Tablets & Capsules

TC1017

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B Tablets & Capsules October 2017 21 blending Using low-content active ingredients as an indicator of overall blend and tablet uniformities Wenming Zeng, Dan Wang, and Doug Roper Pharmavite This article describes the results of blending uniformity studies of a tablet formulation comprising 18 active ingredients, some of which are present in very small amounts. Testing to determine whether all the ingredients are present in the stated amounts would be time consuming and expensive. However, if the low- content active ingredients are uniform in the final blend and in the tablets, then it may be reasonable to assume that the other actives are uniform, too. lending uniformity studies are becoming more impor- tant during product development within the dietary sup- plement industry [1]. A multivitamin and mineral (MVM) dietary supplement product usually contains more than 15 active ingredients. How do you know if each ingredi- ent in the final blend of the MVM product is uniform? So far, data are scarce, if not absent, to answer this question. In the pharmaceutical industry, if an active ingredient of a drug product is greater than or equal to 50 milligrams (mg) per dosage form unit or the active ingredient is greater than or equal to 50 percent of the dosage form unit by weight, a blending uniformity study is not required [2]. Among the FDA's acceptance criteria for blending uniformity of generic drug products are that an active ingredient should be in the range of 90.0 percent to 110.0 percent of the amount specified, and relative standard deviation (RSD) must be no more than 5.0 per- cent (usually based on testing six to 10 samples) [2]. Most drug products contain one active ingredient, and some incorporate two or three active ingredients. Whatever the case, the amount of the active ingredient(s) in a pharmaceutical dosage form (tablet or capsule) by weight is usually 2 percent or more [3]. In the dietary supplement industry, however, an MVM tablet may con- tain more than 15 active ingredients, some of which may account for less than 0.2 percent of the dosage form's weight. Indeed, some supplement ingredients are present in amounts of less than 0.05 percent. At the other end of the spectrum, the active ingredients used in the highest amounts rarely exceed 50 percent of the dosage form. If we follow the pharmaceutical industry's standards, our blending uniformity studies must test for nearly all the active ingredients. In this study, the MVM tablet contains 18 active ingredients, in which only calcium car- bonate—since its use level exceeds 50 percent by weight—need not be tested. The other 17 active ingredi- ents must be tested. But doing so would take a long time and cost a lot of money, an expense that would eventu- ally be borne by consumers. But we can simplify blending uniformity studies of MVM tablets by making a reasonable assumption: If the active ingredients present in lower amounts are uniform in the final blend, then each active ingredient in the MVM tablet can also be considered to be uniform. Therefore, we only need to test several lower-content vit- amin and mineral active ingredients in the final blend. In

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