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TABLET
Prepared By Guided By
VAIBHAV TRIPATHI Dr. Deepak K. Dash
(Asst. Prof.) (Principal)
Royal College of Pharmacy, Raipur (C.G.)
Index
1. Ideal properties
2. Advantages/ Disadvantages
3. Classification of Tablets
4. Excipients
5. Granulation Techniques
6. Equipments
7. Tablet Tooling
8. Processing Problems
Tablet

 Tablets are compressed solid unit dosage form
 containing medicament with/ without excipients.
Ideal properties

 Must be sturdy enough to withstand
shock during PSD
 Must be able to release API at desirable
time and rate
 Must be physico- chemically stable to
maintain physical & chemical integrity
of API till expiry date.
Ideal properties

 Must be free from any sort of defects.
 Must be uniform in wt.
 Must retain all attributes in prescribed
manner for its stability
Advantages
 Easy to administered.
 Easy to dispense.
 More stable.
 Accuracy in dose.
 Bitter and nauseous substance can be
easily dispensed.
 Light and compact.
 Economical.
 Sustained release product is possible by
enteric coating.
Disadvantages
 Problem with compression to crystalline
drug.
 Hygroscopic drugs are not suitable for
compressed tablets.
 Drugs with low or poor water solubility,
slow dissolution, may be difficult to
formulate.
 Cost of production may be increase
because of coating and encapsulation to
remove bitter and unpleasant taste.
 Swallowing is difficult especially for
children and ill (unconscious) patients.
Types
 TABLETS INGESTED ORALLY
ORAL CAVITY TABLETS
TABLETS ADMINISTERED BY
OTHER ROUTE
TABLETS USED TO PREPARE
SOLUTIONS
TABLET TRITURATES
Types
1. TABLETS INGESTED ORALLY
1. Compressed tablet
2. Multiple compressed tablet
3. Sustained action tablet
4. Multilayered
5. Enteric coated
6. Sugar coated
7. Chewable
Types
2.ORAL CAVITY TABLETS
 Buccal tab.
 Sublingual
 Lozenges
 Dental cones
Types
3. Tablets for other routes
 Implantation
 Vaginal
4. Tablets for solution
 Effervescent
Types
5. Tablet triturates
 Dispensing
 Hypodermic
Excipients
Excipients/ additives are mixed with API to fabricate tablet
dosage form
Additives are selected to explore intended effect in tablet.
 Provide proper wt. and vol. to the tablet
 Alter solubility
 BvB modifier
 Improve patient compliance
 Drug release modification
 Helps in product identification
Excipients
1. Diluent
2. Binder / Adhesive
3. Disintegrants
4. Lubricant/ Glidant
5. Coloring Agent
6. Flavoring Agent
7. Sweetening Agent
Excipients
 Diluent
 to increase the bulk vol.
 to permit use of direct compression manufacturing
 Lactose, starch, Dibasic calcium
phosphate dehydrate
 Calcium sulphate dihydrate, Mannitol
 Sorbitol, Sucrose, Dextrose
Excipients
 Binder
 provides strength to the granules
 Acacia, tragacanth- Solution for 10-25% Conc.
 Cellulose derivatives- Methyl cellulose, Hydroxy propyl
 methyl cellulose, Hydroxy propyl cellulose
 Gelatin- 10-20% solution
 Glucose- 50% solution
 Polyvinylpyrrolidone (PVP)- 2% conc.
 Starch paste-10-20% solution
 Sodium alginate
 Sorbitol
Excipients
 Disintegrants
 to facilitate breaking or disintegration in the GIT.
 One part is mixed with other excipients before granules
formation and the other is mixed with the dry granules
before compression.
 Starch- 5-20% of tablet weight.
 Cellulose derivatives- Ac- Di-Sol (sodium carboxy
methyl cellulose)
 Alginate
Excipients
 Lubricant / Glidant
 to prevent adhesion of the tablet materials to the
surface of dies and punches, reduce inter particle
friction
 improve the rate of flow of the tablet granulation by
reducing the friction between the particles.
