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Safety by Design to Target Patient Adherence - Part 1

Each year, the U.S Food and Drug Administration (FDA) approves new solid oral dose prescription medications – and according to reports by Pharma Circle around 25 percent of those dosages are still white tablets (although the numbers are declining).

Add these new drugs to products already on the market, and it quickly becomes clear why the pharmaceutical industry is paying greater attention to the purposeful design of tablets and capsules.

Why smart design works in every party’s best interest

Poor design can cause numerous headaches for the pharmaceutical industry. In 2017, the FDA removed nearly 2,000 drugs and biologics from public use — recalls that hurt sales, damaged the important relationships companies built with customers, and disrupted both supply and supply chains. Poor design also can prompt the FDA to reject regulatory submissions.

And there’s a heartbreaking human cost to poor tablet and capsule design. A landmark report from the Institute of Medicine examining human error as a leading cause of death found that some 7,000 people die each year (USA) because of medication mistakes made within the health-care system.

Adding to this tragic loss of life, the World Health Organization (WHO) reports that prescription drug errors cost US$300 billion annually in avoidable medical waste.

Recently, both the FDA and European Medicines Agency (EMA) issued guidance encouraging patient perspectives to be considered when designing tablets and capsules, a practice the pharmaceutical industry now calls “Safety by Design.”

Whether you call it safety by design, or purposeful pharmaceuticals, your Colorcon BEST® team can help you choose the perfect color and shape to distinguish your product, designed with improved patient safety and medication compliance in mind.

Our experts also offer these tips to help you make informed decisions about tablet design early in the development process.

Tip 1:  Differentiate Multiple Dosage Strengths

As our population ages, polypharmacy is becoming more commonplace. Currently, about 15% of the U.S. population now takes five or more prescription medications.

So now more than ever, it’s increasingly important to create easily distinguished tablets. Similar looking tablets — especially plain white ones — can be readily confused by patients, pharmacists, caregivers and even manufacturers.

One recent example involving a company’s voluntary nationwide recall of generic phenobarbital tablets occurred when it was discovered that a bottle containing 30 mg tablets were mistakenly labeled as 15 mg tablets.



C.O. Truxton, Inc. voluntarily recalled white phenobarbital tablets (30 and 15 mg strength). The 15 mg tablet is debossed with “West-ward 445” on one side and blank on the reverse side; the 30 mg tablet is debossed with “west-ward 450” on one side and scored on the reverse side.

By changing the color and/or shape of the tablet, mislabeling could have been detected prior to distribution.

Tip 2: Choose Colors Carefully

When drug manufacturers are producing multiple dosage strengths, regulatory agencies will look to ensure the color differentiation is clear to medical personnel and lay persons alike.

Recently, a major pharmaceutical manufacturer requested Colorcon’s help with tablet design after their initial submission to the FDA was rejected; regulators said that the doses were too similar in appearance. Judge for yourself.

Keeping end users in mind when designing a tablet is crucial: Even the very best medicine is useless if it isn’t taken as intended.

Rejected submissionpills rejected 2

Approved submissionpills aproved 2

4WD Dispersion Prep quote AL 300x400 green

Tip 3: Research Approvable Color Options

Colorcon knows all about colors and ingredients. With a library of more than 60,000 successful coating formulations, there’s a wide spectrum of opportunity to add color. However, the pigments, ingredients and regulatory requirements for use will define what is approvable for your final use in either pharmaceutical or nutritional products.

Our online Color Selector, available to registered Colorcon website users, provides a great starting point to explore color choice. Once a sample request is submitted, you’re in the hands of the Colorcon expert closest to you. Our specialist will work with you to confirm the right coating system to meet your functional needs and check the acceptability for your application and target market.

color selector

Connect with Colorcon to determine the BEST way to differentiate your product and satisfy regulatory requirements.

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