Almac Pharma Services Supports Industry Consortium to Address Titanium Dioxide Alternative Challenge

Almac Pharma Services, a member of the privately owned Almac Group providing innovative pharmaceutical development, manufacture and commercial services to global pharmaceutical and biotech organisations, has announced the completion of multiple assessments in support of a global pharmaceutical industry Consortium to help address the challenge of titanium dioxide (TiO₂) usage in drug products.

With over 50 years’ experience in product development and an established reputation for oral dose formulation expertise, Almac Pharma Services was selected by the Consortium to support the critical investigation into TiO₂-free systems with the aim of future proofing the delivery of safe and effective solid oral treatment supply to patients in need.

Due to its unique properties, TiO₂ has been used as a colourant, opacifier and for protection from UV radiation on solid oral dosage forms for decades. In 2022, following an assessment by the European Food Safety Authority (EFSA), the EU commission banned TiO₂ from use in food but allowed its ongoing use in medicines upon the recommendation of the EMA, with a further review scheduled for April 2024. The European Commission is expected to make a final decision on the ban in February 2025 following the update EMA assessment^[1].

To coordinate activities and deliver an industry-aligned assessment, a grouping of (>20) industry leading pharmaceutical companies was formed in 2022 to collectively address this via a new pre-competitive industry Consortium. The aim of the ‘Alternatives Consortium’ was to generate evidence that can be used by the EMA to support the re-evaluation of the feasibility of removing TiO₂ from the list of excipients for use in medicines.

In preparation for the pending EMA review, the time sensitive project was initiated in March 2023 and members of the Consortium provided a full brief of the requirements. In true partnership with key members of the group, Almac’s scientific experts conducted multiple assessments with respect to the processibility and manufacture of TiO₂-free options based on their effectiveness, impact on product and general technical feasibility.

Upon completion of the 12-month investigation involving a significant volume of testing, and meeting all key milestones throughout the project, Almac provided a comprehensive range of observations and significant data sets enabling the Consortium to submit their final report to the EMA.

Alan Carmody, TiO₂ Alternative Consortium, experimental and data interpretation work stream lead: “When the consortium approached Almac we set out a significant challenge to evaluate 34 different film coat systems and 17 hard shell capsule systems.  Almac accepted the challenge and have been excellent partners showing resilience and flexibility to meet our requirements and produce the comprehensive data package we required for our submission to the EMA.“

John McQuaid, President & Managing Director, Almac Pharma Services commented on the partnership: “We recognised the enormous challenge a potential ban on titanium dioxide usage could have for many products across the industry. Being able to partner with a global Consortium to support this crucial investigation into suitable TiO₂ alternatives has been incredibly rewarding for our teams as we worked together to find a solution to safeguard patients now, and in the future.”

Last month, Almac Pharma Services announced the completion of a custom-built, high-volume facility significantly increasing its commercial manufacturing and packaging capacity, forming part of the Group’s ongoing global expansion investment programme totalling £400m.

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[1] https://www.raps.org/News-and-Articles/News-Articles/2023/11/Pharma-groups-fight-proposed-ban-on-titanium-dioxi