Formulation and Evaluation of Immediate-Release Quetiapine Fumarate Tablets Via Twin-Screw Melt Granulation

Abstract

Purpose

This study aimed to develop immediate-release Quetiapine Fumarate (QTF) tablets using twin-screw melt granulation (TSMG), a solvent-free and efficient granulation method, and compare their dissolution profiles with the marketed product.

Methods

QTF tablets were formulated using TSMG with varying concentrations of Ludiflash^® as a diluent and HPMC as a binder. Granules were prepared using a twin-screw extruder at 150 °C, optimized for feed rate and screw design. Granules were characterized for flow properties, thermal stability, and molecular interactions using differential scanning calorimetry (DSC) and Fourier transform infrared (FTIR) spectroscopy. Compressed tablets were evaluated for weight variation, hardness, friability, disintegration, and dissolution. Drug release profiles were compared with a commercial product.

Results

TSMG improved granule flow properties, with all formulations exhibiting excellent post-extrusion characteristics. DSC confirmed the retention of QTF crystallinity, and FTIR demonstrated excipient compatibility. The tablets passed pharmacopeial tests for weight variation, hardness, friability, and disintegration. Dissolution studies showed that formulations F4, F5, and F6 released over 85% of the drug within 15 min, comparable to the marketed product.

Conclusion

TSMG is a robust and cost-effective technology for manufacturing immediate-release QTF tablets. The solvent-free process ensures compatibility, thermal stability, and rapid drug release, making TSMG a promising alternative for continuous pharmaceutical production.

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Materials

Quetiapine fumarate was purchased from RIA International LLC, Ludiflash® was gifted by BASF, AFFINISOL™ HPMC HME LV15 Hypromellose was gifted by Colorcon, commercially available quetiapine fumarate tablets were procured from Ascend laboratories LLC and other chemicals used such as methanol, deionized water, etc. were purchased from Fisher Scientific.

Chavan, S., Munnangi, S., Narala, N. et al. Formulation and Evaluation of Immediate-Release Quetiapine Fumarate Tablets Via Twin-Screw Melt Granulation. J Pharm Innov 20, 65 (2025). https://doi.org/10.1007/s12247-025-09981-8

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