Abstract:
The present study aims to investigate the potential of the 3D printing technique to design gastroretentive floating tablets (GFTs) for modifying the drug release profile of an immediate-release tablet. A 3D-printed floating shell enclosing a captopril tablet was designed having varying number of drug-release windows. The impact of geometrical changes in the design of delivery system and thermal cross-linking of polymers were evaluated to observe the influence on floating ability and drug release. Water uptake, water insolubilization, Differential Scanning Calorimetry (DSC), and Attenuated Total Reflection-Fourier Transform Infrared Spectroscopy (ATR-FTIR) were performed to assess the degree of thermal cross-linking of polyvinyl alcohol (PVA) filament. The 3D-printed GFT9 was considered the optimized gastric floating tablet that exhibited >12 h of total floating time with zero floating lag time and successfully accomplished modified-drug release by exhibiting >80% of drug release in 8 h. The zero-order release model, with an r2 value of 0.9923, best fitted the drug release kinetic data of the GFT9, which followed a super case II drug transport mechanism with an n value of 0.95. The optimized gastric floating device (GFT9) also exhibited the highest MDT values (238.55), representing slow drug release from the system due to thermal crosslinking and the presence of a single drug-releasing window in the device.
摘要:
本研究旨在研究3D打印技术设计胃滞留漂浮片剂(GFTs)的潜力,以改变速释片剂的药物释放曲线。设计了一种3D打印的装有卡托普利片剂的浮动外壳,该外壳具有不同数量的药物释放窗口。评估了几何变化对递送系统设计和聚合物热交联的影响,以观察对漂浮能力和药物释放的影响。吸水率,水不溶,差示扫描量热法(DSC),进行衰减全反射-傅里叶变换红外光谱(ATR-FTIR)以评估聚乙烯醇(PVA)长丝的热交联程度。3D打印的GFT9被认为是优化的胃漂浮片剂,其表现出>12小时的总漂浮时间和零漂浮滞后时间,并且通过在8小时内表现出>80%的药物释放而成功地实现了改进的药物释放。零阶释放模型,r2值为0.9923,最适合GFT9的药物释放动力学数据,该数据遵循超级病例II药物转运机制,n值为0.95。优化的胃漂浮装置(GFT9)也表现出最高的MDT值(238.55),表示由于热交联和装置中单个药物释放窗口的存在,药物从系统中缓慢释放。