Excipients at Metagenics
Excipients are used for product stability, product consistency and distribution of active ingredients. We understand both Practitioners and patients need transparency around ingredients and excipients. Below is a list of excipients that may be used within the Metagenics range, along with why we use them and what you need to know about them.
Don’t forget, product specific excipient inclusions can be found on the ingredients tab of the product’s webpage. If a particular product doesn’t have its excipient information listed here, it will soon! In the meantime, our friendly Clinical Support team can assist with any questions or queries. Contact them here.
Excipients we use at Metagenics:
Acacia
Acacia (pictured above) is a natural gum derived from the tree, Acacia senegal. It is utilised in several formulations to emulsify and stabilise ingredients, to bind tablet ingredients together and to promote even dispersion of ingredients to reduce sedimentation. A source of soluble fibre with prebiotic benefits, acacia gum is widely used throughout the health food industry and is considered safe for human consumption.
Beeswax
Beeswax is a sticky, yellowish, moldable substance secreted by honeybees. Most waxes used in the pharmaceutical industry are used for tablet coatings and binding. In manufacturing, yellow and white beeswax are used as thickeners, emulsifiers and as stiffening agents. Beeswax is likely safe for most people when taken by mouth as food or as a medicine. While rare, some people may have an allergic reaction to beeswax.
Calcium Hydrogen Phosphate
Calcium hydrogen phosphate is used as a tableting agent to bind ingredients and maintain tablet shape. It is also an active ingredient present within supplemental calcium products and bone support formulas. Largely composed of calcium and phosphorus, calcium hydrogen phosphate has been shown to have good solubility and absorption and contributes to nutritional calcium intake. Whilst there are other tableting agents that can be effectively used to bind ingredients, these provide no therapeutic activity compared with calcium hydrogen phosphate, which delivers an extra source of calcium.
Carnauba Wax
Carnauba Wax, extracted from palm leaves, is used to polish and smooth tablet formulations, making them easier to swallow. A review by the European Commission (EC) in 2001 found that carnauba wax is non-mutagenic in vitro.
Additionally, animal studies have reported no adverse effects or evidence of tissue accumulation. Consequently, the EC considers carnauba wax to be safe for human consumption.
Cellulose
Microcrystalline cellulose is an organic compound that is used as a diluent within tablets and capsules to add bulk to raw materials, enabling accurate dosing of active ingredients. It is also used within liquid formulations to allow for even dispersion of active ingredients. Cellulose is commonly consumed as part of a typical human diet from plant-based sources of fibre and is safe for human consumption.
Cocoa Powder
The cocoa bean is the seed of the cacao tree (Theobroma cacao), a tropical plant indigenous to the equatorial regions of the Americas. Cocoa is one of the richest sources of polyphenols. It is especially abundant in flavanols, which have potent antioxidant and anti-inflammatory effects. It is used in supplements as a chocolate flavouring.
Croscarmellose Sodium
Croscarmellose sodium is a derivative of sodium and cellulose, which provides a water-soluble matrix that facilitates the breakup of tablets within the gastrointestinal tract. Used in very small amounts, this inactive ingredient has been demonstrated to be an effective vehicle for supplement delivery. While there have been reports regarding adverse gastrointestinal effects when administered in large doses, these are not comparable to the negligible amounts used in manufacturing. As such, croscarmellose sodium is considered safe for human consumption.
Crospovidone
Crospovidone is an insoluble polymer that promotes the uniform dissolution of active ingredients in an aqueous environment (i.e. digestive juices) to enhance absorption and bioavailability. Crospovidone itself is not absorbed from the gastrointestinal mucosa and is eliminated without entering enterohepatic circulation. Some concerns have been raised based on reports of excess levels of peroxide and heavy metals within crospovidone. However, Metagenics conducts thorough quality testing to ensure the safety of all excipients prior to manufacturing, thus mitigating these issues. Further, a review conducted by The European Food Safety Authority (EFSA) concluded crospovidone is safe for human consumption.
Essential Oil (Peppermint, Lime, Orange, Rosemary, Eucalyptus)
Essential Oil is a liquid extracted from a part or a whole plant using a process known as ‘steam distillation’. This process uses steam to extract the ‘essence’ of the plant by distillation process. The essential oil that is produced by this process is a highly concentrated oil which contains volatile essence and aromatic compounds of the plant. Properties of each essential oil varies depending upon the plant from which it is extracted. Essential oils are mostly known to be used in aromatherapy. However, essential oils are also extensively used in health care ointments, sprays, pharmaceuticals, in foods and many other products.
Fructose
Microcrystalline fructose is purified from fruit or vegetables and is used as a sweetening agent to improve product palatability and increase patient compliance. Fructose naturally occurs in many staple food items including fruit and vegetables, breakfast cereals, baked goods and condiments. Given its prevalence in the human diet, it is considered safe for excipient use.
