Aabed Wafa' J, Radwan Asma H, Zaid Abdel Naser, Shraim Naser Y
Department of Pharmacy, College of Medicine and Health Sciences, An-Najah National University, Nablus, State of Palestine.
Int J Hypertens. 2021 Mar 12;2021:6695744. doi: 10.1155/2021/6695744. eCollection 2021.
Amlodipine/valsartan extemporaneous suspension was prepared from available commercial tablets such as Valzadepine. The dissolution profiles for the extemporaneous preparation and the commercial tablet were determined in different pH media. The physical, chemical, and microbial stability of the compounded formulation was evaluated over one-month period at room temperature. Moreover, modeling using GastroPlus™ software was used to build absorption models for both drugs based on the dissolution data. The simulated plasma profiles for both active ingredients were compared with the plasma profiles to examine the similarity of the extemporaneous suspension and the commercial tablets.
The amlodipine/valsartan extemporaneous suspension was successfully prepared with acceptable organoleptic properties. The suspension was stable for four-week period preserving its physical and chemical features. The release profiles of valsartan and amlodipine from the suspension were similar to those from source tablet Valzadepine. modeling predicted the similarity of the extemporaneous suspension and the commercial tablets.
Amlodipine/valsartan extemporaneous suspension could be prepared from available commercial tablets. Moreover, GastroPlus™ can be applied along with the dissolution in order to affirm similarity in extemporaneous compounding situations.
氨氯地平/缬沙坦临时混悬剂由市售片剂（如Valzadepine）制备而成。测定了临时制剂和市售片剂在不同pH介质中的溶出曲线。在室温下对复方制剂的物理、化学和微生物稳定性进行了为期一个月的评估。此外，使用GastroPlus™软件进行建模，根据溶出数据建立两种药物的吸收模型。将两种活性成分的模拟血浆曲线与血浆曲线进行比较，以检验临时混悬剂与市售片剂的相似性。
成功制备了具有可接受感官特性的氨氯地平/缬沙坦临时混悬剂。该混悬剂在四周内保持稳定，其物理和化学特性未发生改变。缬沙坦和氨氯地平从混悬剂中的释放曲线与源片剂Valzadepine相似。建模预测了临时混悬剂与市售片剂的相似性。
氨氯地平/缬沙坦临时混悬剂可由市售片剂制备而成。此外，GastroPlus™可与溶出度测定一起应用，以确认临时复方制剂的相似性。
