Clariant, a sustainability-focused specialty chemicals company, announces new additions to its portfolio of high-performing pharmaceutical ingredient solutions to support the evolution of safe and effective medicines. At CPHI Barcelona, Clariant will unveil three new VitiPure® excipients allowing for a multitude of Active Pharmaceutical Ingredient (API) formulations and administration routes, even for sensitive ones, such as mRNA vaccines and biologic medications, establishing it as a one-stop shop solutions provider to the industry.

“We’ve built on our proven track-record in supporting pharmaceuticals’ production to create a new Health Care Business Line with a broader portfolio of solutions for the industry’s developing technologies such as the injectables segment. With our new excipients, we address the market’s growing trend for high-purity ingredients, by solving inherent stability and bioavailability[1] [TP: see comment above] challenges of Active Pharmaceutical Ingredients so that they can travel to where needed inside the body and be delivered effectively,” comments Michael Haspel, Global Head of Segment Personal, Home & Health Care at Clariant.

Two high-purity grades will make their debut at CPHI, both purified via a patented process to minimize residual impurities in the product:

VitiPure O 80 Superior is a highest quality, low microbial load Polysorbate 80, with low residual impurities, colorless and odorless, offering high stability to APIs. It is a nonionic solubilizer, emulsifying agent and stabilizer used in applications where highest purity requirements are demanded to improve the stability and color of end formulations. Typically, VitiPure O 80 Superior could be best suitable for biologics molecules administered via parenteral drug delivery systems where the API is sensitive to any impurities potentially coming from the excipient.

VitiPure CO 35 Superior is a Polyoxyl 35 Castor Oil with low residual impurities, colorless and odorless, with low microbial load and improves the stability of APIs. It is non-ionic solubilizer typically used in parenteral application where the end formulation should be colorless, and the API is sensitive to impurities from the excipient.

Through launching these highly-purified products, Clariant is unique in offering its customers the flexibility to choose from three different levels of purity for Polysorbate 80 and for PEG 35 castor oil: standard, low microbial, and highly purified options. This offers flexibility to select the most relevant solution for the needs of a specific application level, such as oral, topical, or parenterals.

Also new at CPHI, VitiPure Meglumine LEX, a low-endotoxin and microbial-load grade of Meglumine. It is used as a counterion in contrast media sector, as buffering agent/alkalizer and solubilizer for mild acidic APIs. Applications include oral solid and liquid formulations. VitiPure Meglumine LEX is suitable for formulations where low bioburden and low endotoxin grade is desired.

In line with providing robust regulation support to customers, Clariant offers a detailed investigation report on Nitrosamines analysis for this product as per the existing guideline due to the presence of Nitrogen group (-N-) in its molecular structure. The analysis verifies that it is produced with the most stringent quality standards.

“Our strong focus on quality assurance and years of experience in regulatory affairs through long-standing production of APIs and excipients guarantees best risk assessment for our products, for our customers in their pharmaceutical developments,” adds Vaios Barlas, Global Head of Health Care at Clariant. “At the same time, we are soon opening our Health Care application labs, first in January 2024 in Frankfurt Germany at the Clariant Innovation Center, and afterwards in New Providence, New Jersey, USA, to support our customers in tackling their challenges with hard-to-solubilize APIs. We are all set for collaborative work with our customers.”

Clariant offers an extensive range of Pharmaceutical Excipients for effective solubilization, bioavailability enhancement, controlled release, stabilization, continuous manufacturing, preservation, rheology modification and viscosity enhancement. These complement its range of Polyglycols used as APIs in Laxative formulations and in ophthalmic medicines.

All Clariant Health Care ingredients are manufactured according to IPEC-PQG or ICHQ7 Good Manufacturing Practice (GMP), and supported by dossiers for qualification, registration, and risk assessment as per current EMA / FDA regulatory guidelines.

For more information on Clariant’s one-stop shop solutions for excipients, visit the team at CPHI Barcelona, Spain, October 24-26, 2023, at Stand 5C29 (zone Excipients).

VitiPure® IS A TRADEMARK OF CLARIANT REGISTERED IN MANY COUNTRIES.

[1] Bioavailability describes the effectiveness of a drug to enter the body’s circulation; difficult to absorb actives require solubilizers or emollients to make them absorbable at site of action.

 

Source:clariant.com

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