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

23. October 2020

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.

Nice to know:
The brand name WITEPSOL® is a combination of the production location Witten and the Latin name for „hard fat“ = Adeps solidus.

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 ASafe) 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.

However, IOI Oleo GmbH also offers a few types of hard fats containing particularly high-quality additives for specific purposes, e.g. a non-ionic emulsifier.

This emulsifier enables the incorporation of up to 10% of water or ethanolic-aqueous extracts in order to be able to continue manufacturing appropriate suppositories or ovules.

Another additive is beeswax, which adds a certain plasticity. And Glycerol ricinoleate (SOFTIGEN® 701) is an additive that serves as a smoothing agent and is preferably used in hemorrhoidal preparations.

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.

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Michael Plum

Michael Plum has been a member of our Pharma team since 1989. As Application Engineer, he is in close contact with our global industrial customers. With his background of more than 30 years of experience in the industry, he is a competent contact partner for any technical, regulatory or formulation related questions in the context of IOI’s pharmaceutical excipients. As an experienced and passionate home brewer, Michael Plum attaches great importance on the quality of his homemade products. He applies this setting on the technical related customer’s requests also in order to provide best support to our valued customers.