Maintaining Color Quality Control in Birth Control Pills Protects Patient Health

Color accuracy and consistency are absolutely essential in birth control pills. That’s because many types of birth control pills are color coded based on how much active hormone they contain. This unique color coding system helps birth control users distinguish between the different types of pills in the packet and encourages medication adherence; users can look at both the color and the order of the pills to ensure that they’re taking them as prescribed.

However, if a pharmaceutical company accidentally places these pills in the wrong order, or they fail to test for color consistency in their products, these mistakes could have serious consequences for the manufacturer and the user alike.

For this reason, pharmaceutical companies need to have reliable color quality control protocols in place when they color code their birth control pills. A state-of-the-art spectrophotometer can help you catch potential problems early, ensuring that your birth control pills are consistent in color from batch to batch. By making color quality control a priority, you can produce birth control pills that are effective and easy for your customers to use consistently every day.

Why Birth Control Pills Come in Different Colors

The primary reason birth control pills often come in different colors is that color-coding makes it easier for users to see which pills contain active hormone and which are placebos. Most manufacturers create a 28-day birth control regimen—the first three weeks’ worth of pills contain the hormones estrogen or progestin, while the last week of pills contains no hormones at all. While not all birth control pills follow this 28-day cycle, this is the most common birth control regimen.

Typically, in this type of regimen, manufacturers use two very different colors to make it clear which pills contain active hormones and which pills are placebos. Color coding encourages birth control users to take their pills consistently and in order; rather than skipping a week worth of pills every month, users take seven colorful placebo pills instead.  

However, for this process to work effectively, manufacturers must ensure that their placebo pills appear distinct in color compared to the active pills so that users don’t take the placebo at the wrong time.

The Risks of Incorrect Color in Oral Contraceptives

Consistent color in birth control pills isn’t just a matter of aesthetics; if the pills in a packet are placed in the wrong order, or the active pills are too close in color to the placebo pills, your customers will have a difficult time distinguishing one pill from another, putting them at risk for unwanted pregnancy and health complications.

For example, one birth control manufacturer recently recalled a large batch of product because the pills were placed out of order; the manufacturer accidentally placed the maroon-colored placebo pills at the start of the pack, when these pills should have been placed at the very end. If a user had taken the maroon-colored row of pills first, they would have been left without contraceptive protection and potentially compromised their health.

Users of this brand of birth control pills were able to notice this mistake precisely because the color of the placebo pills differed from the color of the active pills. If the two types of pills had been the same color, neither the user nor the manufacturer would have caught the problem. As such, accurate coloration can have significant protective benefits while color errors can seriously compromise patients’ adherence ability; without a clear distinction between the placebo pills and the active pills, users may not know which pill to take even when numbered correctly. You can prevent this problem by using a spectrophotometer designed to measure the color of pills and tablets.

The Benefits of the Aeros for Birth Control Pill Analysis

Pharmaceutical companies face different color quality control challenges depending on the type of birth control pills they manufacture. Each regimen can benefit from the advanced features of HunterLab’s Aeros spectrophotometer.

One-Phase Pills

One-phase birth control pills are the easiest to test for color consistency because these types of pills are all the same color. Every pill contains the same amount of active hormone, and the user never skips a dose, so there’s no need to use multi-colored pills in the packet.

To test these pills for color consistency, you can measure the color of a large sample of multiple pills using the Aeros, a state-of-the-art non-contact instrument designed specifically to handle non-uniform samples without the need for laborious sample preparation. This spectrophotometer is particularly suitable for pharmaceutical testing because you can non-destructively analyze a sample consisting of hundreds of pills at once; in fact, the Aeros has the largest sample area measurement in the world. Not only does this save you time, it also gives you a better sense of color accuracy and batch-to-batch consistency.

After you place your pills on the Aeros’ sample platform, the platform rotates as it takes multiple measurements of the sample. Once it captures these measurements, it averages them, providing you with an overall color reading for the whole batch. You can then compare this reading to your pre-determined color tolerance standards. Any batch of pills that falls outside of color tolerance can be disposed of right away and you can begin the process of isolating the ingredient or processing variables that caused the unwanted variation.

Two, Three, and Four-Phase Pills

Two, three, and four-phase birth control pills include multiple pill colors in each packet, differentiating between active and placebo pills and sometimes indicating varying amounts of hormone levels within active pills. Because color is an important adherence mechanism, color quality control becomes even more critical than in one-phase products. As such, choosing the right spectrophotometer should be a top priority for manufacturers.

Although maintaining accuracy and consistency of multiple colors is inherently more complex than it is in one-phase regimes, a state-of-the-art spectrophotometer can streamline your color measurement process. The Aeros allows you to create a different tolerance range for each type of pill, which can be easily stored and recalled using the instruments’ software. You can then measure your pill samples according to those color tolerance ranges on a Pass/Fail basis, ensuring that unwanted color variation is rapidly detected. The Aeros may be particularly beneficial for manufacturers of two, three, and four-phase pills because you can measure more pills simultaneously than is possible with other spectrophotometers, which can drastically reduce sample preparation and measurement time when working with multiple colors.

Spectrophotometers Help You Protect Patient Health

The advanced color measurement capabilities of the Aeros will not only help you make your birth control pills more aesthetically-appealing, but also encourage prescription adherence and indirectly improve the efficacy of your drugs. Studies have shown that color consistency makes users more likely to take their pills as prescribed, and as a result, the treatments become more effective. Adherence is especially important when taking birth control pills because a few missed or incorrectly taken pills could negatively impact the drug’s efficacy.

There are also a number of health risks and side effects that can arise when users take birth control pills incorrectly or inconsistently, which is why it’s essential that users know exactly which pill to take every day. By testing for color accuracy and ensuring that your active pills and your placebo pills are distinct in color, you can create birth control regimens that are easy to follow and highly effective, allowing users to take control of their reproductive health.

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HunterLab Quality

Are you ready to create a birth control packet that’s attractive, colorful, and easy to use? Contact us today to find out more about how the Aeros can help. This instrument is specifically designed to test the color of opaque pills and capsules, offering the pharmaceutical industry the most reliable color measurement results in the world.