STABILITY OF A TRIPLE-SOLUTION CONTAINING ROPIVACAINE, KETOROLAC AND EPINEPHRINE
J. Nejatbakhsh, B. Madsen, H. Jespersen and B. Sønniksen.
The Pharmacy Department at Aarhus University Hospital, Denmark
Background: The ambition for The Pharmacy Department at Aarhus University Hospital is to provide drugs that are as ready to use as possible, to minimize errors and enhancing drug safety for patients and to quality assure the handling of drugs. The Department of Orthopaedic Surgery uses a triple-solution containing ropivacaine, ketorolac and epinephrine for local and intraarticular infiltration. The clinical staff on the ward used to prepare the solution. In accordance with the ambition the Pharmacy is now producing the triple-solution. This is made possible by cooperation between The Acute Pain Service, the departments for Clinical Pharmacy, Quality Assurance and the Production Unit at the Pharmacy.
Methods: The triple-solution was quantitative measured for ropivacaine, ketorolac and epinephrine by reverse phase high-performance liquid chromatography (HPLC). Furthermore, pH value was measured, particle content was tested and the Container Closure Integrity Test was performed.
Results: The concentration of ropivacaine, ketorolac and epinephrine decreased respectively 1%, 2% and 10% during storage at 4°C for 20 days and 48 hours at 22°C. None of the tested batches contain less than 90% of the declared content of the three
components.
Conclusion: The triple-solution remained stable during 20 days at 2-8 °C, followed by 48 hours of storage below 25 °C. The Pharmacy now has a regular delivery of the triple-solution to several departments at the hospital.
Reference: 13th EAHP Congress, Maastricht, the Netherlands, 27-29 February 2008
21 setembro 2008
Estabilidade de medicamentos citostáticos
CYTOSTATIC DRUGS PREDILUTED IN NORMAL SALINE IN POLYPROPYLENE INFUSION BAGS FLEBOFLEX®. STABILITY AT SEVERAL STORAGE CONDITIONS.
S. Jané, J. Menéndez, J. Girbau, A. Clopés*, C. Muñoz*, S. Narváez*
Pharmaceutical Technology Department, Laboratorios Grifols & *Servei de Farmàcia del Institut Català d’Oncologia-Hospital Duran i Reynals, Barcelona, Spain
Background: Many cytostatic drugs must be prediluted, before intravenous administration, in an isotonic solution. Normal saline in polypropylene bags is a good option because of its weight when compared to glass and inertness in relation to PVC
Methods: Three Cytostatic drugs, Docetaxel, Doxorubicin•HCl and Cyclophosphamide were prediluted in normal saline solutions at concentrations usually prepared in hospital pharmacy. Glass bottles, polypropylene and pvc bags all of 100ml were used. Docetaxel was not prepared in pvc. They were stored at 5°C and 25°C and controlled up to 7 days for docetaxel, 10 days for Cyclophosphamide and 30 days for doxorubicin•HCl. According to USP monographs when available, colour, turbidity, assay, related compounds and pH were controlled at several intervals for all the drugs. Assay was assessed with HPLC-UV. For PVC bags DEHP content was controlled at the
end of stability.
Results: Docetaxel solutions were stable along the study, Doxorubicin•HCl 30 days at 5°C and 15 days at 25°C, and Cyclophosphamide 6 days at 5°C and 5 days at 25°C.
No DEHP was found in solutions in PVC bags.
Conclusions: Normal saline in polypropylene bags is suitable to prepare stable solutions of Docetaxel, Cyclophosphamide and Doxorubicin•HCl. The physicochemical stability depends on the storage temperature.
Reference: 13th EAHP Congress, Maastricht, the Netherlands, 27-29 February 2008
S. Jané, J. Menéndez, J. Girbau, A. Clopés*, C. Muñoz*, S. Narváez*
Pharmaceutical Technology Department, Laboratorios Grifols & *Servei de Farmàcia del Institut Català d’Oncologia-Hospital Duran i Reynals, Barcelona, Spain
Background: Many cytostatic drugs must be prediluted, before intravenous administration, in an isotonic solution. Normal saline in polypropylene bags is a good option because of its weight when compared to glass and inertness in relation to PVC
Methods: Three Cytostatic drugs, Docetaxel, Doxorubicin•HCl and Cyclophosphamide were prediluted in normal saline solutions at concentrations usually prepared in hospital pharmacy. Glass bottles, polypropylene and pvc bags all of 100ml were used. Docetaxel was not prepared in pvc. They were stored at 5°C and 25°C and controlled up to 7 days for docetaxel, 10 days for Cyclophosphamide and 30 days for doxorubicin•HCl. According to USP monographs when available, colour, turbidity, assay, related compounds and pH were controlled at several intervals for all the drugs. Assay was assessed with HPLC-UV. For PVC bags DEHP content was controlled at the
end of stability.
Results: Docetaxel solutions were stable along the study, Doxorubicin•HCl 30 days at 5°C and 15 days at 25°C, and Cyclophosphamide 6 days at 5°C and 5 days at 25°C.
No DEHP was found in solutions in PVC bags.
Conclusions: Normal saline in polypropylene bags is suitable to prepare stable solutions of Docetaxel, Cyclophosphamide and Doxorubicin•HCl. The physicochemical stability depends on the storage temperature.
Reference: 13th EAHP Congress, Maastricht, the Netherlands, 27-29 February 2008
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