PRESENTED BY P.

RAMYASREE
M.PHARM (PHARMACEUTICS) I YEAR I SEMISTER COP, SKU ANANTAPUR

PROCESSING PROBLEMS OF TABLETS AND REMEDIES

CONTENTS
INTRODUCTION PROCESSING PROBLEMS OF TABLETS CONCLUSION REFERENCES

PROCESSING PROBLEMS OF TABLETS AND REMEDIES

INTRODUCTION
A quality tablet should be free from any visual defect Majority of visual defects are due to Inadequate fines or inadequate moisture in the granules ready for compression or due to faulty machine setting. Functional defects are due to faulty formulation. The imperfections are known as: VISUAL DEFECTS and they are either related to imperfections in any one or more of the following factors: Tableting Process Excipient Machine Other factors

PROCESSING PROBLEMS OF TABLETS AND REMEDIES THE DEFECTS RELATED TO TABLETING PROCESS Capping Lamination cracking THE DEFECTS RELATED TO EXCIPIENT

Picking
Sticking/filming Binding

chipping

PROCESSING PROBLEMS OF TABLETS AND REMEDIES THE DEFECTS RELATED TO MACHINE Poor flow pattern Double impression

THE DEFECTS DUE TO OTHER FACTORS Mottling

PROCESSING PROBLEMS OF TABLETS AND REMEDIES

CAPPING
The upper or lower segment of the tablet separates horizontally, either partially or completely from the main body of a tablet and comes off as a cap, during ejection from the tablet press, or during subsequent handling.

Reason:
Capping is usually due to the airentrapment in a compact during compression, and subsequent expansion of tablet on ejection of a tablet from a die.

PROCESSING PROBLEMS OF TABLETS AND REMEDIES

CAPPING
RELATED TO FORMULATION CAUSES Insufficient usage of binder REMEDIES

Increasing the mount of binder or Adding dry binder such as pregelatinized starch, gum acacia, powdered sorbitol, PVP, hydrophilic silica or powdered sugar Low moisture content Moisten the granules suitably. Add hygroscopic substance e.g.: sorbitol, methyl- cellulose or PEG-4000. Presence of high quantity of fines Remove some or all fines through 100 to 200 mesh screen during granulation Dry the granules properly Insufficiently dried granules Increase the amount of lubricant or Insufficient usage of lubricant change the type of lubricant. Granules when compressed at Compress at room temperature. cool temperature

PROCESSING PROBLEMS OF TABLETS AND REMEDIES

CAPPING
RELATED TO MACHINE
CAUSES Poorly finished dies Deep concave punches or bevelededge faces of punches. Lower punch remains below the face of die during ejection. Incorrect adjustment of sweep-off blade. High turret speed. REMEDIES Polish dies properly. Investigate other steels or other materials. Use flat punches. Make proper setting of lower punch during ejection. Adjust sweep-off blade correctly to facilitate proper ejection. Reduce speed of turret (Increase dwell time).

PROCESSING PROBLEMS OF TABLETS AND REMEDIES

LAMINATION

Lamination is the separation of

a tablet into two or more distinct horizontal layers.

Reason:
Airentrapment during compression and subsequent release on ejection.

PROCESSING PROBLEMS OF TABLETS AND REMEDIES

LAMINATION
RELATED TO FORMULATION REMEDIES
Modify mixing process. Add adsorbent or absorbent. Use a less amount of lubricant or change the type of lubricant.

CAUSES

Oily or waxy materials in granules

Too much of hydrophobic lubricant e.g.: Magnesium-stearate.

PROCESSING PROBLEMS OF TABLETS AND REMEDIES

LAMINATION
RELATED TO MACHINE
CAUSES Rapid relaxation of the peripheral regions of a tablet, on ejection from a die. Rapid decompression REMEDIES Use tapered dies, i.e. upper part of the die bore has an outward taper of 3 to 5. Use pre-compression step. Reduce turret speed and reduce the final compression pressure.

PROCESSING PROBLEMS OF TABLETS AND REMEDIES

CRACKING

Small, fine cracks observed on the upper and lower central surface of tablets, or very rarely on the sidewall of tablets

Reason:
It is observed as a result of rapid expansion of tablets, especially when deep concave punches are used.

PROCESSING PROBLEMS OF TABLETS AND REMEDIES

CRACKING
RELATED TO FORMULATION CAUSES Large size of granules. Too dry granules. Tablets expand. Granulation too cold. REMEDIES Reduce granule size. Add fines. Moisten the granules properly and add proper amount of binder. Improve granulation. Add dry binders. Compress at room temperature.

