Development and Evaluation of Clitoria ternatea Extract–Loaded Orodispersible Films as A Novel Antioxidant Delivery System

ABSTRACT
Background: Oxidative stress plays a significant role in the progression of chronic diseases by causing cellular harm
through reactive oxygen species (ROS). Increasing interest has been shown in natural antioxidants as safer substitutes for
synthetic compounds like butylated hydroxyanisole and butylated hydroxytoluene. Clitoria ternatea (Fabaceae), often
referred to as butterfly pea, is abundant in flavonoids and anthocyanins that demonstrate strong antioxidant and
neuroprotective properties.
Objective: The purpose of this study was to formulate and assess Clitoria ternatea extract-loaded Orodispersible films
(ODFs) as an innovative phytopharmaceutical product aimed at improving antioxidant effectiveness, stability, and patient
adherence.
Methods: Aqueous extracts from the flowers were integrated into hydroxypropyl methylcellulose (HPMC) polymer
matrices via the solvent casting technique. The resulting ODFs were analyzed for their physicochemical properties,
mechanical strength, disintegration time, swelling index, and in vitro dissolution. Antioxidant potential was evaluated
using DPPH, hydrogen peroxide scavenging, and ferric reducing antioxidant power (FRAP) assays. Spectroscopic (UV–
Vis), thermal (DSC), and X-ray diffraction (XRD) analysis were conducted to examine the structural and compatibility
characteristics.
Results: The optimized films were homogeneous, flexible, and dissolved rapidly (30 ± 2 s), exhibiting excellent folding
endurance (>120). Antioxidant tests indicated concentration-dependent radical scavenging activity with IC₅₀ values
similar to those of the crude extract, confirming the preservation of phytochemical efficacy. DSC and XRD studies
revealed that the extract was molecularly dispersed within the polymer matrix, suggesting an enhanced amorphous
nature.
Conclusion: The developed Clitoria ternatea ODFs demonstrated significant antioxidant activity, stability, and rapid
dissolution, indicating their potential as a novel and user-friendly delivery system for natural antioxidants in managing
oxidative stress.
Keywords: Clitoria ternatea, Orodispersible film, Antioxidant activity, Phytopharmaceutical formulation, Oxidative stress