Excipients Community

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  • 1.  Gluten in excipients?

    Posted 07-15-2022 10:13
    I am aware of several recent queries from patients and regulators about the presence of gluten in drug products.  It seems like the most likely source would be excipients derived from wheat (such as wheat starch).  Has anyone else received this type of question?  Also, has anyone associated with the manufacture or supply of excipients had to provide a 'gluten free statement' to users?  Thanks for sharing your insights on this topic.

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    Bruno Hancock Ph.D., FAAPS
    Head of Materials Science
    Pfizer Inc
    Groton CT
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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  • 2.  RE: Gluten in excipients?

    Community Leadership
    Posted 07-18-2022 08:29
    Hi Bruno,
    As far as I know gluten can be found in wheat, rye and barley. It is not found in oats, corn or potatoes. Aside from corn starch, one of the major starch-based excipients is sodium starch glycolate which is typically made from potato starch. There are other chemically modified starches too. Your manufacturer/supplier should be able to tell you which starch is used.
    When I was working at the excipient company, I seem to remember we had to provide such a declaration occasionally.
    Best regards,
    Chris

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    Richard Moreton Ph.D.
    Partner
    Finnbrit Consulting
    Waltham MA
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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    Original Message


  • 3.  RE: Gluten in excipients?

    Posted 07-18-2022 13:29
    Dear Bruno,

    Gluten-free excipients has been quite the issue, especially with Nutra companies.  It ranks up there with not using lactose because of lactose intolerance.  I have been looking to see if there are any studies evaluating the presence or absence of gluten.  I would think that the amount of processing the material goes through before it is a white crystalline powder that the protein would be denatured or absent.  

    Thanks for bringing this up, let's see if anyone else in the community has any insights.

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    Mary Tanenbaum
    Technical & Development Manager
    Barentz North America LLC
    South Carolina
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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    Original Message