Lyophilized fatty emulsions and a process for the production thereof
AssigneeNippon Shinyaku Co., Ltd.
InventorsJunzo Seki, Hirofumi Yamamoto, Shuji Yamane, Yutaka Takahashi, Kouichi Ushimaru
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Abstract
A lyophilized preparation which releases a fat emulsion, wherein the emulsion particle has a mean diameter of 10 to 100 nm, when redissolved prior to use. This preparation is produced by adding maltose in an arbitrary stage of the production of said emulsion prior to lyophilization.
Claims11
A stable lyophilized composition, capable of reconstituting a fatty emulsion in which the mean particle size is 10-100 nm without substantial enlargement of the particle size between prior to lyophilization and after reconstitution with water, which comprises lyophilized lipid emulsion particles for a fatty emulsion wherein said particles comprise a therapeutically effective amount of a therapeutic active substance or a diagnostically effective amount of a diagnostic agent and an amount of maltose effective, upon dispersion of said lyophilized composition in water, to produce a fatty emulsion in which the mean emulsion particle size is 10-100 nm, without substantial enlargement of the particle size between prior to lyophilization add after reconstitution with water, under conditions of storage at elevated temperatures up to 40.degree. C. or the accelerated heating equivalent thereof.
A process for producing a lyophilized fatty emulsion capable of reconstituting a fatty emulsion in which the mean particle size is 10-100nm without substantial enlargement of the particle size between prior to lyophilization and after reconstitution with water, which comprises lyophilizing a fatty emulsion which comprises emulsion particles having a mean particle size of 10-100 nm wherein said particles comprise a therapeutically active substance or a diagnostic agent, and adding to the emulsion prior to lyophilization an amount of maltose effective, upon dispersion of said lyophilized composition in water, to produce a fatty emulsion in which the mean emulsion particle size is 10-100 nm, without substantial enlargement of the particle size between prior to lyophilization and after reconstitution with water, under conditions of storage at elevated temperatures up to 40.degree. C. or the accelerated heating equivalent thereof.
Dependencies are inferred from the claim text.