Patent ID: 8293277
Filing Date: 2012-10-23
Classification: A61K,A61P

Abstract:
1. A solid dose controlled release nanoparticulate composition consisting of: (a) a poorly soluble nanoparticulate drug and at least one surface stabilizer associated with the surface of the nanoparticulate drug, wherein at least 50% of the drug particles have an average particle size of less than about 1000 nm when measured by light scattering techniques, and (b) a rate controlling matrix consists of at least one pharmaceutically acceptable high molecular weight rate-controlling polymer, wherein: (i) the nanoparticulate drug and the surface stabilizer associated with the surface thereof are dispersed in the high molecular weight rate-controlling polymer throughout the rate controlling matrix, (ii) the controlled release nanoparticulate composition provides controlled release of the nanoparticulate drug for a time period ranging from about 2 to about 24 hours, (iii) the concentration of the high molecular weight rate controlling polymer is from about 5 to about 95% (w/w), (iv) the surface stabilizer is selected from the group consisting of gelatin, lecithin, dextran, gum acacia, cholesterol, tragacanth, stearic acid, benzalkonium chloride, calcium stearate, glycerol monostearate, cetostearyl alcohol, cetomacrogol emulsifying wax, sorbitan esters, polyoxyethylene alkyl ethers, polyoxyethylene castor oil derivatives, polyoxyethylene sorbitan fatty acid esters, polyethylene glycols, polyoxyethylene stearates, colloidal silicon dioxide, phosphates, sodium dodecylsulfate, carboxymethylcellulose calcium, carboxymethylcellulose sodium, methylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethyl-cellulose phthalate, noncrystalline cellulose, magnesium aluminum silicate, triethanolamine, polyvinyl alcohol, polyvinylpyrrolidone, tyloxapol, poloxamers, poloxamines, poloxamine 908, dialkylesters of sodium sulfosuccinic acid, sodium lauryl sulfate, an alkyl aryl polyether sulfonate, a mixture of sucrose stearate and sucrose distearate, p-isononylphenoxypoly-(glycidol), SA9OHCO, decanoyl-N-methylglucamide, n-decyl -D-glucopyranoside, n-decyl -D-maltopyranoside, n-dodecyl -D-glucopyranoside, n-dodecyl -D-maltoside, heptanoyl-N-methylglucamide, n-heptyl—D-glucopyranoside, n-heptyl -D-thioglucoside, n-hexyl -D-glucopyranoside, nonanoyl-N-methylglucamide, n-noyl -D-glucopyranoside, octanoyl-N-methylglucamide, n-octyl—D-glucopyranoside, and octyl -D-thioglucopyranoside, and (v) the high molecular weight rate-controlling polymer is selected from the group consisting of polyethylene oxide (PEO), polyvinyl acetate phthalate, gum arabic, agar, guar gum, cereal gums, dextran, casein, gelatin, pectin, carrageenan, waxes, shellac, hydrogenated vegetable oils, polyvinylpyrrolidone, hydroxypropyl cellulose (HPC), hydroxyethyl cellulose (HEC), hydroxypropyl methylcelluose (HPMC), sodium carboxymethylcellulose (CMC), poly(ethylene) oxide, alkyl cellulose, ethyl cellulose, methyl cellulose, carboxymethyl cellulose, hydrophilic cellulose derivatives, polyethylene glycol, polyvinylpyrrolidone, cellulose acetate, cellulose acetate butyrate, cellulose acetate phthalate, cellulose acetate trimellitate, polyvinyl acetate phthalate, hydroxypropylmethyl cellulose phthalate, hydroxypropylmethyl cellulose acetate succinate, polyvinyl acetaldiethylamino acetate, poly(alkylmethacrylate), poly(vinyl acetate), polymers derived from acrylic or methacrylic acid and their respective esters, and copolymers derived from acrylic or methacrylic acid and their respective esters.