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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
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