Storage-stable ready-to-use injectable formulations of thiotepa

Storage-stable ready-to-use injectable formulations of thiotepa

A stable, ready-to-use injectable solution including thiotepa and one or more pharmaceutically acceptable solvents, co-solvents, and/or solubilizing agents. Formulations retain at least 90% and as high as 99% of the purity of thiotepa as measured by HPLC after storage at 25° C./60% RH for a period o...

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Bibliographische Detailangaben
Hauptverfasser: Indravadanbhai, Nirmal Chaitanya, Kannappan, Jayaraman, Kovi, Ravishanker, Thomas, George Roby, Reddy, Thupalli Ajeykumar, Manubhai, Patel Mitesh
Format: Patent
Sprache:eng
Schlagworte:
HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
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Beschreibung
Zusammenfassung:A stable, ready-to-use injectable solution including thiotepa and one or more pharmaceutically acceptable solvents, co-solvents, and/or solubilizing agents. Formulations retain at least 90% and as high as 99% of the purity of thiotepa as measured by HPLC after storage at 25° C./60% RH for a period of 7 days. Certain formulations retain at least 99% of the purity of thiotepa as measured by HPLC after storage for at least six months at 2-8° C.