Clariant Health Care is advancing its excipient strategy through the VitiPure platform, a tiered portfolio designed to address increasingly stringent pharmaceutical formulation, quality and regulatory requirements.

The platform reflects a shift in the pharmaceutical industry from assessing whether an excipient meets basic specifications to evaluating impurity profiles, endotoxin levels, elemental impurities, nitrosamine risks and batch-to-batch consistency. Clariant’s approach is built around aligning excipient purity and performance with the specific requirements of a formulation and its intended patient population.

VitiPure addresses standard pharmacopoeia-grade requirements, while VitiPure Lex is designed for low-endotoxin applications such as injectables and vaccines. VitiPure Superior targets sensitive and stability-critical formulations where quality requirements extend beyond standard monograph compliance.

A key product in the portfolio is VitiPure CO 35 Superior, a premium PEG-35 castor oil developed for oncology injectable formulations. In formulations such as paclitaxel, where PEG-35 castor oil can account for more than half of the excipient volume, colour variation may create regulatory concerns, delay batch release and affect product consistency.

Using proprietary adsorbent technology, VitiPure CO 35 Superior is designed to reduce colour intensity compared with standard commercial grades while maintaining solubilisation efficiency. Clariant said the product supports the development of visually consistent, high-purity injectables for sensitive pharmaceutical applications.

Alongside product development, Clariant has activated its Clear Lake facility in Texas, its first US site dedicated to pharmaceutical-grade PEG excipient manufacturing. The purpose-built facility is GMP-compliant and designed to meet pharmaceutical quality, safety, traceability and regulatory requirements.

The regional manufacturing capability is expected to support customers across North and Latin America through shorter lead times, lower inventory requirements and improved supply continuity.

“This expansion strengthens our ability to provide reliable local supply and positions us as a true partner to the North American pharmaceutical industry,” said Vaios Barlas, Head of Health Care at Clariant.

“At CPhI Milan, we look forward to showing customers what that partnership means in practice, from supply chain reliability to one of the most advanced excipient quality available on the market," added Barlas.