How Film Coating Can Improve the Shelf Life of a Drug
May 22, 2024
Film coating significantly improves the shelf life of a drug by protecting sensitive active pharmaceutical ingredients (APIs) from moisture, oxygen, and light. These and other benefits explain why the percentage of coated tablets are increasing compared to uncoated tablets.
To better understand how film coatings work and what they do to protect drugs from degradation, we spoke with Annabel Bordmann, the General Manager of Film Coatings at Colorcon.
With over two decades of experience in the B2B pharmaceutical and nutraceutical industries, Annabel provides invaluable insights into the strategic use of film coatings and the importance of a holistic approach to pharmaceutical tablet preservation, and the future trends in coating technology.
Q: How do film coatings boost the shelf life of different types of drugs?
A: Film coatings improve three types of APIs. For your most sensitive API, you would have barrier coatings that improve shelf life. For your oxygen-sensitive API, you would have oxygen barrier coatings that improve shelf life. For photosensitive APIs that degrade with light, the opaque aspects of film coating improve shelf life as well.
So for these three applications – moisture, oxygen and photosensitive APIs – the coating definitely will improve the shelf life.
Q: What other things do pharmaceutical companies need to do to protect their APIs?
A: Film coatings are one part of a holistic approach, because obviously we want to also make sure the packaging and the core are also helping preserve the API.
If you have a moisture-sensitive API, coating will be one part of a holistic approach. Then the functional packaging will help with moisture management, and so will excipient selection. So coating is one tool in your toolbox – all three are important.
And it’s not just moisture – it’s the same for oxygen and light.
Q: Why is film coating better than sugar coating?
A: Film coating is easier to apply than sugar coating. Sugar coating is very manual. It’s very time-consuming. Film coating is quicker and more efficient.
Sugar coating does provide some moisture protection, but it is simply too labor-intensive. It takes manual skills, operator skills, and it takes time. Film coating, on the other hand is very easy to apply and it's less is less operator-dependent.
In fact, everybody wants to go with film coating these days. From what I see, the number of companies looking for sugar coatings are shrinking. Today’s pharma companies are struggling to find plants that do sugar coating. Film coating is where the future is going.
Q: What are some of the other benefits of film-coating tablets?
A: Another main benefit of film coatings is the patient experience. With film coating, the tablet is easier to swallow, but it’s also more glossy, so like there is a perception of easiness to swallow.
For patients who take a lot of drugs, with film coating you can have different shades and differentiate from one drug to the other. So you might have a blue one and light blue one and a red one. If everything was uncoated, it will all look the same and the patient will be less likely to adhere to the treatment.
Film coating can also help with branding. There are many different benefits that film coating provides.
Q: What does the film coating process look like?
A: The Opadry or Nutrafinish coating process is really easy to prepare compared with when the customer does it themselves. Essentially, You weigh whatever Opadry you need, then you mix it with water, wait for about 30 to 45 minutes, and then your solution is ready to spray.
So this Opadry concept is very easy to prepare compared to when you buy the individual ingredient, and then you just spray it onto your tablet.
Q: Why is it important to work with an experienced, global brand like Colorcon?
A: It removes the risk from the customer. We put their mind at ease because, for one thing, if they've got different production sites across the world, we can match them with our supplier. So if they produce in India, we can supply from India. If they produce in China, we can supply from China, and so on.
Using Colorcon is more sustainable because there is less movement across the globe. Also, the lead time would be shorter, so it's easier for the buyer to get organized with the stock. And then, in terms of quality, regulatory, and all of that, the customer can get some guarantee from us when it comes to product color consistency and only have to buy one raw material versus five if they make it.
Unlike some of our competitors, we do a long-term agreement with our suppliers that guarantees quality, capacity and making sure that we were sustainable in terms of being there in the future and being able to supply what the market needs in two years, five years, or 10 years. So we have this long-term view.
About the author: Annabel Bordmann is the General Manager of Film Coatings at Colorcon. She has over 20 years experience in B2B Pharmaceutical & Nutraceutical industries.
