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首页> 外文会议>Novel Drug Delivery Systems: Research and Application >Linear drug release donut-shaped tablets prepared using 3DP
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Linear drug release donut-shaped tablets prepared using 3DP

机译：使用3DP制备的线性药物释放甜甜圈形片剂

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摘要

Three dimensional printing (3DP) is a solid freeform fabrication technique which employs powder processing and liquid binder materials in the construction of parts in a layer-wise manner. 3DP has drawn increasing attentions because of its outstanding capability, easy process and flexibility. 3DP is able to provide new strategies for the research and development of novel drug delivery devices due to its ability in controlling three-dimensional position of drugs and functional materials, microstructure, and local composition and surface texture in a single tablet accurately ande producibly.In this study, a kind of donut-shaped tablets conceived to furnish zero-order drug release characteristics are prepared using 3DP. The tablet consists of three sections. Both the top and the bottom sections without drug in them represent an inert and impermeable obstacle to water penetration and drug diffusion. Hydrophilic polymer HPMC with low viscosity is employed as drug carrier matrix to keep the tablets dissolution in erosion mechanism. The middle drug-loaded region is dividednto two parts: the peripheral annulus part has a high concentration of release-retardant materials, while the inner annulus part has a high concentration of drug. Thus, the erosion of the tablet surface is retarded and slower at the beginning of dissolution than the late dissolution process. Combined with the relatively lower concentration of drug in the outer region, the initial burst effect caused by imbibing of water and gelling of HPMC can be eliminated. Later, as the outer releasing surface area of cylindrical matrix decreases with time, the inner releasing surface area of the holes increases synchronously. As the height of the tablets remains stable, hence the erodible volume of the tablets in unitary time can keep comparatively constant, resulting in zero-order release profiles within the whole release period.To realize the designs features of special surface texture, non-uniform drug distributions and local variations of the release-retardant materials, the drug incorporated into the tablets both by dispensing the binder solution and by premixing with the excipients powders. The local variations of both the drug and the release-retardant materials are achieved by dispensing different binder solutions into different regions during the 3DP processes.In vitro dissolutions tests demonstrated that up to 95% of the drug acetaminophen is released from the prepared tablets at constant rates. The coating top and bottom layers had good adhesion strength with the drug-contained sections and offered consistent release retardation for the whole duration of dissolution process. The total release time periods of the drug could be modulated independently by the annulus thicknesses of tablets or by dispensing different passes of binder solution containing release-retardant material EC. The dose of acetaminophen could be modulated independently by the heights of tablets. Morphology and the erosion studies showed that the drug released from the tablets by simultaneous erosion of the outer tablet surface and inner cylindrical surface, keeping a comparatively constant releasing surface area to furnish constant release rate.It can be concluded that 3DP has utility, good flexibility and efficacy in fabricating tablets with complex design features for desired release profiles.
机译：三维打印（3DP）是一种固体自由形式的制造技术，该技术采用粉末加工和液体粘合剂材料以分层方式构造零件。 3DP由于其出色的功能，简便的过程和灵活性而受到越来越多的关注。 3DP能够准确，可生产地控制药物和功能材料的三维位置，微观结构以及局部成分和表面质地，从而能够为新型药物输送装置的研发提供新的策略。本研究使用3DP制备了一种具有零级释药特性的甜甜圈形片剂。数位板包括三个部分。在其中没有药物的顶部和底部都代表了对水渗透和药物扩散的惰性和不可渗透的障碍。低粘度的亲水性聚合物HPMC被用作药物载体基质，以保持片剂在溶蚀机理中的溶解。中间的载药区域被分为两部分：外围的环空部分具有高浓度的缓释材料，而内部的环空部分具有高浓度的药物。因此，在溶解开始时，片剂表面的腐蚀被延迟并且比晚期溶解过程慢。与外部区域中相对较低的药物浓度相结合，可以消除因吸水和HPMC胶凝而引起的初始爆发效应。随后，随着柱状基质的外部释放表面积随时间减小，孔的内部释放表面积同步增加。由于片剂的高度保持稳定，因此片剂在单位时间内的可蚀体积可以保持相对恒定，从而在整个释放期间产生零级释放曲线。要实现特殊表面纹理的设计特征，不均匀药物的分布和缓释材料的局部变化，通过分配粘合剂溶液和与赋形剂粉末预混合，将药物掺入片剂。通过在3DP过程中将不同的粘合剂溶液分配到不同区域中，可以实现药物和缓释材料的局部变化。体外溶出度测试表明，制备的片剂中恒定释放95％的对乙酰氨基酚药物费率。包衣的顶层和底层与药物含有的部分具有良好的粘合强度，并在整个溶解过程中提供了一致的释放延迟。药物的总释放时间段可以通过片剂的环厚度或通过分配不同通道的含有释放延迟材料EC的粘合剂溶液来独立调节。对乙酰氨基酚的剂量可以通过片剂的高度独立调节。形态学和侵蚀研究表明，通过同时侵蚀片剂的外表面和内圆柱面从片剂中释放出的药物，保持了相对恒定的释放表面积，从而提供了恒定的释放速率。可以得出结论，3DP具有实用性，良好的柔韧性制造具有复杂设计特征的片剂以达到所需释放特性的功效和功效。

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