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US 2016/0108009 A1Published application
Novel formulation of metaxalone
AssigneeiCeutica Pty Ltd.
InventorsAaron DODD, Felix MEISER, Marck NORRET, Adrian RUSSELL, H. William BOSCH
Life of this patent
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Abstract
The present invention relates to methods for producing particles of metaxalone using dry milling processes as well as compositions comprising metaxalone, medicaments produced using metaxalone in particulate form and/or compositions, and to methods of treatment of an animal, including man, using a therapeutically effective amount of metaxalone administered by way of said medicaments.
Claims41
A method for producing a composition, comprising the steps of:
- dry milling a solid biologically active material and a millable grinding matrix in a mill comprising a plurality of milling bodies, for a time period sufficient to produce particles of the biologically active material dispersed in an at least partially milled grinding material
- wherein the biologically active material is metaxalone.
The method of any preceding claim, wherein the milling time period is a range selected from the group consisting of:
- between 10 minutes and 2 hours, between 10 minutes and 90 minutes, between 10 minutes and 1 hour, between 10 minutes and 45 minutes, between 10 minutes and 30 minutes, between 5 minutes and 30 minutes, between 5 minutes and 20 minutes, between 2 minutes and 10 minutes, between 2 minutes and 5 minutes, between 1 minutes and 20 minutes, between 1 minute and 10 minutes, and between 1 minute and 5 minutes.
The method of any preceding claim, wherein the dry milling is undertaken in a mechanically agitated attritor mill (horizontal or vertical), vibratory mill or nutating mill, wherein the milling medium is steel balls having a diameter selected from the group consisting of:
- between 1 and 20 mm, between 2 and 15 mm and between 3 and 10 mm.
The method of any preceding claim, wherein the total combined amount of biologically active material and grinding matrix in the mill at any given time is equal to or greater than a mass selected from the group consisting of:
- 200 grams, 500 grams, 1 kg, 2 kg, 5 kg, 10 kg, 20 kg, 30 kg, 50 kg, 75 kg, 100 kg, 150 kg, 200 kg.
The method of any preceding claim, wherein the grinding matrix is a single material or is a mixture of two or more materials in any proportion wherein the single material or a mixture of two or more materials is selected from the group consisting of:
- mannitol, sorbitol, Isomalt, xylitol, maltitol, lactitol, erythritol, arabitol, ribitol, glucose, fructose, mannose, galactose, anhydrous lactose, lactose monohydrate, sucrose, maltose, trehalose, maltodextrins, dextrin, Inulin, dextrates, polydextrose, starch, wheat flour, corn flour, rice flour, rice starch, tapioca flour, tapioca starch, potato flour, potato starch, other flours and starches, milk powder, skim milk powders, other milk solids and dreviatives, soy flour, soy meal or other soy products, cellulose, microcystalline cellulose, microcystalline cellulose based co blended materials, pregelatinized (or partially) starch, HPMC, CMC, HPC, citric acid, tartaric acid, malic acid, maleic acid fumaric acid, ascorbic acid, succinic acid, sodium citrate, sodium tartrate, sodium malate, sodium ascorbate, potassium citrate, potassium tartrate, potassium malate, potassium ascorbate, sodium carbonate, potassium carbonate, magnesium carbonate, sodium bicarbonate, potassium bicarbonate and calcium carbonate. dibasic calcium phosphate, tribasic calcium phosphate, sodium sulfate, sodium chloride, sodium metabisulphite, sodium thiosulfate, ammonium chloride, Glauber's salt, ammonium carbonate, sodium bisulfate, magnesium sulfate, potash alum, potassium chloride, sodium hydrogen sulfate, sodium hydroxide, crystalline hydroxides, hydrogen carbonates, ammonium chloride, methylamine hydrochloride, ammonium bromide, silica, thermal silica, alumina, titanium dioxide, talc, chalk, mica, kaolin, bentonite, hectorite, magnesium trisilicate, clay based materials or aluminium silicates, sodium lauryl sulfate, sodium stearyl sulfate, sodium cetyl sulfate, sodium cetostearyl sulfate, sodium docusate, sodium