Coating and Pharmacokinetic Evaluation of Air Spray Coated Drug Coated Balloons.
Coating and Pharmacokinetic Evaluation of Air Spray Coated Drug Coated Balloons.
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DOI：
10.1007/s13239-018-0346-1
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发表时间：
2018-06
影响因子：
1.8
通讯作者：
Yazdani SK
中科院分区：
文献类型：
--
作者：
Turner EA;Atigh MK;Erwin MM;Christians U;Yazdani SK
药物涂层球囊 (DCB) 正在成为外周动脉疾病 (PAD) 的标准护理治疗方法。 DCB 使用赋形剂来转移和保留抗增殖药物，例如紫杉醇。因此，赋形剂在 DCB 的设计和功能中发挥着至关重要的作用，然而用赋形剂和抗增殖药物涂覆球囊的方法仍然未知。本研究的目的是开发一种包衣和评估 DCB 各种赋形剂的方法。开发了一种空气喷雾器方法，将紫杉醇和各种赋形剂沉积到无涂层的市售血管成形术球囊上。使用高效液相色谱串联质谱法评估血管成形术球囊涂层的药物沉积和涂层效率。使用脉动流生物反应器中收获的猪动脉离体评估涂层血管成形球囊在动脉段中的药物转移和保留。空气喷雾器方法成功地输送了各种赋形剂，包括牛血清白蛋白（BSA）、尿素和碘海醇。空气喷涂方法被配置为同时用紫杉醇和碘海醇涂覆四个血管成形球囊，平均紫杉醇负载为4.0±0.70μg/mm2。日内（内部）和日间（之间）涂层精度（定义为相对标准偏差 (RSD)）分别为 17.2% 和 15.5%。碘海醇-紫杉醇 DCB 的离体部署产生的动脉紫杉醇浓度在 1 小时时为 123.4±44.68 ng/mg (n=3)，在 1 天时为 126.7±25.27 ng/mg (n=3)，在 7 天时为 12.9±12.88 ng/mg (n=3)。这项工作提供了一种快速、廉价的方法的概念验证，可以用紫杉醇和各种赋形剂涂覆市售的血管成形术球囊。
Drug coated balloons (DCB) are becoming the standard-care treatment for peripheral arterial disease (PAD). DCB use excipients to transfer and retain anti-proliferative drugs, such as paclitaxel. Excipients thus play a vital role in the design and function of DCB, however methods to coat balloons with excipients and anti-proliferative drugs remain unknown. The goal of this study was to thus develop an approach to coat and evaluate DCB for various excipients. An air sprayer method was developed to deposit paclitaxel and various excipients onto non-coated commercially available angioplasty balloons. The coating of the angioplasty balloons was evaluated for drug deposition and coating efficiency using high performance liquid chromatography tandem mass spectrometry. Drug transfer and retention of the coated angioplasty balloons into arterial segments were evaluated ex vivo using harvested pig arteries in a pulsatile flow bioreactor. The air sprayer method successfully delivered varying excipients including bovine serum albumin (BSA), urea and iohexol. The air spray method was configured to coat four angioplasty balloons simultaneously with paclitaxel and iohexol with an average paclitaxel load of 4.0±0.70 μg/mm2. The intra-day (within) and inter-day (between) coating precisions, defined as relative standard deviation (RSD), was 17.2 % and 15.5%, respectively. Ex vivo deployment of iohexol-paclitaxel DCB yielded an arterial paclitaxel concentration of 123.4±44.68 ng/mg (n=3) at 1 hour, 126.7±25.27 ng/mg (n=3) at 1 day, and 12.9±12.88 ng/mg (n=3) at 7 days. This work provides proof-of-concept of a quick, inexpensive approach to coat commercially available angioplasty balloons with paclitaxel and various excipients.
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影响因子：
37.8
作者：
Go AS;Mozaffarian D;Roger VL;Benjamin EJ;Berry JD;Blaha MJ;Dai S;Ford ES;Fox CS;Franco S;Fullerton HJ;Gillespie C;Hailpern SM;Heit JA;Howard VJ;Huffman MD;Judd SE;Kissela BM;Kittner SJ;Lackland DT;Lichtman JH;Lisabeth LD;Mackey RH;Magid DJ;Marcus GM;Marelli A;Matchar DB;McGuire DK;Mohler ER 3rd;Moy CS;Mussolino ME;Neumar RW;Nichol G;Pandey DK;Paynter NP;Reeves MJ;Sorlie PD;Stein J;Towfighi A;Turan TN;Virani SS;Wong ND;Woo D;Turner MB;American Heart Association Statistics Committee and Stroke Statistics Subcommittee
通讯作者：
American Heart Association Statistics Committee and Stroke Statistics Subcommittee
影响因子：
10.8
作者：
Pan, Ch. J.;Tang, J. J.;Huang, N.
通讯作者：
Huang, N.
影响因子：
3.5
作者：
Hirsch, Alan T.;Hartman, Lacey;Virnig, Beth A.
通讯作者：
Virnig, Beth A.
影响因子：
1.5
作者：
Gandhi, P. J.;Murthy, Z. V. P.
通讯作者：
Murthy, Z. V. P.
DOI：
10.1002/jbm.b.33494
发表时间：
2016-10-01
影响因子：
3.4
作者：
Lamichhane, Sujan;Anderson, Jordan;Mani, Gopinath
通讯作者：
Mani, Gopinath