Methods for the preparation of liposomes

Inventors

JAVERI, Indu • Nellaiappan, Kaliappanadar

Abstract

Provided herein are methods for preparing liposomes and uses thereof. In certain embodiments, liposomes are prepared without using heat, organic solvents, proteins, and/or inorganic salts in the process. In certain embodiments, the liposomal preparation contains one or more active agents. In certain embodiments, the liposomal preparations are used in the treatment of diseases or disorders.

Core Innovation

The invention relates to a liposome-associated antibody composition in which a plurality of antibody molecules are non-covalently associated with a hydrophobic membrane region of a plurality of unilamellar liposomes. The non-covalent binding is directly between the antibody molecules and lipid molecules in the hydrophobic membrane region and is not mediated by chemical modification of the antibody molecules or lipid molecules. The liposome-associated antibody is stabilized against aggregation.

The invention further provides a method of preparing the liposome-associated antibody composition by contacting a lyophilized or solubilized antibody with an aqueous suspension of unilamellar liposomes. The antibody becomes associated with the hydrophobic membrane region of the liposomes via non-covalent binding directly between antibody molecules and lipid molecules in the hydrophobic membrane region, without chemical modification of the antibody molecules or lipid molecules. The liposome-associated antibody formed by this contacting is stabilized against aggregation.

The document also discloses liposome-encapsulated antibodies, including trastuzumab and adalimumab, and emphasizes that antibody incorporation can occur without covalent conjugation. The compositions are characterized by size-exclusion HPLC profiles and by encapsulated concentrations based on void-volume elution.

The problem addressed is that stable liposome suspensions and stable antibody/protein association are desired while avoiding destabilizing processing and avoiding chemical modification of the antibody and lipid components. The document describes stabilization against aggregation as a core outcome of the non-covalent, direct association between antibody and the hydrophobic membrane region of unilamellar liposomes.

Claims Coverage

The partial content includes two independent claims that cover the resulting liposome-associated antibody composition and a method of preparing that composition. Across these independent claims, the inventive features center on non-covalent, direct association of antibodies to the hydrophobic membrane region of unilamellar liposomes without chemical modification, together with stabilization against aggregation.

Claim coverage is centered on forming liposome-associated antibodies where antibody molecules are non-covalently and directly bound to the hydrophobic membrane region of unilamellar liposomes without chemical modification of the antibody or lipid molecules, and where the resulting liposome-associated antibody is stabilized against aggregation.

Stated Advantages

Documented Applications