Glycerin/Glycerol
Glycerin/Glycerol is a colourless and sweet organic polyol compound used as a carrier and co-solvent, added to raw ingredients in small amounts to increase the solubility of a poorly soluble compound (e.g. oily substances). Glycerin is widely used in a variety of pharmaceutical preparations, and found naturally in many foods, including fruits, vegetables, as well as beverages, cereals and dairy products. As such, it is considered safe for human consumption.
Hydroxypropylcellulose
Hydroxypropylcellulose (HPC) is a derivative of cellulose, a natural polymer found in plant cell wells. The production of hydroxypropylcellulose involves the chemical modification of cellulose through a series of reactions. Hydroxypropylcellulose is used as an excipient in products as a stabiliser, thickener, binder and emulsifier during processing. Regarded as non-toxic and non-irritant, hydroxypropyl starch has an excellent safety profile and, as such is considered safe for human consumption.
Hypromellose
Hypromellose is a viscoelastic polymer that is used as a film coating as it provides a protective overlay around tablet products, creating a barrier between ingredients and environmental stressors to prevent physical damage. Hypromellose coating also increases tablet lubrication, making tablets easier to swallow and masks the colour and taste of ingredients for increased patient compliance. This coating enhances tablet solubility and provides uniform dissolution to control the release of active ingredients, increasing the pharmacological benefits. As hypromellose has not been
associated with toxicity, it is considered safe for human consumption.
Magnesium Stearate
Magnesium stearate is a combination of stearic acid (fatty acid) and magnesium. Whilst magnesium stearate is available from animal sources, Metagenics use a vegetable source throughout capsule and tablet formulations. Magnesium stearate improves the flow of materials through manufacturing equipment and prevents products from sticking, ensuring uniform distribution of active ingredients. Metagenics utilise minimal concentrations between 0.25% and 5.0% w/w, which is less than the amount found in common foods like eggs and salmon. As such, magnesium stearate is considered safe for human consumption.
Malic Acid
Malic acid is an organic acid that occurs naturally in many fruits including apples, cranberries, grapes, peaches, pears, pineapple, plums and raspberries (providing the sour taste characteristic of these fruits). Included within a number of products, malic acid is primarily used to control a formula’s pH and also contributes to the flavour profile of powdered products. Regarded as non-toxic and non-irritant, malic acid has an excellent safety profile and, as such is considered safe for human consumption.
Maltodextrin
Maltodextrin is a polysaccharide purified from vegetables such as corn and grains including rice and is used as a diluent within tablets and capsules to add bulk to raw materials, enabling accurate dosing of active ingredients. Maltodextrin is commonly consumed as part of a typical human diet from plant-based sources of starch and is safe for human consumption.
Medium Chain Triglyceride Oil
Medium-chain triglyceride (MCT) oil contains triglycerides made up of two or three fatty acids attached to 6 to 12 carbon atoms. MCT oil acts as a delivery vehicle and helps to emulsify and stabilise active ingredients in liquid products, thereby enhancing the even dispersion of ingredients and preventing their degradation. Additionally, MCT oil is found in a range of foods, including coconut oil and dairy products, emphasising its safety for human intake.
Methacrylic Acid Copolymer
Methacrylate Acid Copolymer is a long established synthetic polymer that is widely used as an enteric film coating material in oral pharmaceutical formulations. It is not absorbed or metabolised by the body following oral ingestion. Methacrylate Acid Copolymer is used to achieve taste and odour masking as well as rapid disintegration in the gastrointestinal tract. It is typically released in the duodenum of the gastrointestinal tract. Methacrylic Acid Copolymer has a long history of use and has been evaluated as GRAS (Generally Recognised as Safe) for consumption.
Opadry Film Coating (Black/Brown/White/Clear)
Opadry Film Coating is a combination of polyethylene glycol (PEG) and polyvinyl alcohol (PVA), which provides a protective overlay around tablet products, creating a barrier between ingredients and environmental stressors to prevent physical damage. It also helps to increase mechanical strength and facilitate adhesion of ingredients, to allow for easier swallowing. Additionally, the coating controls the release of active ingredients. Opadry has not been associated with toxicity and is considered safe for human consumption.
Povidone
Povidone is a water-soluble polymer that promotes the uniform dissolution of ingredients in an aqueous environment (i.e. within digestive juices), aiding ingredient bioavailability. It is also used to bind ingredients and maintain tablet shape. Povidone itself is not absorbed from the gastrointestinal mucosa and is eliminated without entering enterohepatic circulation. Some concerns have been raised based on reports of excess levels of peroxide and heavy metals within povidone.
However, Metagenics conducts thorough quality testing to ensure the safety of all excipients prior to manufacturing, thus mitigating these issues. No evidence of carcinogenicity has been noted in long-term animal studies, though potential adverse effects linked to stool softening and diarrhoea have been observed. Further, in a review conducted by The European Food Safety Authority (EFSA), researchers concluded that povidone is safe for human consumption.
Rice Bran - Stabilised
Stabilised Rice Bran is the outer layer of the rice kernel, which is carefully processed to retain its nutritional value. Rice Bran is thermally stable with multiple functionalities as a carrier, binder, extender, emulsion and bulking agent.
