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