deoxycholate, N-lauroylsarcosine sodium salt, glyceryl monostearate, glycerol distearate glyceryl palmitostearate, glyceryl behenate, glyceryl caprylate, glyceryl oleate, benzalkonium chloride, CTAB, CTAC, Cetrimide, cetylpyridinium chloride, cetylpyridinium bromide, benzethonium chloride, PEG 40 stearate, PEG 100 stearate, poloxamer 188, poloxamer 338, poloxamer 407 polyoxyl 2 stearyl ether, polyoxyl 100 stearyl ether, polyoxyl 20 stearyl ether, polyoxyl 10 stearyl ether, polyoxyl 20 cetyl ether, polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 61, polysorbate 65, polysorbate 80, polyoxyl 35 castor oil, polyoxyl 40 castor oil, polyoxyl 60 castor oil, polyoxyl 100 castor oil, polyoxyl 200 castor oil, polyoxyl 40 hydrogenated castor oil, polyoxyl 60 hydrogenated castor oil, polyoxyl 100 hydrogenated castor oil, polyoxyl 200 hydrogenated castor oil, cetostearyl alcohol, macrogel 15 hydroxystearate, sorbitan monopalmitate, sorbitan monostearate, sorbitan trioleate, Sucrose Palmitate, Sucrose Stearate, Sucrose Distearate, Sucrose laurate, Glycocholic acid, sodium Glycholate, Cholic Acid, Soidum Cholate, Sodium Deoxycholate, Deoxycholic acid, Sodium taurocholate, taurocholic acid, Sodium taurodeoxycholate, taurodeoxycholic acid, soy lecithin, phosphatidylcholine, phosphatidylethanolamine, phosphatidylserine, phosphatidylinositol, PEG4000, PEG6000, PEG8000, PEG10000, PEG20000, alkyl naphthalene sulfonate condensate/Lignosulfonate blend, Calcium Dodecylbenzene Sulfonate, Sodium Dodecylbenzene Sulfonate, Diisopropyl naphthaenesulphonate, erythritol distearate, Naphthalene Sulfonate Formaldehyde Condensate, nonylphenol ethoxylate (poe-30), Tristyrylphenol Ethoxylate, Polyoxyethylene (15) tallowalkylamines, sodium alkyl naphthalene sulfonate, sodium alkyl naphthalene sulfonate condensate, sodium alkylbenzene sulfonate, sodium isopropyl naphthalene sulfonate, Sodium Methyl Naphthalene Formaldehyde Sulfonate, sodium n-butyl naphthalene sulfonate, tridecyl alcohol ethoxylate (poe-18), Triethanolamine isodecanol phosphate ester, Triethanolamine tristyrylphosphate ester, Tristyrylphenol Ethoxylate Sulfate, Bis(2-hydroxyethyl)tallowalkylamines.
The method of any preceding claim, wherein the grinding matrix is selected from the group consisting of:
- a. lactose monohydrate or lactose monohydrate combined with at least one material selected from the group consisting of:
- xylitol;
- lactose anhydrous;
- microcrystalline cellulose;
- sucrose;
- glucose;
- sodium chloride;
- talc;
- kaolin;
- calcium carbonate;
- malic acid;
- trisodium citrate dihydrate;
- D,L-Malic acid;
- sodium pentane sulfate;
- sodium octadecyl sulfate;
- Brij700;
- Brij76;
- sodium n-lauroyl sacrosine;
- lecithin;
- docusate sodium;
- polyoxyl-40-stearate;
- Aerosil R972 fumed silica;
- sodium lauryl sulfate or other alkyl sulfate surfactants with a chain length between C5 to C18;
- polyvinyl pyrrolidone;
- sodium lauryl sulfate and polyethylene glycol 40 stearate, sodium lauryl sulfate and polyethylene glycol 100 stearate, sodium lauryl sulfate and PEG 3000, sodium lauryl sulphate and PEG 6000, sodium lauryl sulphate and PEG 8000, sodium lauryl sulphate and PEG 10000, sodium lauryl sulfate and Brij700, sodium lauryl sulfate and Poloxamer 407, sodium lauryl sulfate and Poloxamer 338, sodium lauryl sulfate and Poloxamer 188;
- Poloxamer 407, Poloxamer 338, Poloxamer 188, alkyl naphthalene sulfonate condensate/Lignosulfonate blend;
- Calcium Dodecylbenzene Sulfonate (Branched);
- Diisopropyl naphthalenesulphonate;
- erythritol distearate;
- linear and branched dodecylbenzene sulfonic acids;
- Naphthalene Sulfonate Formaldehyde Condensate;
- nonylphenol ethoxylate, POE-30;
- Phosphate Esters, Tristyrylphenol Ethoxylate, Free Acid;
- Polyoxyethylene (15) tallowalkylamines;
- sodium alkyl naphthalene sulfonate;
- sodium alkyl naphthalene sulfonate condensate;
- sodium alkylbenzene sulfonate;
- sodium isopropyl naphthalene sulfonate;
- Sodium Methyl Naphthalene;
- Formaldehyde Sulfonate;
- sodium salt of n-butyl naphthalene sulfonate;
- tridecyl alcohol ethoxylate, POE-18;
- Triethanolamine isodecanol phosphate ester;
- Triethanolamine tristyrylphosphate ester;
- Tristyrylphenol Ethoxylate Sulfate;
- Bis(2-hydroxyethyl)tallowalkylamines.
