Clariant introduces new high-performing excipients

Clariant  present the company’s latest portfolio of products for the health care industry at the upcoming CPHI tradeshow in Milan, Italy, on October 8 through 10, 2024.

“We’ve built on our proven track record by supporting the development and production of pharmaceuticals with a broader portfolio of solutions for the industry’s growing technologies, such as the injectables segment. With our new excipients, we address the market’s need for low endotoxin and highly purified solubilizers,” comments Vaios Barlas, Global Head of Health Care at Clariant.

The VitiPure LEX product line has been designed for customers who require stringent control of the microbial load in their formulations. These co-solvents have been optimized for sensitive applications, as well as for the safe use with a variety of APIs, including those with low water solubility.

VitiPure LEX 3350 S and VitiPure LEX 4000 S not only surpass the general pharmacopoeia monograph requirements, but they have also been risk-assessed in their production for their use as excipients in parenteral applications. In addition to the general monograph requirements, specific microbiological aspects have also been certified.

Polyglykol 1450 S is an alternative polyethylene glycol co-solvent specified according to the current USP-NF monograph, which is additionally meeting the monoethylene and diethylene glycol limits recommended by the corresponding FDA guideline on this topic. Polyglykol 1450 S is produced under IPEC GMP conditions in the form of flakes, which allows easier handling during production. This product surpasses current international pharmacopeia requirements.

The VitiPure Superior line offers nearly colorless excipients and hence adds no color to the final formulation due to its ultra-low residual impurities. Additionally, this line is suitable for APIs that are sensitive to residual impurities and for formulations that require low microbial loads with low endotoxins. VitiPure Superior products are highly-purified excipients, suitable for parenteral formulations. VitiPure CO 35 Superior is addressing the parenteral application where the highest purity of the excipient is required (e.g., Paclitaxel, Phytomenadione, Valrubicin, Ciclosporin, Ixabepilone, Plitidespin, Teniposide, and Utidelone). VitiPure O 80 Superior and VitiPure L 20 Superior are additionally appropriate for the stabilization of human and veterinary vaccines and biologics.

Compared to the standard excipient grade, all three Superior products improve the stability of the finished API formulations. In addition, the steel packaging with nitrogen purging assures low levels of peroxide formation during product storage.

Clariant has developed Meglumine for sensitive formulations where both a low bioburden and low endotoxin grade are required (microbial load: endotoxin max. 1.5 IU/g, TAMC max. 50 cfu/g, TYMC max. 10 cfu/g). This solubilizer can be used as a counter-ion in contrast media (as an alternative to sodium), a buffering agent, and a bioavailability and solubility enhancer of mildly acidic APIs. Due to its low microbial load, Meglumine LEX is suitable for parenteral applications.

Clariant has developed VitiPure HCO for tablet formulations as a lubricant or sustained-release agent (e.g., for APIs such as Clopidogrel, Benazepril, Misoprostol, Ropinirole, Felodipine, Diclofenac, Hydrochlorothiazide, Tadafil, Cefuroxime, etc.). Additionally, VitiPure HCO is suitable as a consistency factor for topical formulations (e.g., for APIs such as Lidocaine, Prilocaine, Betamethasone, Calcipotriene, Urea, Tacalcitol, Hydrocortisone, Minocycline, Glycyrrhetinic acid, etc.). The consistent particle size distribution is well-suited as a tablet lubricant for applications where a hydrophobic lubricant is needed or as a replacement of magnesium stearate. Therefore, this product is suitable for processing through direct compression or dry granulation.