Cabañas Poy Maria Josep, Cañete Ramírez Carme, González di Lauro Sabina X, Rodríguez Garrido Virginia, Roig Carbajosa Gloria, Fernández-Polo Aurora, Clemente Bautista Susana
Servei de Farmàcia, Àrea Maternoinfantil..
Servei de Microbiologia i Parasitologia Clíniques. Hospital Universitari Vall d'Hebron, Barcelona. Spain..
Farm Hosp. 2016 Sep 1;40(5):427-35. doi: 10.7399/fh.2016.40.5.10541.
The oral administration of drugs to the pediatric population involves the extemporaneous preparation of liquid formulations. These formulations have studies on their physicochemical stability, but they often lack microbiological studies. The objective of this study is to check the microbiological quality of five oral liquid formulations prepared with different excipients, which represent five major combinations, in two conditions: kept unopened until the day of the test, and in a multi-dose vial opened daily. The formulations were prepared according to standard operating procedures. Half of each batch was packaged in vials that remained closed until the day of testing, and the other half in a single container which was opened daily. Both the vials and the containers had been previously sterilized. Microbiological tests were performed weekly during the first month of the study, and then every two weeks, until the expiration date. The microbiological quality of oral liquid formulations is determined by the Royal Spanish Pharmacopoeia. The conclusion was that none of the formulations prepared that were packaged in sterilized containers became contaminated, either in unopened vials or in multi-dose containers when they were opened daily.
给儿科人群口服给药涉及到临时配制液体制剂。这些制剂有关于其物理化学稳定性的研究，但往往缺乏微生物学研究。本研究的目的是检查在两种条件下用不同辅料制备的五种口服液体制剂的微生物质量，这五种制剂代表了五种主要组合：在测试当天之前保持未开封状态，以及在每日开启的多剂量瓶中。制剂按照标准操作程序制备。每批制剂的一半包装在小瓶中，直到测试当天一直保持封闭，另一半包装在单个容器中，每天开启。小瓶和容器此前均已灭菌。在研究的第一个月每周进行微生物测试，然后每两周进行一次，直至有效期。口服液体制剂的微生物质量由《西班牙皇家药典》确定。结论是，在灭菌容器中制备的制剂，无论是未开封的小瓶还是每日开启的多剂量容器，均未被污染。
