Multifunctional cellulosic and seaweed-based excipients for pharmaceutical applications

By Rina Chokshi, Global Commercial Marketing Manager DuPont Nutrition & Biosciences

With a combined 300 years of cellulosic experience, DuPont Nutrition & Biosciences has leveraged the cellulosic derivatives formerly offered from the Dow Chemical Company and the cellulosic and seaweed-based ingredients from FMC to form a broad, unique portfolio of multi-functional excipients. Formulators seeking functionalities such as binding/compression, disintegration, lubrication, coatings, and sensory enhancement for both modified and immediate release products can work with DuPont experts to find a cost-effective solution for their high-quality formulations.

It is DuPont’s goal to help pharmaceutical companies tackle their toughest formulation and process challenges. With well-known, essential excipients, manufacturing locations throughout the U.S. and Europe, and decades of technical and analytical expertise, the company helps formulators develop a variety of oral solid and liquid dosage forms.

Cellulosics for controlled-release tablets

DuPont’s new controlled release product, METHOCEL™ DC2 HPMC, offered by DuPont Nutrition & Biosciences, displays the same chemical and controlled release properties as the company’s traditional METHOCEL™ HPMC without employing any additional ingredients: its main advantage is that it is simple to use and allows for easy application during direct compression manufacturing. During continuous manufacturing processes, improved flow properties are essential for maintaining performance and high throughput.

METHOCEL DC2 HPMC’s particle morphology is specifically designed to improve flow, as the particles are more spherical, less fibrous and more homogenous in shape and physical properties than current HPMC offerings. Due to these improved flow properties, there is no need for manufacturers to use more expensive and complex granulation processes. Compared to current HPMC materials, METHOCEL DC2 HPMC also improves content uniformity of the final dosage form in direct compression manufacturing, resulting in lower cost of production and more consistent product performance for patients.

DuPont Nutrition & Biosciences also offers a series of co-processed excipients for continuous manufacturing that provide improved functionality over traditional physical excipient blends, which allows formulators to reduce manufacturing steps while ensuring tablet quality. Avicel® SMCC does not alter the chemical structure of MCC yet exhibits improved compaction and powder flow properties.

The addition of lubricants in the continuous manufacturing process is also very critical in order to achieve desired tablet hardness, but it is also critical to avoid over-lubrication. DuPont’s Alubra® sodium stearyl fumarate can be integrated earlier in the process than alternative products to circumvent over-lubrication and achieve higher compactibility and target drug dissolution.

Marine brown seaweed based anti-reflux solutions

For many patients suffering from gastroesophageal reflux disease (GERD), alginate-based anti-reflux solutions are a safe option for naturally-based support therapy. Formulators seeking to develop a natural anti-reflux product can turn to .

One of the most effective ways to alleviate GERD is to minimize the exposure of the esophagus to acidic refluxate. Due to the high gel properties of alginates and their synergistic actions with other formulation ingredients, a floating gel mass (called a ‘raft’) is created over the stomach contents, preventing these stomach contents from refluxing back to the esophagus ,resulting in decreased heartburn and local irritation.

DuPont’s recent white paper, Sodium Alginate for Anti-reflux Suspensions – Study of Effect of Alginate Quality and Formulation Variables, provides additional technical information on DuPont’s plant-based solutions for GERD.

Advanced analytics service for excipients testing

DuPont aims to be a trusted partner for its customers at every step in the manufacturing process, regardless of the resources they have at their disposal. While most formulators are set up to properly develop drugs with minimal assistance, many are appreciative and receptive to the company’s in-depth knowledge of ingredients, which can help them achieve their goals more efficiently including when it comes to excipient testing.

When DuPont makes its excipients, there are a variety of tests necessary to complete the certificate of analysis for each one. Some tests are easier than others, from checking the pH, which is a fairly simple process, to doing an assay, which can be quite complicated without assistance. When manufacturers buy the company’s products, they are required to conduct their own testing before they can incorporate them into pharmaceutical products, just to make sure no mishaps have occurred during shipping or manufacturing.

As DuPont Nutrition & Biosciences makes these products every day, this kind of testing is easy for the company, and it often has streamlined, more efficient processes than the pharmaceutical manufacturer might have in-house. By collaborating with its customers, DuPont can help them reproduce its methods quickly and efficiently to ensure accurate identification.

DuPont also has several advanced analytical capabilities at its disposal to measure rheology, surface area, viscosity, analysis of texture, thermal properties, and much more. These tools enable the company to assist with measurement and identification of impurities, identify degradation in products, study active pharmaceutical ingredient (API) interactions, and validate existing customer methods and applications.

DuPont offers Certificate of Analysis testing on excipients at all of its manufacturing sites, which are located throughout Europe and the US. The company’s R&D centres located in the US., India and Germany, can offer manufacturers additional analytical expertise.

The Big Q initiative

Big Q – also referred to as Quality Culture– is defined as strategically managing quality in all business processes, products and services as they relate to all relevant interested parties. This approach creates a customer-centric culture, where quality is everyone’s responsibility, and it opens customer touchpoints beyond just the quality of products or manufacturing.

DuPont has recognized how much a culture focused on quality across the organization can improve how it serves its customers: some of the company’s most recent Big Q initiatives were sparked in part by customer feedback about what is important to them right now.

In recent years, customers have reported that they are prioritizing data integrity within their organizations, so DuPont began exploring how data integrity could improve product quality within its own organization as well. When the company realized that there were no industry data integrity standards for excipients or excipient suppliers, it formed a task force and worked to develop its own data integrity initiative. Leveraging guidelines from IPEC, the company developed a policy to facilitate gap analyses at all of its sites, implement solutions and continue future improvements. This initiative benefits customers by giving them increased confidence in DuPont’s production and quality systems and the data that it reports for its products.

Customer-centric engagement

Another example of how DuPont is implementing Big Q on a day-to-day basis is its customer-centric engagement. Its overarching goal is for customers to have zero complaints, so the company is tracking and analyzing customer complaint data and overarching trends, instituting target improvement plans at every plant. DuPont is also engaging key customers and distributors to collaborate on where the company can help them streamline their processes and address any issues they might have on a regular basis. By changing the way pain points are addressed, DuPont provides a tailored customer experience, helping them carry out their businesses faster and more efficiently.

Finally, the company reports any quality event or near miss that impacts or has the potential to impact a customer. It is paying attention to detail, analyzing near-miss reports and constantly implementing ways to guarantee utmost quality. This helps ensure corrective action is taken to prevent recurrence and allows the company to prevent similar events from occurring across the business. In turn, this helps customers save time and money by avoiding lengthy returns and means they can expect to receive a high-quality product so that they can efficiently provide their customers in turn a safe, efficacious drug.

The power of expertise and progress

DuPont believes in the power of expertise and progress. Although the company has been manufacturing its unique portfolio of excipients for decades, it continues to grow by improving its manufacturing, quality, and analytical excellence to deliver for customers. Its ‘solver’ mindset is its greatest asset – DuPont is eager to help solve customers’ formulation challenges through its deep polymer knowledge.