Reamer J T, Grady L T, Shangraw R F, Mehta A M
Am J Hosp Pharm. 1977 Jan;34(1):35-42.
The moisture permeation of unit does repackaging materials used by various hospital and community pharmacies in a metropolitan area was studied. Commercial desiccant pellets were packaged in the same manner used for ordinary tablets and capsules. The samples were weighed and placed in a controlled chamber at about 75% relative humidity and 22 C, and tested for weight gain over a period of 4-10 days. Four types of packages were evaluated: (1) heat-sealed polyethylene bag, (2) polyvinyl chloride cups adhesive-sealed to multiple-ply paper, (3) heat-sealed "polycel-polyfoil" strip packages and (4) polyvinyl chloride/foil multiple-cup blister packs. A wide range of results was found. None of the containers tested was a good moisture barrier, although some offered protection for a limited time. Several needs were identified by this survey. Pharmacists need more information and an increased awareness concerning the permeation characteristics of repackaging materials, suitable operating procedures and the stability of pharmaceutical products. Standards must be established for repackaging materials as well as limits on storage periods for the repackaged pharmaceuticals. Procedures for pharmacists to test their own packaging systems, and a checklist of some important guidelines for repackaging in unit dose containers, are presented.
对大城市地区各医院和社区药房使用的单位剂量重新包装材料的透湿性进行了研究。商用干燥剂颗粒采用与普通片剂和胶囊相同的方式进行包装。对样品进行称重后,置于相对湿度约75%、温度22摄氏度的可控试验箱中,在4至10天的时间内测试其重量增加情况。评估了四种包装类型:(1)热封聚乙烯袋;(2)用粘合剂密封在多层纸上的聚氯乙烯杯;(3)热封“聚赛-聚酯薄膜”条形包装;(4)聚氯乙烯/箔多层杯泡罩包装。结果发现差异很大。尽管有些容器在有限时间内提供了防护,但所测试的容器均不是良好的防潮屏障。本次调查确定了几项需求。药剂师需要更多信息,提高对重新包装材料渗透特性、合适的操作程序以及药品稳定性的认识。必须为重新包装材料制定标准,以及对重新包装药品的储存期限设定限制。本文介绍了药剂师测试自己包装系统的程序,以及单位剂量容器重新包装的一些重要指导原则清单。