Nanoparticles comprising a cyclodextrin and a biologically active molecule and uses thereof
The invention relates to nanoparticles comprising a biodegradable polymer, a cyclodextrin or a derivative thereof, and a biologically active molecule. Said nanoparticles can associate large amounts of biologically active molecules, especially of a hydrophobic nature, and release the biologically active molecule providing sustained and constant plasma levels thereof when they are administered orally or through any other mucosa of the organism.
1. A nanoparticle formulated for oral delivery, the nanoparticle comprising:
a complex comprising 2-hydroxypropyl-β-cyclodextrin and paclitaxel, wherein the paclitaxel is retained in a hydrophobic cavity of the 2-hydroxypropyl-β-cyclodextrin, and
a methyl vinyl ether/maleic anhydride copolymer (PVM/MA) encapsulating the complex thereby forming the nanoparticle,
wherein said nanoparticle prevents the action of a P-glycoprotein enzyme on the paclitaxel, and
wherein the molar ratio paclitaxel/2-hydroxypropyl-β-cyclodextrin is between 1:1 and 1:2.
2. A pharmaceutical composition comprising the nanoparticle according to claim 1 and a pharmaceutically acceptable excipient, carrier or adjuvant.
3. A process for producing nanoparticles according to claim 1 , comprising simultaneously incubating said methyl vinyl ether and maleic anhydride (PVM/MA) and a (2-hydroxypropyl-β-cyclodextrin):(paclitaxel) complex, ([CD:BAM complex]), in an organic solvent, and desolvating said PVM/MA with a hydroalcoholic solution.
4. A nanoparticle according to claim 1 , where in the mean particle size of the nanoparticle is from about 200 nm to about 400 nm.