FIELD: medicine; pharmaceuticals.
SUBSTANCE: invention relates to a method of producing powder, a powder for treating blood coagulation forms of insufficiency or diseases, a pharmaceutical composition containing said powder, as well as using powder for preparing a pharmaceutical composition suitable for treating a disease or genetic disorder associated with a protein which is a human coagulation factor. Method for producing powder containing one or more proteins representing a human blood coagulation factor and a lactic acid-based polymer involves the following steps: mixing and dispersing in water a polymer based on lactic acid with particle size d50 in range of 0.1–2 mcm and one or more proteins representing the human blood coagulation factor; drying dispersion at temperature of not more than 45 °C; pressing the mass dried from the dispersion; grinding of pressed, dried from dispersion mass into powder with particle size d50 in the range from more than 0.5 to not more than 5 mcm. Polymer based on lactic acid is a copolymer polymerised from lactide and glycolide links. One or more proteins representing the human blood coagulation factor are selected from a group comprising factor VIII = anti-haemophilic factor A, factor IX = anti-hemophilic factor B, von Willebrand factor or any combination thereof. Stage c) pressing of dried mass is carried out with compression force from 0.2 to 2 kN.
EFFECT: technical result is obtaining a powder suitable for suspension in water for injections, preferably for intravenous injections, into the human body; development of a soft method of producing said powder, preserving therapeutic or cascade activity with respect to blood coagulation protein, which is a blood coagulation factor, without loss of activity or with low losses.
12 cl, 18 tbl
