Clariant unveiled a new range of advanced pharmaceutical ingredient solutions, reinforcing its commitment to the advancement of safe and efficacious medicines. The company is introducing three innovative VitiPure® excipients designed to accommodate a wide array of Active Pharmaceutical Ingredient (API) formulations and administration methods, including those for delicate substances like mRNA vaccines and biologics.
Michael Haspel, Global Head of Segment Personal, Home & Health Care at Clariant, highlights the company's dedication to supporting pharmaceutical production and addresses the evolving needs of the industry. He states, “With our new excipients, we address the market’s growing trend for high-purity ingredients, by solving inherent stability and bioavailability challenges of Active Pharmaceutical Ingredients so that they can travel to where needed inside the body and be delivered effectively.”
VitiPure O 80 Superior stands out as a top-tier, low microbial load Polysorbate 80, characterized by its minimal residual impurities, colorless and odorless properties. This excipient provides exceptional stability to APIs and serves as a nonionic solubilizer, emulsifying agent, and stabilizer. It is particularly well-suited for biologic molecules administered via parenteral drug delivery systems, ensuring the API remains unaffected by any potential impurities from the excipient.
VitiPure CO 35 Superior, on the other hand, is a Polyoxyl 35 Castor Oil known for its low residual impurities, colorless and odorless attributes, and low microbial load. It enhances the stability of APIs and functions as a non-ionic solubilizer. It is typically employed in parenteral applications where the end formulation must be colorless, and the API is sensitive to impurities from the excipient.
By offering a range of highly-purified products, Clariant sets itself apart, granting customers the flexibility to choose from three different purity levels for Polysorbate 80 and PEG 35 castor oil: standard, low microbial, and highly purified options. This versatility allows for the selection of the most appropriate solution based on the specific application, whether oral, topical, or parenteral.
Introducing VitiPure Meglumine LEX, Clariant introduces a low-endotoxin and low microbial-load grade of Meglumine. This compound is employed as a counterion in the contrast media sector, serving as a buffering agent/alkalizer and solubilizer for mildly acidic APIs. Applications include both oral solid and liquid formulations, making VitiPure Meglumine LEX ideal for formulations requiring a low bioburden and low endotoxin grade.
Clariant also provides comprehensive regulatory support by offering an in-depth analysis report on Nitrosamines, in accordance with existing guidelines due to the presence of Nitrogen groups (-N-) in its molecular structure. This analysis confirms that the product is manufactured to the highest quality standards.