METHOD OF MANUFACTURING AN EMBOLIZING AGENT PRECURSOR
Disclosed herein are methods relating to manufacturing an embolizing agent precursor. Manufacture of the embolizing agent precursor may involve mixing a first component contained within a first container with a second component contained within a second container, the first component including a plurality of negatively charged gaseous components and a first stabilizer, the second component comprising a plurality of positively charged oil components, a second stabilizer, and a cationic surfactant. Further steps may include mixing the first component with the second component such that the first and second component are held together as a single agglomerated entity.
1 . A method of manufacturing an embolizing agent precursor, comprising:
combining a first component contained within a first container with a second component contained within a second container, the first component comprising a plurality of negatively charged gaseous components and a first stabilizer, the second component comprising a plurality of positively charged oil components, a second stabilizer, and a cationic surfactant;
mixing the first component with the second component such that the first and second component are held together as a single agglomerated entity;
adjusting the size of individual oil components from 1 µm to 5 µms;
modifying the pH of the second component to 6.1-7.4;
adjusting the volume concentration of individual oil components to a target concentration of 1-10 µl microdroplets/ml.
2 . The method of claim 1 , further comprising removing excess stabilizer.
3 . The method of claim 1 , wherein the first component is produced in-situ in a colloid mill, simultaneously feeding first stabilizer and gas.
4 . The method of claim 3 , further comprising removing individual gaseous components that have a diameter less than 1 µm.
5 . The method of claim 1 , further comprising providing the first component in a lyophilised form.
6 . The method of claim 1 , wherein the second component is prepared from a thermally sterilised lipid dispersion and a sterile filtered oil component.
7 . The method of claim 6 , wherein the second component is produced in-situ in a colloid mill, simultaneously fed with the lipid dispersion and the oil component, thereby forming a raw emulsion.
8 . The method of claim 7 , wherein the raw emulsion is size fractionated in an in-line centrifuge, removing excess stabiliser that could contaminate the attraction between first component and the second component.
9 . The method of claim 1 , wherein the agglomerated entity is stable for at least 1 hour.