Excipients
What are excipients used for in Metagenics products?
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.
Acacia 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.
Ascorbyl palmitate is a fat-soluble derivative of vitamin C. Used alone and in combination with alpha tocopherol, ascorbyl palmitate functions as a potent antioxidant to protect ingredients from oxidative damage, increasing product stability. Safety studies using both animal and human data have found that ascorbyl palmitate is completely hydrolysed to ascorbic acid and palmitic acid in the gastrointestinal tract, limiting systemic availability. As such, the use of ascorbyl palmitate in manufacturing is considered safe for human consumption.
Black carrot colour is a naturally occurring pigment and colouring agent extracted from purple carrots. The red, purple and blue pigments derive from the flavonoid constituent, anthocyanins, which are abundant in purple carrots. Consumed as part of a typical diet, black carrot colour is regarded as safe for human consumption.
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.
Calcium hydrogen phosphate dihydrate is used within tablets and capsules to add bulk to raw materials to enable accurate dosing of active ingredients. The combination of organic minerals including calcium, hydrogen and phosphate are naturally consumed as part of a typical human diet and is considered safe for human consumption.
Carnauba wax is extracted from palm leaves and is used to polish and smooth tableted formulations to allow for easy swallowing. A review of carnauba wax by the European Commission (EC) in 2001 found this ingredient to be non-mutagenic in vitro. No adverse effects or evidence of tissue accumulation has been reported in animal studies. As such, the EC considers carnauba wax to be safe for human consumption.
Cetomacrogol is also known as macrogol and polyethylene glycol hexadecyl ether, and is a wax used to emulsify and stabilise oil-in-water solutions. It is used to improve the consistency and dispersion of active ingredients within tablet formulations for consistent dosing. The emulsifying properties of this material, combined with non-toxic and non-irritant qualities, account for its wide use within pharmaceutical and cosmetic preparations. Cetomacrogol is not associated with adverse health effects and is regarded as safe for human consumption.
Chlorophyllin contains a combination of water-soluble salts that are closely related to plant-derived chlorophyll. When combined with copper, chlorophyllin-copper complex forms a protective layer within capsules and tablets that protect the capsule contents from light, aiding the preservation of tableted and encapsulated ingredients. No toxic effects have been attributed to chlorophyllin despite more than 50 years of clinical use in humans. Trace levels of copper are generally consumed as part of a typical human diet, and as such, chlorophyllin-copper is safe for human consumption.
Citric acid is a weak, organic acid with a pH between 3 and 6 that is used as an acidifying agent to buffer pH and enhance the liberation of minerals from nutritional supplements in the digestive tract, promoting their absorption. Citric acid is also used to add bulk to raw materials to enable accurate dosing of active ingredients. Citric acid also enhances the flavour profile of powdered supplements. Citric acid is naturally present in the juice of lemons and other citrus fruits making it safe for human consumption.
Colloidal anhydrous silica is a granular form of silica. Metagenics uses colloidal anhydrous silica throughout capsule and tablet formulations to improve the flow of materials through manufacturing equipment and to prevent the formation of clumps, ensuring uniform distribution of active ingredients. Trace levels of silica are generally consumed as part of a typical human diet, and as such, is safe for human consumption.
Croscamellose 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, croscamellose sodium is considered safe for human consumption.
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.²
Dibasic potassium phosphate can be used as an active form of potassium, however, it can also be used as a pH buffering agent, and as an sequestering agent to limit chemical reactivity that occurs when multiple valent minerals are blended together to maintain formulation stability. Further, both potassium and phosphate are organic minerals consumed naturally as part of a typical human diet and are therefore safe for human consumption.
Disodium edetate is the sodium salt form of the organic compound, edetic acid. A constituent within vegetarian capsules, disodium edetate prevents the formula’s ingredients from binding with trace minerals that may be present in water, thereby preventing oxidation of key ingredients and preserving the quality and stability of the product. Although large doses (2.5 mg/kg body weight) taken over a prolonged period have been associated with calcium depletion, safety studies have primarily shown that disodium edetate is poorly absorbed through the gastrointestinal tract and, therefore, poses minimal risk to health or adverse effects. As such, disodium edetate is considered safe for human consumption.
