PARSAFE: computer program for safety assessment and optimization of parenteral nutrition formulations based on chemical speciation analysis

Abstract

Instability arising from the formation of precipitates and lipid emulsion aggregates is common in parenteral nutrition formulations due to the concentration- and pH-dependent incompatibility of some of the vital ingredients. Previously, the boundaries between stability and instability could only be established through the use of laborious and expensive empirical methods. The predictive technique with the concept of chemical speciation (based on the analysis of many competitive thermodynamic equilibriums) has been adapted for use with parenteral fluids so that these detrimental events may now be avoided. A comprehensive computer program, PARSAFE ((C) 1991. Sponsors interested in this program should contact D.R.W.) has been developed for this purpose. PARSAFE encompasses chemical-speciation techniques and contains a large data base of commonly used intravenous fluid constituents together with the appropriate thermodynamic equilibrium constants describing their interactions so that stability prediction may be readily achieved in hospital pharmacy laboratories. We review the relevant physical chemistry required for the successful implementation of PARSAFE and outline the audit trails involved in the development of the predictive model.