Dosage form for high dose-high solubility active ingredients that provides for immediate release and modified release of the active ingredients
AssigneeTorrent Pharmaceuticals Limited
InventorsNavin Vaya, Rajesh Singh Karan, Sunil Sadanand Nadkarni, Vinod Kumar Gupta
Life of this patent
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Abstract
A dosage form comprising of a high dose, high solubility active ingredient as modified release and a low dose active ingredient as immediate release where the weight ratio of immediate release active ingredient and modified release active ingredient is from 1:10 to 1:15000 and the weight of modified release active ingredient per unit is from 500 mg to 1500 mg; a process for preparing the dosage form.
Claims30
A dosage form of combination of high dose high solubility active ingredient, as modified release and low dose active ingredient as immediate release suitable for swallowing;
- comprising an inner portion having a low dose active ingredient as immediate release and an outer portion having a high dose, high solubility active ingredient as modified release, wherein said inner portion is covered by the outer portion from all the sides except a top surface that remains uncovered;
- wherein the outer portion prepared by using dual retard technique to control the release of high dose, high solubility active ingredient, wherein the dual retard technique is a combination of matrix formulation and reservoir formulation comprises
- (a) micro matrix particles consisting of a high dose, high solubility active ingredient and one or more hydrophobic release controlling agents wherein the ratio of high dose, high solubility active ingredient and hydrphobic release controlling agent is in the range of 100:2.5 to 100:30 and
- (b) coating of one or more hydrophobic release controlling agents on said micro matrix particles, wherein the ratio of micro matrix particles and hydrophobic release controlling agent is in the range of 100:2.5 to 100:30 wherein the weight ratio of the immediate release low dose active ingredient and high dose, high solubility modified release active ingredient is from 1:1 to 1:15000 wherein the claimed dosage form does not provide burst release.
A dosage form of combination of high dose high solubility hypolipidemic active ingredient as modified release and low dose hypolipidemic or antithrombotic active ingredient as immediate release, suitable for swallowing;
- comprising an inner portion having a low dose hypolipidemic or antithrombotic active ingredient as immediate release and an outer portion having a high dose high solubility hypolipidemic active ingredient as modified release,wherein said inner portion is covered by the outer portion from all the sides except a top surface that remains uncovered;
- wherein said outer portion prepared by using dual retard technique to control the release of high dose high solubility is a combination of matrix formulation and reservoir formulation comprises:
- (a) micro matrix particles consisting of a high dose high solubility hypolipidemic active ingredient and one or more hydrophobic release controlling agents wherein the ratio of high dose high solubility hypolipidemic active ingredients and hydrophobic release controlling agents is in the range of 100-2.5 to 100:30 and
- (b) a coating of one or more hyrophobic release controlling agents on said micro matrix particles, wherein the ratio of micro matrix particles and hydrophobic release controlling agent is in the range of 100:2.5 to 100:30 wherein the weight ratio of immediate release hypolipidemic or antithrombotic active ingredient and modified release hypolipidemic active ingredient is from 1:1 to 1:15000wherein the claimed dosage form does not provide burst release.
Dependencies are inferred from the claim text.