Witepsol – Hard fats for suppositories and ovules by IOI Oleochemical
1| HARD FACTS ABOUT OUR HARD FATS
The brand name WITEPSOL® is synonym for hard fats mainly used in suppositories and ovules.
Development and production of WITEPSOL® started back in the 1950s at the former Chemische Werke Witten, now known as IOI Oleo GmbH.
Manufacturing takes place in a fully automated process, including pastillation and packaging line operating under clean room-condition.
This state-of-the-art production guarantees the highest possible standard, and in turn the quality of medicine in our ethical environment.
The site in Witten repeatedly has been granted EU GMP-certification and is US FDA-approved.
Based on our cGMP production, our regulatory set-up and our experience – quality you can rely on „Made in Germany“
2| PRODUCT RANGE
For the preparation of an optimal form of rectal medicine or ovule, a single grade is not sufficient. To allow for a better overview of this range, the WITEPSOL® grades are divided into four classes and, within these classes, are arranged in order of increasing melting point.
WITEPSOL® products of series H are hard fats which are characterized by a low hydroxyl value.
WITEPSOL® products of series W are hard fats which are characterized by a higher hydroxyl value.
3| PRODUCTION AND QUALITY CONTROL
WITEPSOL® suppository compounds consist of glycerol esters of vegetable saturated fatty acids, mainly lauric acid.
Starting materials are puri fied, specially selected coconut and palm kernel oils from tropical plantations.
After preliminary puri fication, the oils are cleaved into
their fatty acids and glycerol by means of water at high pressure and acidic or alkaline catalysts. The fatty acid mixture is subjected to catalytic hydrogenation and subsequently to fractional vacuum distillation, and the low molecular weight caproic, caprylic, and capric acids (C6– C10) are removed. The C12– C18 fatty acids are adjusted to the correct mixture for the grade in charge and esteri fied batchwise with puri fied and distilled glycerol. The fatty acid spectrum, the stoichiometry of the reaction mixture, and the reaction times and temperatures determine the properties of the product, such as melting range, solid fat index, hardness, mono-, di-, triglyceride content (emulsi fiability/dispersibility) and viscosity.
The crude reaction mixture is subsequently processed
- Alkali washing to remove free fatty acids (as soaps)
and the catalyst (as fat-insoluble basic compounds)
- Neutral washing to remove excess alkali
- Drying in vacuum
- Adsorptive treatment to remove chromogenic products and traces of catalyst
- Steam distillation in vacuum and repeated drying
- Deep-bed filtration under pressure
Some of the WITEPSOL® grades are then mixed with emulsi fiers or consistency modifying waxes. Directly prior to conversion into pellets or bulk material, another final fine filtration is carried out.
WITEPSOL® contains no stabilizing or decolorizing
chemical additives; it is produced without solvents and virtually no microorganisms are present due to the production process.
See the full brochure on “Witepsol“ here
(click the picture to download the brochure)
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Source: IOI Oleo GmbH brochure “Witepsol”