This document discusses common issues that can occur during tablet compression and how to troubleshoot them. It begins with an introduction that defines compression, consolidation, and compaction. It then outlines several factors that can affect compression, including surface properties, porosity, and moisture content. Several problems are identified such as capping, lamination, cracking, sticking, and picking. Potential causes and solutions are provided for each problem. The impacts of compression issues like weight variation, hardness variation, and friability are also examined. The document concludes by emphasizing the importance of resolving defects to ensure patient acceptance and compliance.
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Troubleshooting Of Compression Issues with complete Solution
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Before We Start
What is Compression?
Compression Machines at Keva Pharmaceuticals
Factors affecting compression
Problems faced during compression
Impacts of compression
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Outline
1.Introduction
2.Factor affecting compression
3.Problem faced during compression
4.Impact of compression
5.Conclusion
6.References
7.Q & A
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Introduction
Compression: According to USP When we apply any force to powder bed then
bulk volume will be reduced, known as Compression.
The reduction in the bulk volume of a material as a result of the removal of void
space by applied pressure.
CONSOLIDATION:
Involves an increase in the mechanical strength of a material resulting from
particle-particle interactions.
COMPACTION:
The compression and consolidation of granules due to an applied force, known as
Compaction.
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Capping
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Causes:
Due to the air entrapment
during compression.
Low moisture in granules.
Deep concave punches.
Remedies/Solution:
Precompression, Reducing the
final compression pressure.
Dry the granules properly.
Use flat punches.
Partial or complete separation of top or
bottom crown of tablet.
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Lamination
Separation of a tablet in to two or more distinct horizontal layers.
Causes:
Too much compression pressure.
Unwanted dried granules.
Remedies:
Accurate compression force should be apply to form tablet.
Add hygroscopic substances certain % of moisture by
e.g. Sorbitol, Methylcellulose, PEG.
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Cracking
Small, fine cracks observed on the upper and lower
central surface of tablets.
Reason:
Deep concave punches.
Too dry granules.
Remedies:
Using Flat punches.
Moisten the granules properly.
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Chipping
Breaking of tablet edges, while the tablet leaves the press or during subsequent
handling.
Reason:
Incorrect machine settings/ Less Binder
Remedies:
The Causes and Remedies of chipping related to Formulation
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Sr. No. CAUSES REMEDIES
1. Machine RPM too fast Reduce machine speed
2. Too dry granules Increase the moisture content of granules.
3. Scratch/uneven Surface Smooth punch
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Sticking
Sticking is the problem where the material adhere to die wall during tablet
compression.
Reason: Fig: Sticking on
punch Face.
Pressure applied is higher.
Excessive moisture in granules.
Rough die surface.
Remedies:
Decrease the pressure to optimum.
Proper drying of granules.
Adding glidant and lubricants.
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Picking
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Material adhere to punch faces
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.This occurs
predominantly in upper faces of the
punches.
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Picking
CAUSES
Excessive moisture in granules
Improper lubrication
Low melting point substances added
Rough or scratched punch faces
REMEDIES
Drying of granules
Increasing lubrication
Use high melting point lubricants
Platting of punch faces by - Chromium
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Mottling
Mottling is the term used to describe an unequal distribution of color on a
tablet.
Causes :
Different colors of excipients or a drug
Migration of dyes to the surface of granules during drying
Improper mixing of color
Remedies:
Change the solvent system (binding system)
Reduce the drying temperature
Mix properly and reduce the size to prevent the mottling.
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Double Impression
Due to free rotation of the punches, having some engraving on their faces.
Reasons For Double impression:
Uncontrolled rotation of either upper punch or lower punch during ejection of a
tablet.
Solution/Remedies:
Use of keyed punches.
Use of Anti-Turning Devices.
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Weight Variation
The tablets of one particular batch should have uniformity in weight. If any
weight variation is found, it should fall within the prescribed limits.
Tablet forms with different weight.
Causes:
Improper feeding of hopper, Poor flow, Lack of glidant and lubricant.
Remedies: Add sufficient amount of glidants and lubricants, proper the amount of
binder, uniform granules/mixing.
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Hardness Variation
Tablets having different hardness value. Generally, as granules size increases,
tablets are found to show increased weight variation, and same occur with the
hardness.
Causes :
Improper binder concentration and uniformity.
Room temperature and RH.
Remedies:
Ensure proper amount and uniformity of binder.
During compression, maintain room temperature and RH.
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Friability
Friability is the tendency of a tablet to crumble or break when subjected to
mechanical stress. The causes of high friability include inadequate binder,
Improper drying of granules, and tablet hardness.
The remedies for high friability include: control of binder, moisture and
compression pressure.
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Conclusion
These visual defects can reduce the acceptability by the users and patient
compliance of the product. In this slide, defects, causes and measures to overcome
these defects have been discussed.
The focus of this discussion is to establish ways to resolve common defects
during the tablet compression, and to identify the root cause of each.
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REFRENCES
1.Lachman L., Liberman, H.A., Joseph L. K. The Theory and Practice of Industrial Pharmacy;
Varghese Publishing House; Mumbai; Third Edition 297-321.
3.Aulton M. pharmaceutics: The science of Dosage Form Design; International Student Edition:
304-321, 347-668.
4.Remington J. Remington: The Science and Practice of Pharmacy; Nineteenth Edition:Volume
1615-1641.
5. Ansel H., Allen L., Jr. Popovich N. Ansels Pharmaceutical Dosage Forms and Drug Delivery
System; Eighth Edition:227-259.
6. Mohrle R Effervescent tablets in Liberman, Lachman, Lachman L. Schwartz.
Pharmaceutical dosage form, Tablets vol- first Indian reprint (2005) Marcel dekkar inc New
York -285-292.
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