Excipient Challenges that are impacting Generic Drug Development

David Schoneker, Global Regulatory Affairs, Colorcon, Inc., Harleysville, PA, USA (DSchoneker@colorcon.com)

Generic drug companies are increasing encountering a number of global challenges related to excipients when developing their drug products.  Regulators in various regions are realizing the importance of excipients and are expecting more information on excipients to be filed in drug applications than previously expected.  For example, the US FDA has been interpreting how to use the Inactive Ingredient Database (IID) more strictly than in the past.  In doing this, they have realized that there are many problems with the existing IID database and are making changes routinely which are causing many concerns for generic drug companies.

There are also many misunderstandings in the generic drug industry related to what types of risk assessments are expected by regulators to meet the ICH Q3D requirements for elemental impurities.  Regulators in China have recently instituted new excipient regulations requiring the submissions of detailed registration dossiers for all excipients which has created significant problems for excipient manufacturers and their generic drug customers.

In some countries, non-scientific studies have been conducted which has resulted in legislators taking precautionary decisions that may cause serious formulation hurdles.  For example, France has recently passed legislation to suspend the use of Titanium Dioxide E171 in foods based on a very poorly designed study that is not based on good science.  There is a potential that this suspension could be extended to pharmaceuticals in France which would cause a major problem for generic drug companies who sell their products in France.  This presentation will provide an overview of all these issues and discuss the impact they are having on generic drug development.

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Abstract Reference & Short Personal Biography of Presenting Author

David R. Schoneker is the Global Regulatory Director – Strategic Relationships at Colorcon. His responsibilities include global coordination of Colorcon’s worldwide regulatory activities and market expansion projects to gain regulatory acceptance of Colorcon’s products and components for various target markets.

He received his B.S. degree from Ursinus College and M.S. in Chemistry from Villanova University.  His previous position at Colorcon was Director of Quality Assurance and Quality Control.  He has been at Colorcon since 1977.  Mr. Schoneker has been active in many professional organizations such as AAPS, PQRI, RAPS, ASQ, ACS and AOAC.  He also is involved with a number of trade organizations such as the International Pharmaceutical Excipients Council (IPEC), the International Association of Color Manufacturers (IACM), the Consumer Health Products Association (CHPA), the International Food Additives Council (IFAC), the Council for Responsible Nutrition (CRN) and the Institute of Food Technologists (IFT).

Mr. Schoneker is currently the President of IACM.  In this role he coordinates IACM’s international regulatory activities related to Synthetic and Natural colorants for use in foods and drugs and participates as one of IACM’s NGO representatives at the Codex Committee on Food Additives (CCFA).

Mr. Schoneker was the Chairman of IPEC-Americas during the period 2007-2009 and is currently a member of the Executive Committee.  He is now serving as the Vice Chair for Science and Regulatory Policy where he is actively involved with the development of Regulatory, Safety, Excipient GMP and Supplier Qualification related guidelines to improve Excipient Acceptability, Safety and Global Supply Chain Security.  Mr. Schoneker previously coordinated International Harmonization efforts for IPEC-Americas and was the USP Liaison for IPEC-Americas.  Mr. Schoneker also Co-Chairs IPEC’s QbD/Product Development Committee, Composition Committee and IID Working Group.