Spectrophotometers Identify Counterfeit Pharmaceuticals With Color Measurement

The World Health Organization (WHO) in 2012 estimated that the global market for counterfeit pharmaceuticals generated $431 billion in gross annual revenues1 for purveyors of those fake products. Since then, WHO has stopped estimating the counterfeit industry’s revenues because of the difficulties in tracking fake prescription drugs. WHO is quick to note that the counterfeit pharmaceutical problem is not confined to developing countries with lax regulations. In 2014, the U.S. Food and Drug Administration (FDA) seized more than $73 million worth of counterfeit drugs, and since 2010, the FDA has tracked and recorded more than 1,400 incidents of adverse reactions caused by counterfeit drugs2.   

 

pills
Counterfeit pharmaceutical products run rampant through internet pharmacies. Image Credit: Flickr User Carlos Lowry (CC BY 2.0)

 

The prevalence of internet pharmacies has elevated the problem to near epic proportions. WHO estimates that more than half of all pharmaceuticals sold over the Internet are counterfeit3. Consumers that buy cheap drugs online, even when their purchases are made from internet pharmacies that appear in every respect to be legitimate, are taking great risks with their own health and safety. Counterfeit pharmaceuticals might be compounded from ingredients that range from inert to harmful or adulterated. Consumers cannot be faulted for attempting to save money on prescription drugs, but they are ill-equipped to detect counterfeit products and inevitably they rely on manufacturers and regulatory authorities to keep the fakes off of the market.

 

At an extreme, regulators and pharmaceutical companies can implement plans to test batches of pharmaceuticals at various stages of the global supply chain with gas chromatography and other sophisticated technologies4. These technologies will distinguish genuine products from knockoffs, but their broad implementation is expensive and impractical. Moreover, local regulatory agencies and shipping inspectors will not have the resources or access to complex analytical tools to implement the kind of widespread screenings that are required to snag every counterfeit pharmaceutical product. A more practical option is to use portable spectrophotometers for rapid early screening of both the pharmaceuticals and their packaging as the first line of defense against counterfeit drugs.

 

Tylenol
Pharmaceutical companies can impede counterfeiters by publishing precise color profiles of their labels. Image Credit: Flickr User Austin Kirk (CC BY 2.0)

 

Color and Pharmaceutical Packaging

 

Legitimate pharmaceutical manufacturers use advanced packaging with holograms, bar codes, and other features to confirm that the enclosed products are real. Packaging color is as critical an indicator of legitimacy as these advanced features.

 

Consumers generally avoid products with inconsistent or dubious packaging5, but consumers that purchase pharmaceuticals from internet pharmacies do not have the luxury of picking and choosing. Counterfeiters might take advantage of this by using cheaper printing and packaging materials. This leaves an opening for a legitimate manufacturer to publish a color profile for its own packaging. Screeners and regulators can then use portable spectrophotometers to measure a pharmaceutical product’s packaging for comparison against a manufacturer’s standard color profile. Any differences will be a first marker of counterfeiting that the regulator can then use to flag a batch for more advanced testing and verification.

 

Drug Color Consistency

 

Counterfeiters are becoming more adept at replicating the appearance of legitimate drugs, but subtle color differences between real and fake drugs are still a strong indication of a counterfeit product. Strict FDA standards on drug production result in products that have identical colors and appearances from batch to batch. Even more so than with pharmaceutical packaging, manufacturers can create color profiles for each of their products. They can then use portable spectrophotometers for quality control and assurance during a manufacturing process. Regulators can also use these devices to sample drug products in supply chains in order to weed out any products that are outside of that profile. Without their own spectrophotometers, counterfeiters will be unable to precisely match the exact profiles of the drugs they are emulating. Certain spectrophotometers can detect differences on UV wavelengths, which would be invisible to the naked eye. This makes color profiles even more difficult to fake without instrumental aid.

 

Using HunterLab’s Devices to Detect Counterfeit Drugs

 

HunterLab has long been at the forefront of providing appearance and color testing instrumentation to the pharmaceutical industry.  To measure both opaque substances at UV wavelengths, regulators can use the UltraScan Vis or Pro.

