INTRALIPID® 10% (10% i.v fat emulsion) (A 10% INTRAVENOUS FAT EMULSION) IS A STERILE, NON-PYROGENIC FAT EMULSION PREPARED FOR INTRAVENOUS ADMINISTRATION AS A SOURCE OF CALORIES AND ESSENTIAL FATTY ACIDS. IT IS MADE UP OF 10% 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.

THE SOYBEAN OIL IS A REFINED NATURAL PRODUCT CONSISTING OF A MIXTURE OF NEUTRAL TRIGLYCERIDES OF PREDOMINANTLY UNSATURATED FATTY ACIDS WITH THE FOLLOWING STRUCTURE:

- 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:

PURIFIED EGG PHOSPHATIDES ARE A MIXTURE OF NATURALLY OCCURRING PHOSPHOLIPIDS WHICH ARE ISOLATED FROM THE EGG YOLK. THESE PHOSPHOLIPIDS HAVE THE FOLLOWING GENERAL STRUCTURE:

-CONTAIN SATURATED AND UNSATURATED FATTY ACIDS THAT ABOUND IN NEUTRAL FATS. R3 PRIMARILY EITHER THE CHOLINE OR THE ETHANOLAMINE ESTER OF PHOSPHORIC ACID.

GLYCERIN IS CHEMICALLY DESIGNATED C3H8O3 AND IS A CLEAR COLORLESS, HYGROSCOPIC SYRUPY LIQUID. IT HAS THE FOLLOWING STRUCTURAL FORMULA:

INTRALIPID® 10% (10% i.v fat emulsion) (A 10% INTRAVENOUS FAT EMULSION) HAS AN OSMOLALITY OF APPROXIMATELY 300 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 1.1 KCAL PER ML OF INTRALIPID 10% (10% i.v fat emulsion) . 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.

1. PADLEY FB: “MAJOR VEGETABLE FATS,“ THE LIPID HANDBOOK (GUNSTONE FD, HARWOOD JL, PADLEY FB, EDS.), CHAPMAN AND HALL LTD., CAMBRIDGE, UK (1986), PP. 88-9.

Last reviewed on RxList: 7/30/2007
This monograph has been modified to include the generic and brand name in many instances.