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Polonini H.C.,Ortofarma Quality Control Laboratories | Silva S.L.,Ortofarma Quality Control Laboratories | Cunha C.N.,Ortofarma Quality Control Laboratories | Brandao M.A.F.,Ortofarma Quality Control Laboratories | Ferreira A.O.,Ortofarma Quality Control Laboratories
Pharmazie | Year: 2016

A challenge with compounding oral liquid formulations is the limited availability of data to support the physical, chemical and microbiological stability of the formulation. This poses a patient safety concern and a risk for medication errors. The objective of this study was to evaluate the compatibility of the following active pharmaceutical ingredients (APIs) in 10 oral suspensions, using SyrSpend® SF PH4 (liquid) as the suspending vehicle: cholecalciferol 50,000 IU/mL, haloperidol 0.5 mg/mL, imipramine hydrochloride 5.0 mg/mL, levodopa/carbidopa 5.0/1.25 mg/mL, lorazepam 1.0 mg/mL, minocycline hydrochloride 10.0 mg/mL, tacrolimus monohydrate 1.0 mg/ mL, terbinafine 25.0 mg/mL, tramadol hydrochloride 10.0 mg/mL and valsartan 4.0 mg/mL. The suspensions were stored both refrigerated (2 - 8 °C) and at controlled room temperature (20 - 25 °C). This is the first stability study for these APIs in SyrSpend® SF PH4 (liquid). Further, the stability of haloperidol,iImipramine hydrochloride, minocycline, and valsartan in oral suspension has not been previously reported in the literature. Compatibility was assessed by measuring percent recovery at varying time points throughout a 90 days period. Quantification of the APIs was performed by high performance liquid chromatography (HPLC-UV). Given the percentage of recovery of the APIs within the suspensions, the beyond-use date of the final preparations was found to be at least 90 days for most suspensions both refrigerated and at room temperature. Exceptions were: Minocycline hydrochloride at both storage temperatures (60 days), levodopa/carbidopa at room temperature (30 days), and lorazepam at room temperature (60 days). This suggests that compounded suspensions of APIs from different pharmacological classes in SyrSpend® SF PH4 (liquid) are stable. Source


Ferreira A.O.,Ortofarma Quality Control Laboratories | Ferreira A.O.,Federal University of Juiz de fora | Polonini H.C.,Ortofarma Quality Control Laboratories | Polonini H.C.,Federal University of Juiz de fora | And 6 more authors.
Journal of Pharmaceutical and Biomedical Analysis | Year: 2016

The objective of this study was to evaluate the feasibility of 10 commonly used active pharmaceutical ingredients (APIs) compounded in oral suspensions using an internationally used suspending vehicle (SyrSpend® SF PH4 liquid): (i) amlodipine, (as besylate) 1.0mg/mL; (ii) chloroquine phosphate,15.0mg/mL; (iii) dapsone, 2.0mg/mL; (iv) phenytoin, 15.0mg/mL; (v) pyridoxine hydrochloride, 50.0mg/mL; (vi) sulfadiazine, 100.0mg/mL; (vii) sulfasalazine, 100.0mg/mL; (viii) tetracycline hydrochloride, 25.0mg/mL; (ix) trimethoprim, 10.0mg/mL; and (x) zonisamide, 10.0mg/mL. All suspensions were stored both at controlled refrigeration (2-8°C) and controlled room temperature (20-25°C). Feasibility was assessed by measuring the percent recovery at varying time points throughout a 90-day period. API quantification was performed by high-performance liquid chromatography (HPLC-UV), via a stability-indicating method. Given the percentage of recovery of the APIs within the suspensions, the expiration date of the final products (API+vehicle) was at least 90 days for all suspensions with regard to both the controlled temperatures. This suggests that the vehicle is stable for compounding APIs from different pharmacological classes. © 2015 Elsevier B.V. Source

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