Celecoxib and amlodipine formulation and method of making the same
AssigneesDexcel Ltd., Kitov Pharmaceuticals Ltd.
InventorYitshak Itsik Efrati
Life of this patent
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Abstract
Provided herein is a celecoxib and amlodipine composition and method of making the same. The composition contains granules containing celecoxib. The amlodipine is incorporated into the composition as an extragranulate.
Claims24
A method for treating pain and/or hypertension, and ameliorating celecoxib-induced elevation of blood pressure in a subject, comprising providing to the subject a pharmaceutical composition comprising
- (i) an admixture comprising
- a dry granulate comprising celecoxib or a pharmaceutically acceptable salt, wherein said dry granulate has a loss on drying (LOD) % of about 2.5% or less, wherein said dry granulate does not include amlodipine;
- and
- an extragranulate comprising amlodipine or a pharmaceutically acceptable salt thereof admixed with the dry granulate;
- and
- (ii) one or more excipients selected from the group consisting of a diluent, a disintegrant, a surfactant, a binder, a glidant, a lubricant, and combinations thereof, wherein the amount of celecoxib is sufficient to cause elevation in blood pressure, and wherein the amount of amlodipine is sufficient to ameliorate blood pressure elevation.
A method for treating pain and/or hypertension, and ameliorating celecoxib-induced elevation of blood pressure in a subject, comprising providing to the subject a pharmaceutical composition comprising a combination of celecoxib and amlodipine, wherein the pharmaceutical composition is prepared from a wet granulation of celecoxib or a pharmaceutically acceptable salt thereof and one or more excipients to obtain a wet granulate, wherein said wet granulate does not include amlodipine, wherein the wet granulate was dried to obtain a dry granulate, wherein the dry granulate has a loss on drying (LOD) % of about 2.5% or less, wherein the dry granulate was admixed with an extragranulate comprising amlodipine or a pharmaceutically acceptable salt thereof and optionally one or more excipients, wherein the amount of celecoxib is sufficient to cause elevation in blood pressure, and wherein the amount of amlodipine is sufficient to ameliorate blood pressure elevation.
Dependencies are inferred from the claim text.