Shelf life reconstituted parenterals

The lyophilized drug nanosuspensions can be transferred to a hnal dry oral dosage form such as tablets or reconstituted prior to administration. Drug nanosuspensions can be directly used as parenteral products. A shelf life of up to three years was shown for selected nanosuspensions. Sterilization can be achieved by aseptic processing of previously sterilized components, membrane filtration for particles sufficiently small or for drugs that can withstand it, steam sterilization, or y-irradiation. 

The shelf life of reconstituted parenterals prepared in the hospital pharmacy is to be determined by the responsible pharmacist (see Sect. 22.6). When Ucensed injection fluids are reconstituted and prepared for individual patients the shelf life is determined by evaluation of the physico-chemical stability and risk of microbiological contamination. Shelf life depends from a microbiological viewpoint on the risks associated with aseptic preparation and the results of validation studies performed under the pharmacy s specified aseptic preparation cmiditions (see Sect. 31.3.6). 

Administer medicines (RTAs). Reconstitution of parenterals is not always described in the Summary of Product Characteristics (SmPC) and Package Information Leaflet (PIL). If so this process may be called reconstitution in excess of the SmPC (see Fig. 1.2). If this is considered to be a variance from the SPmC, it results legally in off-label use and should be supported by evidence, e.g. an appropriate risk assessment including the benefits and evidence about compatibility and a possible longer shelf life (see Sect. 22.6). 

Reconstituted parenteral medicines often have a short shelf life and have to be administered immediately. The shelf life of some sensitive infusion solutions can be prolonged when they are stored under cool conditions and... 

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