Method of preparing pharmaceutical compositions of lipid...

A - Human Necessities – 61 – K

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A61K 9/16 (2006.01) A61K 9/107 (2006.01) A61K 9/127 (2006.01) A61K 9/51 (2006.01) A61K 38/00 (2006.01)

Patent

CA 2297924

The invention relates to a method of preparing a composition of lipid particles comprising a bioactive protein, capable of being subjected to high shear forces without substantial loss of activity, and a lipid agent. The characterizing features of the method are the introduction of a protein preparation and a lipid agent to a homogenization station, whereupon the resulting fluid mixture of protein and lipid agent is subjected to high pressure homogenization. The so formed lipid particles are collected and if necessary further processed into a pharmaceutical formulation.

L'invention concerne un procédé de préparation d'une composition de particules lipidiques, cette composition renfermant un agent lipidique et une protéine bioactive, celle-ci étant capable d'être soumise à des forces de cisaillement élevées sensiblement sans perte d'activité. Ce procédé consiste à introduire une préparation protéinique et un agent lipidique dans une station d'homogénéisation, le mélange fluide de protéine et d'agent lipidique ainsi obtenu étant soumis à une homogénéisation à haute pression. Les particules lipidiques ainsi formées sont ensuite recueillies et si nécessaire traitées, afin d'être transformées en une formulation pharmaceutique.

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