 Stearic acid, Stearic acid salt – Stearic acid,
Magnesium stearate
 Corn Starch – 5-10% conc., Talc-5% conc., Silica
 derivative - Colloidal silicas such as Syloid, Aerosil in
0.25-3% conc.
Excipients
 Coloring Agent
 All coloring agents must be approved and certified by
FDA.
 Improve physical appearance
 Product Identification
 yellow 6-sunset yellow, yellow 5
Tartrazine , green 3- Fast Green,blue 1-
Brilliant
 Blue ,blue 2 - Indigo carmine
Excipients
 Sweetening Agent
 For chewable tablet- flavor oil are used
 Saccharine (artificial): 500 time’s
sweeter than sucrose
 Aspartame (artificial)
Excipients
 Flavoring Agent
 For chewable tablet- flavor oil are used
 Almond Oil, Benzaldehyde
 DL-Menthol,
 Ethyl Acetate
 Ethyl Vanillin
 L-Menthol
 Methyl Salicylate
 Peppermint Oil
Granulation
Process of size enlargement.
Fine or coarse particles are transformed into larger
aggregates.
 To improve flow property
 To prepare powder agglomerates
 To improve bulk density
 To prepare uniform size of aggregates
 To improve compaction
 To reduce the probability of capping
Granulation
Direct Compression
 Tablets are compressed directly from powder blend of
API & suitable additives
 Without altering the physical features of the drug
 It means, no pretreatment (wetting or recompression) is
required
 There is no need to prepare granules
 Potassium salt (chloride, bromide) ammonium chloride
etc.
Direct Compression
Advantages
 Economical - comparably fewer machines, less space,
less time & less labor required
 Stability – better option for thermo labile & moisture
sensitive APIs
 Improved dissolution rate- because tab. Disintegrate
directly into API particles so as to comparatively faster
dissolution
 Minimum machine related problems- less wear & tear
 Simple validation- due to fewer unit operations, easy to
comply GMPs
Direct Compression
Disadvantages
 Segregation - due to differences in density of the API &
excipients.
 Cost – specially process excipients raise the cost of final
product.
 BvB problem - poorly compressible APIs tend to release
only 30 – 40 % active ingredient . It leads to designing
large tab. Which may create difficult to swallow
 variation in functionality
 Lubricant sensitivity
 Re- workability
Dry Granulation
The powder mixture is compacted in large pieces (slug) and
subsequently broken down or sized into granules then final
compression to produce tablet.
 Milling / Screening
 Pre- blending
 Slugging / roller compaction
 Dry screening
 Blending of lubricant
 Compression
Dry Granulation
dies of large capacity tablet press and compacted using flat
faced punches.
 compacted masses are called slugs and process is
called slugging.
 Slugs milled or screened to produce good free flowing
granules for compression.
Dry Granulation
Advantages
 Good for moisture sensitive material
 Compatible for heat sensitive material
Disadvantage
 Specialist equipment is required for granulation by
roller compaction.
 Slugging and roller compaction lead to the generation
of considerable dust.
 Does not permit uniform color distribution
Wet Granulation
Wet granulation is a widely employed method for the
production of compressed tablets.
 Weighing and blending the ingredients
 Preparing a dampened powder or a damp mass
 Screening the dampened powder or damp mass into
pellets or granules
 Drying the granulation (oven)
 Sizing the granulation by dry screening
 Adding lubricant. Dry binder, colorant or Disintegrants
may be also added in this step
 Forming tablets by compression
Wet Granulation
Advantages
 To prevent segregation of the constituents of the powder
blend.
 To improve flowability of the powder mixture.
 To improve the compaction characteristics of the powder
mixture due to better distribution of the binder within
the granules.
