If you want new excipients, regulate them, says BASF

Pharma customers are reluctant to be the first to try a new excipient in their manufacturing process, but at the same time want better and innovative inert ingredients, said BASF research expert Felicitas Guth.

Excipient users race to be “first to be second,” but are reluctant to be the earliest adopters of untried materials, confirmed Sharon Johnson, head of quality at Catalent. Both women were speaking at CPhI Worldwide, which began this week in Madrid, Spain.

Need for novelty

While innovative excipients could help the industry respond to the looming patent cliff, drug delivery obstacles such as solubility, and cost pressures, new compounds rarely hit the market.

Development times – almost as long as for new drugs – as well as high costs, risk, and a prolonged launch phase all put ingredient makers off creating new excipients, according to Guth.

Some companies instead resort to the less risky route of creating modified versions of existing excipients or co-processed compounds (a new combination of established excipients). Modified excipients take two to five years to reach the market, while those with new chemistry can spend more than seven years in product development and market launch.

Characterisation

“Use of novel ingredients is associated with perceived risk,” Guth told the CPhI Pre-Connect Congress. Excipient users want to see a pharmacopeial monograph and a registered drug using the new ingredient before they adopt it themselves, she said.

But materials companies are left to develop their own analytical methods to characterise the compounds. “There is no clear guidance from regulators on how to deal with impurities in excipients,” said BASF’s expert. The company makes do by adapting European pharmacopeial guidelines for similar ingredients.

A review and acceptance procedure for novel excipients that is independent of drug product registration would end the vicious cycle, Guth believes. “This could mitigate the risk of a delayed drug product registration for first-time users and open the door for more innovative excipients.”

IPEC: a future regulator?

BASF’s Guth told this site establishing a review process is a long way off realisation, but she predicted a group like IPEC (International Pharmaceutical Excipients Council) could be the independent organisation the sector needs to oversee the process. New excipients could be regulated and introduced to the market in a similar way to food additives, she added.

Follow in-Pharmatechnologist.com reporters Fiona Barry and Dan Stanton for live Twitter coverage of this year’s CPhI Worldwide conference.