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Copyright 息 Keva Pharmaceuticals
TROUBLESHOOTING OF
COMPRESSION ISSUES
Presenter: Suraj Kumar Sah
25th July , 2023
Keva Pharmaceuticals Pvt. Ltd., Ratnanagar-16, Chitwan
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Copyright 息 Keva Pharmaceuticals
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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Copyright 息 Keva Pharmaceuticals
Outline
1.Introduction
2.Factor affecting compression
3.Problem faced during compression
4.Impact of compression
5.Conclusion
6.References
7.Q & A
3
Copyright 息 Keva Pharmaceuticals
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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Copyright 息 Keva Pharmaceuticals
Factor Affecting Compression
Surface Properties
Porosity
Flow Properties
Compression Force
Compression Speed
Moisture Content
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Copyright 息 Keva Pharmaceuticals
 1. Capping
 2. Lamination
 3. Cracking
 4. Chipping
 5. Sticking
 6. Picking
 7. Mottling
 8. Double Impression
 9. Weight Variation
 10. Hardness Variation
 11. Friability
PROBLEM
FACED
DURING
COMPRESSION
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Copyright 息 Keva Pharmaceuticals
Capping
7
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.
Copyright 息 Keva Pharmaceuticals
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.
8
Copyright 息 Keva Pharmaceuticals
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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Copyright 息 Keva Pharmaceuticals
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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Copyright 息 Keva Pharmaceuticals
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.
11
Copyright 息 Keva Pharmaceuticals
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.
Copyright 息 Keva Pharmaceuticals
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
13
Copyright 息 Keva Pharmaceuticals
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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Copyright 息 Keva Pharmaceuticals
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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Copyright 息 Keva Pharmaceuticals
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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Copyright 息 Keva Pharmaceuticals
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.
17
Copyright 息 Keva Pharmaceuticals
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.
18
Copyright 息 Keva Pharmaceuticals
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.
19
Copyright 息 Keva Pharmaceuticals
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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Copyright 息 Keva Pharmaceuticals
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Copyright 息 Keva Pharmaceuticals
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More Related Content

Troubleshooting Of Compression Issues with complete Solution

  • 1. Copyright 息 Keva Pharmaceuticals TROUBLESHOOTING OF COMPRESSION ISSUES Presenter: Suraj Kumar Sah 25th July , 2023 Keva Pharmaceuticals Pvt. Ltd., Ratnanagar-16, Chitwan 1
  • 2. Copyright 息 Keva Pharmaceuticals Before We Start What is Compression? Compression Machines at Keva Pharmaceuticals Factors affecting compression Problems faced during compression Impacts of compression 2
  • 3. Copyright 息 Keva Pharmaceuticals Outline 1.Introduction 2.Factor affecting compression 3.Problem faced during compression 4.Impact of compression 5.Conclusion 6.References 7.Q & A 3
  • 4. Copyright 息 Keva Pharmaceuticals 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. 4
  • 5. Copyright 息 Keva Pharmaceuticals Factor Affecting Compression Surface Properties Porosity Flow Properties Compression Force Compression Speed Moisture Content 5
  • 6. Copyright 息 Keva Pharmaceuticals 1. Capping 2. Lamination 3. Cracking 4. Chipping 5. Sticking 6. Picking 7. Mottling 8. Double Impression 9. Weight Variation 10. Hardness Variation 11. Friability PROBLEM FACED DURING COMPRESSION 6
  • 7. Copyright 息 Keva Pharmaceuticals Capping 7 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.
  • 8. Copyright 息 Keva Pharmaceuticals 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. 8
  • 9. Copyright 息 Keva Pharmaceuticals 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. 9
  • 10. Copyright 息 Keva Pharmaceuticals 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 10 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 10
  • 11. Copyright 息 Keva Pharmaceuticals 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. 11
  • 12. Copyright 息 Keva Pharmaceuticals Picking 12 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.
  • 13. Copyright 息 Keva Pharmaceuticals 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 13
  • 14. Copyright 息 Keva Pharmaceuticals 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. 14
  • 15. Copyright 息 Keva Pharmaceuticals 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. 15
  • 16. Copyright 息 Keva Pharmaceuticals 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. 16
  • 17. Copyright 息 Keva Pharmaceuticals 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. 17
  • 18. Copyright 息 Keva Pharmaceuticals 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. 18
  • 19. Copyright 息 Keva Pharmaceuticals 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. 19
  • 20. Copyright 息 Keva Pharmaceuticals 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. 20
  • 21. Copyright 息 Keva Pharmaceuticals 21
  • 22. Copyright 息 Keva Pharmaceuticals 22