Magnesium Stearate: What is it doing in your supplements?

[BABY1]

TweetMagnesium Stearate - What is it?

Magnesium stearate is a white substance, solid at room temperature, used in the manufacture of pharmaceutical and supplement tablets and capsules. It is composed of magnesium and stearic acid, and oftentimes, palmitic acid as well.

Why do so Many Companies add it to Their Supplements?

The primary role of magnesium stearate in supplements is to act as a lubricant to prevent tablet and capsule contents from sticking to the machinery that processes them. This ensures that production machinery can operate at maximum speeds and profit targets can be met. In other words, it is primarily used for financial reasons. Read a detailed explanation of magnesium stearate’s role as a lubricant in manufacturing facilities.


What are the Pros and Cons of Magnesium Stearate?

Pros

The pros are for manufacturers that want to improve profit margins. It is far more costly and time-intensive to produce supplements without magnesium stearate.

Cons

Reduction of dissolution time

It is commonly noted in medical literature that magnesium stearate increases the time it takes for tablets and capsules to dissolve due to the film it forms on capsule or tablet ingredients. Magnesium stearate coats a good portion of the molecules in a tablet or capsule, requiring digestive enzymes to break down the magnesium stearate coating before being able to access the nutrients it envelops.

In a study published in the journal Pharmaceutical Technology (April, 1985), the percent dissolution for capsules after 20 minutes in solution went from 90% without stearates to 25% with stearates. In other words, stearates reduced the rate the capsule dissolved by 65%! This may result in the nutrients not dissolving in the appropriate section of the intestines as intended. We are particularly concerned about individuals with impaired digestion who may have more difficulty absorbing nutrients coated with magnesium stearate.

Are There Metal Catalysts in Your Supplement?

Hydrogenated oils are a common source for the magnesium stearate used in pharmaceuticals and supplements. The stearates are made by hydrogenating cottonseed or palm oil. Cottonseed oil has the highest content of pesticide residues of all commercial oils; cotton crops are heavily sprayed. In the hydrogenation process, the oil is subjected to high heat and pressure in the presence of a metal catalyst for several hours, creating a hydrogenated saturated fat. Hydrogenated vegetable fats contain altered molecules derived from fatty acids. According to Udo Erasmus in Fats and Oils, the metal catalyst used in the hydrogenation process may also contaminate the stearates produced.

Source Country

The vast majority of magnesium stearate in supplements comes from China. At Dr. Ron’s Ultra-Pure we have a policy of not using any ingredients from China due to the long list of contaminated ingredients and products coming from China in recent decades, including melamine-tainted baby formula which resulted in hundreds of babies being hospitalized and melamine-tainted pet foods in which thousands of pets were reported to have died, among other tainted items. In 2007, product safety institutions in the U.S., the European Union and several other countries, imposed import bans on many products produced in mainland China due to a confidence crisis. We prefer to work with manufacturers in countries with an excellent history of product safety. We are not saying that every supplement containing magnesium stearate sources this lubricant from China, but China just happens to be a major source of the ingredient. And this does not meet our quality standards for Dr. Ron’s nutritional supplements. We would certainly be happy to consider ingredients from China (although not additives!) if and when the manufacturing industry in that country develops a history of safety and quality.

Contamination

In December 2011 The World Health Organization reported that several batches of magnesium stearate were cross-contaminated with zeolite (sodium aluminium silicate), calcium hydroxide, dibenzoylmethane, bisphenol A and Irganox 1010. While some of these substances may not be harmful, as is the case with zeolite, others are known to be harmful, such as bisphenol A (BPA). The industrial chemical BPA is an endocrine disruptor and has been found to have other harmful effects. The European Union has banned its use in baby bottles and several consumer groups in the U.S. have petitioned the FDA to ban its use in food containers. But whether or not the contaminants found in the magnesium stearate are benign or harmful is not the issue. The issue is that it was contaminated at all.

While we don’t know the percentage of supplements in the U.S. that are contaminated, according to a New York Times article “Nearly all of the herbal dietary supplements tested in a Congressional investigation contained trace amounts of lead and other contaminants…” There have also been news stories over the years about contaminated supplements, such as heavy metals in 20 percent of Ayurvedic herbal products tested in the Boston area in 2004. Clearly, contamination is an issue of concern.

Do You Know What You’re Putting into Your Mouth?

While magnesium stearate is certainly not the only supplement ingredient ever found to be contaminated, the potential for contamination is just one more reason to avoid it. If you do wish to consume supplements containing magnesium stearate, it would be a good idea to ask the manufacturer if they batch-test the supplement for purity. If not, then you really don’t know what you are putting into your mouth.
While we believe that contamination is a concern, we do not support stricter government regulations on dietary supplements due to contamination issues.


Remember, the sole purpose of using magnesium stearate is to make the machines go faster. Supplements can be made without them – it just takes more time, care and attention to detail. Our exclusive process yields absolutely pure supplements – no lubricants, binders, flowing agents, fillers, dyes or additives of any kind – only the pure nutrients.

[BABY1]

Tweetthis is causing my problems with my stomach and mouth. It is in most supplements and meds too. I can longer have any supps with this in it or meds either...at least for awhile. So now I need to get supps without this added filler and they are out there but cost more. same with meds, I have to take liquid form or non generis sometimes do not have this. Amazing what some shit can do. Maybe this is why I am allergic to Fuzo if he sweats out cottonseed oil,lol.

