3D-Assisted Personalized Mucoadhesive Patch for Targeted Delivery of Lidocaine Hydrochloride
DOI:
https://doi.org/10.52340/GBMN.2026.01.01.167Keywords:
3D Printing, lidocaine hydrochloride, mucoadhesive patch, oral drug delivery, personalized medicineAbstract
Background: Conventional local anesthetic dosage forms are often associated with adverse effects such as injection-related pain and prolonged numbness, which limit patient comfort and compliance. The development of personalized drug delivery systems represents a promising strategy to overcome these limitations. Objectives: The aim of this study was to develop and evaluate a personalized mucoadhesive lidocaine hydrochloride patch using three-dimensional (3D) scanning and printing technologies for targeted oral delivery. Methods: A three-dimensional oral cavity model was obtained using a 3D scanner, and the corresponding cast and mold were fabricated in a dental laboratory using 3D printing technology. Twenty-Twenty experimental mucoadhesive patch formulations containing lidocaine hydrochloride were prepared and evaluated for physicochemical and technological parameters, including pH, tensile strength, mass uniformity, thickness, swelling index, moisture content, adhesive properties, and surface morphology. In vitro drug release studies were performed using a Franz diffusion cell, with subsequent spectrophotometric analysis. Results: Based on biopharmaceutical studies, a mucoadhesive lidocaine hydrochloride patch formulation was successfully developed. Among the investigated formulations, F19 was identified as optimal. Its composition consisted of lidocaine hydrochloride (0.5 g), sodium alginate (0.43 g), polyvinyl alcohol (0.4 g), polyethylene glycol 1500 (0.5 g), sorbitol (0.25 g), glycerol (0.7 g), ethyl cellulose (0.1 g), 96% ethanol (5.0 mL), and distilled water (8.0 mL). demonstrated optimal physicochemical and mechanical characteristics. In vitro release studies revealed that approximately 50% of lidocaine hydrochloride was released within the first 15 minutes, followed by sustained release over the subsequent 30 minutes, indicating suitability for local anesthetic application. Conclusions: The study demonstrates that 3D technologies can be effectively used to create personalized molds for the preparation of mucoadhesive patches. The optimized formulation shows potential for targeted oral anesthesia and site-specific drug delivery.References
To create a three-dimensional model of the oral cavity using 3D scanning;
To print the prepared cast by using a 3D printer;
To design a mold for the target area based on the printed oral cavity model/cast;
To determine the formulation of a lidocaine hydrochloride-containing patch;
To develop the manufacturing technology of the patch for a personalized oral target site;
To evaluate the quality characteristics of the lidocaine hydrochloride patch;
To determine the stability of the patch under standard storage conditions.
The processes related to 3D scanning, cast fabrication, and mold design were carried out with the assistance of a dental laboratory using 3D technologies.
The object of the study was lidocaine hydrochloride, and the excipients in the patch formulation are presented in Table 1 according to their functional roles.
The polymer or polymer blend included in each formulation was allowed to swell in distilled water.
In a separate vessel, xylitol (or sorbitol) was melted at its melting temperature (95-97 °C), then PEG 1500 was added under continuous stirring as the temperature decreased to approximately 50 °C.
The molten mixture was cooled to room temperature and then added to the swollen polymer under stirring.
Glycerol was added to the resulting mass, which was subsequently transferred into a mold.
A backing layer consisting of an ethanolic solution of ethyl cellulose was applied to the formed patch and allowed to stand until ethanol had completely evaporated.
The pH of the patches was determined using a digital pH meter in a medium simulating artificial saliva.
The thickness of the patches was measured at multiple points using a digital caliper (vernier caliper), and the average value was calculated.
The average mass and mass uniformity were determined by weighing individual patches.
Tensile strength was measured using a Shimadzu testing instrument. The samples were fixed between two clamps. Moreover, force was applied until the patch broke. The maximum force required to break the patch was recorded.
The swelling index was determined by measuring the weight increase of the patches over time after immersion in artificial saliva.
Moisture content was determined by drying the patches in a drying oven at 70°C until a constant weight was achieved.
Mucoadhesive properties were evaluated qualitatively using a thumb test.
Surface morphology was examined using a digital microscope (Axio Observer, Carl Zeiss).
In vitro drug release studies were performed using a Franz diffusion cell. A cellulose membrane (0.5 mm thickness) was used as the diffusion barrier. The patch was placed on the membrane, and the receptor compartment was filled with a buffer solution simulating artificial saliva (pH 6.7). The experiment was conducted at 37°C to mimic physiological conditions. Samples were collected at predetermined time intervals and analyzed spectrophotometrically to determine the amount of released lidocaine hydrochloride.
Statistical analysis: All experiments were performed in triplicate, and the results are presented as mean ± standard deviation.
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