article · Scientific Reports
Loratadine is an insoluble compound with low oral bioavailability, which leads to side effects when taken orally. To address this, a topical delivery system was developed using drug-loaded nanosponges incorporated into a gel. Nine emulsion formulations were created using ethyl cellulose, polyvinyl alcohol, and dichloromethane via solvent evaporation, guided by a three-squared factorial design that altered the drug-to-polymer ratio and stirring speed. The optimised formulation achieved nanosized, spherical particles with sustained release profiles, good entrapment efficiency, and suitable zeta potential. This preparation was successfully loaded into a carbopol hydrogel. The resulting topical gel remained stable during two months of accelerated storage testing and showed no evidence of skin irritation, offering a controlled and safe alternative topical delivery approach.
Oral medications with low water solubility can cause systemic side effects and poor absorption. Formulating such drugs into topical hydrogels helps deliver the active ingredient directly through the skin in a controlled manner. This research provides a stable nanosponge gel platform that sustains drug delivery without irritating the skin, which may improve patient comfort and safety during treatment.
This work is at an applied and tested laboratory stage. It presents a topical delivery formulation that could interest pharmaceutical manufacturers and developers of novel drug delivery systems targeting localised or transdermal treatments. While the nanosponge gel demonstrated physical stability and non-irritancy in laboratory settings, further clinical trials and regulatory scale-up are required before it could become a commercial product.
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Loratadine (LoR) is a highly lipophilic and practically insoluble in water, hence having a low oral bioavailability. As it is formulated as topical gel, it competitively binds with the receptors, thus reducing the side-effects. The objective of this study was to prepare LoR loaded nanosponge (LoR-NS) in gel for topical delivery. Nine different formulations of emulsion were prepared by solvent evaporation method with polyvinyl alcohol (PVA), ethyl cellulose (EC), and dichloromethane (DCM). Based on 3<sup>2</sup> Full Factorial Design (FFD), optimization was carried out by varying the concentration of LOR:EC ratio and stirring rate. The preparations were subjected for the evaluation of particle size (PS), in vitro release, zeta potential (ZP) and entrapment efficiency (EE). The results revealed that the NS dispersion was nanosized with sustained release profiles and significant PS. The optimised formulation was formulated and incorporated into carbopol 934P hydrogel. The formulation was then examined to surface morphological characterizations using scanning electron microscopy (SEM) which depicted spherical NS. Stability studies, undertaken for 2 months at 40 ± 2 °C/75 ± 5% RH, concluded to the stability of the formulation. The formulation did not cause skin irritation. Therefore, the prepared NS hydrogel proved to be a promising applicant for LoR as a novel drug delivery system (NDDS) for safe, sustained and controlled topical application.
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DOI: 10.1038/s41598-024-55953-2
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