Fractionated coconut oil is widely used in natural supplements as it contains medium-chain triglycerides that act as a delivery vehicle to emulsify and stabilise active ingredients, thereby enhancing the even dispersion of ingredients and protecting them from degradation. Readily consumed within the human diet, fractionated coconut oil is considered safe for excipient use.
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 through diet, it is considered safe for excipient use.
Gamma-tocopherol is an active form of vitamin E that is often used in manufacturing for its antioxidant properties and to maintain the stability of active ingredients within formulations. Vitamin E is a naturally occurring nutrient in many foods, including nuts and seeds, seafood and fruit. Due to the presence of gamma-tocopherol in the diet it is considered safe for use as an excipient.
Gelatin is a food ingredient derived from animal-sourced collagen. Purposed as both a binding and coating agent, gelatin helps to facilitate the adhesion of ingredients and provides a protective film-like overlay around tablets and capsules, creating a barrier between ingredients and environmental stressors to prevent physical damage. It is also used to increase the viscosity of liquid formulations to allow for even dispersion of active ingredients in a liquid format. Gelatin is a common household ingredient that is widely used in cooking processes, emphasising its safety for use as an excipient.
Gellan gum is a plant-based and water-soluble polysaccharide derived from algae. It can withstand harsh environmental stressors, such as heat, and is used as a vegan alternative to gelatin within plant-based capsules to maintain the integrity of capsule shells, thereby protecting the active ingredients within. Gellan gum has been approved for use for food, non-food, cosmetic and pharmaceutical uses based on its excellent safety profile and is safe for human consumption.
Glucose is a simple sugar purified from vegetables such as corn and is used as a cryoprotectant within probiotic formulations to mitigate mechanical stress endured by the bacterial cells during manufacturing processes (i.e. freezing and dehydration). This increases probiotic viability and survival. Glucose occurs naturally in many staple food items, including numerous fruit and vegetables, breakfast cereals, baked goods and condiments, emphasising its safety as an excipient.
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.
Hydrogenated fats are vegetable oils used as lubricants to prevent products sticking to machinery during manufacture, and to facilitate the sustained release of active ingredients. A common constituent found in foods, including packaged snacks and baked goods, as well as a common ingredient used within pharmaceutical formulations. Although a high dietary intake of hydrogenated fats may be associated with potential health risks such as dyslipidaemia, the negligible amounts used in product manufacturing are significantly less than those found in food, and as such are safe for human consumption.
Also known as cellulose or hydroxypropyl cellulose, this excipient is an organic compound that is used as a binding and coating agent to help preserve tablet shape and allow for easy swallowing. Additionally, cellulose is commonly consumed as part of a typical human diet from plant-based sources of fibre and is safe for human consumption.
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.
Iron oxides are naturally occurring minerals composed of iron and oxygen, which partake in several biological and geological activities. For instance, iron oxide is essential to haemoglobin function and oxygen transport within the human body. Iron oxide compounds produce pigments that are considered non-toxic and non-irritant, which masks the colour of ingredients for increased patient compliance. While there have been some reports suggesting toxicity, these have been in the context of iron overload and excessive iron oxide exposure, which are not comparable to the negligible amounts used in manufacturing. As such, iron oxide poses negligible risk when used in appropriate quantities and is regarded as safe for use as an excipient.
Liquid Glucose is a simple sugar extracted from vegetables such as corn, and is used as a tablet and capsule diluent to add bulk to raw materials to enable accurate dosing of potent ingredients, as well as acting as a tablet binder and tonicity-enhancing agent (to balance osmolarity). It is also used as a sweetening agent to improve product palatability and increase patient compliance. Glucose is a naturally occurring in many staple food items including numerous fruit and vegetables, breakfast cereals, baked goods and condiments, emphasising its safety as an excipient.
