INTRALIPID- soybean oil emulsion
Baxter Healthcare Corporation
Intralipid® 20%
A 20% I.V. Fat Emulsion In Excel® Container
DESCRIPTION
Intralipid® 20% (A 20% I.V. Fat Emulsion) Pharmacy Bulk Package is a sterile, non-pyrogenic fat emulsion intended as a source of calories and essential fatty acids for use in a pharmacy admixture program. It is made up of 20% Soybean Oil, 1.2% Egg Yolk Phospholipids, 2.25% Glycerin, and Water for Injection. In addition, sodium hydroxide has been added to adjust the pH so that the final product pH is 8. pH range is 6 to 8.9.
Intralipid® 20% Pharmacy Bulk Package is not intended for direct infusion. It is a sterile dosage form which contains several single doses for use in the preparation of three-in-one or total nutrient admixtures (TNAs) in a pharmacy admixture program.
The soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure:
structure
where r1c r2c r3c are saturated and unsaturated fatty acid residues.
The major component fatty acids are linoleic (44-62%), oleic (19-30%), palmitic (7-14%), linolenic (4-11%) and stearic (1.4-5.5%)1. These fatty acids have the following chemical and structural formulas:
Linoleic acid
C18H32O2 structure
Oleic acid
C18H34O2 structure
Palmitic acid
C16H32O2 structure
Linolenic acid
C18H30O2 structure
Stearic acid
C18H36O2 structure
Purified egg phosphatides are a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure:
structure
structure contain saturated and unsaturated fatty acids that abound in neutral fats. R3 is primarily either the choline or ethanolamine ester of phosphoric acid.
figure
Phosphatidylcholine Phosphatidylethanolamine
Glycerin is chemically designated C3H8O3and is a clear colorless, hygroscopic syrupy liquid. It has the following structural formula:
stuct
Intralipid® 20% (A 20% I.V. Fat Emulsion) has an osmolality of approximately 350 mOsmol/kg water (which represents 260 mOsmol/liter of emulsion) and contains emulsified fat particles of approximately 0.5 micron size.
The total caloric value, including fat, phospholipid and glycerin, is 2.0 kcal per mL of Intralipid® 20%. The phospholipids present contribute 47 milligrams or approximately 1.5 mmol of phosphorus per 100 mL of the emulsion.
The primary container is manufactured from Excel® film, a polypropylene based material comprised of three co-extruded layers.
The plastic container is made from multilayered film specifically designed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.
CLINICAL PHARMACOLOGY
Intralipid&re |
