For Immediate Release:
What the NEW Dietary Supplement GMPs still Lack
In the previous Quality Alert, we introduced you to excipients – the ‘other’ ingredients found in many dietary supplements, which play an important role in maintaining a supplement’s consistency and bioavailability. In short, it’s effectiveness.
But what if your manufacturer doesn’t formulate for or test bioavailability? Are you confident that a product releases key nutrients for absorption by the body without data to prove it? We’re not!
Bioavailability Testing = Available Nutrients
Bioavailability is simple. It is the rate at which key nutrients are released by a supplement for uptake by the body. And it’s even more important than the level of a nutrient in a supplement. If the supplements you purchase don’t release the key ingredients when and where you need them, your body simply won’t benefit.
FDA-Registered Drug Facilities Test Bioavailability
Although the new dietary supplement GMPs are a great leap forward, there are still a few areas where their requirements are lacking. Bioavailability is one of them… There are NO requirements. None!
Supplements manufactured under drug GMPs, on the other hand, confirm product bioavailability through disintegration and dissolution testing. These tests, which have established methods in the United States Pharmacopeia (USP), ensure a supplement releases key components when necessary for optimal nutrient absorption and assimilation. Learn more about these tests below.
But My Capsule Doesn’t Dissolve in Water!
Some consumers, who understand the importance of bioavailability, have tried to mimic standard tests at home. We’ve heard it all… Soaking supplements in water or lemon juice to see if they break down… Crushing the tablets and putting them in vinegar to see if they fully dissolve.
These tests don’t work!
Because specific conditions and equipment are necessary to mimic the temperature, enzyme content, churning action, and acidity of the stomach, it’s important to remember that bioavailability tests can’t be accurately performed outside of a laboratory setting. Some people believe that placing a tablet or capsule in a liquid (water, juice, or vinegar) or baking it at high temperatures will mimic conditions in the human body. But these are unscientific and inaccurate attempts. You won’t reach any accurate conclusion about dissolution and disintegration in the human body with this type of "test."
Give ‘em a Bath: Disintegration and Dissolution Testing Defined
Dissolution and disintegration are laboratory techniques to validate whether capsules and tablets break down and release the nutrients they contain within the stomach. Both procedures involve a bath that mimics the environment of the human stomach. The type of bath that is used for tablets or capsules varies according to the acid or enzyme concentrations listed in the U.S. Pharmacopeia (USP).
Dissolution (USP <711>)
is a regulatory test that is performed on any product that contains vitamins and/or minerals. After the tablet or capsule has been immersed in the bath for a specific amount of time, a liquid sample is extracted, and it is analyzed for the presence of the target vitamin or mineral. Various analytical methods are used in this process.
Disintegration (USP <701>)
testing involves placing the tablet or capsule in a specific type of bath and observing how long it takes the tablet or capsule to break down.
Specialized equipment only, please…
Because specific conditions and equipment are necessary to mimic the temperature, enzyme content, churning action, and acidity of the stomach, it is important to remember that these tests just can’t be accurately performed outside of a laboratory setting. That is, putting a tablet or capsule in water and timing the breakdown process is simply not an accurate method. Real tests go well beyond that—which is why we perform them.
Bioavailability is a True Measure of Quality.
A supplement formulated to be bioavailable can be trusted to release the key components when and where they should. In short, your body will be able to absorb and utilize the nutrients in a bioavailable supplement for optimal results and consistent benefits. Bioavailable means pill to pill, bottle to bottle you can trust the supplement to deliver safe, effective results every time.