Magnesium stearate is a combination of the 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. Stearic acid, which forms a large portion of magnesium stearate, is naturally occurring in many everyday foods including salmon, olive oil, beef, eggs, Brazil nuts and almonds. Metagenics utilise minimal concentrations between 0.25% and 5.0% w/w, which is less than the amount found in common foods. As such, magnesium stearate is considered safe for human consumption.
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). Additionally, malic acid is endogenously synthesised by all living organisms, functioning as a key constituent within the Kreb’s cycle and supporting cellular energy production. 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 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 (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.
MetaFibre™ is a form of digestion-resistant maltodextrin produced by the enzymatic hydrolysis of corn starch. Included within select powder formulations, MetaFibre™ can benefit patient health by helping to maintain gastrointestinal regularity and support beneficial gut flora without affecting the digestion and absorption of nutrients (unlike other fibres). Whilst MetaFibre™ is derived from corn, which is commonly associated with FODMAP sensitivity; it is pertinent to point out that this ingredient is an isolate of corn rather than whole corn itself and is unlikely to aggravate FODMAP-associated symptoms. In saying this, due to individual differences, it is at practitioner discretion to determine the suitability of products containing MetaFibre™ relative to FODMAP sensitives.
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.
Nature identical flavours are used to enhance the flavour profile of liquid and powdered formulations for increased patient compliance. Whilst these are technically synthetic, nature identical flavours resemble the same chemical structure to the equivalent flavour molecule found in nature, with the exception of removal of the residual proteins that contribute to individual sensitivities. Metagenics use both natural flavours and nature identical, in order to provide the most suitable flavour profile for our formulations.
Olive oil is a natural oil extracted from the olive fruit. It is used in preparations that require an oil-soluble delivery system such as lipid emulsions, enabling targeted delivery of active ingredients with limited water solubility. Due to its favourable safety profile and health benefits, olive oil is a common household ingredient that is widely used in cooking processes, emphasising its safety for excipient use.
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.
PEG-35 castor oil is a derivative of castor oil, which is pressed from castor beans. It is used to blend liquids that would not otherwise mix, such as water and volatile oils from herbs, to create an evenly dispersed liquid emulsion. It is also used to preserve food grains including rice, wheat and pulses to prevent spoilage. Patients are likely exposed to PEG-35 in greater amounts from its wide use in commercial products and food, compared to the negligible amounts used in manufacturing (1 mg/mL). This considered, PEG-35 castor oil is safe for human consumption.
Pisum sativum, commonly known as the garden pea, is an easily digestible, plant-based source of protein included in select formulas for its glycine and glutamine amino acid content. Unlike many plant-derived foods, Pisum sativum is naturally low in phytates, lectins and other anti-nutritional factors, therefore providing a high-quality source of protein without impairing the bioavailability of additional nutrients within product formulas.
Polyethylene glycol is used within tablet formulations to emulsify and stabilise ingredients that do not readily combine, creating even dispersion of the formulation’s key ingredients. Polyethylene glycol is widely used in a variety of pharmaceutical preparations, in addition to many packaged foods including dressings, dried soup, cake mix, popcorn, bread and dairy products. Given its prevalence in common commercial products, patients are frequently exposed to greater amounts of polyethelene glycol through diet compared with supplemental concentrations and is considered safe for human consumption.
Polysorbate 80 is synthesised from sorbitol and oleic acid and is used within select capsule formulations to emulsify, stabilise and increase the efficacy of oil-in-water preparations, including essential oils and oil-soluble vitamins. Regarded as non-toxic, polysorbates are frequently used in pharmaceuticals, cosmetics and common foods including ice cream and milk products. Whilst there is concern regarding the effect polysorbate 80 may have on gastrointestinal health, studies demonstrating negative effects were conducted in animal models using unusually high doses. The World Health Organisation stipulates 25 mg/kg bodyweight to be an acceptable daily intake for polysorbate esters. To give context, this would equate to 2 g/d for an 80 kg human, which is substantially lower than supplemental concentrations. As such, the minimal amounts of polysorbate 80 used in manufacturing is considered safe for human consumption.
