Pformulating Gluten-Free

Several of our readers have requested information about the gluten status of certain excipients. The underlying issue here is the intolerance or sensitivity to gluten in certain disease states. Gluten has been linked to gluten-sensitive enteropathy, better known as celiac disease, and also to dermatitis herpetiformis.

What is gluten? Gluten is a protein found in the grains wheat, rye and barley. It is the protein responsible for the tough elastic character of dough.

According to The Gluten Intolerance Group , the following grains contain gluten and should be avoided when formulating for the gluten-free patient:

        Barley, Farina, Karmut, Rye, Spelt, Triticale, and Wheat (durum and semolina)

Grains and starches that are gluten-free and thus good candidates for gluten-free formulation are:

        Amaranth, Arrowroot, Beans, Corn, Millet, Nuts, Potato, Quinoa, Rice, Sorghum, Soy,

        and Tapioca   

Note: Corn does contain glutens, however, corn glutens do not contain the proteins that are found in wheat glutens that are associated with celiac reactions. And therefore, corn can be used in gluten-free formulations.

Based on these guidelines, the following excipients should be acceptable for the formulation of gluten-free nutritional and pharmaceutical products:

Liquids

Most of the syrups used as sweeteners and vehicles that contain sucrose or corn syrup solids should be acceptable.

Alternative sugars such as the sugar alcohols sorbitol, xylitol, and maltitol, should have their source checked before using.

Brown rice syrup is acceptable, unless it was made with barley, therefore, verify the source before use.

Dextrin and maltodextrin are usually derived from corn, but verify that it is not from a wheat source before use.

Mono- and di-glycerides in dry form may be contaminated with gluten, so should probably be avoided.

Tablets and Capsules

    Diluents (fillers):

    --     Starch derived from corn or potato.

            Starch can be derived from other materials, so it is important to check the source before            

            using this material in gluten-free products.

    --    Lactose and other sugars

    --    Cellulose and cellulose derivatives

    --    Calcium phosphate

   Disintegrants:

    --    Sodium Starch Glycolate (derived from corn or potato starch)

    --    Croscarmellose Sodium

    --    crospovidone

    Lubricants:

    --    Magnesium Stearate.

            If from a vegetable source, check that it is acceptable before using this in a gluten-free product.

    --    Stearic Acid

    Binders:

    --    Starch (derived from corn or potato

    --    Cellulosic polymers like methylcellulose and its' derivatives

    --    polyvinylpyrrolidone

Need a supplier? Submit in Excipients Express!!!

Pformulate 10/06/03