Pharmaceutical glaze

Pharmaceutical glaze is an alcohol-based solution of various types of food-grade shellac.[1] The shellac is derived from the raw material sticklac, which is a resin scraped from the branches of trees left from when the small insect, Kerria lacca (also known as Laccifer lacca), creates a hard, waterproof cocoon.[2] When used in food and confections, it is also known as confectioner's glaze, resinous glaze, pure food glaze, natural glaze,[3][4] or confectioner's resin.[5]

Pharmaceutical glaze may contain 20–51% shellac in solution in ethyl alcohol (grain alcohol) that has not been denatured (denatured alcohol is poisonous), [1] waxes, and titanium dioxide as an opacifying agent. Confectioner’s glaze used for candy contains roughly 35% shellac, while the remaining components are volatile organic compounds that evaporate after the glaze is applied.[6]

Pharmaceutical glaze is used by the drug and nutritional supplement industry as a coating material for tablets and capsules. It serves to improve the product's appearance, extend shelf life and protect it from moisture, as well as provide a solid finishing film for pre-print coatings. It also serves to mask unpleasant odors and aid in the swallowing of the tablet.

The shellac coating is insoluble in stomach acid and may make the tablet difficult for the body to break down or assimilate. For this reason, it can also be used as an ingredient in time-released, sustained or delayed-action pills. The product is listed on the U.S. Food and Drug Administration's (FDA) inactive ingredient list.[7]

Shellac is labeled as GRAS (generally recognized as safe) by the US FDA and is used as glaze for several types of foods, including some fruit, coffee beans, chewing gum, and candy. Examples of candies containing shellac include candy corn, Hershey's Whoppers and Milk Duds, Nestlé's Raisinets and Goobers, Tootsie Roll Industries's Junior Mints and Sugar Babies, Jelly Belly's jelly beans and Mint Cremes, Russell Stover's jelly beans, and several candies by Godiva Chocolatier and Gertrude Hawk. M&M's do not contain shellac.[6]

A competing non-animal-based product is zein, a corn protein.[8] It is preferred by some vegans[9] because shellac production can kill many insects.[6]

References
  1. Smolinske, Susan C. (1992). Handbook of Food, Drug, and Cosmetic Excipients. CRC Press. p. 347. ISBN 0-8493-3585-X.
  2. Flinn, Angel. "Shellac and Food Glaze". Retrieved 2013-11-13.
  3. Blech, Zushe Yosef (2004). Kosher Food Production. Blackwell Publishing. p. 275. ISBN 0-8138-2570-9. Many candies are polished with "confectioner's glaze." otherwise known as "resinous glaze." The base of this material is shellac, which is derived from the lac insect. Although most Kashrus organizations accept this material, some do not.
  4. Adams, Cecil (1992). "The Straight Dope: Is some candy coated with beetle juice?". Creative Loafing Media, Inc. Retrieved 2009-02-02.
  5. Dresdner, Michael (13 Jan 2003). "Shellac Bugs?". Woodworker's Journal. Retrieved 3 July 2014.
  6. Yacoubou, Jeanne (30 Nov 2010). "Q & A on Shellac". Vegetarian Resource Group. Retrieved 3 July 2014.
  7. "FDA Inactive Ingredients Database". US Food and Drug Administration. Retrieved 23 August 2013.
  8. Klahorst, Suanne J. (September 1999). "Credible Edible Films". Food Product Design. Retrieved 2009-02-02.
  9. Flinn, Angel (15 Aug 2011). "Shellac & Food Glaze". Gentle World. Retrieved 3 July 2014.
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