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缬沙坦片重新包装为剂量给药辅助器具:热带条件下的物理化学稳定性。

Telmisartan Tablets Repackaged into Dose Administration Aids: Physicochemical Stability under Tropical Conditions.

作者信息

Ma Anthony P, Robertson Sherryl G, Glass Beverley D

机构信息

Pharmacy, College of Medicine and Dentistry, James Cook University, Townsville, QLD 4811, Australia.

出版信息

Pharmaceutics. 2022 Aug 11;14(8):1667. doi: 10.3390/pharmaceutics14081667.

Abstract

Dose administration aids (DAAs) are commonly used to assist patients with chronic disease to manage multiple medications and thus improve adherence. Several brands of telmisartan, commonly prescribed for hypertension, are available in Australia. Manufacturer's storage advice is to leave tablets in the blister strip until administered to patients. This study aimed to investigate the stability of telmisartan tablets when repackaged and stored in DAAs, to identify a brand, which is sufficiently stable to be repackaged. All available brands of telmisartan tablets in Australia, which contain different excipients, were repackaged into DAAs and stored at 30 °C, 75% RH for 28 days before screening, using visual inspection and physical testing. A candidate brand was then selected for physicochemical and photostability testing using pharmacopoeial methods. Repackaged Mizart tablets were shown to be sufficiently stable, when repackaged and stored under tropical conditions (30 °C, 75% RH) for 28 days. Several of the other brands were deemed inappropriate for repackaging, due to physical instability, highlighting the importance of considering not only the drug, but also excipients to ensure the stability of repackaged medicines. Although the repackaging of telmisartan tablets is not advised, this study provides evidence to support the Mizart brand as an option for pharmacists to recommend for repackaging.

摘要

剂量给药辅助装置(DAAs)通常用于帮助慢性病患者管理多种药物,从而提高用药依从性。澳大利亚有几种常用于治疗高血压的替米沙坦品牌。制造商的储存建议是将片剂留在泡罩包装中,直到给患者服用。本研究旨在调查替米沙坦片剂重新包装并储存在剂量给药辅助装置中的稳定性,以确定一个足够稳定可重新包装的品牌。澳大利亚所有含有不同辅料的替米沙坦片剂品牌都重新包装到剂量给药辅助装置中,并在30℃、75%相对湿度下储存28天,然后通过目视检查和物理测试进行筛选。然后使用药典方法选择一个候选品牌进行理化和光稳定性测试。重新包装的米扎特(Mizart)片剂在热带条件(30℃、75%相对湿度)下重新包装并储存28天后,显示出足够的稳定性。其他几个品牌由于物理不稳定而被认为不适合重新包装,这突出了不仅要考虑药物,还要考虑辅料以确保重新包装药品稳定性的重要性。尽管不建议重新包装替米沙坦片剂,但本研究提供了证据支持米扎特品牌作为药剂师推荐重新包装的一个选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4842/9414511/d6c85ab23b2e/pharmaceutics-14-01667-g001.jpg

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