Turning Challenge into Opportunity
Let Colorcon help overcome the challenge of removing titanium dioxide (TiO2) from over-the-counter (OTC) products. Although this seems like a daunting task, it’s a great chance to enhance the consumer experience by improving swallowability and it offers the opportunity to improve color stability, opacity, and productivity for your products.
Importance of Film Coating for Tablets
For manufacturers, film coatings provide significant benefits like protecting the active ingredients from light, moisture, and oxygen and making tablets more robust for packaging and handling.
For consumers, adherence to treatment schedules is important. Managing smell, taste, and good palatability with film coatings helps to create successful outcomes. Consumers are better able to identify and remember the correct tablet for their treatment when they can recognize and associate tablet color with a brand, and a smooth and elegant finish makes tablets easier on the eye as well as easier to swallow.
Understanding the Challenge
TiO2 is an approved food color also used widely in pharmaceuticals. It plays a role in tablet coatings, acting as an opacifier, protecting active materials from light, and adding color.
Recently, the European Food Safety Authority (EFSA) declared that E171 (TiO2) could no longer be considered safe for use as a food additive, with EFSA pledging to exclude it as soon as possible. The industry will most likely see a ban in place before the end of 2021.
Although the ban impacts products designated as food, there is currently no requirement to remove TiO2 from pharmaceuticals. The Association of the European Self‑Medication Industry (AESGP) has formed an E171 task force interacting directly with the European Medicines Agency (EMA), requesting additional data on how much TiO2 is used, if there are replaceable materials and the impact on replacement.
Achieving similar opacity to TiO2 is challenging, which is why Colorcon has invested in developing a series of alternative formulations, including a Nutrafinish® Titanium-Dioxide Free Film Coating System, with excellent whiteness. Through our in-depth understanding of coating materials, we have been able to develop alternative formulations comparable in performance that are visually appealing.
One crucial factor to understand is photostability. Light can degrade active ingredients and fade pigments, in turn altering the tablet's appearance. Colorcon experts have studied tablets coated with TiO2 free formulations exposed directly to light, measuring the pigment against a reference standard on a spectrophotometer. An alternative coating containing calcium carbonate in place of TiO2 gives the best performance providing light protection and helping to minimize color change while improving stability and shelf life.
Turning Challenge into Opportunity with Change
For many OTC brands, this is an ideal time to enhance an existing product – gaining from the latest innovations in TiO2 free film coating, resulting in a better consumer experience.
Opportunity #1 - Improving Tablet Stability
Exposure to environmental moisture can lead to the degradation of sensitive active pharmaceutical ingredients, severely impacting the stability, and efficacy of the drug product. Film coatings can protect sensitive compounds from temperature and humidity excursions before packaging, including instances of bulk product storage, transport, or repackaging. This is an opportunity to improve product stability in primary packaging and ensure in-use product integrity.
Opadry® amb II is the top choice for moisture-sensitive drugs. Check out a recent case study to learn more about the Impact of Moisture Barrier Film Coating on the Stability of Amoxicillin/Clavulanic Acid Tablets. The results confirm Opadry amb II protects the integrity of moisture-sensitive compounds beyond the primary packaging.
Opportunity #2 - Enhancing Productivity
If productivity is a bottleneck in manufacturing, then Opadry® QX, quick and flexible coating, should be your first choice.
Opadry QX sets new productivity, efficiency, and appearance standards for coated tablets. The high solids and low viscosity ingredients of Opadry QX allow coating across a broad range of process parameters in any type of coating equipment, reducing preparation, and coating times, and delivering a premium quality finish. Through application at high solids levels (up to 35 percent), this results in a greater than 40 percent reduction in coating time. In-use flexibility across a wide range of processing parameters means products are easy to transfer from one production facility to another.
Colorcon offers a broad portfolio of products readily available to improve the consumer experience.
Watch this webinar to learn how to film coat your tablets. You will gain insights on how to:
- Improve swallowability
- Differentiate and add brand value
- Promote consumer adherence
- Enhance product stability and improve productivity