- b. lactose anhydrous or lactose anhydrous combined with at least one material selected from the group consisting of:
- lactose monohydrate;
- xylitol;
- microcrystalline cellulose;
- sucrose;
- glucose;
- sodium chloride;
- talc;
- kaolin;
- calcium carbonate;
- malic acid;
- trisodium citrate dihydrate;
- D,L-Malic acid;
- sodium pentane sulfate;
- sodium octadecyl sulfate;
- Brij700;
- Brij76;
- sodium n-lauroyl sacrosine;
- lecithin;
- docusate sodium;
- polyoxyl-40-stearate;
- Aerosil R972 fumed silica;
- sodium lauryl sulfate or other alkyl sulfate surfactants with a chain length between C5 to C18;
- polyvinyl pyrrolidone;
- sodium lauryl sulfate and polyethylene glycol 40 stearate, sodium lauryl sulfate and polyethylene glycol 100 stearate, sodium lauryl sulfate and PEG 3000, sodium lauryl sulphate and PEG 6000, sodium lauryl sulphate and PEG 8000, sodium lauryl sulphate and PEG 10000, sodium lauryl sulfate and Brij700, sodium lauryl sulfate and Poloxamer 407, sodium lauryl sulfate and Poloxamer 338, sodium lauryl sulfate and Poloxamer 188;
- Poloxamer 407, Poloxamer 338, Poloxamer 188, alkyl naphthalene sulfonate condensate/Lignosulfonate blend;
- Calcium Dodecylbenzene Sulfonate (Branched);
- Diisopropyl naphthalenesulphonate;
- erythritol distearate;
- linear and branched dodecylbenzene sulfonic acids;
- Naphthalene Sulfonate Formaldehyde Condensate;
- nonylphenol ethoxylate, POE-30;
- Phosphate Esters, Tristyrylphenol Ethoxylate, Free Acid;
- Polyoxyethylene (15) tallowalkylamines;
- sodium alkyl naphthalene sulfonate;
- sodium alkyl naphthalene sulfonate condensate;
- sodium alkylbenzene sulfonate;
- sodium isopropyl naphthalene sulfonate;
- Sodium Methyl Naphthalene;
- Formaldehyde Sulfonate;
- sodium salt of n-butyl naphthalene sulfonate;
- tridecyl alcohol ethoxylate, POE-18;
- Triethanolamine isodecanol phosphate ester;
- Triethanolamine tristyrylphosphate ester;
- Tristyrylphenol Ethoxylate Sulfate;
- Bis(2-hydroxyethyl)tallowalkylamines.
- c. mannitol or mannitol combined with at least one material selected from the group consisting of:
- lactose monohydrate;
- xylitol;
- lactose anhydrous;
- microcrystalline cellulose;
- sucrose;
- glucose;
- sodium chloride;
- talc;
- kaolin;
- calcium carbonate;
- malic acid;
- trisodium citrate dihydrate;
- D,L-Malic acid;
- sodium pentane sulfate;
- sodium octadecyl sulfate;
- Brij700;
- Brij76;
- sodium n-lauroyl sacrosine;
- lecithin;
- docusate sodium;
- polyoxyl-40-stearate;
- Aerosil R972 fumed silica;
- sodium lauryl sulfate or other alkyl sulfate surfactants with a chain length between C5 to C18;
- polyvinyl pyrrolidone;
- sodium lauryl sulfate and polyethylene glycol 40 stearate, sodium lauryl sulfate and polyethylene glycol 100 stearate, sodium lauryl sulfate and PEG 3000, sodium lauryl sulphate and PEG 6000, sodium lauryl sulphate and PEG 8000, sodium lauryl sulphate and PEG 10000, sodium lauryl sulfate and Brij700, sodium lauryl sulfate and Poloxamer 407, sodium lauryl sulfate and Poloxamer 338, sodium lauryl sulfate and Poloxamer 188;
- Poloxamer 407, Poloxamer 338, Poloxamer 188, alkyl naphthalene sulfonate condensate/Lignosulfonate blend;
- Calcium Dodecylbenzene Sulfonate (Branched);
- Diisopropyl naphthalenesulphonate;
- erythritol distearate;
- linear and branched dodecylbenzene sulfonic acids;
- Naphthalene Sulfonate Formaldehyde Condensate;
- nonylphenol ethoxylate, POE-30;
- Phosphate Esters, Tristyrylphenol Ethoxylate, Free Acid;
- Polyoxyethylene (15) tallowalkylamines;
- sodium alkyl naphthalene sulfonate;
- sodium alkyl naphthalene sulfonate condensate;
- sodium alkylbenzene sulfonate;
- sodium isopropyl naphthalene sulfonate;
- Sodium Methyl Naphthalene;
- Formaldehyde Sulfonate;
- sodium salt of n-butyl naphthalene sulfonate;
- tridecyl alcohol ethoxylate, POE-18;
- Triethanolamine isodecanol phosphate ester;
- Triethanolamine tristyrylphosphate ester;
- Tristyrylphenol Ethoxylate Sulfate;
- Bis(2-hydroxyethyl)tallowalkylamines.
