.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for Patent: 9,156,786

« Back to Dashboard

Details for Patent: 9,156,786

Title:Process to prepare treprostinil, the active ingredient in remodulin.RTM.
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:Jul 02, 2013
Application Number:13/933,623
Claims:1. A process for preparing a pharmaceutical product comprising treprostinil or a treprostinil salt, comprising: combining treprostinil and a base in solution to form a base addition salt; allowing crystallization of the base addition salt of treprostinil; collecting the base addition salt of treprostinil, storing the collected base addition salt at ambient temperature, and preparing a pharmaceutical product comprising treprostinil or a treprostinil salt from the base addition salt after the storage.

2. The process of claim 1, wherein the base addition salt is selected from the group consisting of sodium, ammonia, potassium, calcium, ethanolamine, diethanolamine, N-methylglucamine, and choline.

3. The process of claim 1, further comprising heating the solution of treprostinil and base addition salt.

4. The process of claim 3, further comprising cooling the solution of treprostinil and base addition salt prior to collecting the base addition salt of treprostinil.

5. The process of claim 1, wherein the base comprises an alkali metal cation.

6. The process of claim 5, wherein the alkali metal cation is selected from the group consisting of sodium and potassium.

7. The process of claim 1, wherein the solution comprises a water-miscible organic solvent.

8. The process of claim 1, wherein a mole ratio of the base in solution to treprostinil is about 1.1:1.

9. The method of claim 1, wherein said preparing comprises converting the base addition salt after storage into treprostinil by acidification.

10. The method of claim 1, wherein the quantity of the base addition salt corresponds to a large scale synthesis.

11. The method of claim 9, wherein said converting produces a batch of treprostinil, which has a purity level of treprostinil of at least 99.7% as determined by HPLC.

12. The method claim 11, wherein the batch contains at least 2.9 g of treprostinil.

13. The method of claim 9, wherein said converting produces a batch of treprostinil, which has a purity level of treprostinil of at least 99.8% as determined by HPLC.

14. The method claim 13, wherein the batch contains at least 2.9 g of treprostinil.

15. The method claim 9, wherein the batch contains at least 2.9 g of treprostinil.
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

`abc