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首页> 外文学位 >Development of novel spray coated soft elastic gelatin capsule sustained release formulations of nifedipine, bioavailability and bioequivalence of verapamil HCL controlled release formulations, pharmacokinetics of terbinafine after single oral doses in raptors.
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Development of novel spray coated soft elastic gelatin capsule sustained release formulations of nifedipine, bioavailability and bioequivalence of verapamil HCL controlled release formulations, pharmacokinetics of terbinafine after single oral doses in raptors.

机译：硝苯地平新型喷雾包衣的软弹性明胶胶囊缓释制剂的开发，维拉帕米盐酸盐控释制剂的生物利用度和生物等效性，在猛禽中单次口服剂量后特比萘芬的药代动力学。

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摘要

This dissertation describes the development of a new sustained release formulation of nifedipine. The new formulation was developed by coating commercially available immediate release soft elastic gelatin capsules using a spray coating technique with two different polymeric combinations. Dissolution studies were conducted and showed that controlled release of nifedipine was obtained by increasing the ratio of the water insoluble polymer in the coat and increasing the percent weight gain of the coating. Simulated plasma concentration versus time profiles after administration of 30 mg dose of selected formulations showed a prolonged nifedipine release with concentrations above the minimum effective concentration for up to 12 hours.; Bioavailability and bioequivalence of tableted test formulation of verapamil HCL was determined in 8 volunteers and compared to Covera HSRTM under fed and fasting conditions. The 90% confidence intervals for individual percent ratios of the Cmax, AUC0--58 and AUC 0--infinity were not within the range of 80--125% in both fed and fasted states, suggesting that these formulations are not bioequivalent. However, the bioavailability of verapamil from the new formulation was higher in the fed state but this effect was not statistically significant.; Pharmacokinetics of terbinafine administered orally at single doses of 15, 30, 60 and 120 mg were determined in raptors to recommend an appropriate dosing scheduled for terbinafine in the treatment of Aspergillosis. Calculation of steady state trough terbinafine plasma concentration after administration of daily doses of 15 or 30 mg/day showed that 30 mg daily dose of terbinafine administered orally in raptors produces a steady state trough terbinafine plasma concentration above the minimum inhibitory concentration (MIC) of (0.8--1.6) mug/ml against aspregillus fumigatus. From the data, 30 mg per day oral dose of terbinafine should be the recommended dose for treatment of aspergillosis in raptors. Approximate pharmacokinetic linearity of terbinafine was demonstrated for AUC0--t in the dose range of 15--120 mg while non-linearity for Cmax in the same dose range was demonstrated using the power model.
机译：本文介绍了硝苯地平新型缓释制剂的研制。通过使用喷涂包衣技术将市售速释软弹性明胶胶囊包衣，并使用两种不同的聚合物组合，开发了新配方。进行了溶出度研究，结果表明硝苯地平的控制释放是通过增加涂层中水不溶性聚合物的比例并增加涂层的增重百分比来实现的。在施用30mg剂量的选定制剂后，模拟的血浆浓度与时间的关系曲线显示硝苯地平的释放延长，其浓度超过最小有效浓度长达12小时。在8名志愿者中测定了维拉帕米盐酸盐的片剂测试制剂的生物利用度和生物等效性，并在进食和禁食条件下与Covera HSRTM进行了比较。在进食和禁食状态下，Cmax，AUC0--58和AUC 0--无穷大的百分比百分比的90％置信区间不在80--125％的范围内，这表明这些制剂不是生物等效的。然而，新配方中维拉帕米的生物利用度在喂养状态下较高，但这种作用在统计学上不显着。在猛禽中测定了以15、30、60和120 mg单次剂量口服特比萘芬的药代动力学，以推荐安排用于特比萘芬治疗曲霉病的适当剂量。每天服用15或30 mg /天的剂量后稳态槽特比萘芬血浆浓度的计算表明，在猛禽中口服每天30 mg特比萘芬的口服剂量产生的稳态槽特比萘芬血浆浓度高于（）的最小抑制浓度（MIC）。 0.8--1.6）杯/毫升烟曲霉。根据数据，特比萘芬的每日口服剂量为30 mg，应作为治疗猛禽曲霉病的推荐剂量。在15-120 mg的剂量范围内，特比萘芬对AUC0-t的近似药代动力学线性得到证明，而在相同剂量范围内，Cmax的非线性则通过功效模型得到证明。

著录项

  • 作者

    Fahmy, Sahar Abd El-Sattar.;

  • 作者单位

    Oregon State University.;

  • 授予单位 Oregon State University.;
  • 学科 Health Sciences Pharmacy.
  • 学位 Ph.D.
  • 年度 2004
  • 页码 289 p.
  • 总页数 289
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类 药剂学;
  • 关键词

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