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首页> 外文学位 >The application of coarse particle ethylcellulose and high molecular weight polyethylene oxide in the production of beads by extrusion-spheronization.
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The application of coarse particle ethylcellulose and high molecular weight polyethylene oxide in the production of beads by extrusion-spheronization.

机译：粗颗粒乙基纤维素和高分子量聚环氧乙烷在挤出滚圆法生产微珠中的应用。

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摘要

The present investigation evaluated the potential of coarse particle ethylcellulose (CPEC) and high molecular weight polyethylene oxide (PEO) in the production of beads by an extrusion-spheronization technique. CPEC was investigated as a diluent and PEO as an extrusion aid and a binder. Beads containing CPEC, PEO, and microcrystalline cellulose (MCC) with caffeine as a model drug were manufactured. To compare the effects of particle size of ethylcellulose on properties of the beads, CPEC was substituted with fine particle ethylcellulose (FPEC) in the formulation. Release studies were conducted, and the bead size, shape, yield, and friability were determined. The effects of formulation and process variables and their interactions were studied by a sequential experimental design based on a response surface method. In the initial stage, a two-level, half-fractional factorial design was employed as a screening design, which was subsequently augmented to a central composite design (CCD). Statistical analysis indicated that formulation variables including PEO, MCC, and water content, and two process variables, namely spheronizer speed and spheronization time, significantly affected the properties of the beads. Interactions between two factors have significant effects on several of the measured responses. Simultaneous optimization of the responses was conducted and validated by performing experiments at the optimal conditions. Use of either particle size resulted in beads with acceptable properties. However, CPEC formulations required less water to form a wetted mass suitable for extrusion and showed better tolerance to changes in the water content when compared to FPEC formulations. The friability of the beads produced was less than 2% in either case, although FPEC beads had slightly lower friability values when compared to CPEC beads. Alteration in the drug load from 10% to 70% in the formulation still yielded acceptable product, indicating the suitability of the formulation for a wide range of drug levels. Release profiles showed that there was immediate release of the drug from the beads.;Keywords. Ethylcellulose, polyethylene oxide, extrusion, spheronization, beads, factorial design, response surface method, central composite design, optimization.
机译：本研究评估了通过挤出滚圆法生产珠粒的粗颗粒乙基纤维素（CPEC）和高分子量聚环氧乙烷（PEO）的潜力。研究了CPEC作为稀释剂，研究了PEO作为挤出助剂和粘合剂。制造了包含CPEC，PEO和以咖啡因为模型药物的微晶纤维素（MCC）的珠子。为了比较乙基纤维素的粒径对微珠性能的影响，在配方中用细颗粒乙基纤维素（FPEC）代替了CPEC。进行了脱模研究，并确定了珠的大小，形状，产率和脆性。通过基于响应面方法的顺序实验设计，研究了配方和工艺变量及其相互作用的影响。在初始阶段，采用两级半分数阶乘设计作为筛选设计，随后将其扩展为中央复合设计（CCD）。统计分析表明，包括PEO，MCC和水含量在内的配方变量以及制粒机速度和制粒时间这两个过程变量会显着影响微珠的性能。两个因素之间的相互作用对一些测得的响应有重大影响。通过在最佳条件下进行实验，对响应进行了同时优化，并进行了验证。使用任何一种粒径都可以产生具有可接受性质的珠子。但是，与FPEC配方相比，CPEC配方需要较少的水来形成适合挤出的湿物料，并且对水含量的变化表现出更好的耐受性。在任何一种情况下，尽管与CPEC珠相比，FPEC珠的脆性值略低，但所产生的珠的脆性均小于2％。制剂中载药量从10％更改为70％仍可得到可接受的产品，表明该制剂适用于各种药物水平。释放曲线表明药物立即从珠粒中释放出来。乙基纤维素，聚环氧乙烷，挤出，滚圆，珠粒，析因设计，响应面法，中心复合设计，优化。

著录项

  • 作者

    Mallipeddi, Rama.;

  • 作者单位

    University of the Sciences in Philadelphia.;

  • 授予单位 University of the Sciences in Philadelphia.;
  • 学科 Chemistry Pharmaceutical.;Health Sciences Pharmacy.
  • 学位 Ph.D.
  • 年度 2009
  • 页码 192 p.
  • 总页数 192
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类 药物化学;药剂学;
  • 关键词

  • 入库时间 2022-08-17 11:38:30

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