Vegetable oil, hydrogenated

• JPHydrogenated Oil
• USP–NFHydrogenated Vegetable Oil

Hydrogenated cottonseed oil; hydrogenated palm oil; hydrogenated soybean oil; hydrogenated oil; Lubritab; Sterotex

Mixture of triglycerides of fatty acids obtained by hydrogenating refined vegetable oils · [—]

Polymer, mixture or material of variable composition — no single molecular formula applies.

Lubricant

Typical concentrations: 1–6% lubricant · Dosage forms: Solid

Used as a tablet and capsule lubricant, typically at about 1–6% w/w, and as a matrix-forming agent or hot-melt coating in sustained-release and taste-masked products. It is also used as a viscosity modifier and stiffening agent in ointments, creams and suppository bases, and to thicken oily liquids in soft capsule fills.

Type I material is a white to yellowish-white, waxy fine powder, flakes or pellets with a bland taste and little odour. It consists mainly of triglycerides of saturated C16–C18 fatty acids (palmitic and stearic acids), produced by hydrogenating refined oils such as cottonseed, soybean or palm oil.

Type

USP-NF Type I: hard, high-melting fats used in pharmaceuticals; Type II: softer, lower-melting materials

Melting range

Type I melts roughly between 60 and 85 °C, depending on the source oil

Iodine value

very low for Type I (not more than about 5), showing near-complete saturation

Solubility

practically insoluble in water; soluble in chloroform, light petroleum and hot propan-2-ol

Physical form

fine white powder, flakes or pellets

Stable, and much more resistant to oxidation than the parent oils. Polymorphic transitions can occur on storage after melting, which may change the release from melt-processed products. Store in a well-closed container in a cool, dry place.

Incompatible with strong oxidising agents.

Refined vegetable oil is hydrogenated with hydrogen gas over a nickel catalyst; the catalyst is removed, and the product is bleached, deodorised and then spray-chilled, flaked or milled.

Used in foods and oral pharmaceutical products and generally regarded as non-toxic and non-irritant. Fully hydrogenated fats contain little trans fat, unlike partially hydrogenated oils.

Observe normal precautions for the quantity handled. Avoid generating dust; eye protection and gloves are recommended.

Included in the FDA Inactive Ingredient Database (oral capsules and tablets, and other preparations) and in non-parenteral medicines licensed in Europe.

Hydrogenated castor oil; hydrogenated cottonseed oil; hydrogenated palm oil; hydrogenated soybean oil; glyceryl behenate; glyceryl palmitostearate.

Hydrogenated vegetable oil is a less hydrophobic alternative to magnesium stearate and is less sensitive to over-blending, but higher concentrations are usually needed. When used as a release-controlling matrix, curing or tempering may be needed to stabilise the crystal form.