Assessing the Compatibility of Different Formulations in OrPhyllo™, A Ready-to-Use Base for Personalized Orodispersible Films.

Abstract

Orodispersible films (ODFs) represent a rapidly evolving dosage form that addresses significant challenges in drug delivery, particularly for patients with difficulty swallowing, such as pediatric, geriatric, and psychiatric populations. ODFs disintegrate rapidly on the tongue, eliminating the need for water and offering benefits such as improved patient compliance, faster onset of action, and enhanced bioavailability. This study evaluates the compatibility and beyond-use dates (BUDs) of 12 ODF formulations compounded in OrPhyllo™, a ready-to-use base specifically designed for ODF production. The active pharmaceutical ingredients (APIs) investigated were baclofen (5 and 10 mg), cetirizine (1.25 and 5 mg), coenzyme Q10 (10 and 50 mg), dextromethorphan (7.5 and 15 mg), ketoprofen (12.5 and 25 mg), loratadine (5 and 10 mg), meloxicam (5 and 20 mg), minoxidil (1 and 10 mg), ondansetron (2 and 8 mg), sildenafil (25 and 50 mg), tadalafil (5 and 20 mg), and tramadol (25 and 50 mg). Comprehensive compatibility studies were conducted to determine the BUD and physicochemical integrity of these formulations by using validated ultra-high-performance liquid chromatography (UHPLC) methods and following guidelines for accelerated and long-term stability testing. No Antimicrobial Effectiveness Testing (AET) was conducted as those are nonaqueous dosage forms. The formulations were stored at room temperature (15-30°C) for up to 180 days, individually packed in matte laminated aluminum sachets. Results revealed the following BUDs for each formulation: baclofen (5 mg - 10 mg): 180 days; cetirizine: 60 days; coenzyme Q10: 180 days; dextromethorphan: 180 days; ketoprofen (12.5 mg): 180 days; ketoprofen (>12 mg - 25 mg): 60 days; loratadine: 180 days; meloxicam: 180 days; minoxidil: 180 days; ondansetron (2 mg): 90 days; ondansetron (>2 mg - 8 mg): 30 days; sildenafil: 180 days; tadalafil: 180 days; tramadol: 150 days. These findings affirm the suitability of OrPhyllo™ as a robust vehicle for compounding ODFs, demonstrating compatibility with APIs across a broad spectrum of clinical applications.