PROBLEMS ASSOCIATED WITH TABLET MANUFACTURING

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PROBLEMS ASSOCIATED WITH TABLET MANUFACTURING

Hello dear pharma bloggers

This is blog is aimed to cater the needs of those pharma fresher graduates who have just completed their graduation and looking to find their future in the phrama industry rather than higher education. If you seem to have interest in the production department, or R & D you need to have a keen knowledge of tablets.

Our team ASSIMILATORS have made a small attempt, I hope you all would like this.

Please follow these links before reading this blog, they include a brief note on introduction and tablet processing excipients.

http://www.pharmainfo.net/nandini/blog/introduction-tablets

http://www.pharmainfo.net/narmadha/blog/formulation-excipients-tablets

So to start with the tabletting problems,

With the development of technology, the production process had become more simplified and more mechanized; the complexity of a tablet punching process has increased. But relatively reducing the problems associated with the manufacturing process

In olden days tablets were initially punched on small scale with hand operated machines, which suffered the problem of varied strength and integrity,

http://www.labequipmentsindia.com/product/image/2252.jpg(1)hand operated small scale production machine

(2)medium scale production automated tablet punching machine

(3) (large scale automated fast tablet punching machine.)

but now the tablet punching machines are all mechanized, the mechanical feeding of feed from the hopper into the die, electronic monitoring of the press, but still tablet process problem still persist.

Tablet processing problems can be due to the problem in the formulation or in the compression equipment, or both of them.

Thus we can classify the problems into following three types(4,5,6):

1. Problem due to excipient: chipping, picking, binding, sticking, mottling,

2. Problems during process: capping, lamination.

3. Problem due to machine: double impression.

So at ever y step of the tablet manufacturing process, utmost care should be taken to avoid defected tablet.

1) Problems due to excipient:

This can arise due to the inaccurate addition of excipients or errors in the granulation process. It includes: sticking, picking, binding, mottling.

O Picking:

o Picking happens when a part of the tablets gets sticks to the punch surface and gets eroded from the tablet surface

o This mostly happens with the upper punch. And if this is left unchecked then this may lead to weight variation too.

Sno

Cause

Remedy

1.

Due to engraving or embossing on the upper punch

The letters to be embossed should be in large size particularly on small punches, or the size of the tablet be increased.

2.

Rough punch surface

The punch surface should be coated with chromium so as to get a smooth non adherent face of punch.

3.

Sticky surface of tablet

Colloidal silica may be added in the formula as polishing agent to avoid sticking to the punch

4.

Too deep dividing lines

Reduce the depth of the division.

5.

Excess moisture.

Proper drying of granules.

6.

Hot granules while compression

The granules are to be dried so that they do not stick.

7.

Excess binder.

Reduce the amount or change the binder so that the adhesive force is reduced and more cohesive it becomes.

O Sticking:

o It refers to the sticking of the tablet material with the die walls.

o Due to this sticking with the die walls, additional force is required to eject the tablet form the die walls.

o Sticking also causes production of tablets with rough edges.

o If this problem persists, then this can cause chipping of the tablet.

o It produced unusual stress on the cam track and punch heads resulting in their damage!

Sno

Cause

Remedy

1.

Low pressure

Increase the pressure of punching

2.

Fast compression

Increase the contact time by reducing the speed

3.

Greater concavity of the punch

Reducethe concavity of the punch to optimum level.

O Binding:

o Binding is sticking of the tablet to the die and does not eject properly out of the die.

o It may be mainly due to lack of proper lubricant or less quantity of lubricant, or may be due to excess moisture in the tablet.

Sno

Cause

Remedy

1.

Less or incorrect lubricant

Increase the conc of lubricant or use appropriate lubricant

2.

High moisture content of the tablet material

The granules are to be properly dried.

3.

Hard granules reducing the effectiveness of lubricant

Reduce the size of the granules by passing through 30 mesh so that increased surface area can increase the chances of even binding of the lubricant.

4.

Worn out dies walls

Polish the dies properly

5.

Excess pressure in the die

Reduce the pressure with in the die.

