Episode 8: Colors of Capsules

Capsule Manufacturing: It’s Not Only What’s Inside That Counts

The recent EU ban on Titanium Dioxide and changing customer habits are shaking up capsule production.

Over the past few years, the coloring and manufacturing of pill capsules have undergone significant changes due to new EU regulations and customer demand for natural ingredients. And while originally invented to mask and protect the contents inside a capsule, research suggests that the color of a tablet or pill can affect how patients feel about their medication.

Until recently, manufacturers have primarily used Titanium Dioxide (TiO₂) to create white capsules due to its efficiency in protecting the active ingredients from UV rays. However, this year an EU-wide ban on TiO₂ has forced the industry to move towards alternatives that work as well, or better, than TiO₂. To add to the colorant shake-up, many people are actively avoiding unnatural ingredients in their food and nutritional supplements, which has created a new demand for plant-based capsule colorants. Anticipating these changes and solving the technological challenges in a timely manner are key to a successful long-term strategy for capsule manufacturing.

Curious to Know More?

Listen to the conversation between A View On host Martina Hestericová and Ljiljana Palangetic, Lonza’s Associate Director of Hard Capsules R&D, about the challenges and solutions in current capsule manufacturing.

 

KEY TERMS IN CONTEXT:

Pharmaceutical capsules can be either hard or soft. Soft-shelled capsules are one unique mold that encapsulates the contents, whereas the more widely-used hard-shelled capsules—such as the ones produced by Lonza—are two molded telescopic pieces of capsule: a smaller one contains the active ingredients, and a larger one encloses the capsule.

Titanium dioxide (TiO₂) is a widely-used pigment in capsule manufacturing, as well as in food, paint and sunscreen. Considered completely inorganic and nontoxic from a chemical point of view, it is labeled as an unnatural ingredient for ingestion, and carries the E number E171. Earlier this year, the European Food Safety Authority (EFSA) announced a six-month phasing-out ban of the colorant over concerns about nano-sized particles of TiO₂ accumulating in the body. The full ban takes effect in August.

The dip molding process is the manufacturing process for capsules. The final shape of the two pieces that make the capsules is defined by specifically designed molds, which are dipped in a bath of liquid formulation to pick up material that will, after the drying process, give the final capsule form, shape and composition.