FIELD: medicine; pharmaceuticals.
SUBSTANCE: invention relates to a method for producing lyophilized pellets containing factor VIII, the method comprising the following steps: a) formation of drops of the solution containing factor VIII, and their freezing with formation of pellets, wherein drops are formed by formation of drops of solution containing factor VIII, in cooling tower, which has inner surface of walls with controlled temperature and internal temperature below solution freezing temperature; b) lyophilisation of pellets in a rotating receiver, which is located inside vacuum chamber. Method further includes steps c) storage and homogenisation of lyophilised pellets; d) analyzing the lyophilised pellets during storage and homogenisation thereof; e) loading of lyophilised pellets into containers.
EFFECT: technical result consists in higher specific surface area of pellets, which improves recovery of lyophilised solid substance into liquid for introduction, and more homogeneous pellet morphology, which improves controllability of their properties at later stages of the method.
9 cl, 4 tbl, 4 ex, 12 dwg
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Authors
Dates
2020-10-28—Published
2016-11-04—Filed