 To improve homogeneity and thus ensure content
uniformity
Wet Granulation
Advantages
 Useful technique for the manufacture of tablets
containing low and or high concentrations of
therapeutic agent
 Employs conventional excipients and therefore is not
dependent on the inclusion of special grades of
excipients
Wet Granulation
Disadvantages
 Often several processing steps are required
 Solvents are required in the process which leads to a
number of concerns:
 Drug degradation may occur in the presence of the
solvent.
 The drug may be soluble in the granulation fluid.
 Heat is required to remove the solvent.
Equipments
There are 3 main stages/ operations in tablet production
1. Sizing
2. Mixing
3. Compression
Equipments
1. Sizing
 The sizing (size reduction, milling, crushing, grinding,
 pulverization) is an important step in the process of tablet
manufacturing.
 A fine particle size is essential in case of excipients mixing
with granules for its proper function.
 Fluid energy mill
 Colloidal mill
 Ball mill
 Cutting mill
 Roller mill
 Conical mill
Equipments
1. Sizing
 Fluid energy
mill
Equipments
2. Mixing
 Successful mixing of powder is very crucial to achieve
uniform dose content in each and every compressed tablet.
 Each process of mixing has an optimum mixing time, and
longer mixing may result in an undesired product.
 Blender's optimum mixing time and mixing speed must be
evaluated during mixing.
 "V" blender
 Oblicone blender
 Container blender
 Tumbling blender
 Agitated powder blender
Equipments
2. Mixing
 "V" blender
Equipments
3. Compression
 compression of powder for granulation
 Compression of granules into tablet
 compression of powder for granulation
 Compaction of powder by means of pressure roll.
 To prepare slug
 To produce directly compressible excipients
 Granulation of dry herbal drugs
Eg. chilsonator
Equipments
Equipments
3. Compression
 compression of powder for granulation
 High Shear granulation:
 Little ford Lodgie granulator
 Little ford MGT granulator
 Diosna granulator
 Gral mixer
Equipments
3. Compression
 compression of powder for granulation
 Granulator with drying facility:
 Fluidized bed granulator
 Day nauta mixer processor
 Double cone or twin shell processor
 Topo granulator
Equipments
3. Compression
 Compression of granules into tablet
 Hopper for holding and feeding granules to be
compressed
 Dies that define the size and shape of the tablet
 Punches for compressing the granules within the dies
 Cam tracks for guiding the movement of the punches
 Feeding mechanisms for moving granules from the
hopper into the die
 Tablet ejector
Equipments
3. Compression
A. Single punch machine
 The compression is
applied by the upper
punch
 making the single
punch machine
a “stamping press.”
Equipments
3. Compression
B. Multi-station rotary presses
 The head of the tablet machine that holds the upper
punches, dies and lower punches in place rotates
 As the head rotates, the punches are guided up and
down by fixed cam tracks, which control the sequence of
filling
 Then compression followed by ejection.
Equipments
3. Compression
B. Multi-station rotary presses
Equipments
3. Compression
B. Multi-station rotary presses
 The portions of the head that hold the upper and lower
punches are called the upper and lower turrets
 The portion holding the dies is called the die table
Tablet Tooling
 Tooling means any industrial operation which is done
with the help of a tool.
 Use of suitable tools for an industrial process
 Tablet tooling is a part/ set of machine
 Which consists of a die & upper- lower punches
Tablet Tooling
Tablet Tooling
 Name/ symbol/ design can be engraved into punch face
to get the intended design on tablet.
 Tooling damage can be avoided by calculating the
pressure of compressive load & the pressure at punch
tips.
 The most common tools employed are refer as “BB
TOOLING”.
Tablet Tooling
 5.25 inches in length
 0.75 inches barrel diameter
 1 inch head diameter
Tablet Tooling
 Significance
 To ascertain shape & size of the tablet
 To fix identification mark on the tablet
 Proper tooling helps to meet many provisional
requirements to comply with the protocols of GMPs like
 Dosage uniformity
 Optimum production efficiency
 Aesthetic appearance
Processing Problems
 An industrial pharmacist usually encounters number of
problems during manufacturing.
