In order to aid in normal manufacturing processes such as the tabletizing and encapsulating of dietary supplements, substances called excipients are routinely added to the active ingredients to serve as binders, disintegrants, lubricants, and photoprotectors. We prefer not to use excipients, but at times they are necessary. Even then, we use them in only very small amounts.

Definitions:

Binder: A substance used to hold materials together in tablet form.

Disintegrant: A substance used to ensure that solids disintegrate properly after consumption.

Emulsifier: A product that holds two substances together that otherwise would separate (for example, oil and water).

Lubricant: A substance that helps product material flow well and not stick to processing equipment.

Photoprotector: A substance used to prevent product breakdown caused by light exposure.

Simplexity Health uses the following excipients in our product line:

Beeswax – An emulsifier, it is used to ensure consistency of Super Q10.

Carob – A substance derived from Ceratonia siliqua, a Mediterranean evergreen, it is used to add dark coloring to a capsule or softgel (Super Q10) to protect the contents from light.

Cellulose – Derived from plant material, cellulose is added to compensate for variations in powder density (which can vary from lot to lot) and ensure that each capsule is full. Cellulose forms the supporting cell structure in plants.

Croscarmellose sodium – A binding agent or stabilizer derived from cellulose (plant fiber), it holds materials together in tablet form for shipment and storage and also helps tablets disintegrate after ingestion.

Glycerin – A sweet, syrupy liquid derived from vegetable oils, or as a by-product of fermentation from sugar, as a lubricant in softgel processing. It also aids in dispersion of ingredients in Super Q10.

L-leucine - An amino acid, used as a lubricant.

Maltodextrin – A digestible carbohydrate made from corn or rice starch, it is used in StemPlex as a 'carrier' for vitamin D₃.

Plant Fiber – Used for standardization of products (enzymes and probiotics), plant fiber is also used as a filler for encapsulated products and is the material that comprises the hard shell of vegetarian capsules.

Rice Bran – This ingredient is used for standardization of products (enzymes and probiotics).

Silica (silicon dioxide) – An inorganic compound occurring naturally. It can be used to balance pH and water content or as a lubricant and flow agent.

Titanium dioxide – It is used in conjunction with carob in the softgel coating for Super Q10 to prevent light from reaching the contents.

Vegetable magnesium stearate – Magnesium stearate is a combination of stearic acid and the essential mineral magnesium. It is derived from non-hydrogenated palm and/or coconut oil and it is used as a lubricant or flow agent in the manufacturing process. Magnesium stearate helps keep solid ingredients from disintegrating in the bottle, and it also enables the tablet to break apart and release the active ingredient when the tablet is swallowed. It is considered acceptable as part of a vegetarian or vegan diet. The FDA’s Select Committee on GRAS Substances reported on magnesium stearate safety, concluding that, “There is no evidence in the available information on...magnesium stearate...that demonstrates, or suggests reasonable grounds to suspect, a hazard to the public when they are used at levels that are now current and in the manner now practiced, or which might reasonably be expected in the future. Simplexity Health uses USP grade stearates tested to U.S. Pharmacopeia standards (also known as pharmaceutical grade).

Last revised 08/08