Storage reconstituted parenterals

This section at first deals with examples of a different storage temperature and secondly with the extension of shelf lives for reconstituted parenteral solutions. 

PARENTERAL ADMINISTRATION. The nurse should read the manufacturer s package insert for each drug for instructions regarding reconstitution of powder for injection, storage of unused portions, life of the drug after it is reconstituted, methods of IV administration, and precautions to be taken when the drug is administered. 

For parenteral products specific consideration needs to be included for tonicity adjustment, emulsion globule size, ease of resuspension and sedimentation rate, particle size and particle size distribution, viscosity and syringeability, and crystal form changes. Full consideration should be included of the proposed instructions for dilution or reconstitution of products and of compatibility with the proposed solvents or diluents. This should include a demonstration that the proposed storage temperature and extremes of concentration are suitable. 

Small Volume Parenterals (SVP) Appearance, color, clarity (particulates), pH, and sterility checks at reasonable intervals are minimum standards. Powders for reconstitution should also include residual moisture and stability checks after reconstitution. Except for ampules, upright and inverted storage of final product should also be evaluated. 

Product knowledge implies an understanding of how the product is produced and the consequences for use and storage. In other words the physico-chemical properties such as storage temperature and compatibility with bulk parenterals and infusion tubing. It may also mean awareness of possibly unwanted excipients, e.g. ethanol. Product knowledge and instmctions for the patient are always needed, reconstitution and manipulation prior to use or administration only for particular (groups of) patients or particular medicines. 

Many new active substances are proteins or peptides, which can only be administered parenterally. Proteins and peptides are often unstable, and therefore need extra care in reconstitution, storage and transport. Most protein medicines have to be kept refrigerated (2-8 °C). Storage at too high temperatures will soon cause loss in biological activity. Temperatures below zero give even more risk of breaking up the protein structure. See also Sects. 22.2.5 and 18.4.1. 

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