FIELD: pharmaceuticals.
SUBSTANCE: group of inventions relates to the field of pharmaceuticals, namely to the use of a composition of alkylated cyclodextrin as a pharmaceutical auxiliary in compositions with a pharmaceutical active agent sensitive to the content of chlorides, containing: alkylated cyclodextrin having an average degree of substitution from 2 to 9; less than 500 ppm of phosphate; and 0.07 wt% or less of chloride; wherein the specified composition has an optical density of less than 1 AU (absorbance units), measured by spectrophotometry in the wavelength range from 245 nm to 270 nm for an aqueous solution containing 300 mg/ml of the specified composition of alkylated cyclodextrin, in a cuvette with an absorbing layer thickness of 1 cm; in this case, the specified alkylated cyclodextrin is a sulfoalkyl ether of cyclodextrin of Formula (II):
,
Formula (II)
wherein p is 4, 5 or 6, and R1 is independently selected in each case from -OH or -O-(C2-C6 alkylene)-SO3--T, wherein T is independently selected in each case from pharmacologically acceptable cations, provided that at least one R1 represents -OH and at least one R1 represents O-(C2-C6 alkylene)-SO3--T; and also to the variant where the specified composition has an optical density of less than 1 AU in the wavelength range from 320 nm to 350 nm. Preferably, the pharmacologically active agent is selected from a group consisting of bortezomib, disulfiram, epigallocatechin-3-gallate, salinosporamide A, and carfilzomib.
EFFECT: group of inventions provides the use of alkylated cyclodextrins with a low content of agents leading to drug decomposition.
26 cl, 13 tbl, 21 ex, 10 dwg
