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52 September 2020 Tablets & Capsules 50 newtons) and rapid disintegra- tion (<30 seconds), as shown in Fig- ure 5. Especially, when the ODTs contained poorly water-soluble APIs (such as ibuprofen or ethenzamide), they exhibited excellent hardness and disintegration properties at API content from 50 to 70 percent. This high dosing capacity demonstrates the co-processed excipient's suitabil- ity for use with processed APIs, such as coated APIs for controlled release. ODTs with APIs The co-processed excipient also demonstrated the ability to load a high dose of APIs while maintaining high hardness and rapid disintegra- tion. In fact, the upper limit of API content depends on the API's water solubility. When an API accounted for 30 to 50 percent of the tablet weight, trial ODTs exhibited satis- factory hardness (greater than 40 to Figure 6 Recovery rate evaluated during tableting for ODTs containing API (1.0%) + co-processed excipient (97.5%) + sodium stearyl fumarate (1.0%) + silicon dioxide (0.5%) (Rotary tablet press, 200 mg, 8 mm diameter, flat beveled-edge shape) a. Ibuprofen (58-micron particle size) Recovery rate (%) 110 105 100 95 90 Tableting time (minutes) 0 20 40 60 b. Ibuprofen (142-micron particle size) Recovery rate (%) 110 105 100 95 90 Tableting time (minutes) 0 20 40 60 c. Ascorbic acid (92-micron particle size) Recovery rate (%) 110 105 100 95 90 Tableting time (minutes) 0 20 40 60 Figure 5 Performance of ODTs containing API + co-processed excipient + sodium stearyl fumarate (0.5-1.0%) + silicon dioxide (1.0%) (Rotary tablet press, 200 mg, 8 mm diameter, flat beveled-edge shape) (a) Ibuprofen Disintegration time (seconds) 50 40 30 20 10 0 Tablet hardness (newtons) 20 40 60 80 100 70% 50% 30% (b) Ethenzamide Disintegration time (seconds) 50 40 30 20 10 0 Tablet hardness (newtons) 20 40 60 80 100 120 70% 50% 30% (c) Paracetamol Disintegration time (seconds) 50 40 30 20 10 0 Tablet hardness (newtons) 40 60 80 100 120 50% 30%