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Vegetable Oil Hydrogenated Excipient | Uses, Suppliers, and Specifications

Hydrogenated Vegetal Oil (HVO) is a generic term for several solid lipids approved for use in the pharmaceutical industry as excipients. They typically consist of mixtures of triglycerides of fatty acids that have been transformed through partial or complete hydrogenation into high melting point fats. The commonest HVOs are Hydrogenated Soybean oil; Hydrogenated Palm oil, and Hydronated Cottonseed oil. They are available as fine powders, flakes, or pellets.

Pharmacopoeial Compliance: USP-NF; Ph.Eur; B.P; J.P; I.P

Synonyms and Trade Names: Hydrogenated Vegetable Oil; Hydrogenated Oil; Vegetable Oil, Hydrogenated; Hydrogenated Cottonseed Oil; Hydrogenated Palm Oil; Hydrogenated Soybean Oil; Akofine; Lubritab®; Sterntex®; Softisan® 154; Lipavol H5 C; Sterotex HM

Uses and Applications: Tablet and Capsule Lubricant; Tablet Binder; Hot Melt Extrusion Excipient

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Softisan® 154 - IOI Oleo GmbH

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Lubritab® - JRS Pharma

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Sterotex HM - Abitec Corporation

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Description

Hydrogenated Vegetable Oil is a term used to describe solid fats obtained from different edible oils extracted from plants, such as olives, sunflowers, and soybeans. They comprise different triglycerides of fatty acids. Hydrogenation is used to alter the texture, stability, and extend the shelf life of the final oil, and involves the partial or complete addition of hydrogen atoms (reducing the number of double bonds) into the lipid molecules.

In the pharmacopoeia, two different types of Hydrogenated vegetable oils are defined on the basis of their melting point and iodine value:

Type I Hydrogenated vegetable oils have a higher melting point and lower iodine value, and occur in various forms, e.g. fine powder, flakes, or pellets. The colour of the material depends on noted the manufacturing process and the form. In general, the material is white to yellowish-white with the powder grades appearing more white-coloured than the coarser grades.

Type II Hydrogenated vegetable oil includes partially hydrogenated vegetable oils from different sources that have a wide range of applications. In general, type II materials have lower melting ranges and higher iodine values than type I materials. Many type II materials are prepared to meet specific customer requirements for use in cosmetics and occasionally, topical pharmaceutical products.

Chemical Structure & Identifiers


CAS Registry Number [8016-70-4] (Hydrogenated Soybean Oil)

[68334-00-9] (Hydrogenated Cotton Seed Oil)

[68514-74-9] (Hydrogenated Palm Oil)

Empirical Formula R1COOCH,—CH(OOCR2)—CH2OOCR1

where R1, R2, and R3 are mainly C15 and C17

Molecular Weight (average) 282.5 g/mol
EINECS/EC Number 232-410-2 (Hydrogenated Soybean Oil)

269-804-9 (Hydrogenated Cotton Seed Oil)

271-056-3 (Hydrogenated Palm Oil)

UNII Code (FDA)
A2M91M918C (Hydrogenated Soybean Oil)
Z82Y2C65EA (Hydrogenated Cottonseed Oil)
257THB963H (Hydrogenated Palm Oil)

Regulatory Status

Hydrogenated vegetable oils are approved for use as pharmaceutical excipients and food ingredients. They are also US FDA GRAS listed. They are also included in the US FDA Inactive Ingredients Database [covering oral tablets and capsules, suppositories and topical products). Hydrogenated vegetable oil (Type I) is suitable for use in oral pharmaceutical and food products and, and is generally regarded as a nontoxic and non-irritant material.

Physicochemical Properties

Form Solid, powder
Appearance White to yellowish-white fine powder, flakes or pellets
Density (tapped) 0.57g/ml (Lubritab)
Melting point 61-66C (Lubritab)
Particle size distribution 85% < 177 µm, 25% < 74 µm in size (Lubritab)
Solubility Practically insoluble in water. Soluble in chloroform, petroleum spirit and hot isopropanol

