RESUMEN
Compounded medicinal products should be prepared using an appropriate quality-assurance system. Cleaning and disinfection, as part of this system, are important to avoid cross-contamination of the preparations, reduce the bioburden levels in products, and avoid hazardous drugs residues or toxic chemical exposure of the staff workers. However, manual cleaning is difficult to standardize. Automated robotic cleaning devices are currently available and designed for domestic use only. To fill this gap, a laboratory automated robotic cleaning device (RVC1, FagronLab, The Netherlands) was specially developed to clean and sanitize laboratories of compounding pharmacies and other production facilities of primary healthcare establishments. The objective of this study was to evaluate the efficacy of an automated robotic cleaning device (robotic vacuum cleaner) for compounding pharmacies and other production facilities of primary healthcare establishments. A set of 6 experiments was conducted to evaluate the efficacy of the cleaning procedure using the automated robotic cleaning device. All experiments were conducted at the end of a regular daily routine in the laboratory to simulate a genuine cleaning procedure. Tests were performed both with no forced contamination (to imitate the regular use of the device) and with forced contamination (to mimic unexpected, non-regular contamination, such as in the case of accidents). Total aerobic microbial count and the total combined yeasts and molds count were determined, as well as pathogens identification and the concentration of thiamine hydrochloride and progesterone active pharmaceutical ingredients (deliberately spread on the floor surface for the tests). In real-conditions, both two-step and single-step were adequate to clean the areas and reduce microbiological contamination to non-detected levels, and only the cleaning cycle without the mopping accessory was also suitable (in the two-step cleaning). The same can be seen for the forced-contamination condition, except for the use of the cleaning cycle without the mopping. In terms of chemical contamination, both high and low water-soluble active pharmaceutical ingredients were reduced (completely and 932-fold, respectively) in the single-step cleaning. The RVC1 automated robotic cleaning device showed the necessary microbiological and chemical efficacy to be used in the cleaning routine of compounding pharmacies, both in a singlestep cleaning (brushing, ultraviolet light, and mopping simultaneously) or in a double-step cleaning (brushing and ultraviolet light first, mopping second). It is then recommended to always use the mopping accessory and the ultraviolet light on. The RVC1 can be a valuable add-on method to standardize cleaning.
Asunto(s)
Farmacias , Procedimientos Quirúrgicos Robotizados , Robótica , Desinfección , Contaminación de Medicamentos , Humanos , Procedimientos Quirúrgicos Robotizados/métodos , Robótica/métodosRESUMEN
OBJECTIVES: To evaluate the microbiological and physicochemical compatibility of commonly used proton pump inhibitors (PPIs) esomeprazole, lansoprazole, omeprazole and pantoprazole compounded at a single concentration using SyrSpend SF Alka and stored at refrigerated temperatures (omeprazole was also stored at room temperature because it has the most widespread use). METHODS: Compatibility was assessed by measuring the per cent recovery at varying time points throughout a 90-day period. Quantification of the APIs was performed by a validated high performance liquid chromatography (HPLC-UV) method. This same assay was also used to determine the dosage content uniformity of the suspensions. Microbiological stability ('test in use') was assessed during 60â days and total aerobic microbial count (TAMC), total combined yeasts and moulds count (TYMC), detection of Escherichia coli and pH determination were performed. Antimicrobial effectiveness testing was determined following European Pharmacopoeia guidelines. RESULTS: Beyond-use dates of maximum 60â days for omeprazole (5â mg/mL), pantoprazole (3â mg/mL) and esomeprazole (3â mg/mL) were established. All suspensions that met the physicochemical criteria for stability also met the content uniformity criteria. The suspensions showed no antimicrobial efficiency against bacteria, yeasts and moulds as SyrSpend SF Alka is an unpreserved vehicle, but the 'test in use' showed that the suspensions can remain microbiologically stable for up to 60â days. CONCLUSIONS: SyrSpend SF Alka can be used to compound palatable (taste-masking properties) preservative-free oral suspensions with almost all commonly used PPIs.
RESUMEN
OBJECTIVES: The objective of this study was to evaluate the compatibility of 10 commonly used active pharmaceutical ingredients (APIs) compounded in oral suspensions using a globally available suspending vehicle (SyrSpend SF PH4 liquid): caffeine 10.0â mg/mL, carvedilol 1.0â mg/mL, clomipramine hydrochloride 5.0â mg/mL, folic acid 1.0â mg/mL, hydrochlorothiazide 5.0â mg/mL, loperamide hydrochloride 1.0â mg/mL, methotrexate 2.5â mg/mL, nadolol 10.0â mg/mL, naltrexone hydrochloride 1.0â mg/mL and pentoxifylline 20.0â mg/mL, stored at both controlled refrigerated (2-8°C) and room (20-25°C) temperature. METHODS: Compatibility was assessed by measuring the per cent recovery at different time points throughout a 90-day period. Quantification of the APIs was performed by high performance liquid chromatography (HPLC-UV) using a stability-indicating method. RESULTS: Methods were adequately validated. Forced degradation studies showed that at least one parameter influenced the stability of the APIs. All suspensions were assayed and showed API contents of between 90% and 110% over 90â days. DISCUSSION: Given the percentage of recovery of the APIs within the suspensions, the expiration date of the final products (API+vehicle) was found to be at least 90â days for all suspensions, for both controlled refrigerated and room temperature. CONCLUSIONS: The results suggest that SyrSpend SF PH4 liquid is a stable suspending vehicle for compounding APIs from different pharmacological classes.
RESUMEN
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,15.0 mg/mL; (iii) dapsone, 2.0 mg/mL; (iv) phenytoin, 15.0 mg/mL; (v) pyridoxine hydrochloride, 50.0 mg/mL; (vi) sulfadiazine, 100.0 mg/mL; (vii) sulfasalazine, 100.0 mg/mL; (viii) tetracycline hydrochloride, 25.0 mg/mL; (ix) trimethoprim, 10.0 mg/mL; and (x) zonisamide, 10.0 mg/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.