Module 5 Lesson 1 Flashcards
Criteria of uniformity of mixtures
Should contain 98-102% of the API
methods of uniformity mixtures
coning, and quartering, thief sampler
Criteria for adequacy of wetness
wet granulation
qualitative testing to check if the binder added is enough
wet granulation
Method of adequacy of wetness
damp mass - press thumb - ball crumbles under moderate pressure - next stage
not enough binder. too many fines - produce soft tablets
underwetting
may clog the screen, prolong processing(drying), forms very hard aggregates
overwetting
method (moisture content
gravimetric method, moisture balance analyzer
acceptable limit of moisture content
0.5% to 1%
gravimetric method
weigh - oven - weigh - oven - until constant weight is achived
adhesion of the granules to the die wall
sticking
implications of moisture content
sticking, picking,capping,chipping,lamination
adhesion of the granules to the pouch
picking
complete/partial separation of the top or bottom part of the tablet
capping
separation of small portions of the tablets
chipping
separation into two or more layers of the tablet
lamination
criteria for particle sice distribution
25 grams or more sample
methods for particle size distribution
sieve machine, mesh #
refers to the number of linear openings per square inch
mesh #
Implications for particle size distribution
good granules, fines
good granules
85 to 90%
fines
10 to 15%
are designed to sit in a stack so that material falls through smaller and smaller meshes
Standard sized sieves
range of sieves
40-9500um
the microscope eyepiece is fitted with a micrometer by which the size of the particles may be estimated
optical microscopy
rage of optical microscopy
0.2 - 100um
particles are individually examined
electron microscopy
range of electron microscopy
0.001 - 5um
smallest sieve opening through which 50% or more of the material passes
d50
> 1000
very coarse
355-1000
coarse
180-355
moderately fine
125-180
fine
90-125
very fine
by measuring the terminal settling velocity of particles through a liquid medium in a gravitational centrifugal environment using Andreasen apparatus
Sedimentation
range of sedimentation
0.8 - 300um
apparatus used in sedimentation
andreasen apparatus
distribution of scattered intensity is analysed by computer to yield the particle size distribution
light scattering technique
light scattering techniques
laser diffraction particle size analysis, photon correlation spectroscopy
characterize the flow property of granules/powders
angle of repose
Characterized the compressibility of the powders
Compressibility index and hausners ratio
