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Impact of controlled vacuum induced surface freezing on the freeze drying of human plasma.

Abstract：

:During the freezing step of a typical freeze drying process, the temperature at which nucleation is induced is generally stochastically distributed, resulting in undesired within-batch heterogeneity. Controlled nucleation techniques have been developed to address this problem; these make it possible to trigger the formation of ice crystals at the same time and temperature in all the batch. Here, the controlled nucleation technique known as vacuum induced surface freezing is compared to spontaneous freezing for the freeze drying of human plasma, a highly concentrated system commonly stored in a dried state. The potency of Factor VIII (FVIII), a sensitive, labile protein present in plasma, and the reconstitution time of the dried cakes are evaluated immediately after freeze drying, and after 1, 3, 6 or 9 months storage at different degradation temperatures. We show that the application of controlled nucleation significantly reduces the reconstitution time and in addition helps to improve FVIII stability.

journal_name

Int J Pharm

journal_title

International journal of pharmaceutics

authors

Arsiccio A,Matejtschuk P,Ezeajughi E,Riches-Duit A,Bullen A,Malik K,Raut S,Pisano R

doi

10.1016/j.ijpharm.2020.119290

subject

Has Abstract

pub_date

2020-05-30 00:00:00

pages

119290

eissn

0378-5173

issn

1873-3476

pii

S0378-5173(20)30274-X

journal_volume

582

pub_type

杂志文章

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