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|Title:||Process to prepare treprostinil|
|Abstract:||This present invention relates to an improved process to prepare prostacyclin derivatives. One embodiment provides for an improved process to convert benzindene triol to treprostinil via salts of treprostinil and to purify treprostinil.|
|Inventor(s):||Batra; Hitesh (Herndon, VA), Tuladhar; Sudersan M. (Silver Spring, MD), Penmasta; Raju (Herndon, VA), Walsh; David A. (Palmyra, VA)|
|Assignee:||United Therapeutics Corporation (Silver Spring, MD)|
|Filing Date:||Jun 05, 2013|
|Claims:||1. A process for producing a pharmaceutical composition comprising treprostinil, comprising providing a starting batch of treprostinil having one or more impurities resulting from prior alkylation and hydrolysis steps, forming a salt of treprostinil by combining the starting batch and a base, isolating the treprostinil salt, and preparing a pharmaceutical solution from the isolated salt comprising treprostinil or a pharmaceutically acceptable salt thereof from the isolated treprostinil salt, whereby a level of one or more impurities found in the starting batch of treprostinil is lower in the pharmaceutical composition, and wherein said alkylation is alkylation of benzindene triol. |
2. The process of claim 1, wherein the salt is isolated in crystalline form.
3. The process of claim 2, wherein the isolated salt is at least 99.8% pure.
4. The process of claim 1, wherein the base is selected from the group consisting of sodium, ammonia, potassium, calcium, ethanolamine, diethanolamine, N-methylglucamine, and choline.
5. The process of claim 4, wherein the base is diethanolamine.
6. The process of claim 1, wherein the base is combined with treprostinil that has not been previously isolated.
7. The process of claim 1, wherein the isolated salt is stored at ambient temperature.