Determination of the trapped volume of a liposome
AssigneesMoebius Medical Ltd., Yissum Research Development Company of the Hebrew University of Jerusalem
InventorsYechezkel BARENHOLZ, Keren TURJEMAN, Ron PINKUS
Life of this patent
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Abstract
The present invention relates to a method of determining the trapped volume and the trapped aqueous volume of a plurality of liposomes in a liposomal composition. The method can be used for calculating the concentration of an active pharmaceutical ingredient entrapped within the liposomes and for quality assurance of a pre-formed liposomal composition.
Claims20
A method of determining the specific trapped volume (Vt) and the specific trapped aqueous volume (Vtaq) of a plurality of liposomes comprising at least one lipid in a liposomal composition, the method comprising the steps of:
- (i) adding a marker to said liposomal composition, wherein the marker is liposome impermeable and has a molecular weight equal to or higher than 1 kDa;
- (ii) measuring a signal induced by the marker in said liposomal composition thereby determining the total volume of the liposomal composition;
- (iii) determining the volume of the fluid medium and the interstitial medium between liposomes obtained by separating the fluid medium from the plurality of liposomes and measuring a signal induced by the marker in the fluid medium following separation;
- and
- (iv) calculating the specific trapped volume (Vt) and the specific trapped aqueous volume (Vtaq) of the plurality of liposomes based on the volumes determined in steps (ii) and (iii) and the concentration of the at least one lipid forming the liposomes.
Dependencies are inferred from the claim text.