Oral composition of celecoxib for treatment of pain
AssigneeDr. Reddy's Laboratories, Inc.
InventorsAnkit BAHETI, Bijay Kumar PADHI, Supritha VAKADA, Rajeev Singh RAGHUVANSHI
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Abstract
The present invention relates to a stable oral liquid pharmaceutical composition of celecoxib or its pharmaceutically acceptable salts thereof. The celecoxib present in the compositions as described herein do not show any precipitation when subjected in Fasted-State Simulated Gastric Fluid (FaSSGF) at pH 2.0, temperature of 37° C.±0.5° C. and under stirring at a speed of 50 rpm at least for 60 minutes. It also relates to the process of preparing and method of using said composition of celecoxib.
Claims30
An oral pharmaceutical composition, comprising a reduced dose of celecoxib and at least one pharmaceutically acceptable excipient, wherein said composition a) releases no less than about 70% of the celecoxib at a period of 10 minutes;
- or b) releases no less than about 80% of the celecoxib at a period of 15 minutes, in 900 ml of 0.01N HCl with 0.5% sodium lauryl sulfate, when tested in a USP Type 2 apparatus with sinkers at 50 rpm and 37° C.
An oral pharmaceutical composition, comprising a reduced dose of celecoxib and at least one pharmaceutically acceptable excipient, wherein said reduced dose of celecoxib is about 240 mg and said composition a) releases no less than about 70% of the celecoxib at a period of 10 minutes;
- or b) releases no less than about 80% of the celecoxib at a period of 15 minutes, in 900 ml of 0.01N HCl with 0.5% sodium lauryl sulfate, when tested in a USP Type 2 apparatus with sinkers at 50 rpm and 37° C.
An oral pharmaceutical composition, comprising a reduced dose of celecoxib and at least one pharmaceutically acceptable excipient, wherein said reduced dose of celecoxib is about 180 mg and said composition a) releases no less than about 70% of the celecoxib at a period of 10 minutes;
- or b) releases no less than about 80% of the celecoxib at a period of 15 minutes, in 900 ml of 0.01N HCl with 0.5% sodium lauryl sulfate, when tested in a USP Type 2 apparatus with sinkers at 50 rpm and 37° C.
An oral pharmaceutical composition, comprising a reduced dose of celecoxib and at least one pharmaceutically acceptable excipient, wherein said reduced dose of celecoxib is about 120 mg and said composition a) releases no less than about 70% of the celecoxib at a period of 10 minutes;
- or b) releases no less than about 80% of the celecoxib at a period of 15 minutes, in 900 ml of 0.01N HCl with 0.5% sodium lauryl sulfate, when tested in a USP Type 2 apparatus with sinkers at 50 rpm and 37° C.
Dependencies are inferred from the claim text.