Stability of extemporaneous enalapril maleate suspensions for pediatric use prepared from commercially available tablets.
In this paper, the stability of enalapril maleate in oral formulations prepared from commercially available tablets was investigated. Extemporaneously compounded, 0.1 mg/mL and 1.0 mg/mL, oral suspensions of enalapril maleate in sugar-containing and sugar-free vehicles were stored in the absence of light at 4 degrees and 25 degrees C for 30 days. Enalapril maleate stability was quantified after 7, 14, 21, and 30 days using HPLC method. Viscosities and pH of prepared suspensions were measured on each study day and no appreciable changes from the initial pH and initial viscosities occurred in any of the samples both at 25 degrees and 4 degrees C. It was shown that all the formulations retain minimum 98% of the initial enalapril maleate concentration after 30 days of storage at 25 degrees and 4 degrees C and they may provide an option in situations where the marketed suspension is unavailable.
Sosnowska
Katarzyna
K
Department of Pharmaceutical Technology, Medical University of Białystok, Mickiewicza 2c, 15-222 Białystok, Poland. sosnowskak@umwb.edu.pl
Winnicka
Katarzyna
K
Czajkowska-Kośnik
Anna
A
D000806:Angiotensin-Converting Enzyme Inhibitors / Q000008:administration & dosage / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical / Q000379:methods; D002648:Child; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D004339:Drug Compounding / Q000379:methods; D004355:Drug Stability; D004356:Drug Storage; D004656:Enalapril / Q000008:administration & dosage / Q000737:chemistry*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D014677:Pharmaceutical Vehicles / Q000737:chemistry*; D013535:Suspensions; D013607:Tablets; D013997:Time Factors; D014783:Viscosity
D000806:Angiotensin-Converting Enzyme Inhibitors; D014677:Pharmaceutical Vehicles; D013535:Suspensions; D013607:Tablets; D004656:Enalapril