Modified release composition for highly soluble drugs
AssigneeTorrent Pharmaceuticals Limited
InventorsNavin Vaya, Rajesh Singh Karan, Sunil Sadanand Nadkarni, Vinod Kumar Gupta
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Abstract
A novel modified release dosage form comprising of a high solubility active ingredient, which utilizes dual retard technique to effectively reduce the quantity of release controlling agents. Present invention can optionally comprise additionally another active ingredient as an immediate release form or modified release form. Present invention also relates to a process for preparing the said formulation.
Claims21
A modified release dosage form comprising of a high solubility active ingredient prepared by using dual retard technique to control the release of the high solubility active ingredient, wherein the said dual retard technique is a combination of matrix formulation and reservoir formulation said dosage form consists of a) micro matrix particles which contain a high solubility active ingredient and one or more hydrophobic release controlling agents, and b) a coating of one or more hydrophobic release controlling agents on said micro matrix particles to form a double barrier to control the diffusion of the high solubility active ingredient, wherein the hydrophobic release controlling agents are selected from the group consisting of poly(ethyl acrylate, methyl methacrylate, trimethylammonioethyl methacrylate chloride) 1:2:0.1;
- poly(ethyl acrylate, methyl methacrylate, trimethylamonioethyl methacrylate chloride) 1:2:0.2 and poly(ethyl acrylate, methyl methacrylate) 1:1, polyvinyl acetate dispersion, ethylcellulose, cellulose acetate, lower molecular weight cellulose propionate, medium molecular weight cellulose propionate, higher molecular weight cellulose proprionate, cellulose acetate propionate, cellulose acetate butyrate, cellulose acetate phthalate, cellulose triacetate, poly(methyl methacrylate), poly(ethyl methacrylate), poly(butyl methacrylate), poly(isobutyl methacrylate), poly (hexyl methacrylate), poly(isodecyl methacrylate), poly (lauryl methacrylate), poly(phenyl methacrylate), poly (methyl acrylate), poly (isopropyl acrylate), poly (isobutyl acrylate), poly (octadecyl acrylate), beeswax, carnauba wax, microcrystalline wax, and ozokerite;
- cetostearyl alcohol, stearyl alcohol;
- cetyl alcohol and myristyl alcohol;
- glyceryl monostearate;
- glycerol monooleate, acetylated monoglycerides, tristearin, tripalmitin, cetyl esters wax, glyceryl palmitostearate, glyceryl behenate and hydrogenated castor oil, wherein the active ingredient can be less than or equal to 1500 mg.
A process for the preparation of a modified release dosage form comprising a) preparing a micro matrix particles consisting of high solubility active ingredient and one or more hydrophobic release controlling agent and b) coating the said micromatrix particles consisting of high solubility active ingredient and one or more hydrophobic release controlling agent.
A modified release dosage form comprising metformin hydrochloride prepared by using dual retard technique to control the release of metformin, wherein the said dual retard technique is a combination of matrix formulation and rservoir formulation, said dosage form consist of a) micro matrix particles containing metformin hydrochloride and one or more hydrophobic release controlling agents and b) coating of one or more hydrophobic release controlling agents on said micro matrix particles particles to form a double barrier to control the diffusion of the high soluble active ingredient, wherein the hydrophobic release controlling agents are selected from the group consisting of poly(ethyl acrylate, methyl methacrylate, trimethylammonioethyl methacrylate chloride) 1:2:0.1;
- poly(ethyl acrylate, methyl methacrylate, trimethylamonioethyl methacrylate chloride) 1:2:0.2 and poly(ethyl acrylate, methyl methacrylate) 1:1, polyvinyl acetate dispersion, ethylcellulose, cellulose acetate, cellulose propionate (lower, medium or higher molecular weight), cellulose acetate propionate, cellulose acetate butyrate, cellulose acetate phthalate, cellulose triacetate, poly(methyl methacrylate), poly(ethyl methacrylate), poly(butyl methacrylate), poly(isobutyl methacrylate), poly (hexyl methacrylate), poly(isodecyl methacrylate), poly (lauryl methacrylate), poly(phenyl methacrylate), poly (methyl acrylate), poly (isopropyl acrylate), poly (isobutyl actylate), poly (octadecyl acrylate), waxes selected from the group consisting of beeswax, carnauba wax, microcrystalline wax, and ozokerite;
- fatty alcohols selected from the group consisting of cetostearyl alcohol, stearyl alcohol;
- cetyl alcohol and myristyl alcohol;
- and fatty acid esters selected from the group consisting of glyceryl monostearate;
- glycerol monooleate, acetylated monoglycerides, tristearin, tripalmitin, cetyl esters wax, glyceryl palmitostearate, glyceryl behenate and hydrogenated castor oil wherein the metformin hydrochloride can be less than or equal to 1500 mg.
A process for the preparation of a modified release dosage form comprising a) preparing a micro matrix particles consisting of metformin hydrochloride and one or more hydrophobic release controlling agent and b) coating the said micro matrix particles consisting of metformin hydrochloride and one or more hydrophobic release controlling agent.
Dependencies are inferred from the claim text.