• 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>The International journal of pharmacy practice >Clozapine repackaged into dose administration aids: A common practice in Australian hospitals
【24h】

Clozapine repackaged into dose administration aids: A common practice in Australian hospitals

机译：将氯氮平重新包装成剂量辅助剂：澳大利亚医院的常见做法

获取原文
获取原文并翻译 | 示例
       
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Objectives Clozapine is an atypical antipsychotic used in the treatment of schizophrenia. Due to the patient profile there is a high rate of repackaging of clozapine into dose administration aids (DAAs). Because of reports from hospital pharmacists about discoloration of returned clozapine tablets that have been repackaged into DAAs, the aim of this study was to evaluate the chemical, physical and photostability of these tablets repackaged into a DAA. Method Clozapine tablets were repackaged into DAAs and evaluated for physicochemical stability over a 6-week period at a controlled room temperature (25 ± 1°C; 60 ± 1.5% relative humidity (RH)) and accelerated conditions (40 ± 1°C; 75 ± 1.5% RH). In addition, photostability studies were performed according to the International Committee on Harmonisation (ICH) guidelines. Key findings Chemical stability was confirmed for all storage conditions, including for those photostability (ICH conditions), with the clozapine content occurring within the British Pharmacopoeial (BP) range of 90-110%. Although the physical stability was confirmed for all tests at room temperature (weight uniformity, hardness, friability, disintegration and dissolution), under accelerated conditions the disintegration test did not meet BP requirements. However, the subsequent dissolution test was successful with 85% of clozapine dissolving in 45 min. Conclusions This study illustrates that clozapine, when correctly repackaged, maintains its physical and chemical stability for 6 weeks. As no discoloration of the tablets was observed, it is assumed that the reports received were as a result of improper handling by patients. Based on these findings, it is recommended that patients be advised on the correct handling and storage of their DAAs.
机译：目的氯氮平是一种非典型的抗精神病药，用于治疗精神分裂症。由于患者的情况，将氯氮平重新包装成剂量辅助剂（DAA）的比率很高。由于医院药师曾报道已退回的氯氮平片剂已重新包装到DAA中，因此变色，因此本研究的目的是评估重新包装到DAA中的这些片剂的化学，物理和光稳定性。方法将氯氮平片剂重新包装成DAA，并在受控的室温（25±1°C; 60±1.5％相对湿度（RH））和加速条件（40±1°C;室温）下进行6周的理化稳定性评估。 75±1.5％RH）。此外，根据国际协调委员会（ICH）指南进行了光稳定性研究。主要发现确认了所有储存条件下的化学稳定性，包括那些光稳定性（ICH条件），氯氮平含量在90-110％的英国药典（BP）范围内。尽管在室温下进行的所有测试（重量均匀性，硬度，脆性，崩解和溶解）均已确认了物理稳定性，但在加速条件下，崩解测试未达到BP要求。但是，随后的溶出度测试成功完成，氯氮平在45分钟内溶出了85％。结论这项研究表明，氯氮平正确包装后，可保持其理化稳定性达6周。由于未观察到片剂变色，因此可以认为收到的报告是由于患者处理不当所致。基于这些发现，建议建议患者正确处理和储存其DAA。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号