Our expertise: managing the natural variability of our ingredients
Pharmaceutical ingredients play a key role in drug formulation.
Natural variations in their composition and physicochemical properties can have significant impact on the final drug product performances like safety, physical and chemical stability and bioavailability. In the recent past, ingredient variability has been at the origin of FDA recalls.
Natural-based products are by definition subject to a certain degree of variability but appropriate solutions can be developed to manage this variability and propose consistent plant-based pharmaceutical ingredients. As a manufacturer of highly purified pharmaceutical oils, ADM-SIO has implemented a full management of this natural variability.
Risk assessment can be used to understand variability of naturally-derived pharmaceutical ingredients and identify which material attributes have an impact on the performances of the final dosage form.
For more information on this topic, we invite you to consult the following scientific article: “Managing the natural variability of plant-based pharmaceutical ingredients”
Sourcing of the starting material
A major step in managing the variability is the sourcing of starting materials. Indeed, vegetable oils present different profiles especially due to product variability parameters. It is essential to work closely with starting material suppliers, to discuss and explain clearly what are the needs to guarantee the quality and consistency of the final product.
At ADM-SIO, we led several initiatives to guarantee the quality of our ingredients:
- We select suppliers working with specific crop cultivar and able to mix oils from different origins to guaranty targeted fatty acid profile; but also with dedicated production lines to avoid cross contamination.
- We work with them to improve their extraction processes, therefore avoiding oil damage that can lead to purification troubles. As part of the GMP’s, suppliers are audited for pharmaceutical applications. A pre-delivery sample is sent to the QC lab for analysis and agreement before delivery.
- We select a particular sourcing period over the year to guaranty specific characteristics of the oil like fatty acid composition or specific UV absorbance.
You will find hereafter an overview of the vegetable oils we work with:
Our Raw Materials: Your Success
Natural variability of pharmaceutical ingredients should be part of the risk analysis, which is done during the development of the final dosage form. It can be shown to have caused failures and even recalls from health authorities. Naturally derived pharmaceutical ingredients are particularly exposed to this variability. The main challenge for pharmaceutical laboratories is to carefully select suppliers that have the capacity to manage this variability.
ADM-SIO manufactures API’s and excipients with the same level of requirement. The workshops, manufacturing facilities and analytical equipment are validated and fully qualified. The production complies with cGMP and the facilities are regularly inspected by health authorities such as ANSM and when applicable US FDA.
For us, it does seem normal and essential to have the same strict manufacturing criteria for excipient that represents up to more than 90% of the formula of the drug, than for API itself.
For you, we select the best ingredients to deliver the best lipid-based solutions.