Tablets & Capsules

TC1020

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Tablets & Capsules October 2020 27 Rüdiger Dartsch (rdartsch@biogrund.com) is marketing man- ager at Biogrund (502 901 2980, www.biogrund.com). The company manufactures excipient premixes, which are tai- lor-made and ready-to-use for film coating, tableting, and coloring for the global pharmaceutical and dietary supplement markets. Biogrund is part of the Clean Label Alliance, which supports brands and manufacturers to understand and react to changing requirements in the nutraceutical market. In the pharmaceutical industry, an RSD below 3 per- cent of filled capsules is acceptable. The results of capsule set 2 (ratio 1:2) showed an RSD of 2.23 percent. This indicates that for formulation 2, the right combination of process parameters was able to achieve good powder flow and consistently filled capsules. As these results demonstrate, the natural powder blend CompactCel MAB can absorb 12.5 (set 1) and 9.5 (set 2) percent oil and be filled into hard capsules. These per- centages are much greater than the assumed percentages for the simulated applications (6 percent for hemp, 4 per- cent for vitamin E, and 6 percent for probiotics). Comparing these results with the underlying applica- tions, it is evident that filling an oil-to-powder mixture into hard capsules is a straightforward process and a via- ble alternative dosage form to liquid-filled capsules, soft- gels, or pure oil, assuming that the process uses the right equipment, parameters, and ingredients. A natural substitute exists for each synthetic filler, binder, flow agent, lubricant, and disintegrant commonly used to formulate solid oral dosage forms. However, as previously stated, a 1:1 replacement in the formulation is not always sufficient to replace 100 percent of the syn- thetic excipient's functionality. T&C References 1. Survey data from the Organic Trade Association, ota.com/organic-market-overview/organic-industry-survey. 2. CBI—Ministry of Foreign Affairs, www.cbi.eu/ market-information/natural-ingredients-health-products/ what-demand. Substance Target Details Capsule size Oil content Hemp 20 mg ~30 mg of oil (containing 20 mg of CBD) Size 0 500 mg 6% of oil must be in the capsule Vitamin E 22.5 IU vitamin E, ~15 mg vitamin D3 in 1 capsule ~15 mg of oil (containing 15 mg of vitamin E) Size 1 350 mg ~4% of oil must be in the capsule Probiotics 30 million CFU ~30 mg of oil (containing 30 million CFU of probiotics) Size 0 500 mg 6% of oil must be in the capsule Table 6 Applications simulated in study

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