The Importance of Formulation

An Example – Making Omega-3’s Work For You, Rather than Against You

Keith Block, MD

formulation

In our two previous blog articles we looked at supplement purity and supplement potency. In this article, we will take a look at supplement formulation.

When I formulate supplements for my patients, I often combine multiple nutrients into a single formula in order to more effectively target specific mechanisms. This has the added benefit of making the supplement regimen easier for patients to adhere to, since they are then taking a fewer number of different agents.

Back in the late 1980s, my colleagues and I began to explore and do scientific research into the role of dietary supplements as an adjunct therapy to conventional treatment. It was our contention – and the supporting science continues to grow – that a carefully designed supplement regimen could help patients not only restore their biological integrity, but reduce the side effects of treatment, and even boost treatment efficacy. (In more recent years, we have introduced nutraceuticals in order to address tumor-based molecular mutations and other promotional defects). We began using advanced lab testing to evaluate the blood levels of various nutrients and phytonutrients in our patients. The results of this testing quickly alerted us to the fact that some supplements clearly were not performing as well as others. Whether this was due to quality concerns, potency issues or a combination of both, I couldn’t be sure. However, this was a compelling motivation for me to begin formulating my own supplements. Additionally, the commercially available formulations were not designed specifically for cancer patients or the challenges they were facing. So, with the issue of quality uppermost in our minds, we sought out a manufacturing facility that meets the FDA standards for manufacturing pharmaceuticals. Here’s what we learned along the way.

Fish oil supplements are one example of a supplement that we learned early on can be prone to quality issues, and one that we have since addressed. As most food scientists can tell you, the omega-3 fatty acids in fish oil tend to oxidize quite rapidly upon exposure to air or heat, and oxidized fish oil confers few, if any, health benefits. Also, many of the fish oil products we looked at contained contaminants such as mercury and pesticides. This led us to focus on formulating a fish oil supplement with certain specifications. For example, while investigating the key quality issues with fish oil, we learned that fish caught in the north Arctic Ocean had minimal contamination with PCBs, heavy metals, and common pesticides.

We then opted to test each batch of fish oil with an independent laboratory to evaluate the levels of these contaminants. To further ensure that we met certain quality standards, we undertook careful processing of the fish oil using (1) low-temperature purification and encapsulation techniques, (2) nitrogen flushing to reduce the oxidation of omega-3 fatty acids, and (3) the inclusion of antioxidants to further minimize oxidation. We then elected to filter the fatty acids to develop a purer omega-3 product. Lastly, we decided to enterically coat the fish oil capsules. A capsule that is enterically coated is covered with a substance that does not degrade and release the capsule contents in the stomach; it only degrades when it’s in the intestine. Since the stomach is thus protected from the capsule contents, which can cause gastric irritation, one can largely avoid the fishy-smelling burps that so many consumers complain about when taking fish oil. This effect can be particularly disturbing to cancer patients and others who may have gastrointestinal difficulties due to their disease or medications.

Over the years, and after speaking to many patients, I am confident that this last adjustment has not only improved the consistency with which our patients take fish oil, but that our “healthy obsession” with quality has, in general, earned real dividends in terms of our ability to better serve our patients.

In our next supplement article, we’ll offer specific tips on assessing supplement quality, and take a closer look at safety information, stability, bioavailability and efficacy.

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