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Business & Regulation Standards & Regulation, Ingredients

The IPEC Story: Promoting Ingredients for Success

My mentor – and now departed friend – Lou Blecher used to say, “Excipients don’t get any respect.” He was right. For many years, excipients were the second-class components of drug development. It’s understandable why the API steals all the glory. The API is what gives a medicine its therapeutic properties, but without excipients we wouldn’t be able to deliver medicines effectively to patients. The right choice of excipients can enable companies to more readily manufacture their drug product, produce a stable dosage form, improve shelf life, help with swallowability, enhance patient safety in terms of compliance, and more. Excipients make up a huge percentage of an actual tablet – in some cases up to 99.9 percent!

Today, more and more people in the industry understand and respect the role that excipients play. And I think a lot of this comes down to the work that the International Pharmaceutical Excipient Council (IPEC) has done. The IPEC Federation is a global organization that promotes quality in pharma excipients. I’ve been involved in IPEC since its inception in 1991 and, over the course of three decades, I’ve seen the benefit of the policies and guidelines that we have created for the industry. Many companies have grown to become top-quality industry suppliers that meet globally vetted standards thanks to the work of IPEC.

There was simply no clear GMP regulation in place for excipient operations and the lack of harmonization left many in a state of confusion about what specifications and controls the sector should be using.

One of the biggest challenges with regulating pharmaceutical excipients is that most are made by chemical companies, who make materials for wider industrial use. As well as producing excipients for medicines, they will also be marketing these products to food companies, paint companies, plastics companies, and more. In fact, excipients for pharmaceutical use make up only a fraction of customers for the chemicals industry – and yet the pharma industry has specific GMP regulations for excipients because of the way in which they will be used.

When IPEC was first finding its feet, the unique challenges of the industry were not being addressed with the same level of scrutiny that was given to the production of finished pharmaceutical products or APIs. There was simply no clear GMP regulation in place for excipient operations and the lack of harmonization left many in a state of confusion about what specifications and controls the sector should be using. For example, it was quite normal for an excipient supplier to be told by one customer that its processes were exemplary, and completely unacceptable by another… a frustrating experience! Standards were being interpreted in different ways and arguments were hindering the industry. Some pharma companies wanted the standards at excipient plants to mirror their own but there are limits to what chemical companies are able, or indeed willing, to do when pharmaceuticals are such a small part of their business.

Wine, cheese, and humble beginnings

Many businesses have stories of humble beginnings. Apple, for example, began in a garage in California and when Starbucks first opened its doors in 1971, neither a coffee was brewed nor a pastry sold (the company sold coffee beans and roasting equipment). But when I tell people the story of the early days of IPEC, people chuckle in disbelief. Today, IPEC is an internationally recognized organization, with regional groups in the Americas, Europe, Japan, China and India. IPEC also has partnerships with other associations in Canada, Mexico, Brazil and Argentina. It has tremendous respect worldwide. But the organization’s story began with a good wine and cheese party…

In the early 90s, as part of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) initiatives, the US, European and Japanese pharmacopoeias were eager to harmonize their standards. In particular, they identified that specifications and test methods for excipients were, frankly, a bit all over the place! They felt it was a good area for them to start to work on harmonization and they outlined their thoughts at a conference in Orlando, Florida, which I attended.

Though these early intentions of the pharmacopoeias were noble, at that time they didn’t have the scope and experience that we, whose careers revolved around excipients and formulation, had to truly understand what was needed. After the first day of the conference, Lou Blecher, invited me and others to his hotel room to discuss what we had heard and what those of us in the industry could do to assist the pharmacopeias’ efforts.

Around 18 chemists and formulators descended on Lou’s room, and were invited to enjoy a spread of cheese and wine. As thoughts were thrown around (and wine poured), Lou proposed that we form a trade association. Unlike others, this association would be about science, not business, and the association would be for both the makers and the users of excipients. We decided that if we were meeting the needs of patients and working to ensure that the guidelines we produced helped harmonize the industry, then an increased market presence would naturally occur. The idea certainly sounded good at the time, but we all realized that the wine might be influencing our reasoning...

We decided that if we were meeting the needs of patients and working to ensure that the guidelines we produced helped harmonize the industry, then an increased market presence would naturally occur.

By the next morning, we still thought the idea was worth pursuing and could make a huge difference if we formed such an organization. We also acknowledged that, as scientists, we knew little about the legal processes required to bring this concept into reality. Fortunately, Lou was able to contact a friend (Bob Pinco), who was a lawyer that previously worked for the FDA, to help us formulate a legal framework for our new project. And within weeks we had our first organizational meeting.

