Extemporaneous Compounding and Physiological Modeling of Amlodipine/Valsartan Suspension.

METHOD

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.

RESULTS

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.

CONCLUSION

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.