| Popis: |
To assess the physical, chemical and microbiological stability of two oral suspensions of carbamazepine at concentrations of 2.5% and 5%.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.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.Both oral suspensions are physically, chemically and microbiologically stable for at least 6 months when preserved at room temperature in amber glass flasks. |
