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Tablets & Capsules SDD
imageIn this issue of T&C Solid Dose Digest:
 
 
 
 
 
 
 
vacumax

recro
 
In Tablets & Capsules magazine
 
Gluten in excipients
 
Christopher DeMerlis, Luke Grocholl, Jeffrey Pitt, Irwin Silverstein, Stephen M. Tyler, and Priscilla Zawislak, Regulatory Affairs Committee Gluten Working Group, IPEC-Americas
 
This article discusses the issue of possible gluten content in pharmaceutical excipients.
 
Americans with gluten sensitivities have shown increased concern over the years regarding the presence of gluten in foods. Recently, the possibility of gluten in oral medications has been raised as a concern for gluten-sensitive patients. Gluten proteins found in wheat, barley, and rye are the primary food triggers. The concern is that gluten may be present 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 possible 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 treatment 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.
 
To learn more about this topic, you can read the article "Eye on excipients: Gluten in excipients." You can also find articles under "Excipients" in Tablets & Capsules' Article Archive.
 
 
kikusui

camfilapc
 
Ask an Expert
 
FDA and dietary supplement specifications
 
Q: How do we create dietary supplement specifications that will meet FDA expectations?
 
 
A dietary supplement's manufacturing specifications are a set of defined parameters and associated acceptance criteria that produce a finished product with the desired characteristics and quality. In June 2007, the FDA published 21 CFR Part 111, which established cGMP requirements for dietary supplements. Since then, manufacturers have struggled to understand and comply with these requirements regarding specifications development.
 
 
 
gelita

wilson
 
Feature
 
Flashing during tablet compression, part 1
 
Q: What causes protrusions around the edge of tablets after compression, and how can I prevent this from occurring?
 
imageA: Mike Beyl, Wilson Tool International, says:
 
Protrusions that form along the tablet band during compression are called flashing. Flashing can occur regardless of the tablet shape and is most common when compressing materials that undergo plastic deformation under high pressure. The particle size of the formulation and the amount of pressure applied during compression also affect flashing. This article is the first in a three-part series that will discuss the impacts of flashing, examine its causes, and suggest some preventive measures to help minimize it. In this installment, I'll focus on flashing's impacts and causes.
 
 
 
jost

natoli
 
Industry news
 
 
 
 
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Events and continuing education
 
 
 
 
 
 
 
 
 
 
 
 
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May 6, 2019
 
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Supplier Resources
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T&C Solid Dosage Sourcebook
 
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Send your feedback or questions to Peggy Wright at pwright@cscpub.com.
Peggy Wright
T&C Solid Dose Digest
Editor
pwright@cscpub.com
 
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T&C Solid Dose Digest
Circulation
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Tablets & Capsules
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