.

Deeper Knowledge, Faster

  • Analyze global market entry opportunities
  • Uncover prior art in expired and abandoned patents
  • Drug patents in 130+ countries

► See Plans & Pricing

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

Serving 500+ biopharmaceutical companies globally:

Baxter
Teva
Federal Trade Commission
Cipla
McKesson
Merck
Boehringer Ingelheim
Covington
Cerilliant
Citi

Generated: September 26, 2017

DrugPatentWatch Database Preview

Claims for Patent: ► Subscribe

« Back to Dashboard

Claims for Patent: ► Subscribe

Title:Liquid pharmaceutical formulations of palonosetron
Abstract: The present invention relates to shelf-stable liquid formulations of palonosetron for reducing chemotherapy and radiotherapy induced emesis with palonosetron. The formulations are particularly useful in the preparation of intravenous and oral liquid medicaments.
Inventor(s): Calderari; Giorgio (Rancate, CH), Bonadeo; Daniele (Casalzuigno, CH), Cannella; Roberta (Varese, IT), Macciocchi; Alberto (Melide, CH), Miksztal; Andrew (Palo Alto, CA), Malefyt; Thomas (Carmel Valley, CA), Lee; Kathleen M (Palo Alto, CA)
Assignee: Helsinn Healthcare SA (Lugano/Pazzallo, CH) Roche Palo Alto LLC (Palo Alto, CA)
Application Number:13/901,288
Patent Claims: 1. A method of manufacturing and terminally sterilizing a finished single unit dose vial of palonosetron or a pharmaceutically acceptable salt thereof comprising: a) providing one or more sterile open containers; b) filling said containers with about 5 ml of an aqueous pharmaceutically stable solution of palonosetron or a pharmaceutically acceptable salt thereof; c) sealing said filled containers; d) terminally sterilizing said sealed, filled containers; and e) optionally adjusting said solution to a pH of from about 4.0 to about 6.0 prior to step (c), wherein the pharmaceutically stable solution comprises palonosetron hydrochloride in an amount of about 0.25 mg based on the weight of its free base, an aqueous carrier, and a tonicity agent, and wherein the pharmaceutically stable solution optionally comprises one or a combination of mannitol, a chelating agent, and a citrate buffer.

2. The method of claim 1, wherein said solution comprises a pH adjusting agent.

3. The method of claim 1, wherein said solution has a pH of from 4.5 to 5.5, and wherein said solution further comprises mannitol.

4. A finished single unit dose vial of palonosetron or a pharmaceutically acceptable salt thereof manufactured by the method of claim 3.

5. The method of claim 1, wherein said solution further comprises a pH adjusting agent, a chelating agent, and mannitol.

6. The method of claim 1, wherein said solution comprises HCl or NaOH as a pH adjusting agent, a chelating agent, and mannitol.

7. The method of claim 1, wherein said solution comprises a chelating agent and mannitol.

8. The method of claim 1, wherein said solution comprises a chelating agent.

9. The method of claim 1, wherein said solution comprises mannitol.

10. A finished single unit dose vial of palonosetron or a pharmaceutically acceptable salt thereof manufactured by the method of claim 1.

11. A method of manufacturing and terminally sterilizing a finished single unit dose vial of palonosetron or a pharmaceutically acceptable salt thereof comprising: a) providing one or more sterile open containers; b) filling said containers with an aqueous pharmaceutically stable solution of palonosetron or a pharmaceutically acceptable salt thereof having a palonosetron concentration of 0.05 mg/mL based on the weight of its free base; c) sealing said filled containers; d) terminally sterilizing said sealed, filled containers; and e) optionally adjusting said solution to a pH of from about 4.0 to about 6.0 prior to step (c), wherein the pharmaceutically stable solution comprises palonosetron hydrochloride in a concentration of 0.05 mg/mL based on the weight of its free base, an aqueous carrier, and a tonicity agent, and wherein the pharmaceutically stable solution optionally comprises one or a combination of mannitol, a chelating agent, and a citrate buffer.
« Back to Dashboard

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

Serving 500+ biopharmaceutical companies globally:

Healthtrust
Daiichi Sankyo
QuintilesIMS
Harvard Business School
McKinsey
Accenture
Moodys
Chinese Patent Office
Novartis
Colorcon

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted Heap | Mobile and Web Analytics
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot