Invention Grant
- Patent Title: Pharmaceutical compositions containing pemetrexed having extended storage stability
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Application No.: US13806624Application Date: 2011-07-26
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Publication No.: US09655898B2Publication Date: 2017-05-23
- Inventor: Nagesh R. Palepu , Philip Christopher Buxton
- Applicant: Nagesh R. Palepu , Philip Christopher Buxton
- Applicant Address: US NJ Woodcliff Lake
- Assignee: EAGLE PHARMACEUTICALS, INC.
- Current Assignee: EAGLE PHARMACEUTICALS, INC.
- Current Assignee Address: US NJ Woodcliff Lake
- Agency: Lucas & Mercanti, LLP
- International Application: PCT/US2011/045341 WO 20110726
- International Announcement: WO2012/015810 WO 20120202
- Main IPC: A61K31/519
- IPC: A61K31/519 ; A61K9/08 ; A61K47/10 ; A61K47/12 ; A61K47/18

Abstract:
Long term storage stable pemetrexed-containing liquid pharmaceutical compositions are disclosed. The compositions can include pemetrexed or pharmaceutically acceptable salts thereof; an antioxidant selected from lipoic acid, dihydrolipoic acid, methionine and mixtures thereof; a chelating agent selected from lactobionic acid, sodium citrate, tribasic and mixtures thereof; and a pharmaceutically acceptable fluid. The pH of the compositions is in a range of about 8 to about 9.5. The pemetrexed-containing compositions have less than about 5% total impurities, on a normalized peak area response (“PAR”) basis as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 227 nm, after at least about 18 months of storage at a temperature of from about 5° C. to about 25° C. Methods of preparing the formulation as well as methods of treatment of pemetrexed-susceptible diseases using the same are also disclosed.
Public/Granted literature
- US20130231357A1 PHARMACEUTICAL COMPOSITIONS CONTAINING PEMETREXED HAVING EXTENDED STORAGE STABILITY Public/Granted day:2013-09-05
Information query
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