重新包装成剂量给药辅助器具的丙氯拉嗪片：患者能确保其质量吗？

Prochlorperazine tablets repackaged into dose administration aids: can the patient be assured of quality?

作者信息

Glass B, Mangan M, Haywood A

机构信息

School of Pharmacy and Molecular Sciences, James Cook University, Townsville, Qld, Australia.

出版信息

J Clin Pharm Ther. 2009 Apr;34(2):161-9. doi: 10.1111/j.1365-2710.2008.00981.x.

DOI:10.1111/j.1365-2710.2008.00981.x

PMID:19250136

Abstract

BACKGROUND AND OBJECTIVE

Patients are increasingly requiring their medications to be repackaged into dose administration aids because of the positive outcomes associated with reduction in medication related hospitalization and adverse effects due to improved medicines management. Since the stability of these repackaged medications is not the responsibility of manufacturer, it is important that drug substances with potential stability issues be identified. Thus the objective of this study was to evaluate the stability of prochlorperazine, a light sensitive drug repackaged into dose administration aids (DAAs), in order to provide guidelines to the pharmacist and advice to the patient on appropriate storage.

METHODS

Prochlorperazine tablets were stored repackaged in DAAs and in their original packaging for 8 weeks at ambient (25 +/- 1 degrees C; 60 +/- 1.5% RH), accelerated (40 +/- 1 degrees C; 75 +/- 1.5% RH) and in-use conditions encountered in situ both in a pharmacy and the patients' home. They were assessed for both chemical (using a validated HPLC method) and physical stability according to British Pharmacopoeial (BP) standards. In addition, photostability testing was undertaken under ICH conditions.

RESULTS AND DISCUSSION

Chemical and physical stability was confirmed to be within BP Limits. There were, however, noticeable organoleptic changes in the tablets stored under in-use conditions with a progressive grey discolouration over the 8 weeks, starting in week 2.

CONCLUSION

Despite the confirmation of physical and chemical stability within BP limits, the discoloration and the potential for photodegradants to cause adverse effects in patients must lead us to draw the conclusion that the quality of this medication has been compromised. Pharmacists thus need to take this into account in repackaging and storage of prochlorperazine in DAAs and advise patients to store their DAA protected from light, heat and humidity.

摘要

背景与目的

由于药物管理改善，与减少药物相关住院和不良反应相关的积极结果，患者越来越要求将其药物重新包装成剂量给药辅助工具。由于这些重新包装药物的稳定性并非制造商的责任，因此识别具有潜在稳定性问题的药物物质很重要。因此，本研究的目的是评估重新包装成剂量给药辅助工具（DAA）的光敏药物奋乃静的稳定性，以便为药剂师提供指导，并就适当储存向患者提供建议。

方法

将奋乃静片重新包装在DAA中，并在其原包装中，于环境温度（25±1℃；60±1.5%相对湿度）、加速条件（40±1℃；75±1.5%相对湿度）以及药房和患者家中实际遇到的使用条件下储存8周。根据英国药典（BP）标准，对其进行化学（使用经过验证的高效液相色谱法）和物理稳定性评估。此外，在ICH条件下进行光稳定性测试。