Method for producing solid-lipid composite drug particles

a technology of solid-lipid composite drug particles and lipid-based drug particles, which is applied in the direction of drug compositions, solvent extraction, separation processes, etc., can solve the problems of limited use of drug-containing emulsions, limited liposome-based drug delivery systems, and limited biodegradable polymer nanoparticles, etc., and achieve low temperature processing and high drug loading

US20060008531A1Inactive Publication Date: 2006-01-12FERRO CORP
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Patent Information

Authority / Receiving Office
US · United States
Current Assignee / Owner
Publication Date
2006-01-12
Estimated Expiration
Not applicable · inactive patent

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Abstract

A method of producing solid composite lipid / drug nanoparticles that includes the steps of: (1) dissolving a lipid and a drug in a suitable organic solvent to form a solution; (2) emulsifying the solution in a liquid to form an emulsion having a discontinuous phase of micelles comprising the organic solvent, the drug and the lipid, and a continuous phase comprising the liquid; and (3) contacting the emulsion with a supercritical fluid under conditions suitable to keep the supercritical fluid in a supercritical state, whereby the supercritical fluid extracts the organic solvent from the micelles, causing them to precipitate as organic-solvent free solid composite lipid / drug nanoparticles suspended or dispersed in the liquid.
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Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application is a continuation-in-part of application Ser. No. 10 / 434,426, filed May 8, 2003.BACKGROUND OF THE INVENTION

[0002] 1. Field of Invention

[0003] The present invention relates generally to an apparatus and a method of producing solid-lipid composite drug particles.

[0004] 2. Description of Related Art

[0005] In recent years, solid composite lipid / drug particles have been used for oral, pulmonary and parenteral drug delivery as an alternative to traditional drug delivery systems such as emulsions, liposomes and biodegradable polymer nanoparticles. Solid lipid / drug composite particles provide the advantages of traditional drug delivery systems, such as improved dissolution and controlled release, but avoid some of the disadvantages of traditional drug delivery systems. The use of drug-containing emulsions, for example, is limited by the physical stability of the drug-containing emulsions, and also by the low dissolut...

Examples

example

[0059] Preparation of Emulsions

[0060] Four organic solutions (Examples 1-4, respectively) were prepared by dissolving 5 percent of a lipid (GLUCIRE 50 / 13) and the amounts shown in Table 1 of either Indomethacin or Ketoprofen in chloroform (all amounts are specified as weight percents relative to the weight of the organic solvent). The resulting organic solutions were then dispersed in an aqueous 0.13% w / w of sodium glychocholate solution in the amounts shown in Table 1 in parts by weight relative to water to form coarse oil-in-water (O / W) emulsions. The resulting emulsions were then homogenized using a homogenizer commercially available from Microfluidics, Inc. (Newton, Mass.) at 16,000 p.s.i. in 3 passes.

TABLE 1Weight % ofWeight % of OrganicExampleDrugDrug in SolventSolution in Water1Indomethacin15102Indomethacin10303Indomethacin15304Ketoprofen1530

[0061] Precipitation of Nanoparticles

[0062] An apparatus such as shown in FIG. 1 was used to precipitate solid composite lipid / drug ...