The comments were included in a poster presented at the annual meeting of the Controlled Release Society (CRS) in Canada, which detailed the use of IPEC’s procedure to assess the safety of the delivery excipient, Surelease.
The problem is that while components of Surelease are widely used in drug and food applications, two new grades of the excipient - E-7-19040 and E-7-19050 – are not listed in the US Food and Drug Administration (FDA) Inactive Ingredient Database, meaning their safety must be assessed if they are included in drug products.
However, at present the safety of excipients is only reviewed as part of a new drug application (NDA). As a result potentially useful compounds not listed in the IID - including the new Surelease grades - are unlikely to be used in formulation development unless drugmakers are willing to take them through a 90-day testing process that could cost many millions of dollars.
To try and address this Colorcon used a testing procedure developed by IPEC Americas’ safety committee, whereby an review body – the New Excipient Safety Evaluation Committee (NEEC) – compare existing data with studies identified in FDA Guidance and evaluate where appropriate bridging tests can be used to minimize the need for new analysis.
Lead author Christopher DeMerlis, regulatory affairs Manager at Colorcon and chair of IPEC-Americas Excipient Safety Committee, was pleased with the outcome, suggesting it could be used to expand the use of existing excipients and to “to obtain support for higher levels of use and for new grades not currently listed in the IID.”
He also said the review procedure provided an independent safety evaluation and predicted that the panel's positive conclusion “increases likelihood of use of a new excipient by pharmaceutical companies.”
Colorcon’s use of the safety review procedure – data from which has been filed as part of an official monograph request to the USP – is the first significant development in IPEC Americas' efforts to win regulatory support since its partnership with BASF and Wyeth in 2008.
In that collaborative effort US drugmaker Wyeth, German chemicals firm BASF and IPEC sought to gain FDA approval for the review procedure by using it to demonstrate the safety of use of the excipient Solutol.
In May of that year the FDA told IPEC that its process was a “suitable proxy for an agency review of the excipient” and the USP published a monograph despite the fact the excipient had not been used in a drug approved by the agency.