Disintegration Time:-
Uncoated Tablet
NMT 15 min, in water with Disc 370C ± 20C
Coated Tablet
NMT 30 min, In water with Disc for Film Coated Tab, and NMT 60 min Other than Film coated tablet
Enteric Coated Tab
Intact for 2 hr in 0.1 N HCl & disintegrate within 1 hr in Mixed 6.8 Phosphate buffer. According to USP 2 hr in Simulated gastric fluid, then in Simulated Intestinal Fluid.
Dispersible/Soluble
Within 3 min in water at 250C ± 10C (IP) & 15 – 250C (BP)
Orodispersible
Within 1 min
Effervescent Tab
5 min in 250 ml water at 20 – 300C (IP) & 5 min in 200 ml water at 15-250C (BP)
Buccal & Sublingual
Not Applicable but dissolve within 15 – 30 min.
Uncoated Tablet
NMT 15 min, in water with Disc 370C ± 20C
Coated Tablet
NMT 30 min, In water with Disc for Film Coated Tab, and NMT 60 min Other than Film coated tablet
Enteric Coated Tab
Intact for 2 hr in 0.1 N HCl & disintegrate within 1 hr in Mixed 6.8 Phosphate buffer. According to USP 2 hr in Simulated gastric fluid, then in Simulated Intestinal Fluid.
Dispersible/Soluble
Within 3 min in water at 250C ± 10C (IP) & 15 – 250C (BP)
Orodispersible
Within 1 min
Effervescent Tab
5 min in 250 ml water at 20 – 300C (IP) & 5 min in 200 ml water at 15-250C (BP)
Buccal & Sublingual
Not Applicable but dissolve within 15 – 30 min.
DT Apparatus:- Mesh Apperture:- 2mm (#10), Cycles:- 28 – 32 cycles/min, 50 – 60 mm distance from bottom & top, Temp of water 370C ± 20C. If 1 or 2 tabs fail, repeat for 12 tabs.