Alqahtani Abdulsalam A, Mohammed Abdul Aleem, Fatima Farhat, Ahmed Mohammed Muqtader
Department of Pharmaceutics, College of Pharmacy, Najran University, Najran 11001, Saudi Arabia.
Department of Pharmaceutics, College of Pharmacy, Prince Sattam bin Abdulaziz University, Al-Kharj 11942, Saudi Arabia.
Polymers (Basel). 2023 Aug 26;15(17):3554. doi: 10.3390/polym15173554.
Three-dimensional printing has revolutionized drug manufacturing and has provided a solution to the limitations associated with the conventional manufacturing method by designing complex drug delivery systems with customized drug release profiles for personalized therapies. The present investigation aims to design a gastric floating tablet with prolonged gastric floating time and sustained drug release profile. In the present study, a gastro retentive floating device (GRFD) was designed and fabricated using a fused deposition modelling (FDM)-based 3D printing technique. This device acts as a multifunctional dosage form exhibiting prolonged gastric retention time and sustained drug release profile with improved oral bioavailability in the upper gastrointestinal tract. Commercial polyvinyl alcohol (PVA) and polylactic acid (PLA) filaments were used to design GRFD, which was comprised of dual compartments. The outer sealed compartment acts as an air-filled chamber that imparts buoyancy to the device and the inner compartment is filled with a commercial propranolol hydrochloride immediate-release tablet. The device is designed as a round-shaped shell with a central opening of varying size (1 mm, 2 mm, 3 mm, and 4 mm), which acts as a drug release window. Scanning electron microscope (SEM) images were used to determine morphological characterization. The in vitro buoyancy and drug release were evaluated using the USP type II dissolution apparatus. All the designed GRFDs exhibit good floating ability and sustained drug release profiles. GRFDs fabricated using PLA filament show maximum buoyancy (>24 h) and sustained drug release for up to 10 h. The floating ability and drug release from the developed devices were governed by the drug release window opening size and the filament material affinity towards the gastric fluid. The designed GRFDs show great prospects in modifying the drug release characteristics and could be applied to any conventional immediate-release product.
三维打印彻底改变了药物制造方式,并通过设计具有定制药物释放曲线的复杂药物递送系统以实现个性化治疗,为传统制造方法的局限性提供了一种解决方案。本研究旨在设计一种具有延长胃漂浮时间和持续药物释放曲线的胃漂浮片。在本研究中,使用基于熔融沉积建模(FDM)的3D打印技术设计并制造了一种胃滞留漂浮装置(GRFD)。该装置作为一种多功能剂型,具有延长的胃滞留时间和持续的药物释放曲线,可提高在上消化道中的口服生物利用度。使用市售的聚乙烯醇(PVA)和聚乳酸(PLA)长丝来设计GRFD,其由双隔室组成。外部密封隔室用作充满空气的腔室,赋予装置浮力,内部隔室填充有市售的盐酸普萘洛尔速释片。该装置设计为圆形外壳,具有不同尺寸(1mm、2mm、3mm和4mm)的中心开口,该开口用作药物释放窗口。使用扫描电子显微镜(SEM)图像来确定形态特征。使用USP II型溶出度测定仪评估体外浮力和药物释放。所有设计的GRFD均表现出良好的漂浮能力和持续的药物释放曲线。使用PLA长丝制造的GRFD显示出最大浮力(>24小时)和长达10小时的持续药物释放。所开发装置的漂浮能力和药物释放受药物释放窗口开口尺寸和长丝材料对胃液的亲和力控制。所设计的GRFD在改变药物释放特性方面显示出巨大的前景,并且可以应用于任何传统的速释产品。