 Such problems bring about defects in tablets
 Factors related to processing problems:-
1. Formulation related
2. Tableting process related
3. Machine related
Processing Problems
1. Capping
2. Lamination
3. Cracking
4. Chipping
5. Sticking
6. Picking
7. Binding
8. Mottling
9. Double Impression
10. Wt. variation
11. Black marks on tablets
12. Delayed Disintegration
Processing Problems
1. Capping
 partial or complete removal of top or bottom portion of
tablet.
Reason Remedy
Poorly finished dies Polish dies properly. Investigate
other steels or other materials.
Lower punch remains below the
face of die during ejection.
Make proper setting of lower
punch during ejection.
Damaged upper punch replace the tool
Machine RPM too fast Speed adjustment
Processing Problems
2. Lamination
 Separation of a tablet into two or more distinct
horizontal layers.
Reason Remedy
Air entrapment in granules improve granulation using
tapered dies
Rapid decompression Reduce turret speed and reduce
the final compression pressure.
Large amount of fines in the
granulation
Remove some or all fines through
100 to 200 mesh screen
Processing Problems
3. Cracking
 Small, fine flaws observed on the upper and lower
central surface of tablets
Reason Remedy
Tablet expands on ejection due to
air entrapment.
Use tapered die.
Deep concavities cause cracking
while removing tablets
Use special take-off
Tablets expand. Improve
granulation.
Add dry binders.
Granulation too cold. Compress at room temperature.
Processing Problems
4. Chipping
 Breaking of tablet edges
Reason Remedy
Sticking on punch faces. Dry the granules properly or
increase lubrication.
Too much binding causes chipping
at bottom.
Optimize binding, or use dry
binders.
Groove of die worn at
compression point.
Polish to open end, reverse or
replace the die.
Concavity too deep to compress
powder blend.
Reduce concavity of punch faces.
Use flat punches.
Processing Problems
5. Sticking
 Tablet material adhering to the die wall
Reason Remedy
Granules not dried properly. Dry the granules properly. Make
moisture analysis to determine
limits.
Too little or improper lubrication. Increase or change lubricant.
Too little pressure. Increase pressure
Compressing too fast. Reduce speed.
Processing Problems
6. Picking
 The material is removed or picked up by upper punch
from the upper surface of the tablet.
Reason Remedy
Excessive moisture in granules. Dry properly the granules,
determine optimum limit.
Too much amount of binder. Reduce the amount of binder,
change the type or use dry
binders.
Embossing or engraving letters on
punch faces such as B, A, O, R, P, Q,
G.
Design lettering as large as
possible. Plate the punch faces
with chromium to produce a
smooth and non-adherent face.
Rough or scratched punch faces. Polish faces to high luster.
Processing Problems
7. Binding
 Sticking of the tablet to the die and does not eject
properly out of the die.
Reason Remedy
Too moist granules and extrudes
around lower punch.
Dry the granules properly.
Insufficient or improper lubricant. Increase the amount of lubricant
or use a more effective lubricant.
Poorly finished dies. Polish the dies properly.
Rough dies due to abrasion,
corrosion.
Investigate other steels or other
materials or modify granulation.
Processing Problems
8. Mottling
 An unequal distribution of colour on the surface of a
coloured tablet.
Reason Remedy
Migration of dye in the granules
during drying.
Drying the granules at low
temperature.
Use of different coloration of
medicaments and excipients.
Using the dye which can mask the
colour of all medicaments.
Processing Problems
9. 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.
Reason Remedy
Free rotation of either upper
punch or lower punch during
ejection of a tablet.
Newer presses have anti-turning
devices, which prevent punch
rotation.
Processing Problems
10. Weight Variation
 Weight variation occurs due to improper compression/
formulation of granules in a tablet machine
Reason Remedy
Granules are not in in uniform
size.
Provide uniform granules
Restricted free flow of granules Add Glidant to improve
flowability
Variation in the speed of tablet
machine.
