Orodispersible Film of Letrozole for Enhancing Compliance in Breast Cancer Treatment

Abstract

Background: Breast cancer is a leading cause of morbidity and mortality in women worldwide, with adherence to long-term endocrine therapy proving to be a major clinical challenge. Letrozole (LTZ), a third-generation aromatase inhibitor, is widely used in hormone receptor-sensitive breast cancer; however, its conventional oral tablet form often leads to poor compliance, especially in elderly and dysphagic patients. Objective: The current study aimed to develop and evaluate a patient friendly orodispersible film (ODF) of LTZ to enhance convenience, acceptability, and therapeutic adherence. Methods: LTZ-ODFs were formulated by solvent casting method using hydroxypropyl methylcellulose (HPMC E5) as a film-forming polymer and sodium starch glycolate (SSG) as superdisintegrant and the impact of varying amount of these excipients was evaluated on physicochemical properties and dissolution rate of LTZ. Various formulations (F1-F10) were prepared, the optimized formulation (F3) presented uniform thickness of 0.087 ± 0.013 mm, neutral surface pH (6.9 ± 0.4), excellent folding endurance, and rapid disintegration (14 ± 2 s). Results: In vitro dissolution studies demonstrated more than 95% drug release within 5 min, indicating rapid onset and effective drug dispersion. FTIR spectra confirmed drug excipient compatibility, and stability testing exhibited no significant changes under the accelerated conditions. Conclusion: The developed LTZ-ODF thus may represent a promising alternative delivery system offering improved compliance and enhanced therapeutic efficacy for breast cancer management.