Managing The Natural Variability Of Plant-Based Pharmaceutical Ingredients – ADM White Paper

Managing The Natural Variability Of Plant-Based Pharmaceutical Ingredients – Example Of Vegetable Oils

Why managing variability?

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. 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, SIO has implemented a full management of this natural variability. Risk assessment can be used to understand variability of naturallyderived pharmaceutical ingredients and identify which material attributes have an impact on the performances of the final dosage form.

The origins 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 the 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 and fruits are treated for oil recovery is also of prior importance.

 

Example of geographic variability of soybean oil (from internal analysis)

As an illustration, this graph shows the variation in α-linolenic acid content of crude soybean oil depending on the
geographic origin.

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%.

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) often tighter than food standards.

Besides regulatory requirements, some customers may have very specific needs, often even narrower, related to the formulation of their drug. The European Pharmacopoeia has introduced in certain excipient monographs a section called “Functionality-Related Characteristics”. This non mandatory section explains how functionality should be addressed. The USP General Chapter <1059> on Excipient Performance provides guidance on physical and chemical properties of excipients.

See the full brochure on “ADM White Paper – Managing The Natural Variability Of Plant-Based Pharmaceutical Ingredients Example Of Vegetable Oils” here

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Source: ADM brochure “ADM White Paper – Managing The Natural Variability Of Plant-Based Pharmaceutical Ingredients Example Of Vegetable Oils”

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Quality & Compliance – From Source to Final Product

With more than a century of experience, dedicated production lines and specialized R&D and regulatory teams, ADM offers its customers innovative global solutions tailored to the specific challenges of the pharmaceutical industry. At ADM, we offer a range of products that meet major relevant pharmaceutical regulations and are manufactured according to appropriate cGMP standards. We make delivering compliance and consistency a reality, giving you an edge to innovate with confidence. We are committed to providing only the purest and highest quality products for your end solutions.