GENERANL APPEARANCE
Size,
shape and thickness
Size and
shape: Can be
controlled by size and shape of punches and die of tablet compression machine.
Tablet
thickness (dimensional variation) related to:
a)
Constant compression load: Tablet Thickness varies with tab. weight, die fill and Particle Size distribution.
b)
Constant die fill: Thickness varies with compression load.
Tablet thickness can be measured by:
Micrometer: Measure individual tablet thickness (so accurate information on variation between tab.)
Holding tray: measure total tab. thickness of 5-10 tablet with a sliding caliper scale (not accurate information provider on variation between tabs but overall estimation) to give more rapid readings.
Shape:
Shape of tablet influence the choice of tablet machine used with special slotted punches that run at lower speed than conventional punches that produce round tablets.
Organoleptic properties (color uniformity, odor and taste)
Color
uniformity:
To identify
the product and give good impression to the consumer, while mottling (unequal
distribution of the color on tablet) give bad idea to the manufacturer.
Odor:
Presence of
odor in a batch of tablet could indicate stability problems like: odor of acetic
acid in degrading aspirin tablet.
Taste:
It is
important in chewable tab.
Non
official tests:
A) Hardness (tablet crushing strength)
Tablet
hardness: is the force required to
break a tablet in a diametric compression test.
Tabs
required a certain amount of strength or hardness and resistance to friability
in order to:
- Withstand mechanical shock of handling in manufacture, packaging and shipping.
- In addition the tabs should be
able to withstand reasonable abuse when in the hands of consumer.
Hardness
of tab like its thickness is a function of:
• (Die fill constant) then additional
compression force result in more hardness and less thickness
• (Compression force constant–fixed
distance between upper and lower punches)
then hardness increase with increase in die fill and decrease with lower
die fill.
• Quantity and quality of binder (good
binder result in appropriate tablet hardness and not hinder the release of drug from
tablet).
• Lubricant can affect tablet hardness (if too
high conc. or long time mixing)
Hardness
of different types of tablet
Ordinary tab. 4-8 kg
Chewable tab. 3 kg to prevent
harmful effect on teeth
Lozenges (troches) and sustained
release 10-20 kg
Non official
tests:
B) Friability (abrasion and shock)
Friable
tablet: tablet that tend to powder, chip and
fragment when handled result in:
• Lack elegance and consumer
acceptance.
• Create excessively dirty process in
area of manufacturing as coating and packaging.
• Tab’s weight variation or content
uniformity problems
Factors
affecting friability:
• Addition of large amount of fine
powder to the formula
• Over drying of granules (moisture
content).
• Use of material that is not cohesive to the formula.
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