Thompson Karen C, Zhao Zhongxi, Mazakas Jessica M, Beasley Christopher A, Reed Robert A, Moser Cheryl L
Merck Research Laboratories, P.O. Box 4, WP78-302, West Point, PA 19486, USA.
Am J Health Syst Pharm. 2003 Jan 1;60(1):69-74. doi: 10.1093/ajhp/60.1.69.
The stability of lisinopril in an extemporaneously prepared suspension stored at or below 25 degrees C for 28 days under ambient light exposure was studied. A formulation of 1-mg/mL oral suspension was prepared from commercially available 20-mg lisinopril tablets, using Bicitra and Ora-Sweet SF as the compounding vehicles to make a final volume of 200 mL. Individual samples, stored in 8-oz amber polyethylene terephthalate bottles, were used for each test performed. All samples were stored at 25 degrees C. Appropriateness of the extemporaneous preparation method was performed by shaking three lots of each suspension for 30, 60, and 90 seconds. To test the robustness and reproducibility of the method, two chemists prepared the suspensions from the same three lots of lisinopril tablets. Chemical and physical stability were established by analyzing duplicate samples at time zero and after one, two, four, and six weeks. The solubility of lisinopril was tested from suspensions stored for four weeks. In-use stability was also examined over four weeks. Photochemical stability was examined by exposing three batches of the suspension to maximum light stress in accordance with the International Conference on Harmonization. Antimicrobial-effectiveness testing was also conducted with freshly prepared suspensions and suspensions stored for six weeks. The preparation method used was appropriate and effective. Lisinopril is fully dissolved in the suspension matrix. Satisfactory chemical, physical, and microbiological results were obtained after the suspensions were stored for six weeks at 25 degrees C and 35% relative humidity. Lisinopril suspensions extemporaneously prepared from tablets are stable for at least four weeks when stored at or below 25 degrees C under ambient light exposure.
研究了赖诺普利在室温下于25℃或更低温度储存28天、暴露于环境光下的临时配制混悬液中的稳定性。使用市售的20毫克赖诺普利片剂制备1毫克/毫升的口服混悬液制剂，使用枸橼酸缓冲液和Ora-Sweet SF作为混合媒介，最终体积为200毫升。每次测试使用单独的样品，储存在8盎司琥珀色聚对苯二甲酸乙二酯瓶中。所有样品均储存在25℃。通过对每批混悬液摇晃30、60和90秒来检验临时配制方法的适宜性。为测试该方法的稳健性和可重复性，两名化学家从相同的三批赖诺普利片剂制备混悬液。通过在零时间以及1、2、4和6周后分析重复样品来确定化学和物理稳定性。从储存4周的混悬液中测试赖诺普利的溶解度。还在4周内检查了使用中的稳定性。根据国际协调会议，通过将三批混悬液暴露于最大光照强度来检验光化学稳定性。还对新鲜制备的混悬液和储存6周的混悬液进行了抗菌效力测试。所使用的制备方法是适宜且有效的。赖诺普利完全溶解于混悬液基质中。混悬液在25℃和35%相对湿度下储存6周后，获得了令人满意的化学、物理和微生物学结果。由片剂临时配制的赖诺普利混悬液在室温下于25℃或更低温度储存、暴露于环境光下时至少稳定4周。
