LYOPHILIZATION METHOD TO IMPROVE EXCIPIENT CRYSTALLIZATION

LYOPHILIZATION METHOD TO IMPROVE EXCIPIENT CRYSTALLIZATION
Inventor: JUNEAU JENNIFER (US); KNOWLES SUSAN (US)
Applicant: WYETH CORP (US); JUNEAU JENNIFER (US)
EC: A61K9/19
IPC: A61K9/00; A61K9/19; A61K9/00
Publication info: WO2005089712
Date: 2005-09-29
Abstract of WO2005089712
The present invention provides improved methods to lyophilize (freeze-dry) active ingredients such as proteins, nucleic acids and viruses. The present methods improve the degree of excipient crystallization during lyophilization over prior methods. The improvement in excipient crystallization is based, in part, on a high-temperature annealing step that is conducted prior to or at the same time as secondary drying. Importantly, the hightemperature annealing step does not destabilize active ingredients. Further, the hightemperature annealing step does not require sub-zero annealing steps prior to its enactment in order to provide complete excipient crystallization.
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