Rosen W J, Johnson C E
Liquids Product Development, Abbott Laboratories, North Chicago, IL.
Am J Hosp Pharm. 1989 Nov;46(11):2313-7.
Five methods for removing the maximum volume of liquid from a nifedipine capsule were evaluated for efficiency and reproducibility, and the concentration of nifedipine in Procardia and Adalat 10- and 20-mg capsules was determined The methods evaluated were the needle puncture and squeeze method; the scissors method; the needle and syringe, one-hole method; the needle and syringe, two-hole method; and the capsule in syringe barrel method. The liquid content of 10 Adalat 10-mg capsules was removed by each method, the volume was determined by the weight and specific gravity of the nifedipine liquid, and the mean volumes of nifedipine liquid were compared. A stepwise procedure for using the needle and syringe, one-hole method was developed. The mean nifedipine concentration in Procardia 10- and 20-mg capsules was determined by ultraviolet spectrophotometry by using 30 capsules of each brand and strength. The needle and syringe methods were the most reproducible and efficient procedures for obtaining a desired milligram dosage of nifedipine from the capsules. The two-hole method would be less practical in the clinical setting, however, because it is time consuming and cumbersome. The mean assayed nifedipine concentration in the Procardia and Adalat 10- and 20-mg capsules was within 10% of the concentration reported by the manufacturer for each specific product lot number. Based on reproducibility and efficiency, the needle and syringe methods are the best methods for quantitation of liquid nifedipine doses for patient administration.
评估了从硝苯地平胶囊中去除最大液体量的五种方法的效率和重现性,并测定了心痛定和拜心通10毫克及20毫克胶囊中硝苯地平的浓度。所评估的方法有:针刺挤压法;剪刀法;针筒注射器单孔法;针筒注射器双孔法;以及注射器筒内胶囊法。每种方法去除10粒拜心通10毫克胶囊的液体内容物,通过硝苯地平液体的重量和比重测定体积,并比较硝苯地平液体的平均体积。开发了一种使用针筒注射器单孔法的逐步操作程序。通过紫外分光光度法,使用每种品牌和规格的30粒胶囊,测定心痛定10毫克和20毫克胶囊中硝苯地平的平均浓度。针筒注射器法是从胶囊中获取所需毫克剂量硝苯地平最具重现性和效率的方法。然而,双孔法在临床环境中不太实用,因为它既耗时又麻烦。心痛定和拜心通10毫克及20毫克胶囊中硝苯地平的平均测定浓度在每个特定产品批号制造商报告浓度的10%以内。基于重现性和效率,针筒注射器法是定量液体硝苯地平剂量用于患者给药的最佳方法。