Tablets & Capsules

TC1019

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Tablets & Capsules October 2019 45 Friability. Figure 3b shows that adding piroxicam did not affect fri- ability for lactose-based tablets, although friability was higher than 0.5 percent for compression forces below 9 kilonewtons. Conversely, piroxicam severely impacted fri- ability for MCC-based tablets, as shown in Figure 3a. While fri- ability was below 0.03 percent for the whole compression force range tested (4 to 16 kilonewtons) for placebo tablets, when piroxi- cam was added to the formulation, the MCC-based tablets exhibited a severe dependence on compres- sion force, reaching 2.3 percent for 88-newton tablets and 0.75 percent for 128-newton tablets. Although the addition of piroxicam did not generally affect the friability of DCP-based tablets, no mechanically stable piroxicam tablets with com- pression forces below 7 kilonewtons could be manufactured (Figure 3c). B oth copovidone and O mya- pharm 500-OG at a 5 percent level, restored the friability of the MCC- based formulation to placebo levels (Figure 3a). Interestingly, both dry binders also increased the mechani- cal stability of lactose-based tablets, allowing for friabilit y lower than 0.2 percent for 50-newton tablets (Figure 3b). On the contrary, add- ing the dr y binders to the DCP- based formulation had no impact on friability (Figure 3c). Figure 3 Friability of DC formulations containing 10% piroxicam with and without dry binders a. MCC-based formulations Friability (%) Main compression force (kilonewtons) MCC DC MCC DC + piroxicam MCC DC + piroxicam + 5% Omyapharm 500-OG MCC DC + piroxicam + 5% copovidone 2.50 2.00 1.50 1.00 0.50 0.00 2 4 6 8 10 12 14 16 18 b. Lactose-based formulations Friability (%) Main compression force (kilonewtons) 2.50 2.00 1.50 1.00 0.50 0.00 2 4 6 8 10 12 14 16 18 Lactose DC Lactose DC + piroxicam Lactose DC + piroxicam + 5% Omyapharm 500-OG Lactose DC + piroxicam + 5% copovidone c. DCP-based formulations Friability (%) 2.50 2.00 1.50 1.00 0.50 0.00 Main compression force (kilonewtons) 2 4 6 8 10 12 14 16 18 DCP DC DCP DC + piroxicam DCP DC + piroxicam + 5% Omyapharm 500-OG DCP DC + piroxicam + 5% copovidone Interestingly, both dry binders also increased the mechanical stability of lactose-based tablets, allowing for friability lower than 0.2 percent for 50-newton tablets.

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