All4Nutra
WHY MANAGING VARIABILITY MATTERS?
Pharmaceutical ingredients play a key role in drug formulation. 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.
ADM
With over a century of expertise, ADM provides innovative solutions to the pharmaceutical industry, leveraging dedicated production, specialized R&D, and regulatory teams. Our products comply with major pharmaceutical standards and are produced under strict cGMP guidelines. We prioritize compliance and consistency, enabling innovation with confidence.
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 vegetable 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.
THE ROOT OF VARIABILITY
Natural-based products are by definition subject to a certain degree of variability. It is typically the case of vegetable oils. This variability has different origins like cultivation techniques, weather conditions and soil characteristics. All these parameters play an important role on oil content of the seeds and fruits but also on the fatty acids composition of the vegetable oil.
The supply chain, storage time and condition also impact that quality of vegetable oil. As an example, bad storage conditions can lead to the presence of mycotoxins. Inappropriate drying conditions can lead to the formation of PAH’s (polycyclic aromatic hydrocarbons) like benzo(a)pyrene. The way seeds are fruits are treated for oil recover is also of prior importance.
EXAMPLE OF GEOGRAPHIC VARIABILITY OF SOYBEAN OIL
(FROM INTERNAL ANALYSIS)
From October to April, soybean oil is sourced from crops grown in the north hemisphere (areas in blue). It gives an oil with a higher content in α-linolenic (average around 7.5%) compared to seeds grown in the south hemisphere with an average content of α-linolenic acid around 6.5%. Besides regulatory requirements, customers may require some additional specifications depending on the formulation of their drug.
of crude soybean oil depending on the months and the geographic origin.
In the European Pharmacopoeia, the non-mandatory section “Functionality – Related – Characteristics” as part of some monograph explains how functionality should be addressed. The USP General Chapter <1059> on Excipient Performance provides guidance on physical and chemical properties of excipients.
APPLICABLE STANDARDS:
- Nature can provide vegetable oils with a very wide range of characteristics. Available food grade products are regulated by the CODEX ALIMENTARIUS.
- Pharmaceutical ingredients for their part have to comply with pharmaceutical regulatory standards (pharmacopeias).
See the full White Paper on Precision in Plant-Based Pharmaceutical Ingredients here
(click the picture to download the White Paper)
Source: ADM White Paper Precision in Plant-Based Pharmaceutical Ingredients
