Stabilized reverse micelle compositions and uses thereof

Details Stabilized reverse micelle compositions and uses thereof Stabilized reverse micelle compositions and uses thereof

A - Human Necessities

61

K

A61K 9/127 (2006.01) A61F 13/00 (2006.01) A61K 8/14 (2006.01) A61K 9/107 (2006.01) A61K 9/20 (2006.01) A61K 9/48 (2006.01) A61K 47/48 (2006.01)

Patent

CA 2468845

The invention relates to compositions and methods for drug delivery suitable for promoting the transmucosal absorption of drugs, especially drugs with poor intrinsic bioavailability, such as peptides, proteins, vaccines, and nucleic acids. The delivery system of this invention preferably comprises fatty acid esters and their hydrophilic derivatives that associate with water and other polar solvents to form reverse micelles tha are physiclally stabilized in the presence of gastrointestinal fluid, water, and other hydrophilic solvents. Such stable reverse micelles are formed by suitable mixtures of polymeric or non-polymeric compounds with amphiphiles. Micelles made using these methods undergo phase transformation more slowly resulting in delayed drug release profiles and sustained absorption. When administered as a pharmaceutical to mucosal surfaces following oral ingestion or intranasal administration, therapeutic molecules principally solubilized in the aqueous phase are protected from digestion by mucosal enzymes and other mucosal degradative processes and are taken up by absorptive cell mechanisms and reach appropriate body compartments. The reverse micelle compositions may comprise mono-, di- glycerides and/or their transesterifed products containing C6-C12 fatty acids chains, wherein the transester groups consist of hydrohilic moieties.

Cette invention a trait à des compositions, ainsi qu'aux méthodes correspondantes, permettant une libération de médicament apte à faciliter l'absorption desdits médicaments à travers des muqueuses, notamment des médicaments dotés d'une faible biodisponibilité intrinsèque, tels que des peptides, des protéines, des vaccins et des acides nucléiques. Le système de libération selon l'invention contient, de préférence, des esters d'acides gras ainsi que leurs dérivés hydrophiles s'associant avec de l'eau et d'autres solvants polaires pour former des micelles inverses stables. Apportées sous forme de produit pharmaceutique sur des surfaces muqueuses, après ingestion orale ou administration par voie nasale, les molécules bio-actives principalement solubilisées dans la phase hydrophile, qui sont protégées contre une digestion par des enzymes des muqueuses et autre processus de dégradation par les muqueuses, sont prises en charge par des mécanismes d'absorption cellulaire et atteignent les régions corporelles auxquelles elles sont affectées. Ces compositions à base de micelles inverses peuvent contenir des monoglycérides et/ou leur produits transestérifiés renfermant des chaînes d'acides gras porteurs de 6 à 12 atomes de carbone, les groupes transester se composant de fractions hydrophiles.

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