Abstract

FORMULATION DEVELOPMENT OF MOUTH DISSOLVING FILMS OF QUETIAPINE

K. Senthilkumar*, M. Pharm, PhD and Raj Priya Sennamanaidu, M. Pharm

.

Abstract

Objective: To enhance the solubility and bioavailability of Quetiapine fumarate (QF), a Biopharmaceutical Classification System (BCS) Class II drug, by formulating it into Mouth dissolving films (MDF) that provides rapid disintegration and improved patient compliance. Methods: Preformulation studies were conducted to evaluate organoleptic characters and drug - excipient compatibility by Fourier Transform Infrared spectroscopy (FTIR). MDF was prepared using Quetiapine fumarate - -cyclodextrin (QF-β-CD) inclusion complexes, Hydroxypropyl methylcellulose (HPMC E-15) as a polymer, and Polyethylene glycol (PEG-400) as a plasticizer. The formulations were characterized for physicochemical properties, mechanical properties, Differential Scanning Calorimetry (DSC), Powder X-ray diffraction (PXRD), Scanning Electron Microscope (SEM) analysis and drug release in simulated saliva and gastric conditions. Results: The Quetiapine MDF showed excellent weight uniformity at 225 ± 0.5 mg, smooth surfaces, and a thickness of 41 ± 1.3 μm, with a dispersion time of 26 ± 1 s. The films had a neutral pH of 7, disintegrated quickly (9.2 ± 0.68 s), and contained 98.9 ± 0.31% of the drug. Mechanical tests indicated good flexibility, with a burst strength of 0.067 ± 0.06 N and a tensile strength of 3.21 ± 0.6 MPa. In vitro studies demonstrated 99.3% drug release in simulated salivary fluid (SSF) and 100% in 0.1M hydrochloric acid (HCl) within 30 minutes, confirming enhanced solubility. FTIR analysis showed no significant interactions between QF and excipients, while DSC, PXRD, and SEM confirmed reduced crystallinity and particle size following the formation of the inclusion complex. Conclusion: The formulated Quetiapine MDF met United States Pharmacopeia (USP) standards, showing faster disintegration, enhanced dissolution, and higher bioavailability compared to commercially available immediate-release tablets. By bypassing first-pass metabolism, they improve absorption and patient compliance. The research demonstrated the potential for commercialization as an effective treatment.

Keywords: Quetiapine fumarate, Mouth-dissolving films (MDF), Bioavailability, Inclusion complex, β-Cyclodextrin, Disintegration time, Drug release, Patient compliance.