Physico-chemical analysis of several injectable drug in ready-to-use infusion after microwave freeze-thaw treatment and final storage at 5 ± 3 °C

Ann Pharm Fr. 2011 Sep;69(5):270-6. doi: 10.1016/j.pharma.2011.08.001. Epub 2011 Sep 3.

Abstract

Objective: In hospitals, the majority of the reconstitution of injectable drugs are carried out right before the administration to the patient by the nursing staff. The risks and errors related on their preparation and administration are numerous. The standardization, the centralization of these preparations and reconstitution by the hospital pharmacy make it possible to reduce the various risks and errors To enhance the number of drugs taken in charge, it is necessary to develop the long-term stability of ready-to-use drugs. Freezing seems an easy method but defrosting takes too much time. Some authors develop the concept of microwave treatment and apply this to different drugs. A characteristic of these studies was nevertheless the short period of study after thawing.

Methods: Long-term stability studies were started for different drugs mainly used in the hospital, and verify their stability after freezing at temperature<- 25°C, long-term storage (1 to 4 months), microwave-thawing and long-term storage at 5 ± 3°C.

Results: Sixteen molecules were tested and preserve more than 90% of their initial concentration the day of defrosting by microwave oven like this value a certain number of days at 5 ± 3°C. All the analyses were carried out by HPLC.

Conclusion: The microwave freeze/thawing treatment allows the production of more important batches, makes profit of this technique in workload and material beyond a certain produced quantity. The described results encourage to check the possibilities of taking in charge other molecules regularly used in the Hospital Institutions.

MeSH terms

  • Chromatography, High Pressure Liquid
  • Drug Compounding / methods*
  • Drug Stability*
  • Drug Storage
  • Freezing
  • Infusions, Intravenous
  • Pharmaceutical Preparations / chemistry*
  • Pharmaceutical Solutions
  • Pharmacy Service, Hospital

Substances

  • Pharmaceutical Preparations
  • Pharmaceutical Solutions