Soybean oil, hydrogenated

Химические свойства

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

Использование

Excipient.

Методы производства

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

Фармацевтические приложения

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.

Безопасность

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

хранилище

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.

Несовместимости

Incompatible with strong oxidizing agents.

Регуляторный статус

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.