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,

(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 The letters to be embossed should be in Due to engraving or large size particularly on small punches, 1. embossing on the upper punch or the size of the tablet be increased. The punch surface should be coated with Rough punch surface 2. chromium so as to get a smooth non

3. 4. 5. 6. 7.

Sticky surface of tablet Too deep dividing lines Excess moisture. Hot granules while compression Excess binder.

adherent face of punch. Colloidal silica may be added in the formula as polishing agent to avoid sticking to the punch Reduce the depth of the division. Proper drying of granules. The granules are to be dried so that they do not stick. Reduce the amount or change the binder so that the adhesive force is reduced and more cohesive it becomes.

OSticking: 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 Increase the contact time by reducing the 2. Fast compression speed Greater concavity of the Reducethe concavity of the punch to 3. punch optimum level. OBinding: 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 Increase the conc of lubricant or use 1. Less or incorrect lubricant appropriate lubricant High moisture content of the 2. The granules are to be properly dried. tablet material Reduce the size of the granules by Hard granules reducing the passing through 30 mesh so that 3. effectiveness of lubricant increased surface area can increase the chances of even binding of the lubricant.

4. 5.

Worn out dies walls Polish the dies properly Excess pressure in the die Reduce the pressure with in the die. OChipping: 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 Moistane the granule with an 1. Too much drying hygroscopic substance Polish the punch surface to get a smooth 2. Worn out punches finish Sticking of the tablet material Addition of proper lubricant and properly 3. to the punch dry the granules. Non cylindrical dies with gap Polish the dies so that they become 4. in the edges cylindrical shape. OMottling: 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 A dye may cause mottling 1. when it migrates to the surface during the granulation process When coloured binder solution is not evenly distributed during mixing process Remedy The formulator is intended to change the solvent system, binder system, drying temperature. 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.

2.

A colored active ingredient 3. used along with colourless Addition of appropriate colouring agent. excipients. OCapping: 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 To remove the excess of fines the Large number of fines in the 1. granulation material should bee passed material through 100 to 200 mesh. 2. Improperly dried granules Dry the granules properly. Increase the quantity of binder or use and 3. Inadequate or improper binder appropriate one. Compression may not be firm Compress the tablet material at higher 4. due to cool temperature temperature. Improper setting of the lower Correct height of the lower punch should punch, which causes the 5. be adjusted so that the tablet is smoothly sweep off blade to cut the ejected out. surface OLamination: 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 Precompression step should be included Fast decompression of the 1. in the process, so that the pressure at the tablet final compression is reduces. Granules may contain oily or Suitable adsorbent or absorbent should 2. waxy material 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.