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A study of water vapor transmission rate of blister packs by USP standard and continuous gravimetric protocol.

机译：通过USP标准和连续重量分析协议研究泡罩包装的水蒸气透过率。

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摘要

The water vapor transmission rate (WVTR) is essential in determining the shelf life of pharmaceutical products in the package. The WVTR of blister pack was determined by using USP 671 and the continuous gravimetric protocols. The WVTR values from the two protocols were compared and the accuracy was validated.The WVTR of the blister pack determined using the USP 671 protocol was 0.0452 mg/day/blister with a standard error of 0.0010 while the WVTR using the continuous gravimetric protocol was 0.0652 mg/day/blister with a standard error of 0.0067. The WVTR were compared using t-statistic for unequal sample size with unequal variance and no significant difference was detected. The accuracy of the two protocols was compared through the pooled variance of the data points. USP 671 standard protocol had a pooled variance of 4.99 x 10-4 while for the continuous gravimetric protocol it was 2.13 x 10-5. Therefore the continuous gravimetric protocol showed higher accuracy than the USP standard protocol.Several recommendations have been suggested for the USP standard protocol in order to make the protocol more accurate: for the WVTR of the blister pack, the unsteady state should be considered and excluded from the calculation, Monitoring of the humidity and temperature is critical, Chamber size and the time of equilibrium for the specific relative humidity needs to be outlined.
机译：水蒸气透过率（WVTR）对于确定包装中药品的货架期至关重要。通过使用USP 671和连续重量分析方案确定泡罩包装的WVTR。比较了两种方案的WVTR值并验证了准确性。使用USP 671方案测定的泡罩包装的WVTR为0.0452 mg /天/泡罩，标准误为0.0010，而使用连续重量分析法的WVTR为0.0652毫克/天/泡罩，标准误差为0.0067。使用t统计量比较WVTR，以得出样本量不均且方差不均的WVTR，未发现明显差异。通过汇总数据点的方差比较两种协议的准确性。 USP 671标准协议的合并方差为4.99 x 10-4，而对于连续重量协议，则为2.13 x 10-5。因此，连续重量协议显示出比USP标准协议更高的准确性.USP标准协议已提出了一些建议，以使协议更加准确：对于泡罩包装的WVTR，应考虑不稳定状态并将其排除在外在计算中，湿度和温度的监控至关重要，需要概述腔室尺寸和特定相对湿度的平衡时间。

著录项

  • 作者

    Mehrotra, Nikhil.;

  • 作者单位

    Michigan State University.;

  • 授予单位 Michigan State University.;
  • 学科 Engineering Packaging.
  • 学位 M.S.
  • 年度 2010
  • 页码 87 p.
  • 总页数 87
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类
  • 关键词

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