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Safety by Design to Target Patient Adherence – Part II

If you’ve ever had trouble swallowing a tablet or capsule — feeling like it got “stuck” in your throat —you are not alone. In a survey conducted by Harris Interactive,1 more than 40 percent of adults reported having trouble swallowing prescription medication.

That difficulty, in turn, can cause patients to not comply with prescription drug regimens.

The World Health Organization (WHO) reports that poor patient compliance can lead to additional medical costs and adverse health outcomes, which is why regulators around the world have decided to step in.

Recent guidance from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) highlights the importance of “Safety by Design,” drawing attention to tablet dimension, coating and appearance.

As we shared in our last Connect with Colorcon post which was focused on color, tablet design can influence product differentiation, and affect patient acceptability and compliance.

The regulatory agencies also consider ease of swallowing and patient compliance important issues for manufacturers to address, taking into consideration:

  • Tablet size and shape
  • Tablet coating and color differentiation

By creating your dosage form with the patient in mind, following the tips below, you can make a tablet easier to swallow, both literally and figuratively.

safety by design ii

Tip 1: Minimize size

Smaller is better. An FDA guidance on tablet design reports that complaints from patients about swallowing increase when tablets have diameters exceeding 8 mm. And the agency states that the largest dimension of a tablet or capsule should never exceed 22 mm.

So, how can you overcome the need to develop a large tablet?

In practice, formulators can address size by selecting ingredients and process to effectively minimize overall tablet weight and size. Even so, we know that dose strength, compressibility and other factors make it a challenge to keep tablet size down.

Tip 2: Streamline shape

Changes in dimensions can create a completely different feel of the tablet without altering the dosage size. Shape, diameter and thickness of a tablet can also influence patient perceptions.

Consider the three tablets seen in the image below. While each tablet is sized differently, they all weigh the same.

CwC Quote Rita Steffenino

Safety by Design to Target Patient Adherence

It’s important to know which design will suit patients more, since certain shapes and dimensions may be considered a choking hazard to some. Colorcon’s BEST tablet design service enables brand owners to make better-informed decisions on tablet design; saving significant development time and cost.

Tip 3: Helping the medicine go down

Coating makes the tablet easier to swallow and improves tablet mobility; this is recognized as even more important for elderly people (recent EMA guidance). And as far as coating goes, the glossier the finish and more slip it can provide, the better.

Are all coatings created equal?

The simple answer is no. Depending on desired outcomes, coating properties and functions, formulators need to make the right choice.

Let’s look at two sets of tablets of the same color, shape and size — but with different coatings.

This short video demonstrates that once wetted, the coated tablets on the left slide freely down the plate. However, the tablets on the right-side stick to the plate, and only one continues to move easily.

Even as more water is applied, the stuck tablets don’t budge.

Opadry EZ

HPMC-Based Coating

In real life, this could mean the tablet sticking in the throat or esophagus, where it could start to disintegrate and cause irritation. In patient populations with swallowing difficulty, this is a significant issue to address.

So, remember, when designing a tablet to ease swallowing, make it small — under 8 mm in diameter when possible, and always less than 22 mm. Make it oval shaped, or a shape with more rounded edges, and don’t forget the coating.

To preview your tablet designs and request film coated 3-D printed prototypes, Connect with Colorcon and work directly with our BEST tablet design experts to deliver a perfect finish for your drug products.

 
1 As referenced in FDA Guidance: (June 2015) Size, Shape, & Other Physical Attributes of Generic Tablets and Capsules