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eye on Christopher C. DeMerlis, Luke Grocholl, Jeffrey Pitt, Irwin Silverstein, Stephen M. Tyler, and Priscilla Zawislak IPEC-Americas Regulatory Affairs Committee Gluten Working Group excipients This edition of Eye on Excipients dis- cusses the issue of possible gluten content in pharmaceutical excipients. Americans with gluten sensitivi- ties have shown increased concern over the years regarding the pres- ence of gluten in foods. Recently, the possibility of gluten in oral medica- tions has been raised as a concern for gluten-sensitive patients. Gluten pro- teins found in wheat, barley, and rye are the primary food triggers. The concern is that gluten may be pres- ent in medications that contain starches derived from these foods. Celiac disease is an autoimmune reaction to gluten that affects the small intestine. For patients with celiac disease, consuming gluten leads to gastrointestinal distress and possi- ble other serious medical conditions. Individuals with celiac disease must be made aware if drug products contain gluten at potentially harmful levels. Approximately 1 percent of the US population has celiac disease (FDA 2017) and, currently, the only treat- ment is observance of a gluten-free diet. However, from a regulatory and adverse health effect perspective, foods with gluten levels less than 20 parts per million (ppm) are considered to be acceptably "gluten-free." Most people with celiac disease will vary in their sensitivity to gluten. The International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) believes that the risk of gluten presence in pharmaceutical excipients is very low. Also, the risk to celiac patients from their medications is extremely small and exists only if wheat, barley, or rye-based excipients are used. Excipients derived from wheat are typically highly processed in such a way as to effectively remove or reduce gluten to a tolerable level. There is a slight risk that wheat gluten may be present at low levels (<20 ppm) in certain excipients that are derived from wheat. Typically, gluten is present in the starch of wheat, barley, and rye and to a lesser extent in their deriva- tives. According to the FDA, wheat is usually not used in the production of dr ug product ingredients, and barley and rye are used either rarely or not at all (FDA 2017). Wheat glu- ten itself is very rarely added as an inactive ing redient to oral dr ug products. Please refer to Table 1 for current US FDA Inactive Ingredient Database listings. Table 1 US FDA Inactive Ingredient Database (IID) listings for wheat (as of July 12, 2018) Inactive ingredient Route Dosage form CAS number UNII Maximum potency per unit dose Starch, wheat Oral Capsule, sustained action 9005258 79QS2MG2LP 0.75 mg Starch, wheat Oral Tablet 9005258 79QS2MG2LP 65.59 mg Starch, wheat Oral Tablet, coated 9005258 79QS2MG2LP NA Starch, wheat Oral Tablet, film coated 9005258 79QS2MG2LP 49 mg Wheat Oral Tablet 4J2I0SN84Y 1.16 mg Wheat gluten* Oral Tablet 8002800 1534K8653J NA * According to the FDA, this listing for wheat gluten is very old. The IID contains excipients used in products that have been FDA- approved at some point in time, and the FDA continues to list them regardless of whether the product that was the source of the listing remains on the market. The product associated with this listing for wheat gluten is not currently marketed, and the FDA has not approved any new products that contain wheat gluten. 40 January 2019 Tablets & Capsules

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