The Liposome Company, Inc.

Other

B. Braun Medical Inc.

Royden M Coe

Joel B Portnoff

Kenneth C Raines

John P Grimm

Joel Martin Bartholomew

Lawrence T Boni

Sharma R Minchey

John D Grimm

Robert L Thies

Laura Edgerly-Pflug

Joel Portnoff

A method of sizing liposomes by passing a suspension of liposomes through an aluminum oxide porous film by entering the film via the smaller pores and extruded via the larger pores, under pressure, is disclosed. In a preferred embodiment, the porous film is a branched-pore type anodic aluminum oxide porous film. The process produces a population of liposomes substantially free of liposomes above a predetermined maximum size. Also disclosed is an apparatus for carrying out the invention.

Liposome extrusion process

A formulation preparation device is provided herein which contains a valve assembly, transfer spikes, syringe port and tube, these components being interconnected so as to provide for controlled fluid flow between the spikes and port, through the assembly, in specific directions only. The device has an enclosed, sterilizable, gripable housing and can be used to mix combine fluids in reproducible and predetermined proportions. Combination is accomplished aseptically, avoiding contact between the device's operator and the fluids and the substances combined. Biologically active compounds can be combined with one or more fluids, including such aqueous liposome suspensions, using the device. A formulation preparation kit containing, in addition to the device, the fluids and compounds to be formulated is thus also provided herein; methods of using the device to prepare such formulations are further provided herein.

Formulation preparation device

This invention provides a process for the production of liposomes by combining an organic phase and an aqueous at a volume ratio of less than 3:1; the process can be conducted under conditions which obtain a single-modal population distribution of liposomes encompassing a pre-selected mean particle size. A novel intermediate product obtained during the process, which can itself be used for the topical delivery of a bioactive agent, is also provided.

Method of producing liposomes

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Bordentown, NJ, United States of America

Royden M Coe