaceutical formulation(s) may comprise dissolving bivalirudin in a solvent to form a first solution, efficiently mixing a pH-adjusting solution with the first solution to form a second solution in which the pH-adjusting solution may comprise a pH-adjusting solution solvent, and removing the solvent and the pH-adjusting solution solvent from the second solution.|
|Inventor(s):||Krishna; Gopal (Parsippany, NJ), Musso; Gary (Parsippany, NJ)|
|Assignee:||The Medicines Company (Parsippany, NJ)|
Patent Claim Types:|
see list of patent claims
|Composition; Compound; Process;|
Back Citations: 11th percentile
Forward Citations: 1st percentile
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Type||RLD||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Patented / Exclusive Use|
The Medicines Co
|INJECTABLE;INTRAVENOUS||020873-001||Dec 15, 2000||RX||Yes||7,598,343*PED||► subscribe||Y|
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