Gluten in Pharmaceutical products

Gluten in  Pharmaceutical products

Gluten is a protein found in wheat, barley and rye. Celiac disease (coeliac disease/celiac spur) is an auto immune disease of the digestive tract that affects about 3 million people in united states. When patients with celiac disease ingest gluten, an immunologically mediated inflammatory response occurs that damages the mucosa of the intestine resulting in maldigestion and malabsorption, abdominal pain, diarrhoea, constipation, vomiting and other problems. The treatment for celiac disease is adherence to a gluten free diet.

It is recognized that pharmaceutical products may contain traces of gluten, which will cause acute illness in celiac patients. Potential source of gluten contamination in pharmaceuticals come primarily from excipients (i.e Wheat starch is occasionally used as an excipient  in the formulation of medicinal tablets and capsules in variety of functions, as a diluents, a disintegrant, a glidant or as a binder). However  there is currently no regulatory guidance in place on the acceptable levels of gluten in medicinal products.

Despite few pharmaceuticals are labelled as gluten free, the great majority of drug manufactures do not specify on the product label information regarding gluten content. A great concern comes from the generic drugs which may not contain the same excipients as the brand product.

Declaration of gluten in pharmaceuticals is very important task required for display the gluten status of the product, as the absence of gluten remains the only treatment for celiac patients.