EC GMP directive “still alive”; Cargill
In June the European Commission (EC) dropped its directive that would have made excipients comply with good manufacturing practices (GMP) but Cargill believes the issue will be raised again in the future.
Henry Hussell, marketing manager at Cargill Pharma, and Liesbeth Meeus, the company’s pharma and personal care application centre leader, expressed this view at CPhI 2009 in Madrid, Spain.
Meeus explained that the directive had been dropped because some excipient manufacturers would be unable to comply with GMP, adding that Cargill’s operations are already run to exacting quality standards.
This includes its C*Pharmdoc system, which provides pharma manufacturers with full quality assurance under International Pharmaceutical Excipients Council (IPEC) and Pharmaceutical Quality Group (PGQ) guidelines.
Hussell added that he believes no other excipient manufacturer provides a similar service because of the cost and time commitment. He added that Cargill implemented the system in response to requests from customers.
Excipient to improve compliance
At CPhI 2008 Cargill officially launched its Zerose erythritol excipient and at this year’s show gave an update of the product’s development. Cargill now has 12 months more experience of working with the excipient and has learnt more about its effectiveness at taste masking.
The excipient has been found to be effective at taste masking large quantities of active pharmaceutical ingredients (API) to create chewable tablets that could be an alternative to capsules.
Hussell explained that the aging population, rising demand for products designed for children and some peoples’ dislike of swallowing pills has created a market for chewable tablets. Furthermore, taste masking is a “huge problem” for the pharma industry, according to Hussell.
Cargill believes that Zerose erythritol can help improve patient compliance. Hussell added that the excipient is being used in two pipeline projects and there has been one product launch using the taste masking excipient.
Through this work and other developmental activity Cargill has discovered it can use Zerose erythritol with isomalt to ensure the product is non-hygroscopic.
