Maximizing shelf life and formulation stability are primary concerns for IOI Oleo when it comes to developing new products. “Stress factors such as light or temperature can lead to oxidation and even change a product’s chemical composition,” says Robert Radsziwill, Sales Manager Pharma Europe at IOI Oleo. The company recently had tested the quality of its MIGLYOL® 812 N carrier oil using the established Rancimat method, which evaluates oxidative stability. The test results were encouraging, showing that formulations made with MIGLYOL^® 812 N have a high level of stability and a long shelf life, even without any additional antioxidants. This is exciting news as the European market for CBD products continues to grow, now with an estimated potential of well over € 1 billion.

The test results

MIGLYOL® 812 N is a transparent, taste- and odourless medium-chain triglyceride. It is used as a penetration enhancer, an active agent carrier and a solvent for oral and dermal formulations.

The oxidation stability test took place by means of the above-mentioned Rancimat test, in which the hemp, sesame and olive oil as well as the MIGLYOL® 812 N are exposed to a temperature of 100°C and a constant air flow of 19 L/h for a duration of 48 hours.

The electrical conductivity as well as the induction time of the samples were measured at time 0 and after 48 hours. The electrical conductivity increases due to reaction products that arise during the oxidation process. The induction time is the time until the reaction products arise and characterises the oxidation stability of the oils.

Unlike the comparative oils, MIGLYOL® 812 N showed no significant increase in conductivity in the Rancimat test and also remained in its original appearance with regard to colouring, odour and viscosity. It was characterised by high stability against oxidation, which can be due to various stress factors.

Accordingly, the use of MIGLYOL® 812 N in formulations with CBD or other cannabinoids leads to high product stability with good durability, even without additional stabilisation of the carrier oil with antioxidants.

For the CBD-containing end product, this brings the advantage of being oxidation-stable even in the event of air feed due to repeated withdrawal cycles and showing a constant effectiveness over the entire lifespan.

An overview of the key properties

• EU-GMP excipient “Made in Germany”, FDA-approved
• monographed in Ph. Eur., USP-NF, JPE
• DMF USP IV
• kosher- and halal-certified
• natural, herbal raw materials
• RSPO mass balance option
• pesticide monitoring of the raw materials
• no allergens within the meaning of European food law
• transparent, odourless and tasteless
• advantageous caloric profile
• no addition of antioxidants required
• lasts for at least 36 months after production
• contributes to the maximum durability of the CBD-containing end product