PROCESSING PROBLEMS OF TABLETS AND REMEDIES

CRACKING
RELATED TO MACHINE

CAUSES Tablet expands on ejection due to air entrapment. Deep concavities cause cracking while removing tablets

REMEDIES Use tapered die. Use special takeoff.

PROCESSING PROBLEMS OF TABLETS AND REMEDIES

PICKING
Picking is the term used when a small amount of material from a tablet is
sticking to and being removed off from the tablet-surface by a punch face. The problem is more prevalent on the upper punch faces than on the lower ones. The problem worsens, if tablets are repeatedly manufactured in this station of tooling because of the more and more material getting added to the already stuck material on the punch face.

Reason:
Picking is of particular concern when punch tips have engraving or embossing letters, as well as the granular material is improperly dried.

PROCESSING PROBLEMS OF TABLETS AND REMEDIES

PICKING
RELATED TO FORMULATION

CAUSES
Excessive moisture in granules. Too little or improper lubrication.

REMEDIES
Dry properly the granules, determine optimum limit. Increase lubrication; use colloidal silica as a polishing agent, so that material does not cling to punch faces.

Low melting point substances, Add high melting-point materials. Use may soften from the heat of high meting point lubricants. compression and lead to picking. Too warm granules when compressing. Too much amount of binder. Compress at room temperature. Cool sufficiently before compression.

Reduce the amount of binder, change the type or use dry binders.

PROCESSING PROBLEMS OF TABLETS AND REMEDIES

PICKING
RELATED TO MACHINE
CAUSES Rough or scratched punch faces. REMEDIES Polish faces to high luster. Design lettering as large as possible. Plate the punch faces with chromium to produce a smooth and non-adherent face. Reduce depths and sharpness. Increase pressure to optimum.

Embossing or engraving letters on punch faces such as B, A, O, R, P, Q, G.

Bevels or dividing lines too deep. Pressure applied is not enough; too soft tablets.

PROCESSING PROBLEMS OF TABLETS AND REMEDIES

STICKING
Sticking refers to the tablet material adhering to the die wall. Filming is a slow form of sticking and is largely due to excess moisture in the granulation.

Reason:
Improperly dried or improperly lubricated granules.

PROCESSING PROBLEMS OF TABLETS AND REMEDIES

STICKING
RELATED TO FORMULATION CAUSES Granules not dried properly. Too little or improper lubrication. Too much binder Hygroscopic granular material. Oily or way materials Too soft or weak granules. REMEDIES Dry the granules properly. Make moisture analysis to determine limits. Increase or change lubricant. Reduce the amount of binder or use a different type of binder. Modify granulation and compress under controlled humidity. Modify mixing process. Add an absorbent. Optimize the amount of binder and granulation technique.

PROCESSING PROBLEMS OF TABLETS AND REMEDIES

STICKING
RELATED TO MACHINE

CAUSES Concavity too deep for granulation. Too little pressure.

REMEDIES Reduce concavity to optimum. Increase pressure.

Compressing too fast.

Reduce speed.

PROCESSING PROBLEMS OF TABLETS AND REMEDIES

BINDING
Binding in the die, is the term used when the tablets adhere, seize or tear in the die. A film is formed in the die and ejection of tablet is hindered. With excessive binding, the tablet sides are cracked and it may crumble apart.

Reason:
Binding is usually due to excessive amount of moisture in granules, lack of lubrication and/or use of worn dies.

PROCESSING PROBLEMS OF TABLETS AND REMEDIES

BINDING
RELATED TO FORMULATION CAUSES Too moist granules and extrudes around lower punch. Insufficient or improper lubricant. Too coarse granules. REMEDIES Dry the granules properly. Increase the amount of lubricant or use a more effective lubricant. Reduce granular size, add more fines, and increase the quantity of lubricant. Modify granulation. Reduce granular size.

Too hard granules for the lubricant to be effective. Granular material very abrasive and cutting into dies.
Granular material too warm, sticks to the die.

If coarse granules, reduce its size. Use wear-resistant dies.

Reduce temperature. Increase clearance if it is extruding.

PROCESSING PROBLEMS OF TABLETS AND REMEDIES

BINDING
RELATED TO MACHINE CAUSES Poorly finished dies. Rough dies due to abrasion, corrosion. Undersized dies. Too little clearance. REMEDIES Polish the dies properly. Investigate other steels or other materials or modify granulation. Rework to proper size. Increase clearance.

