Soybean oil, hydrogenated

Chemical properties

White or almost white mass or powder which melts to a clear, pale yellow liquid when heated.

Chemical properties

Hydrogenated vegetable oil is a mixture of triglycerides of fatty acids. The two types that are defined in the USP32–NF27 are characterized by their physical properties.
Hydrogenated vegetable oil type I occurs in various forms, e.g. fine powder, flakes, or pellets. The color of the material depends on the manufacturing process and the form. In general, the material is white to yellowish-white with the powder grades appearing more white-colored than the coarser grades.

The Uses of Soybean oil, hydrogenated

Excipient.

Production Methods

Hydrogenated vegetable oil type I is prepared from refined vegetable oils, which are hydrogenated using a catalyst.

Pharmaceutical Applications

Hydrogenated vegetable oil type I may be used as a lubricant in tablet and capsule formulations. In this application it is used at concentrations of 1–6% w/w, usually in combination with talc, silica or a silicate to prevent sticking to tablet punch faces. It may also be used as an auxiliary binder in tablet formulations.
Hydrogenated vegetable oil type I is additionally used as the matrix-forming material in lipophilic-based controlled-release formulations; it may also be used as a coating aid in controlled-release formulations. It has also been investigated in hydrophobic melt agglomeration.
Other uses of hydrogenated vegetable oil type I include use as a viscosity modifier in the preparation of oil-based liquid and semisolid formulations; in the preparation of suppositories, to reduce the sedimentation of suspended components and to improve the solidification process; and in the formulation of liquid and semisolid fills for hard gelatin capsules.
Fully hydrogenated vegetable oil products may also be used as alternatives to hard waxes in cosmetics and topical pharmaceutical formulations.

Safety

Hydrogenated vegetable oil type I is used in food products and oral pharmaceutical formulations, and is generally regarded as a nontoxic and nonirritant excipient.

Storage

Hydrogenated vegetable oil type I is a stable material; typically it is assigned a 2-year shelf-life.
The bulk material should be stored in a well-closed container in a cool, dry place.

Incompatibilities

Incompatible with strong oxidizing agents.

Regulatory Status

GRAS listed. Included in the FDA Inactive Ingredients Database (oral capsules and tablets; rectal and vaginal suppositories and topical preparations). Included in nonparenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Nonmedicinal Ingredients.