LYOPHILISED PRODUCT AND SUSPENSION OF GAS-FILLED MICROVESICLES Russian patent published in 2024 - IPC A61K49/22 A61K9/10 A61K9/127 A61K9/19 

FIELD: chemistry.

SUBSTANCE: group of inventions relates to production and use of ultrasound imaging techniques with contrast enhancement. Disclosed is a method of producing a lyophilised composition containing (i) an amphiphilic substance comprising a phospholipid and a fatty acid, and (ii) polyethylene glycol as a protective component for lyophilisation, and suitable for preparing a suspension of stabilized gas-filled microvesicles, where the method includes: a) obtaining a liquid mixture comprising said amphiphilic substance and said protective component for lyophilisation in a solvent; b) lyophilizing the liquid mixture to remove said solvent and obtain a lyophilised product; and c) heating said lyophilised product at atmospheric pressure at a temperature higher than 35 °C and up to 50 °C for a period of time from 8 to 20 hours. Following is also proposed: method of making a suspension of gas-filled microvesicles, which involves reconstitution of a lyophilised product obtained according to said method using a pharmaceutically acceptable liquid carrier in the presence of a physiologically acceptable gas with gentle stirring, and a diagnostic method, which includes (i) administering to a patient a suspension of gas-filled microvesicles obtained by said method; and (ii) detecting the ultrasound signal from the region of interest in said patient.

EFFECT: use of the group of inventions provides improved characteristics of the suspension of gas-filled microvesicles obtained by reconstitution of the lyophilised product, which is subjected to additional thermal treatment, compared to suspensions obtained from lyophilised products that have not been subjected to such thermal treatment; in particular, the above thermal treatment of the lyophilised product leads to increased pressure resistance of gas-filled microvesicles, which, as a rule, exhibit an increased duration of presence in the bloodstream after injection.

19 cl, 6 tbl, 4 ex