Issue link: https://www.e-digitaleditions.com/i/1173734
46 October 2019 Tablets & Capsules Disintegration time. Piroxicam did not affect the disinteg ration time of the DCP-based for mula- tion, whereas it decreased that of MCC-based tablets and increased that of lactose-based tablets. Figure 4b shows how the disinteg ration time of the piroxicam-containing lactose-based formulation is highly dependent on hardness, resulting in a disintegration time 6.5 times that of the lactose-based placebo at the same compression force. For exam- ple, 10 kilonewtons of compression force resulted in lactose-based pla- cebo tablets with a hardness of 128 newtons and a disintegration time of less than two minutes, while the same compression force resulted in piroxicam-containing tablets with hardness of 64 newtons and a dis- integration time of approximately 12 minutes. Adding piroxicam to the MCC- ba s ed for mu lat ion r ed u ced the disintegration time up to 40 per- cent. Omyapharm 500-OG did not affect this reduction, while copovi- done increased it significantly (Fig- ure 4a). Not only did the disinte- gration time increase with the addi- tion of copovidone, but disintegra- tion also became strongly depen- dent on tablet hardness. Never- theless, tablets with high hardness and acceptable friability could be manufactured with disintegration times of less than 5 minutes. Both dry binders significantly decreased the disintegration time of the lac- t o s e - b a s e d p i r ox i c a m - c o n t a i n - ing tablets, but only Omyapharm 50 0 -OG restored it to the level of the lactose-based placebo tab- lets. Omyapharm 500-OG did not affect the disintegration time of the DCP-based for mulation, whereas copovidone increased disinteg ra- tion time significantly. However, even for the DCP-based formula- tion with copovidone, disintegra- tion times remained very fast—less than 75 seconds —for the entire compression force range tested. D r u g d i s s olut i o n. F ig u r e 5 shows the dissolution profiles of piroxicam formulated with one of Figure 4 Disintegration time of DC formulations containing 10% piroxicam with and without dry binders a. MCC-based formulations Disintegration time (seconds) 3,000.0 2,500.0 2,000.0 1,500.0 1,000.0 500.0 0.0 Main compression force (kilonewtons) 2 4 6 8 10 12 14 16 18 MCC DC MCC DC + piroxicam MCC DC + piroxicam + 5% Omyapharm 500-OG MCC DC + piroxicam + 5% copovidone b. Lactose-based formulations Disintegration time (seconds) 1,200.0 1,000.0 800.0 600.0 400.0 200.0 0.0 Main compression force (kilonewtons) 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 Disintegration time (seconds) 80.0 70.0 60.0 50.0 40.0 30.0 20.0 10.0 0.0 DCP DC DCP DC + piroxicam DCP DC + piroxicam + 5% Omyapharm 500-OG DCP DC + piroxicam + 5% copovidone Main compression force (kilonewtons) 2 4 6 8 10 12 14 16 18