Calibrate machine speed
Restricted hopper flow Adjust the hopper
Processing Problems
11. Black mark on tablets
 Unwanted mark on tablet due to presence of tiny
particles
Reason Remedy
Granules having black particle Proper screening before
compression
Lubricant, grease or oil may
contaminate the powder
Inspect before using such
materials
Due to traces of any part of
compression machine.
Cleansing on daily basis can avoid
this problem
Manual error Check the material after each &
every process
Processing Problems
12. Delayed disintegration
 When break down of tablets take more time than desired
Reason Remedy
Hard compression Optimize the compression
pressure
Over granulation Improve granulation
Excessive blending time with
lubricant
Adjust the blending time
References
1. Lachman L., Lieberman H.A., Theory And Practice of Industrial Pharmacy, (2009), Indian Edition,
CBS Publication And Distributors, New Delhi.
2. Hayes S. Remington: The Science and Practice of Pharmacy, volume I and volume II. Journal of the
Medical Library Association. JMLA
3. Tablets F. Indian Pharmacopoeia, 2010 Edition. Volume.;2:
4. Tripathi DK, Industrial Pharmacy: A Comprehensive Approach, (2018), Pharma Med. Press/BSP
Books, Andhra Pradesh.
5. Kumar K.P. Sampath, A Text Book of Industrial Pharmacy (2019), Nirali Publication And
Distributors, Maharashtra.
6. https://www.slideshare.net/sanjay2043/tablet-processing-problems
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Tablet - A complete information

  • 1. TABLET Prepared By Guided By VAIBHAV TRIPATHI Dr. Deepak K. Dash (Asst. Prof.) (Principal) Royal College of Pharmacy, Raipur (C.G.)
  • 2. Index 1. Ideal properties 2. Advantages/ Disadvantages 3. Classification of Tablets 4. Excipients 5. Granulation Techniques 6. Equipments 7. Tablet Tooling 8. Processing Problems
  • 3. Tablet   Tablets are compressed solid unit dosage form  containing medicament with/ without excipients.
  • 4. Ideal properties   Must be sturdy enough to withstand shock during PSD  Must be able to release API at desirable time and rate  Must be physico- chemically stable to maintain physical & chemical integrity of API till expiry date.
  • 5. Ideal properties   Must be free from any sort of defects.  Must be uniform in wt.  Must retain all attributes in prescribed manner for its stability
  • 6. Advantages  Easy to administered.  Easy to dispense.  More stable.  Accuracy in dose.  Bitter and nauseous substance can be easily dispensed.  Light and compact.  Economical.  Sustained release product is possible by enteric coating.
  • 7. Disadvantages  Problem with compression to crystalline drug.  Hygroscopic drugs are not suitable for compressed tablets.  Drugs with low or poor water solubility, slow dissolution, may be difficult to formulate.  Cost of production may be increase because of coating and encapsulation to remove bitter and unpleasant taste.  Swallowing is difficult especially for children and ill (unconscious) patients.
