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

IF 2.7 4区医学 Q2 PHARMACOLOGY & PHARMACY Journal of Pharmaceutical Innovation Pub Date : 2025-04-02 DOI:10.1007/s12247-025-09981-8

Salonee Chavan, Siva Ram Munnangi, Nagarjuna Narala, Sateesh Kumar Vemula, Michael Repka

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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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富马酸奎硫平速释片双螺杆熔体造粒制备及评价

目的本研究旨在采用双螺杆熔融制粒（TSMG）这种无溶剂、高效的制粒方法开发富马酸喹硫平（QTF）速释片剂，并将其溶出度曲线与上市产品进行比较。使用双螺杆挤压机在 150 °C 下制备颗粒，并对喂料速率和螺杆设计进行了优化。使用差示扫描量热法（DSC）和傅立叶变换红外光谱法（FTIR）对颗粒的流动特性、热稳定性和分子相互作用进行了表征。对压制片剂的重量变化、硬度、易碎性、崩解度和溶解度进行了评估。结果表明，ResultsTSMG 改善了颗粒的流动性，所有配方都表现出优异的挤压后特性。DSC 证实了 QTF 结晶性的保留，而 FTIR 则证明了辅料的相容性。片剂通过了药典规定的重量变化、硬度、易碎性和崩解性测试。溶出度研究表明，F4、F5 和 F6 配方在 15 分钟内释放了 85% 以上的药物，与市场上销售的产品相当。无溶剂工艺确保了兼容性、热稳定性和药物的快速释放，使 TSMG 成为连续制药生产的一种有前途的替代技术。

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来源期刊

Journal of Pharmaceutical Innovation PHARMACOLOGY & PHARMACY-

CiteScore

3.70

自引率

3.80%

发文量

审稿时长

>12 weeks

期刊介绍： The Journal of Pharmaceutical Innovation (JPI), is an international, multidisciplinary peer-reviewed scientific journal dedicated to publishing high quality papers emphasizing innovative research and applied technologies within the pharmaceutical and biotechnology industries. JPI''s goal is to be the premier communication vehicle for the critical body of knowledge that is needed for scientific evolution and technical innovation, from R&D to market. Topics will fall under the following categories: Materials science, Product design, Process design, optimization, automation and control, Facilities; Information management, Regulatory policy and strategy, Supply chain developments , Education and professional development, Journal of Pharmaceutical Innovation publishes four issues a year.