FocusExcipients earn prestige - and scrutiny

16 January 2008 23:41  [Source: ICIS news]

By Clay Boswell

NEW YORK (ICIS news)--Although active pharmaceutical ingredients (APIs) will always be the most important component of a drug, excipients - the “inactive” ingredients - have seen their status steadily rise over the past few decades.

Excipients serve a host of functions, with typical examples being binders, disintegrants, fillers or diluents, lubricants, sweeteners and coatings, whose relevance will vary, depending on the dosage form - whether oral or injectable, solid or liquid.

Collectively, these materials accounted for a $3.5bn (€2.3bn) global market in 2006, according to Wellesley, Massachusetts-based market research firm BCC Research, which recently published the report, “Excipients in Pharmaceuticals”. BCC sees the market growing at an average rate of 3.8%/year, to $4.3bn in 2011.

Thirty or 40 years ago, excipients were regarded as simple ingredients with modest roles, according to Peggy Bennett, industry manager, at Kline, a research and consulting firm in Little Falls, New Jersey. They were generally either fillers, bulking out a tablet or capsule so that it might be easily consumed, or binders, holding a tablet together.

In the years since, however, excipients have been recognised as true functional/performance ingredients. They have a profound influence on bio-availability, which pharmacologists, armed with a deeper understanding of the influence of formulation on pharmacokinetics, have used to their advantage.

Throat coatings have been used to improve the aesthetics of tablets by making them easier to swallow. Enteric coatings have improved bio-availability and enabled the sustained release of active ingredients.

Lubricants and glidants have improved economics by facilitating the manufacturing process. New excipients have been developed to replace animal-source excipients. Other new excipients have enabled new dosage forms and advanced drug delivery systems.

“Advanced delivery systems can completely change drug formulations and create a major impact [either positive or negative] on demand for excipients,” said Norma Corbitt, senior analyst and author of the BCC study.

Corbitt said that convenience and acceptability should drive the volume of excipients consumed in advanced delivery systems from 454m lbs (206,000 tonnes) in 2006 to 536m lbs in 2011, a 3.4% compound annual growth rate (CAGR). Value-wise, the market would grow from $553m to $646m, a CAGR of 3.2%.

Unlike APIs, whose manufacture is governed by GMPs (good manufacturing practices) enforced by national regulatory authorities, the manufacture of excipients is not. Drug manufacturers are themselves held responsible by regulatory authorities for ensuring the quality of the excipients they purchase.

For the most part, this system has been successful, but cases such as the substitution of diethylene glycol for glycerine in cough syrup prepared in Panama in 2006 - which led to the death of 21 people and injury to 38 more -- have revealed the potential for disaster. The European Union’s answer has been to initiate a process to mandate GMPs for excipients.

Using GMP guidelines published by the International Pharmaceutical Excipient Council (IPEC) as a model, the Enterprise Directorate General (EDG) of the European Commission has been working closely with industry to consider the many different interests affected, said Kevin McGlue, director, global quality assurance at Colorcon and chair of IPEC Europe’s GMP Committee.

“The debate at the moment is all about setting GMP requirements that are appropriate to excipients, and do not simply mirror those developed for active pharmaceutical ingredients,” he said.

The difficulty, he explained, is that “there is no excipient industry, just a market”. Suppliers range from commodity food ingredient manufacturers to specialists in functional ingredients for pharmaceuticals. Excluding colours and flavours, over 1,200 excipients are in use, but only 300-400 have monographs in recognised pharmacopoeia.

Another problem will be the lack of global harmonisation if the EU is the only market with such regulations.

The EDG expects to produce a report later this quarter. “I have no idea what that will bring,” said McGlue.

($1.00 = €0.67)

For a more extensive discussion of the excipient market, be sure to check out the 28 January issue of ICIS Chemical Business.

ICIS Copyright © Reed Business Information 2009

Author: Clay Boswell
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