- d. Sucrose or sucrose combined with at least one material selected from the group consisting of:
- lactose monohydrate;
- lactose anhydrous;
- mannitol;
- microcrystalline cellulose;
- glucose;
- sodium chloride;
- talc;
- kaolin;
- calcium carbonate;
- malic acid;
- tartaric acid;
- trisodium citrate dihydrate;
- D,L-Malic acid;
- sodium pentane sulfate;
- sodium octadecyl sulfate;
- Brij700;
- Brij76;
- sodium n-lauroyl sacrosine;
- lecithin;
- docusate sodium;
- polyoxyl-40-stearate;
- Aerosil R972 fumed silica;
- sodium lauryl sulfate or other alkyl sulfate surfactants with a chain length between C5 to C18;
- polyvinyl pyrrolidone;
- sodium lauryl sulfate and polyethylene glycol 40 stearate, sodium lauryl sulfate and polyethylene glycol 100 stearate, sodium lauryl sulfate and PEG 3000, sodium lauryl sulphate and PEG 6000, sodium lauryl sulphate and PEG 8000, sodium lauryl sulphate and PEG 10000, sodium lauryl sulfate and Brij700, sodium lauryl sulfate and Poloxamer 407, sodium lauryl sulfate and Poloxamer 338, sodium lauryl sulfate and Poloxamer 188;
- Poloxamer 407, Poloxamer 338, Poloxamer 188, alkyl naphthalene sulfonate condensate/Lignosulfonate blend;
- Calcium Dodecylbenzene Sulfonate (Branched);
- Diisopropyl naphthalenesulphonate;
- erythritol distearate;
- linear and branched dodecylbenzene sulfonic acids;
- Naphthalene Sulfonate Formaldehyde Condensate;
- nonylphenol ethoxylate, POE-30;
- Phosphate Esters, Tristyrylphenol Ethoxylate, Free Acid;
- Polyoxyethylene (15) tallowalkylamines;
- sodium alkyl naphthalene sulfonate;
- sodium alkyl naphthalene sulfonate condensate;
- sodium alkylbenzene sulfonate;
- sodium isopropyl naphthalene sulfonate;
- Sodium Methyl Naphthalene;
- Formaldehyde Sulfonate;
- sodium salt of n-butyl naphthalene sulfonate;
- tridecyl alcohol ethoxylate, POE-18;
- Triethanolamine isodecanol phosphate ester;
- Triethanolamine tristyrylphosphate ester;
- Tristyrylphenol Ethoxylate Sulfate;
- Bis(2-hydroxyethyl)tallowalkylamines.
