What Is The Process Of Tablet Compression?
Process
of Tablet Compression:
• Compression is the process of conversion of
granules to a compact mass within specified limits with the help of a machine
called a tablet compression machine.
In this process formation of a tablet takes
place when powder mostly in the form of granules moves into the die cavity and
then is compressed between upper and lower punches under the two large opponent
wheels in which the lower wheel is fixed while the upper one moves.
•After granulation next step of manufacturing
is compression. Machine equipment and cubicle (Including walls and floor) are
properly cleaned. Area cleanliness as per the requirement of the line clearance
procedure is performed before the start of the new batch. after thorough checks
and satisfaction, the production pharmacist signs the line clearance sheet,
followed by approval from the QA officer on a random basis.
• After line clearance, the machine operator
fixes the machine parts and tools in the machine. All the parts must be
properly cleaned and dry.
• the First step in compression is the
filling of the hopper with granules and manually running to fill the die cavity
and then the granules are compressed between the upper and lower punch under
the two wheels with pressure resulting in the formation of the tablet.
• 2nd step is to get the required weight of
the tablet. Start the machine with minimum pressure and speed and check the
weight of the tablet manually on the electronic balance and adjust the weight
by moving the knob attached to the weight adjustment cam, either clockwise or
anti-clockwise as per need until the weight is adjusted. weight increases if
the knob is moved anticlockwise and vice versa.
• 3rd step of compression is to adjust the
hardness and thickness of the tablet as per requirement. adjust the hardness
either by rotating the knob (attached to the lower fixed wheel ) clockwise or
anti-clockwise. clockwise rotation will increase the hardness and vice versa.
check the thickness of the tablet with the help of a verifier clipper. Continue
the trial until the tablet of specific hardness and thickness is achieved.
• After preliminary adjustment run the
machine with full capacity and do the following important checks during
the compression period;
1. Take the weight of 20 tablets as per
product requirement on the well-calibrated small electronic weighing
balance(capacity in grams), note it on the in-process sheet and repeat it after
every one or half hours.
2. Confirm the thickness through a well-calibrated
verifier clipper and note it on the in-process sheet at minimum two hours
intervals.
3. check the hardness of tablets by weighing
usually 20 tablets, and transferring them into the friability testing
apparatus. run it for 4 minutes and then note the difference in weight before
and after the operation. It must be less than 1%. friability tester must have
100 revolutions in 4 minutes.
• The quantity of tablets used for the
friability test depends upon the weight of a unit tablet. If the weight of the
single tablet is less than 650 mg then use 20 tablets otherwise utilize only 10
tablets
4. Perform the disintegration test by putting
one tablet in each channel. Apparatus usually consists of 4 baskets, each
containing 6 channels. Baskets are fixed in the assembly .baskets containing
tablets are then dipped in a water chamber and then run the apparatus at
36-38°c until all the tablets are broken down into small pieces which could
easily pass through a mesh of 10 sizes. note the time of disintegration. It
must be within specification.
• when all the parameters are satisfactory,
draw a sample of twenty tablets and send it to the Quality control department
for physical and chemical analysis.
• Frequency of disintegration and friability
checking must be at the start of the machine and then once daily.
• Note that the disintegration is only
done for uncoated tablets.
• Tablets after ejection from the machine
pass through the metal detector installed at the end of the compression machine
which detects the metal and rejects the tablets before falling into the output
container. check the efficiency of the metal detector at the start of the
machine and then randomly during the operation.
• Hydraulic pressure is transmitted through
static fluid equally in all directions in the machine as per Pascal's rule.
• Direct compression is usually executed when
there is a risk of deterioration of moisture-sensitive or heat-sensitive
material (used in the preparation of tablets)during granulation.
• Tablets are usually divided into four types
based on administration;
1. Tablets ingested through oral routes like
compressed tablets, sugar-coated tablets chewable tablets and enteric-coated
tablets. They are usually water soluble and absorbed through the stomach.
2. Tablets which are used in the buccal
cavity like buccal tablets and sublingual tablets.
3. Tablets administered through another route
like Implementation tablets and vaginal tablets.
4. Tablets used for the preparation of
solutions like effervescent tablets and dispensing tablets.
• Punches are differentiated by the length of
the stem. The length of the upper punch is small while the length of the lower
punch is large which helps him in the ejection of tablets from the die.
Tablet compressions machines are divided into
four types based on the diameter of dies and punch which is also called
tooling. i.e, B type, D type, BB type and DD type.
• Major tools are B type and D type with the
following characteristics.
1. B type is used for small tablets with a
maximum diameter of 19 mm.
2. D type which is used for large tablets
having a maximum diameter of 25 mm.
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