DISINTEG Flashcards
- determine whether tablets, capsules, or granules disintegrate within the prescribed time when placed in a liquid medium at the experimental conditions presented
- does not imply complete solution of the unit or even of its active constituent
DISINTEGRATION TEST
state in which any residue of the unit, except fragments of insoluble coating or capsule shell, remaining on the screen of the test apparatus or adhering to the lower surface of the disk, if used, is a soft mass having no palpably firm core
COMPLETE DISINTEGRATION
tablet by itself in a solution without disintegration
VERY LIMITED DISSOLUTION
tablet into granules
LIMITED DISSOLUTION
tablets disintegrated completely – powdered, no granules present
BEST DISSOLUTION
APPARATUS
- 6 open-ended transparent tubes
- tubes are held in a vertical position by two plates
- 10-mesh wire cloth at the bottom, attached to the under surface of the lower plate
BASKET-RACK ASSEMBLY
APPARATUS
volume of beaker used
1000mL
APPARATUS
thermostatic arrangement
35-39C
APPARATUS
a device for raising and lowering the basket in the immersion fluid is at a constant frequency rate of ____ cycles/min through a distance of 53-57mm
29-32
APPARATUS
- permitted only where specified or allowed in the monograph
- prevents the sample from coming out of the assembly
CYLINDRICAL DISKS
DISINTEGRATION MEDIA (IMMERSION FLUIDS)
temperature is maintained at
37 ∓ 2C
DISINTEGRATION MEDIA (IMMERSION FLUIDS)
- distilled water
- 0.1 HCl
- stimulated gastric fluid TS
- stimulated intestinal fluid TS
DISINTEGRATION MEDIA (IMMERSION FLUIDS)
Stimulated Gastric Fluid TS
NaCl
pepsin
HCl
DISINTEGRATION MEDIA (IMMERSION FLUIDS)
Stimulated Intestinal Fluid TS
monobasic potassium phosphate
H2O
NaOH
pancreatin
what should you do if 1 or 2 tabs failed to disinteg completely
repeat the test on 12 addntl tabs
USP CRITERIA for DISINTEG
all tabs should be disintegrated
there should not be more than 2 tabs not disinteg completely