- e. Glucose or glucose combined with at least one material selected from the group consisting of:
- lactose monohydrate;
- lactose anhydrous;
- mannitol;
- microcrystalline cellulose;
- sucrose;
- sodium chloride;
- talc;
- kaolin;
- calcium carbonate;
- malic acid;
- tartaric acid;
- trisodium citrate dihydrate;
- D,L-Malic acid;
- sodium pentane sulfate;
- sodium octadecyl sulfate;
- Brij700;
- Brij76;
- sodium n-lauroyl sacrosine;
- lecithin;
- docusate sodium;
- polyoxyl-40-stearate;
- Aerosil R972 fumed silica;
- sodium lauryl sulfate or other alkyl sulfate surfactants with a chain length between C5 to C18;
- polyvinyl pyrrolidone;
- sodium lauryl sulfate and polyethylene glycol 40 stearate, sodium lauryl sulfate and polyethylene glycol 100 stearate, sodium lauryl sulfate and PEG 3000, sodium lauryl sulphate and PEG 6000, sodium lauryl sulphate and PEG 8000, sodium lauryl sulphate and PEG 10000, sodium lauryl sulfate and Brij700, sodium lauryl sulfate and Poloxamer 407, sodium lauryl sulfate and Poloxamer 338, sodium lauryl sulfate and Poloxamer 188;
- Poloxamer 407, Poloxamer 338, Poloxamer 188, alkyl naphthalene sulfonate condensate/Lignosulfonate blend;
- Calcium Dodecylbenzene Sulfonate (Branched);
- Diisopropyl naphthalenesulphonate;
- erythritol distearate;
- linear and branched dodecylbenzene sulfonic acids;
- Naphthalene Sulfonate Formaldehyde Condensate;
- nonylphenol ethoxylate, POE-30;
- Phosphate Esters, Tristyrylphenol Ethoxylate, Free Acid;
- Polyoxyethylene (15) tallowalkylamines;
- sodium alkyl naphthalene sulfonate;
- sodium alkyl naphthalene sulfonate condensate;
- sodium alkylbenzene sulfonate;
- sodium isopropyl naphthalene sulfonate;
- Sodium Methyl Naphthalene;
- Formaldehyde Sulfonate;
- sodium salt of n-butyl naphthalene sulfonate;
- tridecyl alcohol ethoxylate, POE-18;
- Triethanolamine isodecanol phosphate ester;
- Triethanolamine tristyrylphosphate ester;
- Tristyrylphenol Ethoxylate Sulfate;
- Bis(2-hydroxyethyl)tallowalkylamines.
- f. Sodium chloride or sodium chloride combined with at least one material selected from the group consisting of:
- lactose monohydrate;
- lactose anhydrous;
- mannitol;
- microcrystalline cellulose;
- sucrose;
- glucose;
- talc;
- kaolin;
- calcium carbonate;
- malic acid;
- tartaric acid;
- trisodium citrate dihydrate;
- D,L-Malic acid;
- sodium pentane sulfate;
- sodium octadecyl sulfate;
- Brij700;
- Brij76;
- sodium n-lauroyl sacrosine;
- lecithin;
- docusate sodium;
- polyoxyl-40-stearate;
- Aerosil R972 fumed silica;
- sodium lauryl sulfate or other alkyl sulfate surfactants with a chain length between C5 to C18;
- polyvinyl pyrrolidone;
- sodium lauryl sulfate and polyethylene glycol 40 stearate, sodium lauryl sulfate and polyethylene glycol 100 stearate, sodium lauryl sulfate and PEG 3000, sodium lauryl sulphate and PEG 6000, sodium lauryl sulphate and PEG 8000, sodium lauryl sulphate and PEG 10000, sodium lauryl sulfate and Brij700, sodium lauryl sulfate and Poloxamer 407, sodium lauryl sulfate and Poloxamer 338, sodium lauryl sulfate and Poloxamer 188;
- Poloxamer 407, Poloxamer 338, Poloxamer 188, alkyl naphthalene sulfonate condensate/Lignosulfonate blend;
- Calcium Dodecylbenzene Sulfonate (Branched);
- Diisopropyl naphthalenesulphonate;
- erythritol distearate;
- linear and branched dodecylbenzene sulfonic acids;
- Naphthalene Sulfonate Formaldehyde Condensate;
- nonylphenol ethoxylate, POE-30;
- Phosphate Esters, Tristyrylphenol Ethoxylate, Free Acid;
- Polyoxyethylene (15) tallowalkylamines;
- sodium alkyl naphthalene sulfonate;
- sodium alkyl naphthalene sulfonate condensate;
- sodium alkylbenzene sulfonate;
- sodium isopropyl naphthalene sulfonate;
- Sodium Methyl Naphthalene;
- Formaldehyde Sulfonate;
- sodium salt of n-butyl naphthalene sulfonate;
- tridecyl alcohol ethoxylate, POE-18;
- Triethanolamine isodecanol phosphate ester;
- Triethanolamine tristyrylphosphate ester;
- Tristyrylphenol Ethoxylate Sulfate;
- Bis(2-hydroxyethyl)tallowalkylamines.
