Liposyn II

DESCRIPTION

Liposyn II (Intravenous Fat Emulsion) is a sterile, nonpyrogenic fat emulsion for intravenous administration. It is supplied in both a 10% and 20% concentration.

Liposyn II 10% contains 5% safflower oil, 5% soybean oil, up to 1.2% egg phosphatides added as an emulsifier and 2.5% glycerin in water for injection. May contain sodium hydroxide for pH adjustment. pH 8.0 (6.0 9.0). Liposyn II 10% has an osmolarity of 276 mOsmol/liter (actual). The total caloric value of Liposyn II 10% including fat, phospholipid and glycerol is 1.1 kcal/mL. Of this total, approximately 0.6 kcal/mL is supplied by linoleic acid.

Liposyn II 20% contains 10% safflower oil, 10% soybean oil, 1.2% egg phosphatides and 2.5% glycerin in water for injection. May contain sodium hydroxide for pH adjustment, pH 8.3 (6.0 - 9.0). Liposyn II 20% has an osmolarity of 258 mOsmol/liter (actual). The total caloric value of Liposyn II 20% including fat, phospholipid and glycerol is 2.0 kcal/mL. Of this total, approximately 1.2 kcal/mL are supplied by linoleic acid.

Both Liposyn II 10% and Liposyn II 20% contain emulsified fat particles of approximately 0.4 micron in diameter, similar to naturally occurring chylomicrons.

Safflower oil and Soybean Oil, USP are mixtures of neutral triglycerides.

R₁C-, R₂C- and R₃C- are saturated and unsaturated fatty acid residues. The major component fatty acids of the 50/50 safflower/soybean oil mixture are approximately 65.8% linoleic, 17.7% oleic, 8.8% palmitic, 3.4% stearic, and 4.2% linolenic acid. These fatty acids have the following chemical formulas:

Egg phosphatides, purified, are primarily a mixture of naturally occurring phospholipids which are isolated from the egg yolk.

R₁C- and R₂C- are the same saturated and unsaturated fatty acid residues that abound in neutral fats. R₃ is primarily either the choline (HOCH₂CH₂CH₃)₃ ester or ethanolamine (HOCH₂CH₂NH₂) ester of phosphoric acid (H₃PO₄).

Glycerin, USP is chemically designated C₃H₈O₃ and is a clear colorless, hygroscopic syrupy liquid.

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