The rise of independent excipients

Continuous manufacturing, for example, has evolved at a relatively fast pace, leaving drug manufacturers feeling equally challenged and encouraged to evaluate their current production methods and adopt new technologies. The end result will be the creation of better drugs, increased speed to market and more accessible healthcare worldwide.

For many, the gateway to realising these advancements has been excipients. Time and costs during the production stage of drugs are of constant concern to manufacturers and drug costs remain a top priority for insurers and governmental agencies. The efficiency made possible by novel excipients makes them ideal to facilitate continuous manufacturing.

Designed for purpose
The potential of continuous manufacturing is somewhat predicated on the industry’s ability to create and approve new excipients, which is a vital component of supporting continuous manufacturing’s ever-advancing landscape. Existing excipients may not be able to address all the needs of the continuous process and there is a clear need for excipients that are designed for the purpose of the continuous process. For this reason, as formulations become more complex, drug formulators will no longer be able to depend on current solutions and must explore unique, adjacent pathways to optimise solutions to their furthest extent.

To better meet the demands of each individual drug formulation, the term “Designed for Purpose” has gained major traction to represent the need to create independent excipients that fit specific formulation needs and challenges. Individualised solutions will enable drug formulators to handpick excipients to ensure that they are fit for a given formulation, all while optimising end-use performance. These excipients enable robust formulations that can accommodate production variability without impacting the performance, stability or quality of the drug.

It is critical to move beyond current regulatory limitations to push pharmaceutical development to its fullest potential. Even though drug manufacturers recognise the vast opportunity that lies within novel excipients, there is hesitation to adopt because of the lack of an independent pathway to review the safety of novel excipients, even when these ingredients have been safely used in food. For this reason, the topic of novel excipients is forcing regulatory agencies and industry leaders to explore new approaches to open up pathways for approval and the acceptance of novel excipients.

When adopting novel excipients, it’s imperative to have a close working relationship with forward-thinking excipient suppliers that offer technical expertise and educational support to push beyond current regulatory roadblocks. These relationships can be an indispensable resource to both individual formulation developments and the advancement of continuous manufacturing throughout the entire industry.

Importance of close and consistent collaboration
A close working relationship between excipient suppliers and drug manufacturers is more important than ever before to ensure that vital support is readily available. This can include the development of new excipients, re-evaluating or reformulating with current excipients or navigating challenging regulatory landscapes.

The dependence on excipients has prompted this close collaboration to ensure their current supply is consistent and quality is upheld to control variability. Direct access to trusted, capable suppliers provides drug manufacturers with a better understanding of excipient properties and allows them to better predict performance.

A better understanding of how products perform when used in continuous processes is required. This includes better control of all the key attributes of raw materials and how they impact the manufacturability and quality of the final drug product. There is a long list of excipient attributes that drug manufacturers must consider when choosing the best technology for individual formulations, including particle size, particle morphology, density in relation to impact on powder flowability, compactibility and the critical quality attributes of excipients impacting the performance of the final drug product.

By tapping into the extensive expertise and industry knowledge of partner suppliers, drug manufacturers have all the necessary support to choose the strongest fit for their unique formulations. Choosing the ideal fit not only translates to increased speed to market ... but also eliminates potential mishaps and prevents late-term development disasters.

Exploiting an innovation engine
DowDuPont Pharmaceutical Excipients combines market leading products and rich pharma experience from FMC and Dow to create the industry’s broadest and most versatile range of oral solid dosage excipients. Its newly combined portfolio gives customers access to even more excipients for use in continuous manufacturing.

One way that Dow Pharma Solutions has pushed the innovation envelope is through the creation of the AFFINISOL HPMC hot melt extrusion (HME) excipient, an HPMC material designed with a polymer substitution architecture that enables thermal processability in HME procedures. This novel excipient offers extended HME process flexibility to choose polymer viscosities that optimise solubility and drug release profiles.

Currently, there are very few excipients designed specifically for hot melt extrusion and the technique is attracting significant interest from the industry to enable the continuous production of a wide range of dosage formulations. Dow also offers a solution for the industry wide trend to switch from batch production to continuous manufacturing through the creation of METHOCEL DC2 hydroxypropyl methylcellulose (HPMC). The product is engineered to improve dry powder flow for streamlined matrix-tablet manufacture and improved drug content uniformity. This can help to shorten production times and reduce manufacturing costs by up to 60%.

Industry outlook
The uptick of drug recalls because of contamination in the manufacturing process, enormous losses in manufacturing costs from inefficient processes and an increasing number of drugs that are currently in short supply is quickly shifting continuous manufacturing from a want to a business must-have. The implementation of continuous manufacturing will bring about many changes that will likely have lasting positive effects on the pharmaceutical industry.

Recognising change at this scale is impossible to accomplish alone, and collaborations between drug manufacturers and suppliers will arise out of necessity to help navigate the complexity of continuous manufacturing. Increased excipient utilisation to facilitate continuous manufacturing will have a lasting impact on the pharmaceutical industry, and those that join forces with their excipient suppliers to tackle current and future challenges will come out on top in the modernisation of the pharmaceutical industry.