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首页> 美国卫生研究院文献>Polymers >Hydroxypropyl Methylcellulose E15: A Hydrophilic Polymer for Fabrication of Orodispersible Film Using Syringe Extrusion 3D Printer
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Hydroxypropyl Methylcellulose E15: A Hydrophilic Polymer for Fabrication of Orodispersible Film Using Syringe Extrusion 3D Printer

机译：羟丙基甲基纤维素E15：使用注射器挤出3D打印机制造奥多到的膜的亲水性聚合物

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摘要

Extrusion-based 3D printing technology is a relatively new technique that has a potential for fabricating pharmaceutical products in various dosage forms. It offers many advantages over conventional manufacturing methods, including more accurate drug dosing, which is especially important for the drugs that require exact tailoring (e.g., narrow therapeutic index drugs). In this work, we have successfully fabricated phenytoin-loaded orodispersible films (ODFs) through a syringe extrusion 3D printing technique. Two different grades of hydroxypropyl methylcellulose (HPMC E5 and HPMC E15) were used as the film-forming polymers, and glycerin and propylene glycol were used as plasticizers. The 3D-printed ODFs were physicochemically characterized and evaluated for their mechanical properties and in vitro disintegration time. Then, the optimum printed ODFs showing good mechanical properties and the fastest disintegration time were selected to evaluate their drug content and dissolution profiles. The results showed that phenytoin-loaded E15 ODFs demonstrated superior properties when compared to E5 films. It demonstrated a fast disintegration time in less than 5 s and rapidly dissolved and reached up to 80% of drug release within 10 min. In addition, it also exhibited drug content uniformity within United States Pharmacopeia (USP) acceptable range and exhibited good mechanical properties and flexibility with low puncture strength, low Young’s modulus and high elongation, which allows ease of handling and application. Furthermore, the HPMC E15 printing dispersions with suitable concentrations at 10% w/v exhibited a non-Newtonian (shear-thinning) pseudoplastic behavior along with good extrudability characteristics through the extrusion nozzle. Thus, HPMC E15 can be applied as a 3D printing polymer for a syringe extrusion 3D printer.
机译：基于挤出的3D印刷技术是一种相对较新的技术，其具有以各种剂型制造药物产品的潜力。它提供了与传统制造方法相比的许多优点，包括更准确的药物给药，这对于需要精确定制的药物尤为重要（例如，窄治疗指数药物）。在这项工作中，我们通过注射器挤出3D印刷技术成功地制造了诸如苯妥英的Orodersible薄膜（ODF）。使用两种不同的羟丙基甲基纤维素（HPMC E5和HPMC E15）作为成膜聚合物，用甘油和丙二醇用作增塑剂。 3D印刷的ODF在物理化学表征和评估其机械性能和体外崩解时间。然后，选择最佳的印刷ODF，显示出良好的机械性能和最快的崩解时间以评估其药物含量和溶解谱。结果表明，与E5薄膜相比，苯妥林素的E15 ODFS显示出优异的特性。它证明了不到5秒的快速崩解时间，并在10分钟内快速溶解并达到80％的药物释放。此外，它还在美国药典（USP）可接受的范围内表现出药物含量均匀性，并且具有低穿刺强度，低杨氏模量和高伸长率的良好机械性能和灵活性，允许易于处理和应用。此外，具有10％w / v的合适浓度的HPMC E15印刷分散体表现出非牛顿（剪切稀疏）假塑性行为，以及通过挤出喷嘴的良好挤出性特性。因此，HPMC E15可以应用于用于注射器挤出3D打印机的3D打印聚合物。

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