Tablets & Capsules

TC0514DTR

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18 May 2014 Tablets & Capsules Capsules and Capsule Filling Desktop Reference softgels Fish oil softgels: A comparison of delayed-release disintegration performance Laura K. Scattergood Colorcon A fishy aftertaste and unpleasant burps may deter consumers from taking fish oil supplements. There are several ways man- ufacturers can minimize these disagreeable effects to promote compliance. This article compares the disintegration performance of softgels that employ two commercially available options. Furthermore, a GRAS material can either be self- affirmed as such by a panel of experts or a GRAS notice can be submitted to the FDA for approval. A GRAS notice submission requires a detailed summary of the data substantiating that the use of the specified ingredient is GRAS and thus exempt from pre-market approval requirements. If the FDA finds no problems with the summary data, it will confer a "no objection" opinion. That is not, however, the same as the FDA approving a specific use of the material, which requires a complete food-additive petition. Therein lies a common point of confusion in the dietary-supplement industry: A non-dietary ingredient may be GRAS in some applications, but not necessarily GRAS for dietary supplements. That's because the ingredient must be evaluated and approved specifically for its use in supple- ment applications at the intended use levels and for a spe- cific associated daily exposure. Use in a different food cat- egory, a higher level of use, and/or a higher daily exposure would require a GRAS panel to extend the original GRAS report to cover such use in a dietary supplement. Additionally, the specifications of a material must match the specifications of the original material reviewed in the GRAS panel's assessment. While one supplier may have self-affirmed GRAS status for its particular material, that sta- tus cannot be used to justify including the same material from another supplier in the dietary supplement. Therefore, it is essential for supplement manufacturers using GRAS ingredients in their formulations to obtain the GRAS report or summary information for the specific material they are using and for its specific intended use and exposure level. Approved for pharma, not for food Methacrylic acid copolymer type C (MACC) and polyvinyl acetate phthalate (PVAP) are commonly used in enteric pharmaceutical applications. They are not listed food additives in 21 CFR, and no GRAS notices for them appear on the FDA's website. In light of the regulatory limitations on these enteric polymers, formulators of dietary supplements have turned to GRAS gastro-protective film coatings. One option is shellac-based coatings. Shellac, a natural resin secreted by the insect kerria lacca (lac beetle), is insoluble in acidic con- ditions and soluble at higher pH levels [3]. Due to its insolubility in water, shellac is typically used in solvent- F ish oil supplements are a good source of omega-3 fatty acids and are selling very well thanks in part to the recommendation of the American Heart Association. But many consumers forego the potential health benefits of fish oil because they dislike the fishy aftertaste. Plus, when fish oil softgels dissolve prematurely—in the stom- ach instead of the small intestine—consumers may expe- rience unpleasant fishy burps and stop taking the supple- ments. Applying a coating that delays dissolution of the soft- gel until it reaches the small intestine can prevent these undesirable side effects and promote compliance. In addi- tion, a coating enhances stability and overall product per- formance because it protects the softgel from moisture. Although enteric coating systems for drug products are well established [1], the polymers commonly used in those coatings are not approved for use in dietary supple- ments or foods [2]. Formulators thus face the challenge of minimizing the unpleasant aftertaste and burps without using pharmaceutical coatings. After briefly reviewing the laws governing dietary-supplement ingredients, this arti- cle compares the disintegration performance of fish oil softgels made using two commercially available enteric technologies. The ABCs of GRAS All non-dietary ingredients used in dietary supple- ments must be listed as an FDA-approved food additive in 21 CFR or be deemed "generally recognized as safe" (GRAS) for their intended uses and exposure levels. Under sections 201 and 409 of the Federal Food, Drug, and Cosmetic Act, any substance intentionally added to food is deemed a food additive and thus subject to pre- market review and approval by the FDA. An exception can be made when a substance is generally recognized by qualified experts as being adequately safe under the con- ditions of its intended use. g-Scatterart_18-21_Nutra 4/30/14 1:43 PM Page 18

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