To learn more about which instrument would be ideal for your production process, contact our friendly, professional sales force today.

  1. “Deadly fake Viagra: Online pharmacies suspected of selling counterfeit drugs,” 2015,  http://www.cnn.com/2015/08/31/health/counterfeit-medications/
  2. “Counterfeit Drugs Are Flooding the Nation’s Pharmacies And Hospitals,” 2016, http://www.aarp.org/health/drugs-supplements/info-2016/counterfeit-prescription-drugs-rx.html
  3. “Rise in online pharmacies sees counterfeit drugs go global,” 2015, http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)00394-3/fulltext?rss%3Dyes
  4. “Countering the Problem of Falsified and Substandard Drugs,” https://www.ncbi.nlm.nih.gov/books/NBK202524/
  5. “Combat counterfeiting with packaging design and color consistency,” 2016, http://www.packagingdigest.com/packaging-design/combat-counterfeiting-with-packaging-design-and-color-consistency-2016-02-17

Measuring Color and Haze in Liquid Pharmaceuticals Protects Patient Health

 

The color of liquid medications can have a big impact on how patients perceive, experience, and take medications. | Image Source: Pexels user Pixabay

Last winter, in the midst of my worst cold of the season, color-coded mediation led me astray. Dazed, I reached into my medicine cabinet and popped a blue liquid-filled capsule out of its packaging, ready to get some symptom relief and finally be able to rest. But that’s not what happened. Rather than falling into a deep sleep, I felt jittery with unwanted energy and paced around my house in the early hours of the morning, unable to stay still. Sure, my cold symptoms were held at bay, but what I needed was rest. Confused, I returned to the medicine cabinet and took a closer look at the box of cold medicine. It was then that I saw the blue capsules were for daytime while the pale yellow capsules were for nighttime, the polar opposite of my feverish assumptions. That sleepless night made me appreciate the value of logical and correct medication color more than ever before.

 

Since the 1970s, pharmaceutical companies have increasingly recognized the value of color in medications. | Image Source: Pexels user freestocks.org

The Value of Color in Pharmaceuticals

 

Until the mid-20th century, virtually all pill pharmaceuticals were white and all liquid pharmaceuticals were clear.1 But in 1975, the introduction of soft gel capsule technology made it possible to produce vibrantly colored medications for the first time and the idea took off. Today, pharmaceuticals, particularly liquid forms, come in an endless array of hues.

 

This emergence of pharmaceutical color isn’t just about arbitrary aesthetics. The color of medication matters and it matters in multiple ways:

 

Shaping Patient Perception

The color of medication can have a significant impact on the expectations consumers have regarding efficacy and performance. A 2015 study published in Food Quality and Preference found that white headache medications were perceived as the most effective by respondents, while light green medications were assumed to be the least effective. Respondents also reported that they perceived red and light red pills to be the most stimulating and they expected light blue pills to have the most pleasing taste. Some also reported that they expected red and blue pills to be harder to swallow than pills of other colors.2 As such, pharmaceutical companies are increasingly interested in creating medications that enhance consumer perception through the creative use of color.

 

Shaping Patient Experience

Not only does the color of medication affect people’s expectations, it also affects what they actually experience. As Jill Morton of Color Matters notes, “Patients respond best when color corresponds with the intended results of the medication.” For example, blue sleep medications help people achieve better quality sleep than medications of other colors, even if the ingredients are identical. Thoughtful selection of medication color as it relates to each specific medication is, therefore, paramount to optimize efficacy and create the best possible user experiences.

