PREPARATION AND OPTIMIZATION OF ONCE DAILY QUETIPINE FUMARATE SUSTAIN RELEASE TABLETS

Objective: Quetiapine fumarate (QF) belongs to the atypical antipsychotic class. The elimination half-life of QF is 6 h necessitates the development of sustain release (SR) formulation. In the current research, two polymers, HPMC K100M and Polyox WSR N80, were used in combination as per the central composite design (CCD) with an objective of sustained drug release for 24 h with low initial burst release. Methods: The SR matrix tablets of QF were prepared by wet granulation method. Fourier transform infrared and differential scanning calorimetry study for the physical mixture of QF with HPMC K100M and Polyox WSR N80 in 1:1 ratio demonstrated compatibility between the drug and polymers. The selection of the optimum formulation highlights the precision of CCD in optimizing the formulation parameters to achieve the desired release profile. Results: The integration of two polymers, HPMC K100M (58.2 mg/tablet) and Polyox WSR N80 (44.8 mg/tablet), proved effective in modulating the drug release dynamics. Specifically, the polymers synergistically contributed in attaining the desired responses vis-à-vis Q1 9.73%, t50 10.45 h, and Q18 82.46%, thereby ensuring minimized initial burst release and sustained release of QF over 24 h. Conclusion: The development of a once-daily formulation aligns with modern patient-centric approaches in pharmaceutical design, catering to convenience and improving quality of life for patients requiring long-term therapy.