Development and Characterization of Mucoadhesive Thin Film as an Oral Mucosal Drug Delivery System of Carbinoxamine Maleate

Abstract

Objective: Thin film (TF) is an oral mucosal drug delivery system that disintegrates and dissolves the drug rapidly when placed on any oral mucosal tissue. This work aimed to develop and characterize TF containing carbinoxamine maleate (CM) for the symptomatic treatment of seasonal and perennial allergies and other allergic conditions. Methods: Three optimized batches were developed by solvent-casting method with different ratios of blends of hydroxypropyl methylcellulose (HPMC) E50LV and polyvinylpyrrolidone (PVP) K12 or K85-95 as mucoadhesive film-forming polymers. The produced TFs were subjected to physicochemical and mechanical characterization. Results: The weight and thickness of TF were in the range of 40.47 mg ± 0.49 to 65.70 mg ± 1.51 and 50.80 μm ± 1.11 to 95.20 μm ± 2.50, respectively. The percent drug load was found to be within the acceptable limit for content uniformity. Within 15 minutes, the amount of CM released from thin films of Batch 3 was 81.04% ± 1.91 which was significantly slower than Batch 1 and Batch 2. The disintegration of TFs was achieved in less than 180 seconds. Results of mechanical testing revealed high values of Young’s modulus with no significant difference between batches. The incorporation of blends of HPMC E50 LV and PVP K85-95 at a ratio of 1:1 notably decreased tensile strength and elongation at break. Conclusion: This work demonstrates the successful development of TF as an adequate delivery system for the administration of CM. The selection of the film-forming polymer type, grade, and ratio can impact the characteristics of the TF and modify the delivery of CM. Keywords: Mucoadhesive Polymers, Thin Film, Drug Delivery, Carbinoxamine Maleate.