Abstract
Three-dimensional (3D) printing is an emerging technology that has high application potential for individualized medicines and complex solid dosage forms. This study is designed to explore binder jet 3D printing (BJ-3DP) for the development of high-precision and repeatable compound levetiracetam-pyridoxine hydrochloride (LEV-PN) multicompartmental structure dispersible tablets. PN was dissolved in printing ink directly and accurately jetted into the middle, nested layer of the tablet, and precise control of the drug dose was achieved through the design of printing layers. With modification of the drying method, the “coffee ring” effect caused by drug migration during the curing and molding of the tablets was overcome. Furthermore, 3D topography showed that the tablets have a promising surface morphology. Scanning electron microscopy and porosity results indicated that the tablets have a loose interior and tight exterior, which would ensure good mechanical properties while enabling the tablet to disintegrate quickly in the mouth and achieve rapid release of the two drugs. This study used BJ-3DP technology to prepare personalized multicompartmental structures of drug systems and provides a basis for the development of complex preparations.
Highlights
Since the 2015 implementation of the Precision Medicine Initiative in the United States, the worldwide demand for personalized and tailored pharmaceutical tablets has risen continually in the past few years
This study demonstrated that the use of self-developed binder jet 3D printing (BJ-3DP) allowed the preparation of compound levetiracetam-pyridoxine hydrochloride (LEV-Pyridoxine hydrochloride (PN)) multicompartmental structure dispersible tablets
PN was dissolved in the printing ink and directly jetted into the middle, nested layer of the tablet with precision to implement partitioned combination printing, avoiding drug stability problems
Summary
Since the 2015 implementation of the Precision Medicine Initiative in the United States, the worldwide demand for personalized and tailored pharmaceutical tablets has risen continually in the past few years. Studies have shown that approximately 80% of adverse effects from drug intake are related to inappropriate doses or combined doses [1]. Maximizing the efficacy and safety of drugs administered to every patient is a priority in modern health care. The need for the development of patient-specific drug dosing has been well recognized, for pediatric and geriatric populations that differ from a “standard patient” in many aspects [2,3]. Levetiracetam (LEV) is a second-generation antiepileptic drug that has been widely recognized as the global “gold standard” for treatment of epilepsy because of its minimal adverse effects, good tolerability, and high safety profile.
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