- g. xylitol or xylitol combined with at least one material selected from the group consisting of:
- lactose monohydrate;
- lactose anhydrous;
- mannitol;
- microcrystalline cellulose;
- sucrose;
- glucose;
- sodium chloride;
- talc;
- kaolin;
- calcium carbonate;
- malic acid;
- tartaric acid;
- trisodium citrate dihydrate;
- D,L-Malic acid;
- sodium pentane sulfate;
- sodium octadecyl sulfate;
- Brij700;
- Brij76;
- sodium n-lauroyl sacrosine;
- lecithin;
- docusate sodium;
- polyoxyl-40-stearate;
- Aerosil R972 fumed silica;
- sodium lauryl sulfate or other alkyl sulfate surfactants with a chain length between C5 to C18;
- polyvinyl pyrrolidone;
- sodium lauryl sulfate and polyethylene glycol 40 stearate, sodium lauryl sulfate and polyethylene glycol 100 stearate, sodium lauryl sulfate and PEG 3000, sodium lauryl sulphate and PEG 6000, sodium lauryl sulphate and PEG 8000, sodium lauryl sulphate and PEG 10000, sodium lauryl sulfate and Brij700, sodium lauryl sulfate and Poloxamer 407, sodium lauryl sulfate and Poloxamer 338, sodium lauryl sulfate and Poloxamer 188;
- Poloxamer 407, Poloxamer 338, Poloxamer 188, alkyl naphthalene sulfonate condensate/Lignosulfonate blend;
- Calcium Dodecylbenzene Sulfonate (Branched);
- Diisopropyl naphthalenesulphonate;
- erythritol distearate;
- linear and branched dodecylbenzene sulfonic acids;
- Naphthalene Sulfonate Formaldehyde Condensate;
- nonylphenol ethoxylate, POE-30;
- Phosphate Esters, Tristyrylphenol Ethoxylate, Free Acid;
- Polyoxyethylene (15) tallowalkylamines;
- sodium alkyl naphthalene sulfonate;
- sodium alkyl naphthalene sulfonate condensate;
- sodium alkylbenzene sulfonate;
- sodium isopropyl naphthalene sulfonate;
- Sodium Methyl Naphthalene;
- Formaldehyde Sulfonate;
- sodium salt of n-butyl naphthalene sulfonate;
- tridecyl alcohol ethoxylate, POE-18;
- Triethanolamine isodecanol phosphate ester;
- Triethanolamine tristyrylphosphate ester;
- Tristyrylphenol Ethoxylate Sulfate;
- Bis(2-hydroxyethyl)tallowalkylamines.
- h. Tartaric acid or tartaric acid combined with at least one material selected from the group consisting of:
- lactose monohydrate;
- lactose anhydrous;
- mannitol;
- microcrystalline cellulose;
- sucrose;
- glucose;
- sodium chloride;
- talc;
- kaolin;
- calcium carbonate;
- malic acid;
- trisodium citrate dihydrate;
- D,L-Malic acid;
- sodium pentane sulfate;
- sodium octadecyl sulfate;
- Brij700;
- Brij76;
- sodium n-lauroyl sacrosine;
- lecithin;
- docusate sodium;
- polyoxyl-40-stearate;
- Aerosil R972 fumed silica;
- sodium lauryl sulfate or other alkyl sulfate surfactants with a chain length between C5 to C18;
- polyvinyl pyrrolidone;
- sodium lauryl sulfate and polyethylene glycol 40 stearate, sodium lauryl sulfate and polyethylene glycol 100 stearate, sodium lauryl sulfate and PEG 3000, sodium lauryl sulphate and PEG 6000, sodium lauryl sulphate and PEG 8000, sodium lauryl sulphate and PEG 10000, sodium lauryl sulfate and Brij700, sodium lauryl sulfate and Poloxamer 407, sodium lauryl sulfate and Poloxamer 338, sodium lauryl sulfate and Poloxamer 188;
- Poloxamer 407, Poloxamer 338, Poloxamer 188, alkyl naphthalene sulfonate condensate/Lignosulfonate blend;
- Calcium Dodecylbenzene Sulfonate (Branched);
- Diisopropyl naphthalenesulphonate;
- erythritol distearate;
- linear and branched dodecylbenzene sulfonic acids;
- Naphthalene Sulfonate Formaldehyde Condensate;
- nonylphenol ethoxylate, POE-30;
- Phosphate Esters, Tristyrylphenol Ethoxylate, Free Acid;
- Polyoxyethylene (15) tallowalkylamines;
- sodium alkyl naphthalene sulfonate;
- sodium alkyl naphthalene sulfonate condensate;
- sodium alkylbenzene sulfonate;
- sodium isopropyl naphthalene sulfonate;
- Sodium Methyl Naphthalene;
- Formaldehyde Sulfonate;
- sodium salt of n-butyl naphthalene sulfonate;
- tridecyl alcohol ethoxylate, POE-18;
- Triethanolamine isodecanol phosphate ester;
- Triethanolamine tristyrylphosphate ester;
- Tristyrylphenol Ethoxylate Sulfate;
- Bis(2-hydroxyethyl)tallowalkylamines.
