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Desktop 3D printing of controlled release pharmaceutical bilayer tablets

机译:控释药物双层片剂的桌面3D打印

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摘要

Three dimensional (3D) printing was used as a novel medicine formulation technique for production of viable tablets capable of satisfying regulatory tests and matching the release of standard commercial tablets. Hydroxypropyl methylcellulose (HPMC 2208) (Methocel™ K100M Premium) and poly(acrylic acid) (PAA) (Carbopol® 974P NF) were used as a hydrophilic matrix for a sustained release (SR) layer. Hypromellose® (HPMC 2910) was used as a binder while microcrystalline cellulose (MCC) (Pharmacel® 102) and sodium starch glycolate (SSG) (Primojel®) were used as disintegrants for an immediate release (IR) layer. Commercial guaifenesin bi-layer tablets (GBT) were used as a model drug (Mucinex®) for this study. There was a favourable comparison of release of the active guaifenesin from the printed hydrophilic matrix compared with the commercially available GBT. The printed formulations were also evaluated for physical and mechanical properties such as weight variation, friability, hardness and thickness as a comparison to the commercial tablet and were within acceptable range as defined by the international standards stated in the United States Pharmacopoeia (USP). All formulations (standard tablets and 3D printed tablets) showed Korsmeyer-Peppas n values between 0.27 and 0.44 which indicates Fickian diffusion drug release through a hydrated HPMC gel layer.
机译:三维(3D)打印被用作一种新型药物制剂技术,用于生产能够满足法规测试并与标准商业片剂的释放量匹配的可行片剂。羟丙基甲基纤维素(HPMC 2208)(Methocel™K100M Premium)和聚丙烯酸(PAA)(974P NF)被用作用于持续释放(SR)层的亲水性基质。 (HPMC 2910)被用作粘合剂,而微晶纤维素(MCC)(102)和羟乙酸淀粉钠(SSG)(Primojel)被用作速释(IR)层的崩解剂。商用愈创甘油醚双层片剂(GBT)用作本研究的模型药物(Mucinex®)。与可商购的GBT相比,活性愈创甘油醚从印刷的亲水性基质中的释放有一个有利的比较。与市售片剂相比,还评估了印刷制剂的物理和机械性能,例如重量变化,易碎性,硬度和厚度,并且在美国药典(USP)中所述的国际标准所定义的可接受范围内。所有制剂(标准片剂和3D打印片剂)的Korsmeyer-Peppas n值在0.27至0.44之间,表明Fickian扩散药物通过水合HPMC凝胶层释放。

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