Titanium dioxide (E171) and its role in formulation

In this article Mike Tobyn from Bristol Myers Squibb, Jonathan Kaye from GSK, David Harris from MSD and Eli Lilly’s Jason Melnick discuss the role of E171 (titanium dioxide) in the identification of solid oral dosage forms.

The ability to uniquely identify oral solid dosage (OSD) forms has been recognised by regulatory authorities worldwide as one of the mechanisms to reduce medication errors and to detect falsified medicines. Changes in the appearance of medicines has been identified as a factor in patient compliance and, therefore, clinical outcomes.

In the development of a new drug product, it is necessary that each dosage form or strength incorporates mechanisms that enable its unique identification. The ability to identify medicines is regarded, in European Medicines Agency (EMA) guidance,1 as a key mechanism for reducing medication errors: elderly patients frequently use multiple medicinal products (polypharmacy) which may in itself cause adherence problems which may be partly overcome by the pharmaceutical design of the medicines used (eg, a wider range of colours, sizes and tablet shapes is known to assist the recognition of medicines and hence to reduce the risk of errors).1

Once on the market, unique identification is a key mechanism for helping to prevent and identify falsified medicines. Falsified medicines present significant risks to patients, and their identification and removal is a key goal of healthcare regulators throughout the world.2 Having unique, difficult‑to‑falsify features makes the medicines supply chain safer.