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COMPOSITIONS AND METHOD FOR STABILIZING A PHARMACEUTICAL FORMULATION, AND METHODS OF MAKING AND USING THE SAME
专利权人:
Xin WEN
发明人:
Xin WEN,Sen WANG
申请号:
US15807405
公开号:
US20180133329A1
申请日:
2017.11.08
申请国别(地区):
US
年份:
2018
代理人:
摘要:
The disclosure pertains to compositions to stabilize nutrient, food, pharmaceutical, and biological formulations by preventing the crystallization or precipitation of carbohydrates used in the formulations. The compositions contain (i) one or more carbohydrates, sugars, sugar alcohols, analogs thereof, and/or derivatives thereof and (ii) one or more antifreeze proteins (AFPs), mimetics thereof, and/or analogs thereof and methods of making and using the same. The AFP may be selected from antifreeze polypeptides and antifreeze peptides, analogs and mimetics of antifreeze proteins, active fragments of such antifreeze proteins, polypeptide and peptide mimetics, antifreeze peptoids and polymers, and combinations thereof. The carbohydrate, sugar or sugar alcohol has the formula CmHnOp, where m is an integer of 5 or 6, n is an integer of 2m or 2m+2, and p is equal to m, or the formula CaHbOc, where a is an integer of 10-12 or 15-18, b is 2a−2 when a is an integer of 10-12 or 2a−4 when a is an integer of 15-18, and c is a−1 when a is an integer of 10-12 or a−2 when a is an integer of 15-18. The AFP, AFP analog, or AFP mimetic inhibits or controls crystallization of the carbohydrate (e.g., during the storage of the solution of the carbohydrate or the analog or derivative thereof, during the freeze-drying of a formulation using the carbohydrate or the analog thereof) and stabilize the solution or the formulation using the carbohydrate or the carbohydrate analog or derivative.
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