Pharmacopeoeal Specifications

  BP JP USP-NF USP-NF
      Type 1 Type 2
Official name Hydrogenated Vegetable Oil Hydrogenated Vegetable Oil Hydrogenated Vegetable Oil Hydrogenated Vegetable Oil
Authorised uses Excipient Excipient Excipient Excipient
Definition specified specified specified specified
Identification specified n/a n/a n/a
Characters specified specified n/a n/a
Melting range 57.70oC 57-85oC 20-50oC
Heavy metals specified specified ≤0.001% ≤0.001%
Moisture and coloration n/a specified n/a n/a
Alkali n/a specified n/a n/a
Chloride n/a specified n/a n/a
Nickel n/a specified n/a n/a
Iodine value ≤5 n/a 0-5 55-80
Saponification value 175-205 n/a 175-200 175-200
Loss on drying ≤0.1% n/a ≤0.1% ≤0.1%
Acid value ≤4.0 ≤2.0 ≤4.0 ≤4.0
Unsaponifiable matter ≤0.8% n/a ≤0.8% ≤0.8%
Residue on ignition n/a ≤0.1% n/a n/a
Assay n/a n/a n/a n/a
Labelling n/a n/a specified specified

Key: n/a Specification is not listed

*All claims with respect to conformity are subject to our Terms and Conditions. No express or implied warranty is made for specific properties or fitness for any particular application or purpose.

Applications in Pharmaceutical Formulations or Technology

Hydrogenated vegetable oils are versatile materials that can be used as tablet and capsule lubricants, tablet binders (matrix formers) and suppository bases.

Type I Hydrogenated vegetable oil can be used as a lubricant in tablet and capsule formulations. For this application, they are added at concentrations of 1-6% w/w, typically in conjunction with Talc, Silica or other Silicate-based material to prevent sticking onto tablet machine tooling. It has reportedly been used as a secondary binder in tablet formulations.

Type 1 Hydrogenated vegetable oil is also suitable for use as a matrix-forming excipient in lipophilic-based controlled-release formulations and as a coating material for controlled-release formulations.

Additional uses of Type 1 Hydrogenated vegetable oil include:

  • Viscosity modifiers in the formulation of oil-based liquid and semisolid formulations
  • Adjunct ingredients in the preparation of suppositories, for instance, to mitigate sedimentation of suspended ingredients components and enhance the solidification process
  • Aids in the development of liquid and semisolid fills for hard gelatin capsules.

Due to their hardness, narrow melting point range and softening as well as their stability against oxidation, Hydrogenated vegetable oils are especially suitable as ingredients in the development of all types of cosmetic and pharmaceutical sticks (eyebrow pencils, lining pencils, lipsticks, grease sticks) for compact and liquid make-up preparations, greasy make-ups, mascaras, lip-gloss preparations, foundations, eyeliners etc.

Fully Hydrogenated vegetable oil grades can also be used to replace hard waxes in cosmetics and topical pharmaceutical products.

Safety and Precautions

Hydrogenated vegetable oils are approved pharmaceutical excipients and are also GRAS listed. They are generally regarded as non-toxic and non-irritant excipients and included in the US FDA Inactive Ingredients Database (covering oral tablets and capsules, and topical products). Type 1 Hydrogenated vegetable oils are suitable for use in food products.

There is a large body of evidence that indicates that consumption of Hydrogenated vegetable oils (commonly known as trans fatty acids) increases the risk of cardiovascular diseases. Health authorities now advise limiting their intake as much as possible. When added to products, labelling guidelines require identification of the per cent of energy from trans fats.

Stability and Storage Conditions

Hydrogenated vegetable oil is a stable excipient. Products from different manufacturers may vary in their characteristics owing to differences in the source of the vegetable oil used for hydrogenation. Certain materials are made from mixed hydrogenated oils, e.g. |Hydrogenated soybean oil and Hydrogenated castor oil. However, Type 1 is assigned a 24-month shelf-life. The bulk material should be stored in a well-closed container in a cool, dry place and away from direct sources of heat or light.

When handling the bulk material, workers should observe standard SHEQ precautions appropriate to the circumstances and quantity of material being processed. The wearing of suitable gloves, eye protection, and a dust mask is recommended when handling the material.

Sustainability and Environmental Impact

A sustainability assessment of Hydrogenated vegetable oil has not been undertaken.

Manufacturers & Suppliers

IOI Oleo GmbH

  • Softisan® 154 (Hydrogenated Palm Oil)

JRS Pharma

  • Lubritab® (Hydrogenated Cottonseed Oil)

Abitec Corporation

  • Sterotex® HM (Hydrogenated Soybean Oil)

Additional Resources (Downloads)

References and Literature Used

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