[The long-term chemical stability of injectable drugs reconstituted in Hospital Pharmacy].

Abstract

Background: Other injectable preparations than parenteral nutrition admixture and injectable cytotoxic drugs could be prepared by Centralised IntraVenous Admixture Service (CIVAS) if the Long-term stability of the drugs is known. However, this information is not always available.

Purpose: To develop a program of chemical drug stability analysis in collaboration between Hospital Pharmacy, Medical Laboratory and Scientific Support Unit to determine the long-term stability of largely used injectable anti-infectious and non-anti-infectious drugs.

Material and methods: After a setup of the High Performance Liquid Chromatography (HPLCI method, 28 drugs were reconstituted in laminar air flow hood, 17 of them stored directly at 5 +/- 3 degrees C and 19 stored in the freezer at -20 degrees C, thawed by microwave following a standardised procedure and stored at 5 +/- 3 degrees C before use. Concentration stability was evaluated by regression analysis.

Results: For each drug, long-term stability has varied from 11 days to 180 days. The freeze-thaw treatment by microwave may enhance the stability (from 30 to 120 days) and allow batch-scale production of intravenous drugs, less expensive in term of manpower and sterile device than a drug reconstitution at the ward. The results were published by 55 posters in international congress and by 36 publications in national and international pharmaceutical journals.

Conclusions: Our findings contribute to enhance the scale of drugs that may be take on by a CIVAS.