Abstract
Extrusion-based 3D printing technology is a relatively new technique that has a potential for fabricating pharmaceutical products in various dosage forms. It offers many advantages over conventional manufacturing methods, including more accurate drug dosing, which is especially important for the drugs that require exact tailoring (e.g., narrow therapeutic index drugs). In this work, we have successfully fabricated phenytoin-loaded orodispersible films (ODFs) through a syringe extrusion 3D printing technique. Two different grades of hydroxypropyl methylcellulose (HPMC E5 and HPMC E15) were used as the film-forming polymers, and glycerin and propylene glycol were used as plasticizers. The 3D-printed ODFs were physicochemically characterized and evaluated for their mechanical properties and in vitro disintegration time. Then, the optimum printed ODFs showing good mechanical properties and the fastest disintegration time were selected to evaluate their drug content and dissolution profiles. The results showed that phenytoin-loaded E15 ODFs demonstrated superior properties when compared to E5 films. It demonstrated a fast disintegration time in less than 5 s and rapidly dissolved and reached up to 80% of drug release within 10 min. In addition, it also exhibited drug content uniformity within United States Pharmacopeia (USP) acceptable range and exhibited good mechanical properties and flexibility with low puncture strength, low Young’s modulus and high elongation, which allows ease of handling and application. Furthermore, the HPMC E15 printing dispersions with suitable concentrations at 10% w/v exhibited a non-Newtonian (shear-thinning) pseudoplastic behavior along with good extrudability characteristics through the extrusion nozzle. Thus, HPMC E15 can be applied as a 3D printing polymer for a syringe extrusion 3D printer.
Highlights
Over the last few decades, there has been a growing interest in the use of three-dimensional (3D) printing technology within the medical and pharmaceutical fields to fabricate the customizable solid dosage forms that suit different needs, preferences and individual characteristics of eachPolymers 2020, 12, 2666; doi:10.3390/polym12112666 www.mdpi.com/journal/polymersPolymers 2020, 12, 2666 patient [1]
The results showed that n values were less than 1.0 (0.66 to 0.78) for all hydroxypropyl methylcellulose (HPMC) E5 and HPMC E15 dispersions indicating the shear-thinning pseudo-plasticity nature, and the n values decreased with increasing of polymer concentration, indicating more intense shear-thinning
The rheological properties and dimensional accuracy tests for different concentrations of HPMC E5 and HPMC E15 dispersions were performed to determine the optimal concentration and viscosity that were appropriate for the customized syringe extrusion 3D printer
Summary
Over the last few decades, there has been a growing interest in the use of three-dimensional (3D) printing technology within the medical and pharmaceutical fields to fabricate the customizable solid dosage forms that suit different needs, preferences and individual characteristics of eachPolymers 2020, 12, 2666; doi:10.3390/polym12112666 www.mdpi.com/journal/polymersPolymers 2020, 12, 2666 patient [1]. Three-dimensional printing is a manufacturing method that can fabricate 3D-printed products of any shape and size on-demand from digital design software through depositing materials layer-by-layer [2] This technology involves three commonly used techniques: printing-based inkjet (IJ). ODFs are the relatively novel dosage form prepared by using hydrophilic polymers and designed to rapidly disintegrate within a minute in the buccal cavity, without requiring water [5] This dosage form exhibits several advantages over other oral dosage forms, including ease of administration to pediatric and geriatric patients experiencing dysphagia (swallowing difficulty), dose flexibility and improving the bioavailability of drugs due to high vascularity and high permeability in the buccal cavity [6]. 3D-printed films can be formulated with less amount of time
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