Direct compression tablet formulation of celecoxib enabled with a pharmaceutical solvate

Area of Science:

• Pharmaceutical Sciences
• Drug Delivery Systems
• Materials Science

Background:

• Celecoxib, an anti-inflammatory drug, is only available in capsule form.
• Capsule formulations present limitations in faster onset and manufacturing cost.
• Commercial celecoxib (Form III) exhibits poor flow and low bulk density, unsuitable for direct compression tablet manufacturing.

Purpose of the Study:

• To develop a direct compression tablet formulation for celecoxib.
• To overcome the poor flow and low bulk density issues of commercial celecoxib.
• To create a more cost-effective and faster-acting celecoxib dosage form.

Main Methods:

• Utilized a pharmaceutically acceptable dimethyl sulfoxide (DMSO) solvate of celecoxib.
• Developed a direct compression (DC) tablet formulation incorporating the DMSO solvate.
• Evaluated tablet manufacturability, disintegration, and in vitro dissolution performance.

Main Results:

• Successfully developed a DC tablet formulation using a celecoxib DMSO solvate.
• Achieved satisfactory manufacturability, disintegration, and in vitro dissolution for 200 mg celecoxib tablets.
• Overcame challenges associated with poor flow, low bulk density, and tablet lamination of commercial celecoxib.

Conclusions:

• A celecoxib DMSO solvate is effective in creating a direct compression tablet formulation.
• The developed tablet formulation offers improved manufacturability and performance compared to commercial capsules.
• This advancement facilitates a more efficient and potentially lower-cost production of celecoxib tablets.