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Navigating the Maze of Global Pharmaceutical Regulations.

When a pharmaceutical company wanted to change the color of a tablet they were manufacturing, they faced a number of challenges. Adding color to a pharmaceutical product is a complex process, and many colorants are not approved for pharmaceutical use. Since every pharmaceutical product is subject to strict regulation and certification from the very first stages of product development, a change in formulation, even if it's just a simple change in color, initiates a stringent review and testing process. In the past, most pharmaceutical products were white. Technological advancements that began in the 1960s have allowed the development of unlimited colors and combinations for every application, and now coloring is an important part of pharmaceutical manufacturing for a number of reasons, but primarily for identification purposes. With the world’s aging demographic, the ability to visually discern one pill from another has become a crucial public safety issue.

But adding color to a pharma product isn’t just a matter of throwing in a bit of dye. There are many colorants that are not approved for pharmaceutical use. Every pharmaceutical ingredient undergoes rigorous testing for a number of qualities individually, and again in combination with other ingredients before a product can enter the global health care system.

Univar Colour is an EMEA-based division that helps manufacturers with their color formulations, with a focus on food, personal care and pharmaceutical applications. Our Colour group works out of a state-of-the-art dedicated technical and laboratory facility, blending custom specialty colors and providing technical support and assistance in legislation and industry regulatory issues.

They're experts in color technology, and offer a range of products specifically suited to the pharmaceutical industry, including glycerine pastes, iron oxide blends, printing inks and lake dispersions, each of which can be tailored to specific formulations.

A particular challenge of pharmaceutical colorants is that pharma manufacturing facilities are clean and sterile by nature (think white and stainless steel), and even a small amount of a colorful powder introduced to such a facility will within minutes contaminate the area. And since pharmaceutical applications use minute quantities of colorant, and precision is key, weighing also becomes an issue. Our Colour group's ability to prepare color dispersed onto specific substrates such as salt, alumina, sugar, lactose, silica or maltodextrin, gives pharmaceutical companies exacting control over color content in a formulation, and allows them to process color without risk of powder contamination of their facilities.

When the pharmaceutical company approached Univar about the color formulation for their tablet, the first question our Colour team asked was "Where will the product be distributed?" Not all colors approved for pharmaceutical use in the EMEA countries are approved for use by the USA’s Food and Drug Administration, and determining the geography in which a product will be sold dictates how the formulation and documentation process will proceed.

Univar Colour's usual first line choice for diluting color is salt. But the customer had already registered a previous and similar product with a sodium sulfate-based formulation. The Colour team recognized that altering the color of the new tablet would be a simple matter if they stuck with the sodium sulfate base–the customer could avoid starting at the very first step of the registration process for the new product. Using a sodium sulfate substrate would keep the regulatory process more manageable, and reduce the product's time to market.

Since the approval process is rigid, the Univar Colour team would have to be flexible. They had recently formulated a very similar color with a salt substrate, so the percentages of colorant required were already established. The color formulation then became a simple matter of incorporating the colorant into the sodium sulfate base. Because Univar Colour was able to formulate a color compatible with the previously registered product, the customer was able to eliminate much of the development process, and after an abbreviated testing period, the product is now available commercially.

Univar's understanding and expertise in the pharmaceutical regulatory arena is why the pharmaceutical industry looks to Univar for colorants, excipients, APIs, process aids and solvents. The assistance our Pharma and Colour teams provide goes well beyond a comprehensive portfolio of ingredients, though. We offer administrative efficiencies including lot control, change management and documentation, even third-party supplier audits for excipients to IPEC guidelines, delivering a rainbow of products and services to the pharmaceutical industry.