27 May 2024

New penetration and bioavailability booster for pharmaceuticals

Improving bioavailability is a key consideration when it comes to developing pharmaceuticals, especially where APIs (active pharmaceutical ingredients) are concerned. Many do not dissolve well in water, making it difficult to design acceptable drug release profiles to support applications in healthcare. Functional lipid IMWITOR^® 742 from Nordmann partner IOI Oleo can help formulators overcome this challenge.

Functional benefits of IMWITOR^® 742

When developing pharmaceuticals, drug release profiles often need to include a booster in order to achieve good results. This is a well-known issue for many formulators and developers.

Pills and capsules on a table and on leaves

IOI Oleo’s Pharma Business Unit supplies a wide range of plant-based mono-, di- and triglycerides that can be used in a variety of different dosage forms. IMWITOR^® 742 is especially versatile and addresses many of the challenges associated with poor water solubility during pharmaceutical manufacture and patient administration.

The innovative and multifunctional product can:

serve as a solubilizer for a variety of molecules
act as a penetration enhancer when applied externally
promote permeation when used internally, due to its high concentration of medium-chain fatty acids

Scientific aspects and application

In terms of surface and tissue activity, IMWITOR^® 742’s performance is achieved by a monoester content of approximately 60% and the presence of free hydroxyl groups along the molecular backbone. Recognized as a GRAS substance (“Generally Recognized As Safe”), IMWITOR^® 742 is suitable for oral administration.

IMWITOR^® 742’s chemical structure is what makes it so effective, but also gives it a distinct and somewhat unpleasant taste. This should be taken into account when considering dosage levels; alternatively, capsules may be an appropriate dosage form.

Quality assurance and improving bioavailability

For both oral and topical administration, IMWITOR^® 742 increases bioavailability and facilitates ease of processing for poorly water-soluble drugs. Scientific approaches using the SEDDS formulation technique have shown that IMWITOR^® 742 is an efficient tool to address the challenges of formulating APIs that fall into classes II and IV of the Biopharmaceutical Classification System (BCS).

IMWITOR^® 742 fulfills the requirements set by the Ph. Eur. Monograph for “Glyceryl Monocaprylocaprate, Type I” as well as those from the USP-NF Monograph “Glyceryl Mono and Dicaprylocaprate”. It is manufactured in IOI Oleo’s US FDA cGMP-approved plant in Witten, Germany.

IOI’s specialty materials for pharmaceuticals are EU GMP-certified by the German authority responsible for the district.

IOI Oleo also holds a Certificate of Suitability (CEP 2021-199) for IMWITOR^® 742, issued by the EDQM in Strasbourg.

The use of high-quality, plant-based raw materials and validated manufacturing methods are what give IMWITOR^® 742 its outstanding purity, effectiveness and consistent overall quality – allowing IOI Oleo to address the need for reliable functionality, material compliance and quality in galenics.