Why the WITEPSOL® brand is used as a synonym for hard fat

IOI Oleo GmbH is well known as one of the leading European manufacturers of oleochemical specialties. The team in the Pharma Business Unit has made a name for itself throughout the world with the most diverse products under the WITEPSOL® brand. These hard fats of the highest quality have already been widely recognised in the pharmaceutical sector for more than 50 years. They are mainly used for the production of suppositories and ovules.

Production through “De Novo Synthesis”

WITEPSOL® hard fats are produced via a so-called “De Novo Synthesis”, i.e. a direct esterification process using glycerol and fatty acids. This esterification process is carried out within a fully GMP compliant environment, which is regularly inspected and certified by the competent governmental authority.

WITEPSOL® hard fats without additives fulfil the requirements for hard fats laid down in the monographs of the most important pharmacopoeia, the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopeia (USP-NF). A Type IV US Drug Master File for WITEPSOL® hard fats without additives has also been issued (DMF No. 420).

What is special about WITEPSOL® hard fats?

WITEPSOL® hard fats without additives are based entirely on sustainable sources of vegetable origin (primarily palm kernel oil). They consist of vegetable-based glycerol and edible, vegetable fatty acids, ranging mainly from C12 to C18.

In addition to their well-known rectal or vaginal routes of administration, WITEPSOL® hard fats are also suitable as structure formers in emulsions or as a fat component in wound tissues. WITEPSOL® hard fats without additives are GRAS substances (Generally Recognized As Safe) and are regarded as a Cocoa Butter Substitute (CBS) acc. to CRF §172.861.

As they exhibit a neutral odour and taste, WITEPSOL® hard fats can also be used for the production of chewing tablets or as a capsule filling mass, among other uses.

A Broad Range of Possibilities

The WITEPSOL® hard fat range comprises 17 different types with melting ranges from 31° C to 43° C that meet practically all of the established requirements, depending on which route of administration and which API is used.

All WITEPSOL® hard fats are manufactured as pastilles. These pastilles are produced using state-of-the-art equipment; pastillation is carried out in a Class D clean room. The process of filling the product into cardboard boxes with PE inliners takes place in a covered laminar flow section. From the development to the production and on to the delivery to the customer, our aim is always to set standards.

As a result of these high demands on quality and the outstanding properties of the WITEPSOL® hard fats, they have been established throughout the world as versatile and multifunctional high-quality excipients for the production of suppository and ovule components for decades now. The WITEPSOL® brand name has practically become a synonym for hard fat.