Expert advice for difficult problems

News

Announcements and Regulatory Updates

Titanium Dioxide (E171 grade) and the Search for Replacement Opacifiers and Colorants: Supplier Readiness Survey, Case Studies and Regulatory Perspective

Go to the link below to get a copy of a really great paper that has just been published by the IQ Consortium related to the technical and regulatory challenges that would exist if the EU Commission were to extend their unjustified ban of TiO2 (E171) to pharmaceuticals. The paper summarizes a survey of a number of pharma companies concerning what they are doing concerning assessment of TiO2-Free coatings and capsules and the challenges they are seeing.

The paper then provides a number of case studies of actual technical studies that have been done to look at various properties and aspects of using TiO2-free coatings and capsules for both new and existing drugs. The results show that there are very serious technical and regulatory challenges that would exist if TiO2 were to be banned in the EU which would result in European patients (and those in aligned countries) not having access to many of the drugs they need.

Titanium Dioxide (E171 grade) and the Search for Replacement Opacifiers and Colorants: Supplier Readiness Survey, Case Studies and Regulatory Perspective - Journal of Pharmaceutical Sciences (jpharmsci.org)

David Schoneker