[MOUNTAIN-MAN]

TweetThanks for that info I did not know about it esp in meds

[BABY1]

TweetIs magnesium stearate safe to use as a supplement excipient?

There is much debate among supplement manufacturers, practitioners and the general public on the use of magnesium stearate and other excipients. Many say that it is not toxic and fine for use in foods and food supplements, while others say the opposite.
We firmly believe that excipients such as magnesium stearate should not be in food supplements due to toxicity and reduced bioavailability. Please don't just accept this, take a look for yourself . . . but before you do lets take a scientific look at precisely what magnesium stearate is.
What is magnesium stearate?

Magnesium stearate is a lubricant, a salt containing two equivalents of stearate (the negatively charged anion of stearic acid) and one positively charged magnesium cation (Mg2⁺). Magnesium stearate is also called octadecanoic acid and magnesium salt. Magnesium stearate is not soluble in water and has hydrophobic properties, meaning that it is water-repelling. Its chemical formula is Mg(C₁₈H₃₅O₂)₂ and it is a very fine white powder with a soapy texture.
What is magnesium stearate used for?

The main use of magnesium stearate is in the manufacture of tablet, capsule and powder supplements. It is added to formulations to improve the flow properties of the powder, this also helps to compress the tablet without sticking to the mold and machinery parts whilst improving clean down time. Magnesium stearate is typically used in a concentration range of 0.25% to 2% but we have heard of it being used up to 5%. High values can result in decreased absorption of the product; in the pharma industry it is widely known that magnesium stearate prolongs disintegration.
What is magnesium stearate derived from?

Magnesium stearate is made from bovine and vegetable sources. The vegetable source is made by hydrogenating cottonseed or palm oil. Cotton crops are heavily sprayed and have the highest content of pesticide residues of all commercial oils. In the hydrogenation process, hydrogen gas is forced into the oil at high pressures in the presence of a metal catalyst for a few hours. Hydrogenated vegetable fats contain altered molecules derived from fatty acids (trans fat) and many scientists believe these carry serious health risks.
Discussion

Is magnesium stearate safe? The information in the above paragraphs certainly flags up the need for caution in using magnesium stearate. To reiterate:

• Toxicity; cotton crops are heavily sprayed and have the highest content of pesticide residues of all commercial oils.
• Hydrogenation; hydrogenated vegetable fats contain altered molecules derived from fatty acids (trans fat) that have serious health risks.
• Reduced bioavailability; decreased absorption of the product.

Increasingly health conscious people are aware of the problems with pesticide toxicity and usage of hydrogenated oils, but few are aware of the issues involving supplement excipients such as magnesium stearate. A component of magnesium stearate is stearic acid. Research shows stearic acid suppresses the body's natural killer cells, a type of lymphocyte (a white blood cell) and a component of the innate immune system. It produces a reaction in the gut to form a film or lining that works as a barrier that stops or limits the absorption of nutrients.* Stearic acid may prevent absorption by individuals with compromised digestive systems. Magnesium stearate and stearic acid also present the problem that delivery of the active ingredient may be considerably further down the intestinal tract than the site originally intended. This may result in the nutrient being delivered away from its optimal absorption site. Not only can this impede absorption, in some cases it might be harmful to the liver.** The addition of palmitate or stearate to cultured cells led to activation of a death program with a morphology resembling that of apoptosis. Palmitates and stearates caused cardiac and other types of cells to undergo programmed cell death.***

To achieve the correct flow properties magnesium stearate has to be thoroughly mixed with the active ingredients and in doing so magnesium stearate coats a good percentage of the molecules of the ingredients. This then requires digestive enzymes to first break down the magnesium stearate coating before being able to assimilate the nutrients, which has a negative impact for people suffering with digestion problems, the sick and elderly.
Disintegration Time (DT)

The standard disintegration time for immediate release oral dosage forms is generally within 15-30 minutes once in the stomach. One way to investigate the bioavailability of a supplement is to fill a glass with white vinegar (as this mimics stomach acid) and drop in a tablet or capsule. If the supplement does not dissolve or fully disintegrate within 30 minutes this will impact on the nutrients the human body is able to assimilate in the appropriate section of the intestines as intended.
We manufacture our own supplements without magnesium stearate

At Health Leads the quality of the product is paramount, not just the returns, so we will not use magnesium stearate or any other industry standard excipients that we believe to be detrimental. Many supplement manufacturers use magnesium stearate solely because it enables the faster production of supplements - saving a great deal of money - but at what cost to nutritive values.
In choosing to manufacture our own additive free supplements, we go to great lengths to ensure the best available ingredients are used. There are a few nutritional supplements where it is not possible to fill capsules with only the active ingredient, in these cases we use organic rice flour. With our supplements we fill each capsule to the brim with the best ingredients, putting purity & quality first because we care about our customers.


Ref: * Molecular basis for the immunosuppressive action of stearic acid on T cells. Immunology. 1990 July; 70(3): 379?386. PMCID: PMC1384169
Ref: ** Czap, AL. Townsend Letter For Doctors and Patients, July 1999, Vol.192; Pg. 117-119.
Ref: *** Sparagna, GC, Hickson-Bick, DL, Department of Pathology and Medicine, University of Texas Health Science Center, Houston. American Journal of Medical Science, Jul 1999; pg. 15-21.
Ref: https://www.carterpharmaceuticalconsu...facturing.html
Ref: https://www.integratedhealth.com/excipients.html
Ref: https://www.pharmainfo.net/tablet-rul...lation-tablets