Meissner Svenja, Bansal Mahima, Dela Cruz Paula Donamae, Hanning Sara, Svirskis Darren
School of Pharmacy, The University of Auckland, New Zealand.
Int J Pharm Compd. 2020 Mar-Apr;24(2):140-147.
In New Zealand, there are no liquid formulations of omeprazole commercially available, therefore suspensions must be extemporaneously compounded from solid dosage forms for patients with swallowing difficulties. The funding for solid dosage forms of omeprazole changes frequently, often every one to two years, without consideration of the impact this may have when extemporaneously compounded liquid dosage forms are required. This study examined suspensions compounded from various solid dosage forms of omeprazole with the purpose of identifying suitable quality formulations and evaluating their chemical and physical stability. Six different solid dosage forms of omeprazole that are available in New Zealand, including capsules, tablets, and powder, were used to prepare 2-mg/mL suspensions in 8.4% w/v sodium bicarbonate solution. The suspensions were then assessed visually for quality and by quantifying sedimentation rate over 120 minutes. Two products, stored in amber bottles at either 4°C or 25°C, demonstrated acceptable quality over a 30-day period whilst monitoring physical and chemical stability on day 0, 7, 14, 20, and 30. Four of the formulated suspensions were deemed to be of poor quality due to either a lack of uniformity or rapid sedimentation, attributes that could lead to inaccurate dosing. Acceptable quality suspensions were prepared from Losec and Dr. Reddy's brands of omeprazole 20-mg capsules. For both brands, a change in color was observed after 20 days and 7 days when stored at 4°C and 25°C, respectively. Chemical stability was determined using a stability-indicating high-performance liquid chromatographic method, with >90% of the active remaining for 30 days when kept at 4°C, and 20 days when stored at 25°C. Not all brands are suitable for extemporaneously compounding omeprazole suspensions. Losec and Dr. Reddy's brands of capsules were suitable to prepare quality omeprazole suspensions. Omeprazole suspensions compounded from these products are stable for 20 days if stored at 4°C and protected from light.
在新西兰，奥美拉唑没有市售的液体制剂，因此对于有吞咽困难的患者，必须从固体剂型临时配制混悬液。奥美拉唑固体剂型的资金资助频繁变化，常常是每1至2年就变动一次，而未考虑到当需要临时配制液体制剂时这可能产生的影响。本研究检验了由各种奥美拉唑固体剂型配制的混悬液，目的是确定合适的优质制剂并评估其化学和物理稳定性。使用新西兰可获得的6种不同的奥美拉唑固体剂型，包括胶囊、片剂和粉末，在8.4% w/v碳酸氢钠溶液中制备2mg/mL的混悬液。然后对混悬液进行外观质量评估，并在120分钟内定量沉降率。两种产品，分别储存在4°C或25°C的琥珀色瓶中，在30天期间质量可接受，同时在第0、7、14、20和30天监测物理和化学稳定性。由于缺乏均匀性或沉降过快，4种配制的混悬液被认为质量较差，这些特性可能导致给药不准确。由洛赛克（Losec）和雷迪博士（Dr. Reddy's）品牌的奥美拉唑20mg胶囊制备出了质量可接受的混悬液。对于这两个品牌，分别在4°C和25°C储存时，20天和7天后观察到颜色变化。使用稳定性指示高效液相色谱法测定化学稳定性，在4°C保存时，活性成分在30天内剩余>90%，在25°C储存时为20天。并非所有品牌都适合临时配制奥美拉唑混悬液。洛赛克和雷迪博士品牌的胶囊适合制备优质的奥美拉唑混悬液。由这些产品配制的奥美拉唑混悬液如果在4°C储存并避光，可稳定20天。
