Allen L V, Erickson M A
College of Pharmacy, University of Oklahoma Health Sciences Center, Oklahoma City 73117, USA.
Am J Health Syst Pharm. 1996 Sep 1;53(17):2073-8. doi: 10.1093/ajhp/53.17.2073.
The stability of drugs commonly prescribed for use in oral liquid dosage forms but not commercially available as such was studied. Ketoconazole 20 mg/mL, metolazone 1 mg/mL, metronidazole 50 mg/mL, procainamide hydrochloride 50 mg/ mL, and spironolactone 25 mg/mL were prepared in a 1:1 mixture of Ora-Sweet and Ora-Plus (Paddock Laboratories), a 1:1 mixture of Ora-Sweet SF and Ora-Plus (Paddock Laboratories), and cherry syrup and placed in 120-mL polyethylene terephthalate bottles. The sources of the drugs were powder, capsules, and tablets. Six bottles were prepared per liquid; three were stored at 5 degrees C and three at 25 degrees C, all in the dark. A sample was removed from each bottle immediately after preparation and at intervals up to 60 days and analyzed for drug concentration by stability-indicating high-performance liquid chromatography. At least 93% of the initial drug concentration was retained in all the oral liquids for up to 60 days. There were no substantial changes in the appearance or odor of the liquids, or in the pH. Ketoconazole 20 mg/mL, metolazone 1 mg/mL, metronidazole 50 mg/mL, procainamide hydrochloride 50 mg/ mL, and spironolactone 25 mg/mL were stable for up to 60 days at 5 and 25 degrees C in three extemporaneously compounded oral liquids. INDEX TERMS: Anti-infective agents; Antifungals; Capsules; Cardiac drugs; Cherry syrup; Compounding; Containers; Diuretics; Incompatibilities; Ketoconazole; Liquids; Metolazone; Metronidazole; Polyethylene terephthalate; Powders; Procainamide hydrochloride; Spironolactone; Stability; Storage; Suspending agents; Tablets; Temperature; Vehicles.
对常用于口服液体制剂但尚无市售产品的药物稳定性进行了研究。将酮康唑20mg/mL、美托拉宗1mg/mL、甲硝唑50mg/mL、盐酸普鲁卡因胺50mg/mL和螺内酯25mg/mL分别制备于Ora-Sweet和Ora-Plus（帕多克实验室）的1:1混合物、Ora-Sweet SF和Ora-Plus（帕多克实验室）的1:1混合物以及樱桃糖浆中，并置于120mL聚对苯二甲酸乙二酯瓶中。药物来源为粉剂、胶囊和片剂。每种液体配制6瓶；3瓶储存于5℃，3瓶储存于25℃，均置于暗处。配制后立即从每瓶中取出一个样品，并每隔一段时间直至60天取样，通过稳定性指示高效液相色谱法分析药物浓度。在长达60天的时间里，所有口服液中至少保留了93%的初始药物浓度。液体的外观、气味或pH值均无实质性变化。酮康唑20mg/mL、美托拉宗1mg/mL、甲硝唑50mg/mL、盐酸普鲁卡因胺50mg/mL和螺内酯25mg/mL在三种临时配制的口服液中于5℃和25℃下长达60天均稳定。索引词：抗感染药；抗真菌药；胶囊；心脏药物；樱桃糖浆；配制；容器；利尿剂；配伍禁忌；酮康唑；液体；美托拉宗；甲硝唑；聚对苯二甲酸乙二酯；粉剂；盐酸普鲁卡因胺；螺内酯；稳定性；储存；助悬剂；片剂；温度；赋形剂。
