ABSTRACT
Objetivo Analizar la estabilidad fisicoquímica y microbiológica de dos suspensiones orales de carbamazepina al 2,5 y al 5%.MétodoLas suspensiones orales se elaboraron a partir de carbamazepina en polvo y los vehículos comerciales Ora-sweet SF® y Ora-plus®. Se realizaron controles de calidad físicos (pH, estado de la suspensión y características organolépticas), químicos (cromatografía líquida de alta resolución [HPLC]) y microbiológicos a los 2, 4 y 6 meses de la preparación. Resultados La concentración a los 6 meses de las suspensiones de carbamazepina al 2,5% y al 5% resultó de 22,9mg/ml y de 45,9mg/ml, respectivamente, con valores de riqueza obtenidos mediante la cromatografía líquida de alta resolución se encontraron entre el 90 y el 110%, tal y como exige la Farmacopea Americana 23 NF18. Durante el período del estudio no se observó modificación de los parámetros físicos ni crecimiento en los cultivos microbiológicos realizados. Conclusiones Ambas suspensiones orales son estables física, química y microbiológicamente durante al menos 6 meses a temperatura ambiente y en frasco de vidrio topacio (AU)
Objective To assess the physical, chemical and microbiological stability of two oral suspensions of carbamazepine at concentrations of 2.5% and 5%.MethodsBoth oral suspensions were compounded from powdered carbamazepine and Ora-Sweet SF® and Ora-Plus® commercial compounding excipients. At the 2, 4 and a 6-month marks, different quality assays were performed, comprising physical (pH, state of the suspension, organoleptic properties), chemical (HPLC) and microbiological assays. Results The final concentration at 6 months for both the 2.5% and 5% carbamazapine suspensions was 22.9 and 45.9mg/ml respectively, with calculated richness values between 90 and 110% fulfilling USP23 NF18 requirements. No changes in physical properties and no culture growth were observed during the study period. Conclusion Both oral suspensions are physically, chemically and microbiologically stable for at least 6 months when preserved at room temperature in amber glass flasks(AU)
Subject(s)
Humans , Carbamazepine/pharmacology , Drug Stability , Drug Compounding/methods , Administration, Oral , Pharmaceutical Preparations/analysisABSTRACT
OBJECTIVE: To assess the physical, chemical and microbiological stability of two oral suspensions of carbamazepine at concentrations of 2.5% and 5%. METHODS: Both oral suspensions were compounded from powdered carbamazepine and Ora-Sweet SF(®) and Ora-Plus(®) commercial compounding excipients. At the 2, 4 and a 6-month marks, different quality assays were performed, comprising physical (pH, state of the suspension, organoleptic properties), chemical (HPLC) and microbiological assays. RESULTS: The final concentration at 6 months for both the 2.5% and 5% carbamazapine suspensions was 22.9 and 45.9 mg/ml respectively, with calculated richness values between 90 and 110% fulfilling USP23 NF18 requirements. No changes in physical properties and no culture growth were observed during the study period. CONCLUSION: Both oral suspensions are physically, chemically and microbiologically stable for at least 6 months when preserved at room temperature in amber glass flasks.
