Disintegration and Dissolution Testing of Green Tea Dietary Supplements: Application and Evaluation of United States Pharmacopeial Standards.

Autor:	Gusev PA; Methods and Application of Food Composition Laboratory, Beltsville Human Nutrition Research Center, Agricultural Research Service, Department of Agriculture, Beltsville, Maryland 20705. Electronic address: pavel.gusev@usda.gov., Andrews KW; Methods and Application of Food Composition Laboratory, Beltsville Human Nutrition Research Center, Agricultural Research Service, Department of Agriculture, Beltsville, Maryland 20705., Savarala S; Methods and Application of Food Composition Laboratory, Beltsville Human Nutrition Research Center, Agricultural Research Service, Department of Agriculture, Beltsville, Maryland 20705., Tey PT; Methods and Application of Food Composition Laboratory, Beltsville Human Nutrition Research Center, Agricultural Research Service, Department of Agriculture, Beltsville, Maryland 20705., Han F; Methods and Application of Food Composition Laboratory, Beltsville Human Nutrition Research Center, Agricultural Research Service, Department of Agriculture, Beltsville, Maryland 20705., Oh L; Methods and Application of Food Composition Laboratory, Beltsville Human Nutrition Research Center, Agricultural Research Service, Department of Agriculture, Beltsville, Maryland 20705., Pehrsson PR; Methods and Application of Food Composition Laboratory, Beltsville Human Nutrition Research Center, Agricultural Research Service, Department of Agriculture, Beltsville, Maryland 20705., Dwyer JT; Office of Dietary Supplements, National Institutes of Health, Department of Health and Human Services, Bethesda, Maryland 20814., Betz JM; Office of Dietary Supplements, National Institutes of Health, Department of Health and Human Services, Bethesda, Maryland 20814., Kuszak AJ; Office of Dietary Supplements, National Institutes of Health, Department of Health and Human Services, Bethesda, Maryland 20814., Costello R; Office of Dietary Supplements, National Institutes of Health, Department of Health and Human Services, Bethesda, Maryland 20814., Saldanha LG; Office of Dietary Supplements, National Institutes of Health, Department of Health and Human Services, Bethesda, Maryland 20814.
Jazyk:	angličtina
Zdroj:	Journal of pharmaceutical sciences [J Pharm Sci] 2020 Jun; Vol. 109 (6), pp. 1933-1942. Date of Electronic Publication: 2020 Feb 18.
DOI:	10.1016/j.xphs.2020.02.005
Abstrakt:	Approved performance quality tests are lacking in the United States Pharmacopeia (USP) for dietary supplements (DSs) containing green tea extracts. We evaluated the applicability of USP <2040 > general chapter protocols for disintegration and dissolution testing of botanicals to GT DSs. Of 28 single-ingredient GT DSs tested in 2 to 4 lots, 9 (32.1%) always passed the disintegration test, 8 (28.6%) always failed, and 11 (39.3%) showed inconsistent results. Of 34 multi-ingredient DSs tested in 2 lots, 21 (61.8%) passed and 8 (23.5%) failed in both lots, and 5 (14.7%) exhibited inconsistent performance. When stronger destructive forces were applied (disk added), all of the capsules that had failed initially, but not the tablets, passed. In dissolution testing, for the release of epigallocatechin-3-gallate (EGCG), only 6 of 20 single-ingredient DSs passed. Unexpectedly, with the addition of pepsin (prescribed by USP), only one additional DS passed. These results raise concerns that EGCG was not released properly from GT DS dosage forms. However, the general USP protocols may be inadequate for this botanical. More biorelevant destructive forces may be needed to break down capsules and tablets strengthened by the EGCG's interaction with shell material and to overcome the inhibition of digestive enzymes by EGCG. (Copyright © 2020 American Pharmacists Association®. All rights reserved.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu