What is an excipient? Are the 'Other Ingredients' Really Necessary in Our Supplements?
We call them an ‘excipient’. We often receive emails here at Oxford Vitality about the safety and purpose of these ‘other ingredients’. What are they they for? Are they really necessary? Are they causing problems to our health? Simply put, the answer is ‘No’, here’s why….
What is an excipient?
An excipient is a non-nutritive ingredient used to bind the tablet and aid the flow of ingredients during production. There are a wide array of tablet excipients used for different functions these include:
- Glidants, etc.
Many of the nutrient/herbal/botanical ingredients used to make tablets come in powder forms of different textures, this means that they require tailored excipients to ensure a perfect tablet texture. Furthermore, it promotes consistency in the tablets texture and prevents degradation or damage.
What is Magnesium Stearate?
Magnesium Stearate is a salt form of Stearic acid, containing magnesium. Stearic acid, in its non-salt version is a long chain saturated fatty acid containing 18 carbons. Stearic acid is found naturally in foods such as, meat, fish poultry, dairy products, fruits and vegetables. Our stearate is sourced form plant form, in plant oils. This is then combined with magnesium to form magnesium stearate.
The role of magnesium stearate is to act as a lubricant and increase the efficiency of the production process. It prevents the ingredients from sticking together and causing blockages in the tablet machinery. Furthermore, its purpose in the body is thought to aid solubility and absorption. Some even claim that it helps the movement of the tablet through the gastrointestinal tract.
Magnesium stearate is the most common excipient used for this purpose because it is so effective [1,2]. However, there has been question as to its safety! What must be made clear is that it is non-toxic. When stearates enter the body they mainly convert to oleic acid. Although, it is technically a fat is has no threat to cardiovascular disease, unlike other fats. Chelated forms such as Magnesium Stearate found in our tablets have been approved by all the important bodies. Dr Sahelian stated,
‘“There is no evidence that small amounts of stearic acid are harmful.” [2,3]
It is believed that consumption below 2500mg/kg per day is considered safe in humans .
What is Microcrystalline Celluose?
Microcrytalline Cellulose (MCC) is a Tablet Dilutent, or a Filler. This enables the tablet to be made into form whilst housing the nutrient that you require. This eases drug administration as all the person is required to do is swallow the tablet. Its properties include anti-caking, emulsifier and bulking agent . It is very effective at creating the solid form that makes up the tablets, as its texture lends itself well to being compressed. Furthermore it is quick to dissolve thus releasing the nutrients within the tablet to be absorbed .
Chemically it is known as C6H10O5, and is colloquially referred to as wood pulp. Cellulose is a substance found in the cell wall of plants. It is what gives plants their plants a woody texture and snap. The product that we use is 100% pure plant extract.
There is very little suspicion as to the safety of MCC because it is so natural. Also, the Food and drug administration (FDA) have approved MCC, describing it as Generally regarded as safe (GRAS). One concern was that MCC may contain radioactive elements. Studies have been conducted and approved by WHO that state that following a 150g daily dosage no radioactive matte was found in urine of faecal samples .
What is Dicalcium Phosphate?
Dicalcium phosphate has a chemical formula of CaHPO4 and is also known by the name ‘Dibasic calcium phosphate’. It is a relatively stable compound that has two forms that is Dibasic anhydrous and dihydrate.
In tablets Dicalcium phosphate is used as a dilutent or a filler. This means it is used to form the bulk of the tablet. It is one of the most popular forms of excipient because it has brilliant flow properties which means it increases the output of the machines.
There are no concerns in any medical journals that indicate suspicion or concern for those consuming dicalcium phosphate in tablet from on a daily basis. According to the Food and Drug Administration agency (FDA) Dicalcium Phosphate has been certified as GRAS, meaning generally recognised as safe. Furthermore it is accepted and widely used as a food/drug additive in UK, US and Europe [8,9].
What is Silicon Dioxide?
Silicon Dioxide is formed naturally when silicon is exposed to oxygen. This forms a white crystalline powder that is highly effective at producing drugs and tablets. Its role within in tablet I to act as an anticaking agent. This simply means it prevents the powders from clumping to each other, or to the machinery. It aids flow and efficiency in the tabletting process.
There has been some concern as to the safety of ingesting silcon dioxide. That is, it is able to cross the blood brain barrier. However the US environmental protection aganecy have placed it in category 3 for its toxicity, which is the lowest grade of toxicity you can have. Furthermore, the Food and Drug Administration agency (FDA) have classified it as ‘GRAS’ which means Generally recognised as safe. This means that in very small doses (that you will find in tablets) silcon dioxide will pose no harmful effects to the body. The limit is set at no more than 2% total food weight .
Here are Oxford Vitality, we aim to improve your health not harm it, therefore we have out many hours into researching the best and most effective ingredients and excipients to provide you with the most effective supplement for your health.
- R&KM. (2007). Stearic Acid. Available: http://www.beefnutrition.org/cmdocs/beefnutrition/stearicacid.pdf.
- Axe.J. (2016). Most Supplements Contain Magnesium Stearate — Is It Safe?. Available: https://draxe.com/magnesium-stearate/.
- Now Health. (2016). Magnesium Stearate FAQs. Available: https://www.nowfoods.com/now/nowledge/magnesium-stearate-faqs.
- Søndergaarda, D.; Meyera, O.; Würtzena, G. (1980). "Magnesium stearate given peroprally to rats. A short term study". Toxicology. 17 (1): 51–55. doi:10.1016/0300-483X(80)90026-8. PMID7434368.
- USDA. (2016). Technical Evaluation Report Cellulose. Available: https://www.ams.usda.gov/sites/default/files/media/Cellulose_TR%202_11_2016.pdf.
- Drugs.com. (2016). Microcrystalline Cellulose. Available: https://www.drugs.com/inactive/microcrystalline-cellulose-48.html.
- WHO. (1998). Safety and Evaluation of Food additives and Contaminants. Available: http://www.inchem.org/documents/jecfa/jecmono/v040je03.htm.
- Drugs.com. (2016). Dicalcium Phosphate. Available: https://www.drugs.com/inactive/dicalcium-phosphate-643.html.
- Kibbe.A. (2000). Calcium Phosphate, Dibasic Dihydrate. In: Kibbe.A Handbook of Pharmaceutical Excipients. 3rd ed. London: American Pharmaceutical Association. Pg.60-62.
- Cash. L. (2015). What Is Silicon Dioxide in Supplements?. Available: http://www.livestrong.com/article/520897-what-is-silicon-dioxide-in-supplements/.