Too much pressure in the Reduce pressure. OR tablet press. Modify granulation.

PROCESSING PROBLEMS OF TABLETS AND REMEDIES

CHIPPING
Chipping is defined as the breaking of tablet edges, while the tablet leaves the press or during subsequent handling and coating operations.

Reason:
Incorrect machine settings, specially mis-set ejection takeoff.

PROCESSING PROBLEMS OF TABLETS AND REMEDIES

CHIPPING
RELATED TO FORMULATION

CAUSES Sticking on punch faces Too dry granules. Too much binding causes chipping at bottom.

REMEDIES Dry the granules properly or increase lubrication. Moisten the granules to plasticize. Add hygroscopic substances. Optimize binding, or use dry binders.

PROCESSING PROBLEMS OF TABLETS AND REMEDIES

CHIPPING
RELATED TO MACHINE
CAUSES Groove of die worn at compression point. Barreled die (center of the die wider than ends) Edge of punch face turned inside/inward. REMEDIES Polish to open end, reverse or replace the die.

Polish the die to make it cylindrical

Polish the punch edges

Concavity too deep to compress Reduce concavity of punch faces. Use properly. flat punches.

PROCESSING PROBLEMS OF TABLETS AND REMEDIES

POOR FLOW PATTERN

The phenomenon of flow of granules from hopper to the disc cavity via feed frame

Reason :
Non uniform flow of granules from the hopper leads to incomplete filling of die cavity Machine when operated at high speed in comparison to granulation flow, leads to incomplete filling of die cavity

PROCESSING PROBLEMS OF TABLETS AND REMEDIES

POOR FLOW PATTERN

RELATED TO FORMULATION

CAUSES
Less usage of glidant

REMEDIES
Use required amount of glidant RELATED TO MACHINE

CAUSES The geometry of the hopper also affects the flow pattern

REMEDIES Attach vibrators to the sides of the hopper in order to improve the granulation flow

PROCESSING PROBLEMS OF TABLETS AND REMEDIES

DOUBLE IMPRESSION
Double Impression involves only those punches, which have a monogram or other engraving on them.

Reason:
At the moment of compression, the tablet receives the imprint of the punch. Now, on some machines, the lower punch freely drops and travels uncontrolled for a short distance before riding up the ejection cam to push the tablet out of the die, now during this free travel, the punch rotates and at this point, the punch may make a new impression on the bottom of the tablet, resulting in Double Impression. If the upper punch is uncontrolled, it can rotate during the short travel to the final compression stage and create a double impression.

PROCESSING PROBLEMS OF TABLETS AND REMEDIES

DOUBLE IMPRESSION
THE CAUSES AND REMEDIES OF DOUBLE IMPRESSION CAUSE REMEDIES

Use keying in tooling, i.e. inset a key Free rotation of either upper alongside of the punch, so that it fits the punch or lower punch punch and prevents punch rotation. during ejection of a tablet. Newer presses have anti-turning devices, which prevent punch rotation.

PROCESSING PROBLEMS OF TABLETS AND REMEDIES

MOTTLING

Mottling is the term used to describe an unequal distribution of colour

on a tablet, with light or dark spots standing out in an otherwise uniform surface.

Reason:
One cause of mottling may be a coloured drug, whose colour differs from the colour of excipients used for granulation of a tablet.

PROCESSING PROBLEMS OF TABLETS AND REMEDIES

MOTTLING
CAUSES A colored drug used along with colorless or whitecolored Excipients. REMEDIES

Use appropriate colorants.

Change the solvent system, Change the binder, A dye migrates to the surface Reduce drying temperature and of granulation while drying. Use a smaller particle size Improperly mixed dye, especially during Direct Compression. Improper mixing of a coloured binder solution. Mix properly and reduce size if it is of a larger size to prevent segregation. Incorporate dry colour additive during powder blending step, then add fine powdered adhesives such as acacia and tragacanth and mix well and finally add granulating liquid.

PROCESSING PROBLEMS OF TABLETS AND REMEDIES

CONCLUSION
During tablet manufacture, an industrial pharmacist usually encounters many problems. Solving these problems requires an in-depth knowledge of tablet-formulation as well as machineoperating processes.

PROCESSING PROBLEMS OF TABLETS AND REMEDIES

REFERENCES
Modern pharmaceutics by Gilbert S. Banker, Christopher T. Rhodes Theory and practice of Industrial pharmacy, Lackmann and Lieberman Pharmaceutical dosage forms, Vol 1 by Lackmann and Liebermann www.pharmainfo.net