3D printing offers the advantage of being able to modify dosage form geometry, which can be exploited to modify release characteristics. In this study, we investigated the influence of the surface area to volume ratio (SA/V) to change and predict release profiles of 3D printed dosage forms. Geometries with varying SA/V and dosages were designed and printed, and drug dissolution was investigated. Three drug substances were used: pramipexole, levodopa (both BCS I) and praziquantel (BCS II). Two polymers were chosen as matrix formers: polyvinyl alcohol (water-soluble) and ethylene vinyl acetate (inert). Drug release was characterized using the mean dissolution time (MDT) and established equations that describe complete dissolution curves were applied. Predictions were validated with previously un-printed dosage forms. Based on an identified MDT-SA/V correlation, the MDT can be predicted with a deviation of ≤5 min for a given SA/V. Using correlations of fit parameters and SA/V, RMSEP values of 0.6–2.8% and 1.6–3.4% were obtained for the BCS I formulations and RMSEP values of 1.0–3.8% were obtained for the BCS II formulation, indicating accurate prediction over a wide range of dissolution profiles. With this approach, MDT and release profiles of dosage forms with a given SA/V can be precisely predicted without performing dissolution tests and vice versa, the required SA/V can be predicted for a desired release profile.

中文翻译：

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基于片剂几何形状的表面积与体积比预测 3D 打印口服药物的药物释放

3D 打印提供了能够修改剂型几何形状的优势，可用于修改释放特性。在这项研究中，我们研究了表面积与体积比 (SA/V) 对改变和预测 3D 打印剂型释放曲线的影响。设计并打印了具有不同 SA/V 和剂量的几何形状，并研究了药物溶出度。使用了三种药物：普拉克索、左旋多巴（BCS I）和吡喹酮（BCS II）。选择两种聚合物作为基质形成剂：聚乙烯醇（水溶性）和乙烯醋酸乙烯酯（惰性）。使用平均溶出时间 (MDT) 表征药物释放，并应用描述完整溶出曲线的已建立方程。先前未印刷的剂型对预测进行了验证。基于已识别的 MDT-SA/V 相关性，对于给定的 SA/V，可以以≤5 分钟的偏差预测 MDT。使用拟合参数和 SA/V 的相关性，BCS I 公式获得了 0.6-2.8% 和 1.6-3.4% 的 RMSEP 值，BCS II 公式获得了 1.0-3.8% 的 RMSEP 值，表明对广泛的溶出曲线。使用这种方法，无需进行溶出度测试即可精确预测具有给定 SA/V 的剂型的 MDT 和释放曲线，反之亦然，可以预测所需的 SA/V 以获得所需的释放曲线。BCS II 配方获得了 8%，表明在广泛的溶出曲线范围内准确预测。使用这种方法，无需进行溶出度测试即可精确预测具有给定 SA/V 的剂型的 MDT 和释放曲线，反之亦然，可以预测所需的 SA/V 以获得所需的释放曲线。BCS II 配方获得了 8%，表明在广泛的溶出曲线范围内准确预测。使用这种方法，无需进行溶出度测试即可精确预测具有给定 SA/V 的剂型的 MDT 和释放曲线，反之亦然，可以预测所需的 SA/V 以获得所需的释放曲线。