This Article Full Text Full Text (PDF) An erratum has been published Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Saved Citations Download to citation manager Request Permissions Request Reprints Add to My Marked Citations Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Citing Articles via Scopus Google Scholar Articles by Driscoll, D. F. Articles by Bistrian, B. R. Search for Related Content PubMed PubMed Citation Articles by Driscoll, D. F. Articles by Bistrian, B. R. Social Bookmarking                         What's this?

Physical Stability of 20% Lipid Injectable Emulsions via Simulated Syringe Infusion: Effects of Glass vs Plastic Product Packaging

From the Department of Medicine, Division of Clinical Nutrition and the Nutrition/Infection Laboratory, B. I. Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts

Correspondence: David F. Driscoll, PhD, B. I. Deaconess Medical Center and Harvard Medical School, Baker Building, Suite 605, 185 Pilgrim Road, Boston, MA 02215. Electronic mail may be sent to ddriscol{at}bidmc.harvard.edu.

Background: The United States Pharmacopeia (USP) has proposed large-globule-size limits to ensure the physical stability of lipid injectable emulsions, expressed as the percent fat >5 µm, or PFAT₅, not exceeding 0.05%. Visibly obvious phase separation as free oil has been shown to occur in some samples if PFAT₅ is >0.4%. We recently found that lipids, newly packaged in plastic (P), exceed the proposed USP limits and seem to produce less stable total nutrient admixtures compared with those made from conventional glass (G), which do meet proposed USP standards. We tested the possible stability differences between 20% lipid injectable emulsions in either P or G in a simulated neonatal syringe infusion study. Methods: Eighteen individual syringes were prepared from each 20% lipid injectable emulsion product (n = 36) and attached to a syringe pump set at an infusion rate of 0.5 mL/hour. The starting PFAT₅ levels were measured at time 0 and after 24 hours of infusion, using a laser-based light obscuration technique as described by the USP Chapter <729>. The data were assessed by a 2-way analysis of variance (ANOVA) with Container (G vs P) and Time as the independent variables and PFAT as the dependent variable. Results: At time 0, the starting PFAT₅ level for lipids packaged in G was 0.006% ± 0.001% vs 0.162% ± 0.026% for P, whereas at the end of the infusion they were 0.013% ± 0.003% and 0.328% ± 0.046%, respectively. Significant differences were noted overall between groups for Container, Time, and Container-Time interaction (all p < .001). Bonferroni tests showed significant differences in PFAT₅ levels between Containers at time 0 (T-0; p < .001) and T-0 vs T-24 for P-based lipids (p < .001), whereas no such differences were noted for Time for the G-based lipids. Similar results were noted for PFAT₁₀ levels. Conclusions: We confirm that presently available lipid injectable emulsions packaged in newly introduced plastic containers exceed the proposed USP <729> PFAT₅ limits and subsequently become significantly less stable during a simulated syringe-based infusion. Although modest growth (p = NS) in large-diameter fat globules was observed for the glass-based lipids, they remained within proposed USP globule size limits throughout the study. Glass-based lipids seem to be a more stable dosage form and potentially a safer way to deliver lipids via syringe infusion to critically ill neonates.

Journal of Parenteral and Enteral Nutrition, Vol. 31, No. 2, 148-153 (2007)
DOI: 10.1177/0148607107031002148


CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				G. Hardy and M. Puzovic Formulation, Stability, and Administration of Parenteral Nutrition With New Lipid Emulsions Nutr Clin Pract, October 1, 2009; 24(5): 616 - 625. [Abstract] [Full Text] [PDF]

				D. F. Driscoll Letter to the Editor JPEN J Parenter Enteral Nutr, July 1, 2009; 33(4): 451 - 452. [Full Text] [PDF]

				D. F. Driscoll, A. Thoma, R. Franke, K. Klutsch, J. Nehne, and B. R. Bistrian Lipid globule size in total nutrient admixtures prepared in three-chamber plastic bags Am. J. Health Syst. Pharm., April 1, 2009; 66(7): 649 - 656. [Abstract] [Full Text] [PDF]

				C. Gallegos, P. Partal, and J. M. Franco Droplet-size distribution and stability of lipid injectable emulsions Am. J. Health Syst. Pharm., January 15, 2009; 66(2): 162 - 166. [Abstract] [Full Text] [PDF]

				D. F. Driscoll Globule-size distribution in injectable 20% lipid emulsions: Compliance with USP requirements Am. J. Health Syst. Pharm., October 1, 2007; 64(19): 2032 - 2036. [Abstract] [Full Text] [PDF]

				D. F. Driscoll Safety and Stability of Lipid Emulsions--Response Nutr Clin Pract, June 1, 2007; 22(3): 370 - 372. [Full Text]