 

Promoting Adherence

Colors can act as visual shortcuts to identifying pharmaceuticals, helping people who have difficulties reading labels or who are dealing with multiple medications easily pick out a particular medication on sight. As the population ages and comes to depend on a growing number of daily medications, pharmaceutical companies are increasingly implementing color-coding strategies in both packaging and in the design of the drugs themselves to facilitate adherence and minimize medication errors. Researchers have also found that maintaining consistency between brand name and generic medications is critical to decreasing rates of discontinuation, putting new pressure on manufacturers of generic drugs to prioritize the aesthetics of their products.[3. If Color or Shape of Generic Pills Changes, Patients May Stop Taking Them,” July 14, 2014, https://www.washingtonpost.com/national/health-science/if-color-or-shape-changes-patients-more-likely-to-stop-taking-much-needed-drugs/2014/07/14/60e687f4-0b8c-11e4-8341-b8072b1e7348_story.html ]

 

syringe with blue liquid
HunterLab’s Vista allows for simultaneous color and haze measurement, simplifying quality control procedures. | Image Source: Flickr user Sean Michael Ragan

 

Simultaneous Color and Haze Measurement

 

Liquid medications present opportunities for rich colors that enhance patient perception, experience, and adherence in ways we could not have imagined a century ago. The important roles served by these colors mean that color monitoring must be a critical component of quality control efforts throughout the manufacturing process. Spectrophotometric color measurement offers the best way of analyzing color behavior at all points of production quickly and easily. By capturing objective color data and instantly alerting you to unwanted color variation, you can ensure that only correctly colored pharmaceuticals are released into the marketplace. As a growing number of consumers come to rely on color-coding, this is essential for protecting public health and preventing medication errors as well as fortifying brand image.

 

But color is only part of the equation when it comes to liquid pharmaceuticals. Monitoring turbidity, or haze, is critical for creating medications with correct formulations and desirable physical attributes. Not only can the presence of haze point to a potentially dangerous process error such as incomplete dissolution, it can also compromise consumer confidence and cause confusion for those who rely on visual identification. As such, haze measurement is an essential part of quality control protocols. Today, advances in spectrophotometric technology allow color and haze to be analyzed together in a single measurement using revolutionary instruments such as HunterLab’s Vista. By measuring color and haze simultaneously, you can avoid time-consuming double measurements and reduce product waste. This is particularly important for those working with highly valuable, rare, or potentially hazardous materials, helping you minimize the number of samples necessary for accurate analysis and limit operator exposure to potent chemicals.

 

HunterLab Quality
HunterLab has been a leader in the field of spectrophotometry for over 60 years. Our renowned line of products has been developed in response to the needs of our customers in the pharmaceutical industry, helping us ensure that our technologies can be readily integrated into your quality control program. With the release of the HunterLab Vista, we are entering a new era of liquid color and haze measurement, opening up the door to more rapid, simple, and economical analysis. In doing so, we expand your ability to make innovative use of pharmaceutical color while safeguarding consumer health. Contact us to learn more about our comprehensive range of spectrophotometers, customizable software packages, and world-class customer support services.

  1. “The Color of Medications”, http://www.colormatters.com/color-symbolism/the-color-of-medications
  2. “Assessing the Expectations Associated with Pharmaceutical Pill Colour and Shape”, June 2015, http://www.sciencedirect.com/science/article/pii/S095032931500138X

What’s Really in Prescription Drugs? The Value of Impurity Analysis and Spectrophotometers

Impurity analysis is not only important for maintaining consistency and product quality. Patient safety and reliability are equally important, if not more so. Lawsuits against pharmaceutical companies have reached epidemic levels over the past decade, and the number of products recalled has increased accordingly. These figures are not only astonishing, but unacceptable and preventable. Safety and effectiveness are the top concerns for pharmaceutical consumers, and companies must make sure that they use the highest level of technology to assure patient safety and satisfaction.

Super Man and Kryptonite
The consequences of impurities may be greater than you think.
Image Source: www.glasbergen.com

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Color-Coding Technology: 50 Shades of Grey Pills?

Color-coding technology may be one of the most valuable tools to consider when it comes to prescription medications. The rainbow of pills lining the shelves of our local drug stores do not simply appeal to an eccentric and liberal palate; they are a product of color-coding technology that is used to provide security to both the patient and the healthcare industry. Pharmaceutical companies know the importance of quality control and color application in the production of prescription medications and the equipment needed to maintain safety. Spectrophotometers provide the essential piece of technology needed to monitor and develop pharmaceutical products that are easy to identify, which can play a crucial role towards eliminating the extensive margin of human error.

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