O Chipping:

o Chipping usually happens around the tablet surface, small pieces are broken out or chipped out of the tablet.

o It is mainly due to improper machine setting, like ejection of the tablet.

Sno

Cause

Remedy

1.

Too much drying

Moistane the granule with an hygroscopic substance

2.

Worn out punches

Polish the punch surface to get a smooth finish

3.

Sticking of the tablet material to the punch

Addition of proper lubricant and properly dry the granules.

4.

Non cylindrical dies with gap in the edges

Polish the dies so that they become cylindrical shape.

O Mottling:

o Mottling is uneven distribution of the colour on the surface of the tablet, with dark and light patches on it.

o It is mainly due to different colouration of the excipient or the degradation product of the tablet is coloured.

(7)

Sno

Cause

Remedy

1.

A dye may cause mottling when it migrates to the surface during the granulation process

The formulator is intended to change the solvent system, binder system, drying temperature.

2.

When coloured binder solution is not evenly distributed during mixing process

The addition should in the sequence of First the powder colorant is added followed by the binder like acacia or tragacanth, followed by the addition of granulating liquid, and properly mixed.

3.

A colored active ingredient used along with colourless excipients.

Addition of appropriate colouring agent.

O Capping:

o Capping is a complete or partial separation of the upper or lower surface of the tablet horizontally, when the tablet comes out of the die.

o When the air is entrapped in between the tablet material in a die, and when the material gets compressed between the two punches, the air entrapped also gets compressed, but when the pressure is released on the tablet I.e. when the two punched move apart and the tablet ejects out of the die, the compressed sir expands and leads to capping.

Sno

Cause

Remedy

1.

Large number of fines in the material

To remove the excess of fines the granulation material should bee passed through 100 to 200 mesh.

2.

Improperly dried granules

Dry the granules properly.

3.

Inadequate or improper binder

Increase the quantity of binder or use and appropriate one.

4.

Compression may not be firm due to cool temperature

Compress the tablet material at higher temperature.

5.

Improper setting of the lower punch, which causes the sweep off blade to cut the surface

Correct height of the lower punch should be adjusted so that the tablet is smoothly ejected out.

O Lamination:

o It is similar to capping but here the tablet gets separated into layers.

o It can once again occur due to the air entrapment or due to the high speed of turret

Sno

Cause

Remedy

1.

Fast decompression of the tablet

Precompression step should be included in the process, so that the pressure at the final compression is reduces.

2.

Granules may contain oily or waxy material

Suitable adsorbent or absorbent should be added.

(8)

(tablet capping and lamination)

O Double impression:

o It is seen when the tablet punches have engraving or monograms on it to be embossed on the tablet.

o When the tablet material comes into the die for the compression both the punches come in contact with the tablet material and compress it, the next step is ejection of the tablet from the die,

o During ejection process the lower punch travels a small distance down and then comes up to give a gentle push to the tablet, at this point when the lower punch moves down and comes up it moves in a swirlling motion, due to the free rotation when it comes in contact with the tablet for the second time to push it up it leaves another impression on the tablet. Which is leads to double impression.

o To avoid this key are to be used along the sides of the punches, so that it prevents rotation of the punches.

This blog is free from plagiarism.

Reference:

1. http://www.labequipmentsindia.com/product/image/2252.jpg

2. http://product-image.esuppliersindia.com/00431839/s/3/Tablet-Punching-Machine.jpg

3. http://www.gmpchina.net/image/p/gzpt1060.jpg

4. The theory and practice of industrial pharmacy by Leon Lacman, Herbert A Lieberman, Joseph L.Kang third edition, Varghese publishing house page no -311-314

5. Pharmaceutical Dosage Forms Tablets, Vol. 1, pg.no- 188-190

6. http://www.authorstream.com/Presentation/sabapathi-369361-problems-tablet-manufacturing-science-technology-ppt-powerpoint/

7. http://www.justice.gov/dea/programs/forensicsci/microgram/mg0206/mg0206_fig3.jpg

8. http://upload.wikimedia.org/wikipedia/en/2/27/Tabletfailure.jpg