1 School of Pharmaceutical Sciences, Jaipur National University, Jaipur, Rajasthan, India
2 Lal Bahadur Shastri College of Pharmacy, Jaipur, India
3 Jaipur School of Pharmacy, Maharaj Vinayak Global University, Dhand, Tehsil-Amer, Jaipur-302028
* Corresponding Author: Puneet Gupta
Background:
Loratadine, an antihistamine of 2nd generation, is widely advised for management of allergic conditions but suffers from delayed onset of action in conventional oral dosage forms. Oral thin films (OTFs) offer a promising alternative, ensuring rapid drug release, improved patient compliance, and easy administration without water.
Methods:
Loratadine OTFs were developed using solvent casting method and optimized through a 3² full factorial design, with Hydroxypropyl Methylcellulose (HPMC K4M) and Chitosan as independent variables. Preformulation studies included organoleptic assessment, FTIR, UV spectrophotometry, melting point, solubility, and calibration curve construction. The films were evaluated for physicochemical properties (transparency, thickness, surface pH, appearance, weight variation, elongation, tensile strength, folding endurance, drug and moisture content), dissolution profile, in-vitro disintegration time, and surface morphology using scanning electron microscopy (SEM). Statistical optimization was led using DesignExpert® software, and kinetics of drug release were analysed via Higuchi, Korsmeyer–Peppas, first-order, and zero-order models.
Results:
Optimized batch (F3) exhibited desirable mechanical strength (0.92 N/mm²), high folding endurance (194 ± 3.94), surface pH within physiological range (7.4), and high drug content (99.12%). It showed a speedy in-vitro disintegration time of 12 seconds along with cumulative medication release of 98.22% within 25 minutes. Drug release followed Higuchi and Korsmeyer–Peppas models, revealing diffusion-controlled and anomalous transport mechanisms. SEM analysis revealed a smooth, homogenous surface morphology, confirming uniform drug distribution. Statistical modeling confirmed significant influence of polymer concentrations on disintegration time, drug content, and release profile (p < 0.005, desirability = 0.922).
Conclusion:
The developed Loratadine OTFs demonstrated excellent physicomechanical properties, rapid disintegration, and high drug release, making them a promising platform for fast-acting antihistaminic therapy. This formulation strategy holds potential for enhancing therapeutic efficacy and patient compliance in allergic condition management.
Keywords: Loratadine, Oral thin films, 3² full factorial design, In-vitro dissolution, Antihistaminic, Higuchi model
How to cite this article: Panda S, Gupta P, Khunteta A, Gupta MK. Development, Characterization, and In-Vitro Evaluation of Antihistaminic Oral Thin Films of Loratadine. Int J Drug Deliv Technol. 2026;16(1s): 325-336. DOI: 10.25258/ijddt.16.1s.40
Source of support: Nil.
Conflict of interest: None