Storage of Aqueous Solutions for Parenteral Infusion

Rubin, RobertJ.

doi:10.1016/s0140-6736(72)91535-8

Cited by 11 publications

(2 citation statements)

References 3 publications

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“…DEHP, used as a plasticizer in PVC bags. is reported to be practically insoluble in aqueous-based intravenous solutions such as 0.9% saline and 5% dextrose [9]. In the present study, very low levels of DEHP and cyclohexanone were detected in the product.…”

Section: Discussionsupporting

confidence: 40%

Stability assessment of lyophilized intravenous immunoglobulin after reconstitution in glass containersand poly(vinyl chloride) bags

Parti

Mankarious

1997

Biotech and App Biochem

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Human intravenous immunoglobulin (IGIV) has been in use for the past 20 years. This biological product is commonly provided in liquid or lyophilized dosage form. When the lyophilized product is rehydrated, it is usually administered within 2-3 h from time of complete dissolution. While this practice is advisable whenever possible, occasionally the patient or care-giver may need to delay the infusion. Hence, a study of the stability of lyophilized IGIV after reconstitution with water for injection was conducted. The reconstituted product was stored either in its original glass container or pooled into poly(vinyl chloride) (PVC) bags. The effect of extended storage on the active ingredient (IgG), excipients (glucose, albumin) and extractables [sodium from glass vials, and di-(2-ethyl-hexyl) phthalate and cyclohexanone from PVC bags] was evaluated. The stability of the active ingredient was evaluated by physico-chemical tests (molecularsize distribution, pH, appearance, total protein), monitoring titres of a specific antibody (hepatitis B surface antigen) and an antibody functional test (bacterial opsonization). To evaluate the risk of microbial contamination during reconstitution and pooling procedures, sterility, pyrogen and animal-safety tests were included in the protocol. The potential of IgG polymerizing in solution during storage and subsequent complement activation was evaluated by assaying for non-specific binding of complement (anti-complement activity). Results show that aseptically reconstituted IGIV is stable and remains sterile up to 48 h at 5 degrees C. The reconstituted product was also found to be stable at room temperature (25 degrees C) up to 12 h.

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