Chuong Monica, Taglieri Catherine A, Huang Szu Yu, Sariol Anthony, Kitigawa Reina, Barman Koushik, Mistry Amee, Harris Donna L, Kerr Stephen G
School of Pharmacy, MPCHS University, Boston, Massachusetts.
CuraHealth Hospital, Boston, Massachusetts.
Int J Pharm Compd. 2019 Nov-Dec;23(6):504-510.
In a previous study, the results of which were provided in an article published in the International Journal of Pharmaceutical Compounding, it was determined that FLAVORx's Grape flavor in extemporaneously compounded omeprazole oral liquid was found suitable. A follow-up study was conducted in which the authors explored four additional flavors (Professional Compounding Centers of America's Cherry Concentrate and their Orange Concentrate, and FLAVORx's Bubble Gum flavor and their Watermelon flavor) to allow pharmacists and patients greater flexibility and options to flavor omeprazole oral liquid. Oral liquids were compounded using 20-mg omeprazole delayed-release capsules, 8.4% sodium bicarbonate, and each of four flavors to reach drug concentration at 2 mg/mL and flavor at 1.2% v/v (n=3). After the delayed-release pellets were disintegrated, the prescription bottles were stored in cold temperature overnight. For flavor alone in 8.4% sodium bicarbonate solution, samples were prepared the same as above except no omeprazole delayed-release capsules were added. High-performance liquid chromatographic assay was adopted from the United States Pharmacopeia's Omeprazole Monograph, but it is for the unflavored oral liquid. In order to ensure assay robustness, stability indication tests, 0.1 N HCl (acid), 0.1 N NaOH (base), 50°C (heat), and 3% hydrogen peroxide were also performed to the flavored omeprazole oral liquids, as well as to the individual flavor alone in sodium bicarbonate solution without omeprazole. Professional Compounding Centers of America's Cherry Concentrate, Orange Concentrate, and FLAVORx's Watermelon flavor showed no interference with the drug, and the assays were robust. However, FLAVORx's Bubble Gum flavor displayed five mini peaks at 280 nm with one embedded in omeprazole peak. The resolution of a Bubble Gum peak immediately next to an omeprazole peak computed by column kinetics was 0.91, while the separation factor was 1.15. A good separation is generally >1.5. This study examined only the Cherry Concentrate, Orange Concentrate, Bubble Gum flavor, and Watermelon flavor from the specified manufacturers. An insignificant interference was shown between FLAVORx's Bubble Gum flavor with omeprazole. The results are not intended to infer that all brands of the same flavor names would react the same way. Omeprazole and all four studied flavors should be protected from oxidation insult.
在之前一项研究中（其结果发表于《国际药物制剂学杂志》上的一篇文章），已确定即配型奥美拉唑口服液中FLAVORx的葡萄口味是合适的。开展了一项后续研究，作者在其中探究了另外四种口味（美国专业配药中心的樱桃浓缩液和橙子浓缩液，以及FLAVORx的泡泡糖口味和西瓜口味），以便药剂师和患者在为奥美拉唑口服液调味时有更大的灵活性和更多选择。使用20毫克奥美拉唑缓释胶囊、8.4%的碳酸氢钠以及四种口味中的每一种来配制口服液，以使药物浓度达到2毫克/毫升，口味达到1.2%（体积/体积）（n = 3）。在缓释微丸崩解后，将药瓶在低温下储存过夜。对于仅含8.4%碳酸氢钠溶液的口味，除了不添加奥美拉唑缓释胶囊外，按照上述相同方法制备样品。采用美国药典奥美拉唑专论中的高效液相色谱法测定，但该方法是针对无调味口服液的。为确保测定的稳健性，还对加味奥美拉唑口服液以及不含奥美拉唑的碳酸氢钠溶液中的单一口味进行了稳定性指示试验，即0.1 N盐酸（酸）、0.1 N氢氧化钠（碱）、50°C（热）和3%过氧化氢试验。美国专业配药中心的樱桃浓缩液、橙子浓缩液以及FLAVORx的西瓜口味对药物无干扰，测定结果稳健。然而，FLAVORx的泡泡糖口味在280纳米处显示出五个小峰，其中一个嵌入奥美拉唑峰中。通过柱动力学计算，紧邻奥美拉唑峰的泡泡糖峰的分离度为0.91，而分离因子为1.15。一般来说，良好的分离度>1.5。本研究仅考察了指定制造商的樱桃浓缩液、橙子浓缩液、泡泡糖口味和西瓜口味。FLAVORx的泡泡糖口味与奥美拉唑之间显示出轻微干扰。这些结果并非旨在推断所有相同口味名称的品牌都会有相同的反应。奥美拉唑和所有四种研究口味都应防止受到氧化损伤。
