Development and optimization of intermediate release ketoprofen tablets by central composite design.

Area of Science:

• Pharmaceutical Technology
• Drug Delivery Systems
• Formulation Development

Background:

• Development of cost-effective drug delivery systems is crucial for patient compliance.
• Intermediate release formulations offer a balance between immediate and sustained drug action.
• Optimization of tablet formulations requires careful selection of excipients and manufacturing processes.

Purpose of the Study:

• To develop and optimize intermediate release (IntR) ketoprofen tablets using a direct compression technique.
• To investigate the impact of microcrystalline cellulose, methocel K4M, and starch on tablet properties.
• To evaluate the in vitro drug release and stability of the optimized ketoprofen formulations.

Main Methods:

• Utilized central composite design (CCRD) for formulation optimization.
• Prepared fifteen different ketoprofen tablet formulations (F1-F15) varying excipient concentrations.
• Evaluated powder blend properties (Angle of Repose, Carr's Index, porosity) and tablet characteristics (friability, compressibility). Performed in vitro dissolution studies in various pH media and analyzed release kinetics (Hixson-Crowell model, f1, f2, MDT, ANOVA).

Main Results:

• Optimized formulations (F6, F7, F14) demonstrated acceptable physicochemical properties and micromeritics.
• In vitro dissolution studies showed similarity to the reference formulation (F15) across different pH media.
• Drug release followed the Hixson-Crowell model, indicating anomalous transport (non-fickian diffusion), with stable profiles under accelerated conditions.

Conclusions:

• Cost-effective intermediate release ketoprofen tablets were successfully developed using direct compression and CCRD.
• The optimized formulations exhibited favorable drug release characteristics and stability, suitable for therapeutic use.
• This approach provides a viable method for developing optimized oral drug delivery systems.