Microparticle compositions and methods for the manufacture...

Details Microparticle compositions and methods for the manufacture... Microparticle compositions and methods for the manufacture...

A - Human Necessities

61

K

A61K 9/16 (2006.01)

Patent

CA 2420621

Microparticles with adsorbed complexes of macromolecule and detergent, methods of making such microparticles, and uses thereof, are disclosed. The microparticles comprise a polymer, such as a poly(.alpha.-hydroxy acid), a polyhydroxy butyric acid, a polycaprolactone, a polyorthoester, a polyanhydride, and the like, and are formed using cationic, anionic, or nonionic detergents. The surfaces of the microparticles have absorbed thereon a complex of biologically active macromolecules, such as nucleic acids, polypeptides, antigens, and adjuvants, and a detergent. Preferred polymers are poly(D,L-lactide-co-glycolides), more preferably those having a lactide/glycolide molar ratio ranging from 40:60 to 60:40 and having a molecular weight ranging from 30,000 Daltons to 70,000 Daltons. Preferred macromolecules are bacterial and viral antigens (such as HIV antigens, meningitis B antigens, streptococcus B antigens, and Influenza A hemagglutinin antigens) as well as polynucleotides that encode for such antigens.

L'invention se rapporte à des microparticules comportant des complexes adsorbés de macromolécule et de détergent, à des procédés de fabrication de telles microparticules ainsi qu'à l'utilisation de ces dernières. Ces microparticules comprennent un polymère du type poly(.alpha.-hydroxy-acide), acide polyhydroxybutyrique, polycaprolactone, polyorthoester, polyanhydride et analogue, et elles sont formées au moyen de détergent cationique, anionique ou non ionique. Un complexe composé de macromolécules biologiquement actives, telles que des acides nucléiques, des polypeptides, des antigènes et des adjuvants, ainsi que d'un détergent, est adsorbé à la surface de ces microparticules. Les polymères préférés sont des poly(D,L-lactide-co-glycolides), particulièrement ceux présentant un rapport molaire lactides/glycolides compris entre 40:60 et 60:40 et possédant un poids moléculaire compris entre 30000 daltons et 70000 daltons. Les macromolécules préférées sont des antigènes bactériens et viraux (tels que des antigènes du VIH, des antigènes de la méningite B, des antigènes des streptocoques B et des antigènes de type hémagglutine du virus de Influenza A) ainsi que des polynucléotides qui codent ces antigènes.

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