- i. microcrystalline cellulose or microcrystalline cellulose combined with at least one material selected from the group consisting of:
- lactose monohydrate;
- xylitol;
- lactose anhydrous;
- mannitol;
- sucrose;
- glucose;
- sodium chloride;
- talc;
- kaolin;
- calcium carbonate;
- malic acid;
- tartaric acid;
- trisodium citrate dihydrate;
- D,L-Malic acid;
- sodium pentane sulfate;
- sodium octadecyl sulfate;
- Brij700;
- Brij76;
- sodium n-lauroyl sacrosine;
- lecithin;
- docusate sodium;
- polyoxyl-40-stearate;
- Aerosil R972 fumed silica;
- sodium lauryl sulfate or other alkyl sulfate surfactants with a chain length between C5 to C18;
- polyvinyl pyrrolidone;
- sodium lauryl sulfate and polyethylene glycol 40 stearate, sodium lauryl sulfate and polyethylene glycol 100 stearate, sodium lauryl sulfate and PEG 3000, sodium lauryl sulphate and PEG 6000, sodium lauryl sulphate and PEG 8000, sodium lauryl sulphate and PEG 10000, sodium lauryl sulfate and Brij700, sodium lauryl sulfate and Poloxamer 407, sodium lauryl sulfate and Poloxamer 338, sodium lauryl sulfate and Poloxamer 188;
- Poloxamer 407, Poloxamer 338, Poloxamer 188, alkyl naphthalene sulfonate condensate/Lignosulfonate blend;
- Calcium Dodecylbenzene Sulfonate (Branched);
- Diisopropyl naphthalenesulphonate;
- erythritol distearate;
- linear and branched dodecylbenzene sulfonic acids;
- Naphthalene Sulfonate Formaldehyde Condensate;
- nonylphenol ethoxylate, POE-30;
- Phosphate Esters, Tristyrylphenol Ethoxylate, Free Acid;
- Polyoxyethylene (15) tallowalkylamines;
- sodium alkyl naphthalene sulfonate;
- sodium alkyl naphthalene sulfonate condensate;
- sodium alkylbenzene sulfonate;
- sodium isopropyl naphthalene sulfonate;
- Sodium Methyl Naphthalene;
- Formaldehyde Sulfonate;
- sodium salt of n-butyl naphthalene sulfonate;
- tridecyl alcohol ethoxylate, POE-18;
- Triethanolamine isodecanol phosphate ester;
- Triethanolamine tristyrylphosphate ester;
- Tristyrylphenol Ethoxylate Sulfate;
- Bis(2-hydroxyethyl)tallowalkylamines.
- j. Kaolin combined with at least one material selected from the group consisting of:
- lactose monohydrate;
- xylitol;
- lactose anhydrous;
- mannitol;
- microcrystalline cellulose;
- sucrose;
- glucose;
- sodium chloride;
- talc;
- kaolin;
- calcium carbonate;
- malic acid;
- tartaric acid;
- trisodium citrate dihydrate;
- D,L-Malic acid;
- sodium pentane sulfate;
- sodium octadecyl sulfate;
- Brij700;
- Brij76;
- sodium n-lauroyl sacrosine;
- lecithin;
- docusate sodium;
- polyoxyl-40-stearate;
- Aerosil R972 fumed silica;
- sodium lauryl sulfate or other alkyl sulfate surfactants with a chain length between C5 to C18;
- polyvinyl pyrrolidone;
- sodium lauryl sulfate and polyethylene glycol 40 stearate, sodium lauryl sulfate and polyethylene glycol 100 stearate, sodium lauryl sulfate and PEG 3000, sodium lauryl sulphate and PEG 6000, sodium lauryl sulphate and PEG 8000, sodium lauryl sulphate and PEG 10000, sodium lauryl sulfate and Brij700, sodium lauryl sulfate and Poloxamer 407, sodium lauryl sulfate and Poloxamer 338, sodium lauryl sulfate and Poloxamer 188;
- Poloxamer 407, Poloxamer 338, Poloxamer 188, alkyl naphthalene sulfonate condensate/Lignosulfonate blend;
- Calcium Dodecylbenzene Sulfonate (Branched);
- Diisopropyl naphthalenesulphonate;
- erythritol distearate;
- linear and branched dodecylbenzene sulfonic acids;
- Naphthalene Sulfonate Formaldehyde Condensate;
- nonylphenol ethoxylate, POE-30;
- Phosphate Esters, Tristyrylphenol Ethoxylate, Free Acid;
- Polyoxyethylene (15) tallowalkylamines;
- sodium alkyl naphthalene sulfonate;
- sodium alkyl naphthalene sulfonate condensate;
- sodium alkylbenzene sulfonate;
- sodium isopropyl naphthalene sulfonate;
- Sodium Methyl Naphthalene;
- Formaldehyde Sulfonate;
- sodium salt of n-butyl naphthalene sulfonate;
- tridecyl alcohol ethoxylate, POE-18;
- Triethanolamine isodecanol phosphate ester;
- Triethanolamine tristyrylphosphate ester;
- Tristyrylphenol Ethoxylate Sulfate;
- Bis(2-hydroxyethyl)tallowalkylamines.
