Zaid Abdel Naser, Shtayah Rania, Qadumi Ayman, Ghanem Mashour, Qedan Rawan, Daibes Marah, Awwad Somud Abu, Jaradat Nidal, Kittana Naim
Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine.
Department of Research and Development, Pharmacare Ltd., Ramallah, Palestine.
Am J Health Syst Pharm. 2017 Oct 1;74(19):1579-1583. doi: 10.2146/ajhp160235.
The stability of an extemporaneously prepared rosuvastatin suspension stored over 30 days under various storage conditions was evaluated.
Rosuvastatin suspension was extemporaneously prepared using commercial rosuvastatin tablets as the source of active pharmaceutical ingredient. The organoleptic properties, dissolution profile, and stability of the formulation were investigated. For the stability studies, samples of the suspension were stored under 2 storage conditions, room temperature (25 °C and 60% relative humidity) and accelerated stability chambers (40 °C and 75% relative humidity). Viscosity, pH, organoleptic properties, and microbial contamination were evaluated according to the approved specifications. High-performance liquid chromatography was used for the analysis and quantification of rosuvastatin in selected samples. Microbiological investigations were also conducted.
The prepared suspension showed acceptable organoleptic properties. It showed complete release of rosuvastatin within 15 minutes. The pH of the suspension was 9.8, which remained unchanged during the stability studies. The microbiological investigations demonstrated that the preparation was free of any microbial contamination. In addition, the suspension showed stability within at least the period of use of a 100-mL rosuvastatin bottle.
Extemporaneously prepared rosuvastatin 20-mg/mL suspension was stable for 30 days when stored at room temperature.
评估临时配制的瑞舒伐他汀混悬液在不同储存条件下储存30天的稳定性。
以市售瑞舒伐他汀片作为活性药物成分来源，临时配制瑞舒伐他汀混悬液。对该制剂的感官性质、溶出曲线和稳定性进行了研究。在稳定性研究中，混悬液样品分别储存在两种条件下，室温（25℃，相对湿度60%）和加速稳定性试验箱（40℃，相对湿度75%）。根据批准的规格对粘度、pH值、感官性质和微生物污染进行评估。采用高效液相色谱法对选定样品中的瑞舒伐他汀进行分析和定量。还进行了微生物学研究。
所制备的混悬液具有可接受的感官性质。瑞舒伐他汀在15分钟内完全释放。混悬液的pH值为9.8，在稳定性研究期间保持不变。微生物学研究表明该制剂无任何微生物污染。此外，该混悬液在至少100 mL瑞舒伐他汀瓶的使用期内表现出稳定性。
临时配制的20 mg/mL瑞舒伐他汀混悬液在室温下储存30天稳定。
