Injectable aqueous dispersions of propofol

Details Injectable aqueous dispersions of propofol Injectable aqueous dispersions of propofol

A - Human Necessities

61

K

A61K 31/05 (2006.01) A61K 9/107 (2006.01)

Patent

CA 2338703

A stable, sterile, and injectable aqueous dispersion of a water-insoluble microdroplet matrix of mean diameter from about 50 nm to about 1000 nm consisting essentially of between about 1% to about 15 % of propofol; between about 1 % to about 8 % of a propofol soluble diluent; between about 0.5 % to about 5 % of a surface stabilizing amphiphilic agent; of a pharmaceutically acceptable water-soluble polyhydroxy additive that acts as a tonicity modifier; and provided the ratio of propofol to diluent is about 1:4 to about 1:0.1 and the ratio of propofol to amphiphilic agent is about 1:0.8 to about 1:2.5, and the composition has a viscosity of from about 0.8 to about 15 centipoise.

L'invention concerne une dispersion aqueuse stable, stérile et injectable d'une matrice de microgouttelettes d'un diamètre moyen compris entre 50 et environ 1000 nm et constituée essentiellement de 1 % à environ 15 % de propofol; de 1 % à environ 8 % d'un diluant soluble dans le propofol; de 0,5 % et environ 5 % d'un agent amphiphile stabilisateur de surface; d'un additif hydrosoluble pharmaceutiquement acceptable polyhydroxylé qui agit comme un modificateur de tonicité, à condition que la proportion du propofol par rapport au diluant soit entre environ 1:4 et 1:0,1 et que la proportion du propofol par rapport à l'agent amphiphile soit entre environ 1:0,8 et environ 1:2,5, la composition ayant une viscosité comprise entre environ 0,8 et 15 centipoises.

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