Several companies were great supporters from the start, including my own employer, Colorcon; with a number of employees around the world involved in IPEC from the start! The company was certainly supportive of our cause to help harmonize standards for excipients. Other companies that also got involved in those early days were GAF (which later became ISP, then Ashland), Hercules, (now Ashland), Merck, Sharpe and Dohme, Dow Chemical (now Dupont), Hoffman La-Roche (now Roche) and Servier to name a few specifically.

During one of IPEC’s early meetings, I suggested that, as well as working with the international pharmacopoeias to harmonize their standards, an effort should be made to help unify GMP standards for excipients. In my role as Director of Quality at Colorcon, I was having to deal with the issue of differing opinions from one customer to the next, and I wondered if others were also experiencing the same problems. From the perspectives of both the end-users and producers of excipients, the idea made sense for the industry and was welcomed by both sides. IPEC’s GMP committee was set up soon after and was involved in the development and publication of the first excipient GMP guideline in 1995. Internationally recognized and used as the basis for most of the standards on excipients (to date), the publication was one of our first major accomplishments – and a powerful statement as to what the association could achieve.

IPEC has been going for almost 30 years now, and we’ve had some great successes and a huge impact on the international mindset toward excipients! Not bad for a group of scientists who crammed themselves into a tiny room late one evening for cheese, wine and a discussion about excipients!

Out with the old

IPEC has helped solve a number of issues for excipient and pharmaceutical companies and published a joint IPEC-PQG Good Manufacturing Practices Guide, a Good Distribution Practices Guide, an Excipient Qualification Guide, a Certificate of Analysis Guide, the Significant Change Guide for Pharmaceutical Excipients, a Technically Unavoidable Particle Profile Guide, and many more (all available at But there are still other challenges. One frustration is that although excipient companies are developing some truly innovative technologies, they are not being used by the industry due to a reluctance to be first. If new excipient products continue to be unused, then it could affect innovation in excipients going forward; after all, a lot of work and cost goes into creating a new excipient, including market research and regulatory work.

Ever since the formation of IPEC, the concern about bringing novel excipients to market has lingered – perhaps hardly surprising given the notoriously conservative and safety conscious attitude of the pharma industry. Historically, the industry has continued to formulate with 100-year-old excipients – and although these may work, they do not always work as well as they should. Pharmaceutical companies do acknowledge the benefits of new excipients, but they rarely want to be the first to use them. Companies can also be hesitant to use modified versions of well-known excipients in their drug products. I’ve seen excipients companies develop some advanced co-processed formulations of commonly used excipients, such as spray dried versions of corn starch and pregelatinized corn starch, that give better performance – pharma companies have even raved about the benefits! But still they dismiss them in preference of more established options that have precedence of use.

The reluctance of pharmaceutical companies to adopt new excipients may be tied to the fact that the FDA lacks robust regulation on the introduction of new excipients to market.

The reluctance of pharmaceutical companies to adopt new excipients may be tied to the fact that the FDA lacks robust regulation on the introduction of new excipients to market. Currently, there is no independent process for the FDA to review the safety of an excipient; excipients cannot be approved on their own and must be a part of a drug product and reviewed during the drug registration and approval. The only process available to pharma is to take the plunge and see what happens when a novel excipient is added to their formulation – a choice which many companies are simply unwilling to make.

The crux of the issue is that now, more than ever, pharmaceutical companies need new ideas to help develop drug formulations for their pipelines. There are more insoluble APIs than ever, thanks to new technologies and techniques, and new excipients may be needed to optimize formulations for emerging technologies, such as 3D printing and continuous manufacturing. Countless numbers of drugs sent to the FDA for approval have been scrapped because the right dosage forms required for the effective delivery of these products were not available – a terrible situation when we have so many innovative options in an industry that
could help!

IPEC and the IQ Consortium ( have teamed up to hold discussions with the FDA to establish a novel excipient qualification process, which I really hope could result in the formation of an FDA committee to review data on new excipients. If the FDA agrees to this, it would go a long way in mitigating the industry’s concerns and allow companies to jump in and use newer materials, which could resolve many issues they face in terms of drug development, stability and quality. The pharma industry is one of the most innovative industries in the world – and we can do better if companies are given the help they need to be confident in adopting new ingredients and technologies.

IPEC has, throughout its history, helped put a spotlight on excipients and worked with regulators to affect change. We haven’t lost the enthusiasm or verve we had when we first created the association! I hope we will continue to make progress in this area. The risks of ignoring the problem are great. If companies continue to avoid novel excipients then it could lead to a stagnation in innovation – a problem for pharma and patients alike.

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About the Author
With David Schoneker

Global Regulatory Director, Strategic Relationships at Colorcon and Vice Chair for Science and Regulatory Policy for IPEC.

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