A call to action is reverberating through the pharmaceutical community for the establishment of a viable regulatory pathway for new or modified excipients, which would empower industry to develop more quality-by-design-based formulations.
Picking up the mantle from the industry side are the International Pharmaceutical Excipients Council (IPEC) and the IQ Consortium, who are working together to develop a proposal for the pathway that will be compelling to FDA.
An independent FDA safety review system for excipients that would foster their being designed and/or adapted to meet the increasingly-sophisticated demands of formulating pharmaceuticals has been an objective of IPEC’s since its formation two decades ago.
In turn, the frustrations of pharmaceutical manufacturers of not having new excipients in their formulation toolbox has forced the concern onto the front burner of the IQ Consortium, formed to help “advance science-based and scientifically-driven standards and regulations for pharmaceutical and biotechnology products” (IPQ July 9, 2012).
The dimensions of the problem created by the lack of a pathway for new and co-processed excipients as well for their use in strengths that exceed that listed in FDA’s Inactive Ingredients Database (IID) were articulated by a panel of experts at a session of the IPEC ExcipientFest conference in late April in Raleigh, North Carolina.
Included on the panel were representatives from excipient manufacturers Colorcon (Regulatory Affairs Manager Chris DeMerlis) and BASF (Pharmaceutical Ingredients and Services Marketing Head Nigel Langley), excipient users GlaxoSmithKline (Product Development Director Vinod Tuliani) and Boehringer Ingelheim (Pharmaceutics VP Keith Horspool), and an industry consultant (FinnBritt Consulting Pharmaceutical Sciences VP Chris Moreton). The panel was moderated by Pharmaceutical Technology Editor Cynthia Challener.
The panel discussion encompassed a wide range of excipient manufacture, supply and use issues that are impacted by the current regulatory paradigm. In focus were the related economics, formulation science impacts, market needs, incentives and risks, as well as efforts under way to address the problems.