| 20100055165 | LIPOSOMAL GEL PHTHALOCYANINE PREPARATION FOR PHOTODYNAMIC THERAPY OF TUMORS AND ITS MANUFACTURING - Liposomal gel hydrophobic phthalocyanine (FCH) preparation for photodynamic therapy of tumors and other diseases is composed of lecithin liposomes or liposomes on the basis of other lipids, with incorporated curing drug, which can be chosen either from a group including hydrophobic hydroxyaluminum phthalocyanine, hydrophobic aluminum phthalocyanine, hydrophobic zinc phthalocyanine, hydrophobic silicone phthalocyanine, or organic silicone phthalocyanine, or hydrophobic phthalocyanine without the core metal; while resulting liposomes are mixed in ratios of 10:1 to 1:10 with a translucent gel, advantageously on the basis of carboxymethylcellulose. The added curing drug can be coated by glucose or other saccharides, by polyethylenglycol or other usable polymers, as lecithin or other lipids, or by sodium chloride or other salts usable in pharmacology. Liposomal gel hydrophobic phthalocyanine (FCH) preparation is manufactured on the following schema: Lecithin or other lipid of a pharmacological purity at concentration between 10 to 40 mg per ml of sterile isotonic solution is fluidised on a microfluidizer in particular chamber to the final particle size smaller than 1000 nm, in temperature higher than 0° C. and a pressure at 500 to 2000 Bar; then while stirring the curing drug or the treated curing drug is added in the ratio of 5:1 to 0.1:1 in relation to the lecithin or other lipid; the resulting suspension is again fludized on a microfludizer in particular smaller chamber to the final particle size smaller than 500 nanometer, with pressure at least 1000 to 2000 Bar, in temperature higher than 0° C.; the resulting suspension is then mixed with a translucent gel in ratios of 10:1 to 1:10; Alternatively, first lecithin or other lipid of a pharmacological purity at concentration between 10 to 40 mg per ml of sterile isotonic solution is microfludized on a microfluidizer in particular chamber to the final particle size smaller than 1000 nm, a pressure at least 1000 to 2000 Bar and temperature higher than 0° C.; Afterwards, in parallel the curing drug or the treated curing drug is separately microfluidized in amounts corresponding to the ratio of 5:1 to 0.1:1 in relation to the lecithin or other lipid in an equal volume of fluid, advantageously on the basis of sterile isotonic solution to the final particle size smaller than 1000 nanometer, and with pressure at 1000 to 2000 Bar; Afterwards both microfludized components are mixed together and again microfludized on a microfludizer in particular chamber with a pressure at 1000 to 2000 Bar and temperature higher than 0° C. to the final particle size maximum of 500 nanometer, the resulting suspension is fluidised on a microfluidizer in a particular smaller chamber with a pressure at least 1000 to 2000 Bar and temperature higher than 0° C. to the final particle size smaller then 500 nm, the resulting suspension is then mixed with a translucent gel in ratios of 10:1 to 1:10; Alternatively, Lecithin or other lipid in the pharmacological purity at the concentration of 10 to 40 mg per milliliter of sterile isotonic solution is first treated by extrusion across the filters with a size 10 to 500 nm together with the curing drug or the treated curing drug in the ratio of 5:1 to 0.1:1 related to the lecithin or other lipid; and the resulting suspension is again fluidised on a microfluidizer in a particular chamber with a pressure at least 1000 to 2000 Bar and temperature higher than 0° C. to the final particle size smaller then 500 nm, with a pressure at least 1000 to 2000 Bar and temperature higher than 0° C., the resulting suspension is mixed with a translucent pharmaceutical gel in a ratio of 10:1 to 1:10. | 03-04-2010 |