- k. Talc combined with at least one material selected from the group consisting of:
- lactose monohydrate;
- xylitol;
- lactose anhydrous;
- mannitol;
- microcrystalline cellulose;
- sucrose;
- glucose;
- sodium chloride;
- kaolin;
- calcium carbonate;
- malic acid;
- tartaric acid;
- trisodium citrate dihydrate;
- D,L-Malic acid;
- sodium pentane sulfate;
- sodium octadecyl sulfate;
- Brij700;
- Brij76;
- sodium n-lauroyl sacrosine;
- lecithin;
- docusate sodium;
- polyoxyl-40-stearate;
- Aerosil R972 fumed silica;
- sodium lauryl sulfate or other alkyl sulfate surfactants with a chain length between C5 to C18;
- polyvinyl pyrrolidone;
- sodium lauryl sulfate and polyethylene glycol 40 stearate, sodium lauryl sulfate and polyethylene glycol 100 stearate, sodium lauryl sulfate and PEG 3000, sodium lauryl sulphate and PEG 6000, sodium lauryl sulphate and PEG 8000, sodium lauryl sulphate and PEG 10000, sodium lauryl sulfate and Brij700, sodium lauryl sulfate and Poloxamer 407, sodium lauryl sulfate and Poloxamer 338, sodium lauryl sulfate and Poloxamer 188;
- Poloxamer 407, Poloxamer 338, Poloxamer 188, alkyl naphthalene sulfonate condensate/Lignosulfonate blend;
- Calcium Dodecylbenzene Sulfonate (Branched);
- Diisopropyl naphthalenesulphonate;
- erythritol distearate;
- linear and branched dodecylbenzene sulfonic acids;
- Naphthalene Sulfonate Formaldehyde Condensate;
- nonylphenol ethoxylate, POE-30;
- Phosphate Esters, Tristyrylphenol Ethoxylate, Free Acid;
- Polyoxyethylene (15) tallowalkylamines;
- sodium alkyl naphthalene sulfonate;
- sodium alkyl naphthalene sulfonate condensate;
- sodium alkylbenzene sulfonate;
- sodium isopropyl naphthalene sulfonate;
- Sodium Methyl Naphthalene;
- Formaldehyde Sulfonate;
- sodium salt of n-butyl naphthalene sulfonate;
- tridecyl alcohol ethoxylate, POE-18;
- Triethanolamine isodecanol phosphate ester;
- Triethanolamine tristyrylphosphate ester;
- Tristyrylphenol Ethoxylate Sulfate;
- Bis(2-hydroxyethyl)tallowalkylamines.
517 more elements
The method of any preceding claim, wherein a milling aid or combination of milling aids is used where the milling aid is selected from the group consisting of:
- colloidal silica, a solid or semi solid surfactant, a liquid surfactant, a surfactant that can be manufactured into a solid or semisolid, a polymer, a stearic acid and derivatives thereof.
The method of any preceding claim, wherein a facilitating agent is used or combination of facilitating agents is used where the facilitating agent is selected from the group consisting of:
- surfactants, polymers, binding agents, filling agents, lubricating agents, sweeteners, flavouring agents, preservatives, buffers, wetting agents, disintegrants, effervescent agents, agents that may form part of a medicament, including a solid dosage form.
A composition comprising particles of metaxalone dispersed in at least two partially milled grinding materials, wherein the particles have at least one of
- a. a median particle size as measured on a particle volume basis is less than or equal to a size selected from the group consisting of 2000 nm, 1900 nm, 1800 nm, 1700 nm, 1600 nm, 1500 nm, 1400 nm, 1300 nm, 1200 nm, 1100 nm, 1000 nm, 900 nm, 800 nm, 700 nm, 600 nm, 500 nm, 400 nm, 300 nm, 200 nm and 100 nm;
- and
- b. an average particle size as measured on a particle number basis is less than or equal to a size selected from the group consisting of 2000 nm, 1900 nm, 1800 nm, 1700 nm, 1600 nm, 1500 nm, 1400 nm, 1300 nm, 1200 nm, 1100 nm, 1000 nm, 900 nm, 800 nm, 700 nm, 600 nm, 500 nm, 400 nm, 300 nm, 200 nm and 100 nm.
Dependencies are inferred from the claim text.