Tannous Elias, Tal Yana, Amarny Kamal
Hillel Yaffe Medical Center, Hadera, Israel.
Int J Pharm Compd. 2016 Sep-Oct;20(5):438-439.
Although commercial preparations of oral potassium supplements are usually available, there are times when our Medical Center is faced with situations in which the oral solution of potassium chloride is not available. This solution is necessary for our pediatric outpatients who cannot swallow tablets and need an oral solution. Moreover, there are no studies available which describe an extemporaneously prepared potassium chloride oral solution on which we can rely for assigning a beyond-use date. The aim of this study was to formulate an extemporaneous pediatric oral solution of potassium chloride and to determine the physical and chemical stability of this preparation. We prepared 1 mMoL/mL by withdrawing 25 mL of potassium chloride 14.9%. Ora-Sweet SF was added to 50 mL in a metered flask. The solution was kept refrigerated (2°C to 8°C). Samples were withdrawn to measure potassium concentration, pH, and microbial overgrowth. The test was performed by our biochemical laboratory. The oral solution of potassium chloride 1 mMoL/mL stored at 2°C to 8°C maintained at least 91% of the initial concentration for 28 days. There were no notable changes in pH, and the solution remained physically stable with no visual microbial growth. The oral solution of potassium chloride 1 mMoL/mL prepared in Ora-Sweet and stored at 2°C to 8°C in amber glass bottles is expected to remain stable for 28 days.
虽然通常可以买到口服钾补充剂的商业制剂,但我们医疗中心有时会面临无法获得氯化钾口服溶液的情况。对于无法吞咽片剂而需要口服溶液的儿科门诊患者来说,这种溶液是必需的。此外,目前尚无研究描述我们可以据此确定有效期的临时配制的氯化钾口服溶液。本研究的目的是配制一种临时使用的儿科氯化钾口服溶液,并确定该制剂的物理和化学稳定性。我们通过吸取25 mL 14.9%的氯化钾溶液,在容量瓶中加入Ora-Sweet SF至50 mL,制备出1 mmol/mL的溶液。该溶液保存在冷藏温度(2°C至8°C)下。取出样品测量钾浓度、pH值和微生物过度生长情况。测试由我们的生化实验室进行。1 mmol/mL的氯化钾口服溶液在2°C至8°C下储存28天,至少保持初始浓度的91%。pH值没有明显变化,溶液在物理上保持稳定,没有肉眼可见的微生物生长。用Ora-Sweet配制并保存在2°C至8°C的琥珀色玻璃瓶中的1 mmol/mL氯化钾口服溶液预计可稳定保存28天。