Bot Detector
Download FREE Sample Issue or Article
Subscribe Today
A subscription to IJPC includes a print copy delivered by postal mail and on-line access to electronic PDF copies of your subscribed issues.

Zinc Content of Commercial Diluents Widely Use in Drug Admixtures Prepared for Intravenous Infusion

Author(s):  Desai Narendra R, Shah Syed M, Koczone Julianna, Vencl-Joncic Maja, Sisto Christopher, Ludwig Stephen A

Issue:  Sep/Oct 2007 - Veterinary Compounding
View All Articles in Issue

Abstract:  During ongoing quality improvement efforts with two Wyeth parenteral products, Protonix and Zosyn, we noted that dosing solutions prepared from the products yielded inconsistent results on the United States Pharmacopeia Chapter <788> test for subvisible particulates. This manuscript discusses variables that have a direct impact on intravenous products meeting compendial monograph specifications under conditions that are encountered in the clinical setting. The rubber stoppers of vials used for parenteral products, different parts of commercial admixture bags, and the tubing of the administration sets and devices contain residual amounts of metal ions, plasticizers, and other additives incorporated for specific functions. The transition metal ions, including zinc and copper, may leach into drug products during manufacture and during storage of dosing admixture bags prepared for infusion in hospital pharmacies or clinics. The metal ions may compromise the quality of the infusion admixture through catalytic drug degradation and/or generation of undesirable metal ion complexes, which may convert soluble drug molecules into insoluble particulates. To preserve the quality of the drug product, it is essential that metal ion leachables be controlled proactively during manufacture of the drug product; knowledge of metal ion contents in the commercial diluents used for reconstitution, admixture preparation, and flushing of the administration lines is also critical.

Related Keywords: Narendra R. Desai, PhD, Syed M. Shah, PhD, Juliana Koczone, Doctor in Pharmacy, Maja Vencl-Joncic, BS, Christopher Sisto, MS, Stephen A. Ludwig, PhD, drug admixtures, drug combinations, zinc contaminants, contamination, injectables, parenteral administration, intravenous administration, IV bags, PVC, polymers, polyvinylchloride, polyethylene, polypropylene, plasticizers, leaching, metal ion complexes, commercial diluents, compatibility


Printer-Friendly Version

Download in electronic PDF format for $35

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/Buy
Zinc Content of Commercial Diluents Widely Use in Drug Admixtures Prepared for Intravenous Infusion Desai Narendra R, Shah Syed M, Koczone Julianna, Vencl-Joncic Maja, Sisto Christopher, Ludwig Stephen A Sep/Oct 2007 426-432 Buy
A Review of Parenteral Admixtures Requiring Select Containers and Administration Sets Rice Stephen P Mar/Apr 2002 120-122 Buy
Physico-chemical Stability of MabThera Drug-product Solution for Subcutaneous Injection under In-use Conditions with Different Administration Materials Mueller Claudia, Dietel Elde, Heynen Severin R, Nalenz Heiko, Goldbach Pierre, Mahler Hanns-Christian, Schmidt Johannes, Grauschopf Ulla, Schoenhammer Karin May/Jun 2015 261-267 Buy
Use of a Closed-system Drug Transfer Device (PhaSeal) and Impact on Preparation Time Sanchez-Rubio Ferrandez J, Lozano M C, Iglesias I, Sanchez-Rubio Ferrandez L, Rodriguez Vargas B, Moreno Diaz R Sep/Oct 2012 431-433 Buy
PreScription: 2017 Pharmacy Compounding Issues: The U.S. Food and Drug Administration, Harzardous Drugs, and Wasted Drugs Allen Loyd V Jr Sep/Oct 2017 356 Buy
Discrepancies in the Law and the U.S. Food and Drug Administration Pharmacy Compounding Compliance Policy Guidelines Allen Loyd V Jr Jul/Aug 2016 351 View Sample
Rapid-Dissolve Technology: An Interview With Loyd V. Allen, Jr., PhD, RPh Allen Loyd V Jr Nov/Dec 2003 449-450 Buy
Does Your Drug Expertise Include Clinical Pharmaceutics? Newton David W May/Jun 2016 202-206 Buy
Basics of Sterile Compounding: Clinical Hazards of Injectable Drug Administration Akers Michael J May/Jun 2016 217-222 Buy
Intravenous Admixture Preparation Considerations, Part 2: Incompatibilities and Factors Involved Allen Loyd V Jr Jan/Feb 2020 44-50 Buy