Potassium acetate is the acetate salt form of the essential micromineral, potassium. It is widely used in several industries as an acidity regulator and preservative, as well as an intravenous and parental supplement for the treatment and prevention of hypokalaemia. Potassium acetate is used in several vegetarian capsule-containing formulas, where it aids the gelling process necessary for capsule formation. Oral ingestion is generally regarded as non-toxic and non-irritant and, as such, is considered safe for human consumption.
Potassium sorbate is an antimicrobial preservative used in select liquid formulas. While there have been reports of skin reactions after topical applications in hypersensitive individuals, to date there are no reported systemic reactions following oral consumption. The World Health Organisation has established 25 mg/kg body-weight as an acceptable daily intake, which markedly exceeds supplemental amounts. Additionally, higher concentrations of potassium sorbate can be found in common foods such as bottled juice, which contains 0.2%/serve. Comparatively, a strength of 0.02%/dose is used within Metagenics products, which is equivalent to 1% of the amount found in juice. As such, the use of potassium sorbate in manufacturing is considered safe for human consumption.
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, with the extent of possible adverse effects linked to stool softening and diarrhoea. Further, in a review conducted by The European Food Safety Authority (EFSA), researchers concluded that povidone is safe for human consumption.
Propylene glycol is an organic compound used to stabilise ingredient contents contained within a capsule, and to promote capsule flexibility. It is extensively used in pharmaceutical preparations, cosmetic products, and within packaged foods including dressings, dried soups, cake mix, popcorn, bread, and dairy to provide uniform flavour. Propylene glycol is regarded as non-toxic and is readily metabolised by the liver and excreted through urine. With less <1.4%/capsule used in product manufacture, the risk of adverse effects is extremely low and is considered safe for human consumption.
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 ascorbate is the sodium salt form of vitamin C. Used as both an active and excipient ingredient, sodium ascorbate provides a source of buffered vitamin C, as well as providing antioxidant properties to both the consumer and the formula itself, where it minimises oxidative processes and enhances formula stability. Sodium ascorbate is regarded as non-toxic in doses of up to 1000 mg or 15 mg/kg body weight. Therefore, the negligible amount used in manufacturing is considered safe for human consumption.
Sodium benzoate is used as an antimicrobial and preservative to ensure shelf stability. For this reason, sodium benzoate is widely used across a number of industries including cosmetics, foods and pharmaceuticals. Fruits and vegetables are also rich sources, particularly berries such as cranberry at 1300 mg/kg (0.13%). Whilst sodium benzoate can be safely used at concentrations of up to 5%, a low potency strength of 0.1% is utilised in manufacturing; less than the equivalent in cranberries. Moreover, the small amount of sodium benzoate included in select formulas counters any potential issues regarding bacterial contamination. As such, sodium benzoate is considered safe for human consumption.
Commonly known as salt, sodium chloride is included within select products to create isotonicity, maintaining osmotic quality and enabling the concentration of active ingredients to remain evenly dispersed throughout the formula. Due to its prevalence in the human diet, sodium chloride is considered safe for use in manufacturing.
Sodium lauryl sulfate (SLS) is a compound commonly used to emulsify and stabilise ingredients that do not readily combine, creating a uniform dispersion of the formula’s key constituents. These properties have led to extensive use of SLS within personal care products including cosmetic formulas, soaps, shampoos and toothpastes. SLS has been associated with skin and eye irritation when applied topically, as well as stomach upset when orally ingested. However, such adverse reactions are most prominent when used in hypersensitive individuals that are prone to skin reactions or when used in high concentrations, which typically range from 0.01% to 50%. The small amounts used in supplements are significantly less to those associated with adverse reactions and, as such, is considered safe for human consumption.
