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3D 打印与新型胶囊壳溶出度测试用于输送对乙酰氨基酚。

3D Printing and Dissolution Testing of Novel Capsule Shells for Use in Delivering Acetaminophen.

机构信息

Department of Systems Science and Industrial Engineering, The Thomas J. Watson College of Engineering and Applied Science, Binghamton University, 4400 Vestal Pkwy. E., Binghamton, NY 13902, USA.

Department of Pharmaceutical Sciences, School of Pharmacy and Pharmaceutical Sciences, Binghamton University, 96 Corliss Ave., Johnson City, NY 13790, USA; Department of Biomedical Engineering, The Thomas J. Watson College of Engineering and Applied Science, Binghamton University, 4400 Vestal Pkwy. E., Binghamton, NY 13902, USA.

出版信息

J Pharm Sci. 2021 Dec;110(12):3829-3837. doi: 10.1016/j.xphs.2021.08.030. Epub 2021 Aug 29.

DOI:10.1016/j.xphs.2021.08.030
PMID:34469748
Abstract

Individualized drug delivery improves drug efficacy and safety for patients. To implement individualized drug delivery, patient-specific tailored dosages produced on a small scale are needed. However, current pharmaceutical manufacturing is not suitable for personalized dosage forms. Although convenient to deliver various drugs, current gelatin capsules using animal collagen protein have many limitations, such as releasing drugs too fast and incompatibility with some diets. In contrast, 3D printed capsules have great potential to advance individualized treatments. In this paper, we 3D printed and tested non-animal-based capsule shells for the delivery of acetaminophen. Capsule shells were composed of poly(vinyl) alcohol (PVA) and PVA blends with 5-25% hydroxypropyl methylcellulose (HPMC). Dissolution of acetaminophen when delivered in -hese capsule shells was tested using a USP dissolution test apparatus 2 (paddle type) at gastric pH. The novel shells were compared to each other and to commercially available hard gelatin capsules. Dissolution results show that acetaminophen when delivered in 3D printed capsules was slower than when delivered by gelatin capsules. Increasing the percentage of HPMC in the blend further delayed its release and dissolution. This delay could potentially increase the efficacy and reduce the side effects of acetaminophen. These shells also offer a non-animal-based alternative to gelatin capsules. Furthermore, 3D printing of capsule shells with specific polymer blends may be useful for patient-specific therapy in compounding pharmacies across the country.

摘要

个体化药物输送可提高患者的药物疗效和安全性。为了实现个体化药物输送,需要小规模生产针对患者定制的剂量。然而,当前的制药生产并不适合个性化的剂型。虽然当前使用动物胶原蛋白的明胶胶囊在输送各种药物方面非常方便,但它们存在许多局限性,例如药物释放过快,以及与某些饮食不兼容。相比之下,3D 打印胶囊在推进个体化治疗方面具有巨大的潜力。在本文中,我们 3D 打印并测试了用于输送扑热息痛的非动物基胶囊壳。胶囊壳由聚乙烯醇(PVA)和 PVA 与 5-25%羟丙基甲基纤维素(HPMC)的混合物组成。使用 USP 溶解试验仪 2(桨式)在胃 pH 值下测试了这些胶囊壳中扑热息痛的溶解情况。将新型壳与彼此以及市售的硬明胶胶囊进行了比较。溶解结果表明,与明胶胶囊相比,3D 打印胶囊壳中输送的扑热息痛释放速度较慢。在混合物中增加 HPMC 的百分比进一步延迟了其释放和溶解。这种延迟可能会提高扑热息痛的疗效并降低其副作用。这些壳还为明胶胶囊提供了一种非动物基替代品。此外,使用特定聚合物混合物 3D 打印胶囊壳可能对全国的药剂师配药具有特定的患者治疗意义。

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