Introducing Medisca Nutraceuticals

Download in electronic PDF format for $25



Search the Complete Journal Archives

Physical Assessments of Lipid Injectable Emulsions via Microscopy: A Comparison to Methods Proposed in the United States Pharmacopeia Chapter <729>

Author(s):  Driscoll David F, Nehne Jorg, Horst Peterss, Klutsch Karsten, Bistrian Bruce R, Wilhelm Niemann

Issue:  Jul/Aug 2006 - Sterile Preparations
View All Articles in Issue

Abstract:  In confirming the stability of lipid injectable emulsions, the United States Pharmacopeia has recently recommended that light scattering be used to determine the mean droplet size (i.e., fineness of the dispersion), and light obscuration or light extinction be used to quantify the extent of the large-diameter tail (i.e., coarseness of the dispersion). In confirming the results obtained by these two methods, the usefulness of a third method, differential interference contrast microscopy using an oil immersion technique was investigated. The physical stabilities of 95 different formulations made from 20% w/v lipid emulsions were evaluated by all three methods. A wide spectrum of globule-size distributions was investigated, measured by light obscuration and expressed as the volumeweighted percent of fat greater than 5 micrometers (PFAT5) from very fine (0.001%) to very coarse (0.596%) formulations. The responses obtained by the light scattering method did not reflect the values for the large-diameter tail (i.e., coalescence) seen with the less stable emulsions, whereas these differences were detectable using the differential interference contrast microscopy technique. It was concluded that differential interference contrast microscopy provides complementary data about the physical stability of lipid injectable emulsions and can be applied as a confirmatory evaluation to the methods proposed in United States Pharmacopeia Chapter <729>.

Related Keywords: David F. Driscoll, PhD, Jorg Nehne, PhD, Horst Peterss, Karsten Klutsch, PhD, Bruce R. Bistrian, MD, PhD, Wilhelm Niemann, PhD, lipid inectable emulsions, stability, droplet size, quality control, photon correlation spectroscopy, dynamic light scattering, light obscuration, light exteniction, microscopy, parenteral nutrition

Related Categories: NUTRITION AND NUTRICEUTICALS, PARENTERALS, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

Printer-Friendly Version

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/Buy
Physical Assessments of Lipid Injectable Emulsions via Microscopy: A Comparison to Methods Proposed in the United States Pharmacopeia Chapter <729> Driscoll David F, Nehne Jorg, Horst Peterss, Klutsch Karsten, Bistrian Bruce R, Wilhelm Niemann Jul/Aug 2006 309-315 Buy
Rapid-Dissolve Technology: An Interview With Loyd V. Allen, Jr., PhD, RPh Allen Loyd V Jr Nov/Dec 2003 449-450 Buy
The Basics of Compounding Emulsions, Part 2 Allen Loyd V Jr May/Jun 2001 198 Buy
Particle Size Distribution of Propofol Injection from Ampules and Vials: The Benefits of Filitration Driscoll David F, Deaconess Beth Israel, Lawrence Kenneth R, Lewis Keith, Bistrian Bruce R Mar/Apr 1997 118-120 View Sample
Evaluation of a Simple Method for Visual Detection of Microprecipitates in Blends of Parenteral Drug Solutions Using a Focussed (Tyndall) Light Beam Veggeland Turid, Brandl Martin Jan/Feb 2010 78-81 Buy
Effect of Penetration Enhancers on the Percutaneous Delivery of Pain Management Actives Trimble John, Light Bob May/Jun 2016 250-256 Buy
Quality-Control Analytical Methods: Specific-Gravity Determinations of Liquids and Semisolids Allen Loyd V Jr Nov/Dec 2003 477 Buy
Quality-Control Analytical Methods: Glossary of Quality Control/Quality Assurance Terms in Pharmaceutical Compounding Kupiec Thomas C, Okeke Claudia, Allen Loyd V Jr, Denison Clay Jul/Aug 2005 300-302 Buy
Quality-Control Analytical Methods: Homogeneity of Dosing Forms Kupiec Thomas C, Vu Nicole, Branscum David Jul/Aug 2008 340-343 Buy
Quality-Control Analytical Methods: Designing a Quality-Control Potency Testing Program for a Compounding Pharmacy Zolner William J Sep/Oct 2009 412-418 Buy