Sorbitan monolaurate is derived from the esterification of the sugar alcohol, sorbitol, with fatty acids. A key constituent used within a capsule coating formula, sorbitan monolaurate is used to emulsify and stabilise oil-in-water ingredients. For this reason, it is frequently used within the cosmetics, food and oral supplement industries. Sorbitan monostearate is regarded as non-irritant and has not been associated with toxicity, therefore it is considered safe for human consumption.
Sorbitan monostearate is an ester derived from fatty acids, sorbitan and stearic acid. It is utilised in select probiotic formulations to emulsify ingredients, creating even particle dispersion for accurate dosing. Due to it's non-irritant properties, sorbitan monostearate is widely used across several industries including food manufacturing (particularly baked goods), oral supplements and cosmetics. As sorbitan monostearate has not been associated with toxicity, it is considered safe for human consumption.
Sorbitol solution is a sugar alcohol and is used within gelatin capsules to promote capsule flexibility, as a stabilising agent for ingredients, as a sweetening agent, and to provide bulk to tablet products for accurate dosing of active ingredients. Unlike other sweetening agents, such as simple sugars and starches, sorbitol is absorbed slowly from the gastrointestinal tract and is readily metabolised by the liver, which assures a lower rise in blood glucose and insulin levels. In addition to its wide use within a number of pharmaceutical products, sorbitol occurs naturally in many fruits, including berries, apples, pear, peaches, apricots, nectarines, and dried fruits. The amounts found in product manufacturing are significantly less to those found naturally in fruit, and as such, is safe for use in manufacturing.
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.
Derived from vegetable sources such as corn, starch sodium octenyl succinate is considered a modified starch based on the changes that occur within its natural carbohydrate composition in response to the cooking processes. It is frequently used in food products to blend ingredients that do not readily combine. As a prebiotic compound, starch sodium octenyl succinate is hydrolysed by intestinal enzymes and gut microbiota and is deemed safe for human consumption by the European Food and Safety Authority (EFSA).
Stearic acid is a fatty acid used as a tablet and capsule lubricant to prevent products sticking to machinery, in addition to helping bind ingredients together. Stearic acid is a naturally occurring compound found in high quantities within common foods. For instance, one piece of roast chicken thigh delivers approximately 359 mg of stearic acid, whilst half a bar of milk chocolate contains 1,283 mg of stearic acid. Given that dietary consumption of stearic acid has been shown to pose no adverse effects to human health, it is considered safe for human consumption.
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 principle sweetener within the Metagenics product range. Furthermore, stevia has an excellent health and safety profile, which is supported by both animals and human studies.
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.
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.
Sunflower oil is a non-volatile oil, rich in vitamin E, that has been pressed from sunflower seeds. It is used to add bulk to tablet products and to facilitate binding of ingredients, creating a uniform dispersion of the formula’s key constituents for accurate dosing. With a favourable health and safety profile, sunflower oil is a common household ingredient that is widely used in cooking processes, emphasising its safety for human consumption.
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.
Tapioca starch is a gluten-free flour derived from the starch of cassava root. Commonly used in both household and commercial cooking, tapioca starch is utilised in supplemental manufacturing as a bulking agent to enable accurate dosing of active constituents, to bind tablet ingredients together and to aid dispersion of tablet formulas through the gastrointestinal tract for enhanced absorption. As such, it is safe for use as an excipient.
A common ingredient used in baking, tartaric acid used in manufacturing for its antioxidant properties, which help to maintain the stability of active ingredients within formulations. As such as, tartaric acid and is safe for use as an excipient.
Titanium dioxide is a naturally occurring mineral that is created when titanium reacts with oxygen. Because of its white colour, titanium dioxide is widely used as a pigment, providing whiteness and opacity to numerous products including pharmaceutical tablets, cosmetics and sunscreen, in addition to many packaged foods such as cheese, sauces, skimmed milk, ice cream, confectionary products, and baked goods. Given its prevalence in common commercial products, patients are frequently exposed to greater amounts of titanium dioxide through diet and lifestyle compared with supplemental concentrations, which contain minimal amounts. Therefore, the risk of adverse effects is extremely low and is safe for human consumption.
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.