Silicon Dioxide
Silicon Dioxide is a compound composed of silicon and oxygen that is found naturally in the earth’s crust, as well as in numerous plants, vegetables and drinking water. It is included in several formulas to improve the flow of ingredients during manufacturing, reducing adhesion and preventing ingredients from sticking to machinery. Silicon dioxide is generally regarded as safe and has a very low risk for toxicity when orally administered, with evidence demonstrating no adverse effects when used at very high doses of up to 9,000 mg/kg body weight. Given this, silicon dioxide is considered appropriate for excipient use and safe for human consumption.
Sodium Phosphate Dibasic
Sodium Phosphate Dibasic is also known as disodium phosphate and is one of the most commonly found excipients in pharmaceutical formulations. It may be used to adjust pH and as a thickener and buffering agent. This chemical is considered non-hazardous and is considered safe for use.
Sodium Starch Glycolate
Sodium starch glycolate is used as a pharmaceutical grade dissolution excipient for tablets and capsules. Sodium starch glycolate absorbs water rapidly, resulting in swelling which leads to rapid disintegration of tablets and granules. It is used as a disintegrant, a suspending agent and as a gelling agent. It is widely recognised in the pharmaceutical industry for its adaptability and compatibility with many active pharmaceutical ingredients and processing technologies.
Soya Oil
Soya Oil is widely used to stabilise vitamin actives and to facilitate their absorption. The soya oil used within select products undergoes extensive purification to deliver a high quality oil that exceeds industry standards. Additionally, the protein fraction of soy is removed, which is the cause behind many of the sensitivity reactions associated with soy. In pharmaceutical preparations, soybean oil emulsions are commonly used as part of parenteral nutrition regimens. Additionally, soya oil is a common household ingredient that is widely used in cooking processes, emphasising its safety for everyday use.
Stevia Rebaudiana
Stevia rebaudiana is a plant with naturally sweet properties. Its bioactive constituents are estimated to be between 200 to 300 times sweeter than sucrose, which enables a product to be sweet and pleasant tasting with the addition of only a very small amount of stevia. An added advantage of stevia is that it provides sweetness without affecting blood glucose levels, making it the primary sweetener within the Metagenics product range. Furthermore, stevia has an excellent health and safety profile, which is supported by both animals and human studies.
Sucrose
Sucrose is a sugar compound with several manufacturing benefits such as providing a protective overlay to tablets, granulating and compacting powder substances, increasing viscosity, enhancing the dispersion of ingredients within liquid, and increasing product palatability. Sucrose occurs naturally in many fruits, vegetables and grains, and is also found in several processed foods. As such, sucrose is considered safe for use as an excipient.
Sucralose
Sucralose is as a sweetening agent used to increase product palatability, enhance the dispersion of ingredients within liquid, provide bulk to tablet products, and deliver accurate dosing of active ingredients. Despite its sweet taste, sucralose is non-caloric and does not affect carbohydrate metabolism, therefore producing no glycaemic response. Subsequently, sucralose does not adversely affect dental health. Available for commercial purchase, sucralose is frequently used by consumers as a sugar substitute with a favourable safety profile, and as such is considered safe for use in
manufacturing.
Talc
Talc is a mineral clay composed of magnesium, silicon and oxygen. It is used to improve the flow of ingredients during manufacturing, reducing adhesion and preventing products from sticking to the machinery, as well as providing bulk to tablet formulas for consistent dosing. For this reason, it is widely used in the cosmetics, food processing, pharmaceutical and supplement industries. Most of the concern surrounding talc relates to contamination of its natural form with asbestos found in underground talc deposits, which has been associated with carcinogenic effects, unlike the purified talc in consumer products. Additionally, research suggests that adverse health effects associated with talc relate to topical, intranasal or intravenous abuse of talc-containing products. Comparatively, oral ingestion is regarded as non-toxic and, as such, is appropriate for use in manufacturing.
Water (Purified)
Purified Water is used as an excipient in pharmaceutical applications and is a crucial ingredient in the processing, formulating and manufacturing of pharmaceuticals and supplements.
Xylitol
Xylitol is a sweeting agent used in pharmaceutical and food processing. It is a sugar alcohol, which is a type of carbohydrate but it does not actually contain alcohol. Xylitol occurs naturally in many fruits and vegetables and is produced by the human body during normal metabolism. Xylitol is produced commercially from hardwood trees and fibrous vegetation. It has about the same sweetness as sugar but with one-third the calories. Xylitol is generally safe and well tolerated, but like other sugar alcohols, it can cause digestive issues such as bloating and diarrhea in some people.
Xanthan Gum
Also known as corn sugar gum, xanthan gum is a polysaccharide created when simple sugars are fermented by the bacteria, Xanthomonas campestris. A thickening and stabilising ingredient, xanthan gum is commonly used in many commercial and home-prepared foods, where it provides a texture alternative for plant-based diets (substituting gelatin) and food sensitivities such as dairy, eggs and soy. While xanthan gum has been shown to produce soft stool when consumed in excessive quantities, safety studies have primarily found no adverse outcomes when used in appropriate amounts, emphasising its safety for human consumption.