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Manufacturing process for liposomal preparations

A liposome preparation, lipid technology, applied in the field of liposome preparations, preparation of liposome preparations, can solve problems such as insufficient supply

Inactive Publication Date: 2006-03-29
NEOPHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

As a result, current methods of preparing liposomal formulations are insufficient to provide commercial quantities of liposomal formulations of many pharmaceutical agents

Method used

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  • Manufacturing process for liposomal preparations
  • Manufacturing process for liposomal preparations
  • Manufacturing process for liposomal preparations

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[0038] The present invention also provides liposomal formulations produced by the methods of preparation as described herein and methods of use of these formulations. Liposome formulations of the invention can generally be formulated for administration to human or animal patients. For these applications, the formulations of the invention may comprise, in addition to the liposomal formulation of the active agent, nontoxic, inert pharmaceutically suitable excipients. Pharmaceutically suitable excipients include all types of solid, semi-solid or liquid diluents, fillers and formulation auxiliaries. Tablets, lozenges, capsules, pills, granules, suppositories, solutions, suspensions and emulsions, pastes, ointments, gels, creams, lotions, powders or sprays may be suitable pharmaceutical preparations. Suppositories may contain, in addition to liposomal active agents, suitable water-soluble or water-insoluble excipients. Suitable excipients are those in which the liposomal active a...

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Abstract

The present invention provides manufacturing processes for liposomal preparations. In accordance with the methods, a lipid fraction is dissolved in a water-miscible organic solvent. This solution comprising the lipid fraction can be added to and mixed with an aqueous solution under conditions to form a bulk liposomal preparation. Desirably, the preparation can include one or more active principals. The bulk liposomal preparation can be further processed as desired, for example, by size fractionation or reduction, removal of the water-miscible organic solvent, freeze-drying, or other treatment. The methods permit the production of liposomal formulations on a large or commercial scale.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to co-pending US Provisional Patent Application 60 / 446,895, filed February 11, 2003, which is hereby incorporated by reference in its entirety. [0003] Technical Field of the Invention [0004] The present invention relates to methods of preparing liposome formulations and liposome formulations produced by these methods. Background of the invention [0005] There are many well-known methods for preparing liposomal formulations of various active ingredients (typically antineoplastic agents, antifungal agents, etc.). These methods include, for example, ethanol dilution, film hydration, the dichloromethane method, and the like. [0006] Other methods have been proposed, including dissolving liposome-forming lipids with tert-butanol to prepare dry lipid powders by lyophilization (see eg, US Patents 6,146,659 and 6,090,407). Hydration of dry liquid powders with an appropriate aqueous mediu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/127A61K31/337A61K31/4745
CPCA61K9/1277A61K9/19A61K31/337A61K9/127A61K31/4745A61P35/00
Inventor S·巴姆蒂帕梯Z·阿赫马I·阿赫马
Owner NEOPHARM CO LTD
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