# 2 - HOW TO BEGIN "SCD" > COMMON EXCIPIENT INGREDIENTS IN MEDICATIONS


Benzyl alcohol made synthetically from benzyl chloride which is derived from toluene (a tar oil)

Cellulose (methylcellulose, hydroxymethylcellulose, microcrystalline, powdered)—obtained from

fibrous plant material (woody pulp or chemical cotton)

Cetyl alcohol derived from a fat source (spermaceti, which is a waxy substance from the head of

the sperm whale)

Croscarmellose sodium an internally cross-linked sodium carboxymethylcellulose for use as a

disintegrant in pharmaceutical formulations. It contains no sugar or starch.

Dextrans sugar molecules

Detrates mix of sugars resulting from the controlled enzymatic hydrolysis of starch

Dextrins result from the hydrolysis of starch (primarily corn or potato) by heat or hydrochloric acid.

It can also be obtained from wheat, rice or tapioca

Dextri-maltose A sugar that may be obtained from barley malt

Dextrose A sugar that is obtained from corn starch

Fructose A sugar also known as levulose or fruit sugar

Gelatin Obtained from the skin, white connective and bones of animals (by boiling skin,tendons,

ligaments, bones, etc with water)

Glycerin Historically, glycerin (also known as glycerol), was made the following ways:

• Saponification (a type of chemical process) of fats and oils in the manufacturing of soaps

• Hydrolysis of fats and oils through pressure and superheated steam

• Fermentation of beet sugar molasses in the presence of large amounts of sodium sulfite

• Today it is made mostly from propylene (a petroleum product)

Glycerols obtained from fats and oils as byproducts in the manufacture of soaps and fatty acids

(may also be listed as mono-glycerides or di-glycerides)

Glycols products of ethylene oxide gas

Iron oxide (rust) used as a coloring agent

Kaolin A clay-like substance

Lactilol Lactose derivative

Lactose Lactose, or milk sugar, is used in the pharmaceutical industry as a filler or binder for the

manufacture of coated pills and tablets

Maltodextrin A starch hydolysate that is usually obtained from corn but can also be extracted from

wheat, potato or rice

Mannitol derived from monosaccharides (glucose and mannose)

Polysorbates chemically altered sorbitol (a sugar)

Povidone synthetic polymers (crospovidone)

Pregelatinized starch A starch that has been chemically or mechanically processed. The starch

can come from corn, wheat, Potato or tapioca

Shellac A natural wax product used in tablet or capsule coating

Sodium lauryl sulfate derivative of the fatty acids of coconut oil

Sodium starch glycolate A starch that is usually obtained from potato but may come from any

starch source

Stearates (calcium, derived from stearic acid (a fat; occurs as a glyceride in tallow and other

animal fats and oils, as well as magnesium) some vegetables; prepared synthetically by

hydrogenation of cottonseed and other vegetable oils)

Sucrose Refined sugar also known as refined sugar, beet sugar or cane sugar     

Titanium dioxide chemical not derived from any starch source used as a white pigment

Triacetin derivative of glycerin (acetylation of glycerol)

Silcon dioxide dispersing agent made from silicon

 

ROLE OF THE FOOD AND DRUG ADMINISTRATION

The United States Food and Drug Administration (FDA) is responsible for overseeing the safe

Manufacturing of drug products. While they maintain strict regulations for the active ingredient of the drug product, they provide minimal over-site for what excipients can be added. The drug manufacturers must utilize only FDA approved excipients, but the quantity and type of excipient is not specifically regulated. This is important to understand, especially in the manufacturing of generic drug products, since generic product does not have to contain the same excipients as the brand name product. The generic drug manufacturers must demonstrate certain absorption characteristics when they reproduce a drug, but all other aspects can differ.

 

WHEN TO CALL THE DRUG MANUFACTURER

Where can a consumer or health care professional obtain the necessary drug information? Can this information be trusted? The consumer or health care professional needs to consider two questions when an inquiry is made about the gluten content of a drug. The first question is what are the inactive ingredients or excipients? Excipients are listed in the package insert and should be the first place a pharmacist looks for information (Table 1). Once the excipients are read the second question that should be asked is, what is the source of the ingredient? Again, the package insert provides the pharmacist with the starting point. One of the first key words to look for in the inactive ingredients section is starch. As mentioned previously, starch can be derived from several sources including corn, potato, tapioca, and wheat. If the product lists starch as “cornstarch” or “starch (corn)” it can be assumed to be GF. If starch by itself is listed, a call to the manufacturer is the only way to confirm the source of the starch. Other common terms include pregelatinized starch and sodium starch glycolate. Both products are starches derived from corn, wheat, potato, or rice, however, they have been chemically treated or processed. Despite manipulation, some gluten can remain, although it is unlikely. There are also the four “Dex-ingredients” derived from starch (dextrans, dextrose, dextrates, dextrins). Dextrans come from corn and potato starch; dextrose comes from corn. These Dex-ingredients are not a problem for CD patients. Dextrates and Dextrins can come from any starch source so a call to the manufacturer is the only way to know if it contains gluten. It is important to know that other ingredients are derived from wheat, but are not hazardous because of the process in

which they are made; conversely, just because a product is processed does not mean all gluten has been removed. For instance, some alcohols are derived from wheat. Because the alcohol is purified, the alcohol contains no protein (gluten) making it safe for CD patients. On the other hand, a product may originally start without glutens, but in the manufacturing process, may become cross-contaminated. This is exactly the reason that a pharmacist should call the manufacturer as the second step even after reviewing the inactive ingredients in the package insert. This step should be taken as a safeguard whenever possible. Patients with CD often receive education about the GF diet from a dietitian because they are the experts in the field. It is the same case with medications. Pharmacists are the experts in drug information, which includes knowing if excipients contain gluten. Patients are referred to pharmacists for that information just like they are referred to dietitians to get information about diet. Unfortunately, many pharmacists are not well-versed enough about CD and the medications and Celiac Disease—Tips From a Pharmacist

 

PRACTICAL GASTROENTEROLOGY • JANUARY 2007 E CELIAC DIET, SERIES #5

 

http://www.healthsystem.virginia.edu/internet/digestive-health/nutritionarticles/PlogstedArticle.pdf