  • 8. Types  TABLETS INGESTED ORALLY ORAL CAVITY TABLETS TABLETS ADMINISTERED BY OTHER ROUTE TABLETS USED TO PREPARE SOLUTIONS TABLET TRITURATES
  • 9. Types 1. TABLETS INGESTED ORALLY 1. Compressed tablet 2. Multiple compressed tablet 3. Sustained action tablet 4. Multilayered 5. Enteric coated 6. Sugar coated 7. Chewable
  • 10. Types 2.ORAL CAVITY TABLETS  Buccal tab.  Sublingual  Lozenges  Dental cones
  • 11. Types 3. Tablets for other routes  Implantation  Vaginal 4. Tablets for solution  Effervescent
  • 12. Types 5. Tablet triturates  Dispensing  Hypodermic
  • 13. Excipients Excipients/ additives are mixed with API to fabricate tablet dosage form Additives are selected to explore intended effect in tablet.  Provide proper wt. and vol. to the tablet  Alter solubility  BvB modifier  Improve patient compliance  Drug release modification  Helps in product identification
  • 14. Excipients 1. Diluent 2. Binder / Adhesive 3. Disintegrants 4. Lubricant/ Glidant 5. Coloring Agent 6. Flavoring Agent 7. Sweetening Agent
  • 15. Excipients  Diluent  to increase the bulk vol.  to permit use of direct compression manufacturing  Lactose, starch, Dibasic calcium phosphate dehydrate  Calcium sulphate dihydrate, Mannitol  Sorbitol, Sucrose, Dextrose
  • 16. Excipients  Binder  provides strength to the granules  Acacia, tragacanth- Solution for 10-25% Conc.  Cellulose derivatives- Methyl cellulose, Hydroxy propyl  methyl cellulose, Hydroxy propyl cellulose  Gelatin- 10-20% solution  Glucose- 50% solution  Polyvinylpyrrolidone (PVP)- 2% conc.  Starch paste-10-20% solution  Sodium alginate  Sorbitol
  • 17. Excipients  Disintegrants  to facilitate breaking or disintegration in the GIT.  One part is mixed with other excipients before granules formation and the other is mixed with the dry granules before compression.  Starch- 5-20% of tablet weight.  Cellulose derivatives- Ac- Di-Sol (sodium carboxy methyl cellulose)  Alginate
  • 18. Excipients  Lubricant / Glidant  to prevent adhesion of the tablet materials to the surface of dies and punches, reduce inter particle friction  improve the rate of flow of the tablet granulation by reducing the friction between the particles.  Stearic acid, Stearic acid salt – Stearic acid, Magnesium stearate  Corn Starch – 5-10% conc., Talc-5% conc., Silica  derivative - Colloidal silicas such as Syloid, Aerosil in 0.25-3% conc.
  • 19. Excipients  Coloring Agent  All coloring agents must be approved and certified by FDA.  Improve physical appearance  Product Identification  yellow 6-sunset yellow, yellow 5 Tartrazine , green 3- Fast Green,blue 1- Brilliant  Blue ,blue 2 - Indigo carmine
  • 20. Excipients  Sweetening Agent  For chewable tablet- flavor oil are used  Saccharine (artificial): 500 time’s sweeter than sucrose  Aspartame (artificial)
  • 21. Excipients  Flavoring Agent  For chewable tablet- flavor oil are used  Almond Oil, Benzaldehyde  DL-Menthol,  Ethyl Acetate  Ethyl Vanillin  L-Menthol  Methyl Salicylate  Peppermint Oil
  • 22. Granulation Process of size enlargement. Fine or coarse particles are transformed into larger aggregates.  To improve flow property  To prepare powder agglomerates  To improve bulk density  To prepare uniform size of aggregates  To improve compaction  To reduce the probability of capping
  • 24. Direct Compression  Tablets are compressed directly from powder blend of API & suitable additives  Without altering the physical features of the drug  It means, no pretreatment (wetting or recompression) is required  There is no need to prepare granules  Potassium salt (chloride, bromide) ammonium chloride etc.
  • 25. Direct Compression Advantages  Economical - comparably fewer machines, less space, less time & less labor required  Stability – better option for thermo labile & moisture sensitive APIs  Improved dissolution rate- because tab. Disintegrate directly into API particles so as to comparatively faster dissolution  Minimum machine related problems- less wear & tear  Simple validation- due to fewer unit operations, easy to comply GMPs
  • 26. Direct Compression Disadvantages  Segregation - due to differences in density of the API & excipients.  Cost – specially process excipients raise the cost of final product.  BvB problem - poorly compressible APIs tend to release only 30 – 40 % active ingredient . It leads to designing large tab. Which may create difficult to swallow  variation in functionality  Lubricant sensitivity  Re- workability
  • 27. Dry Granulation The powder mixture is compacted in large pieces (slug) and subsequently broken down or sized into granules then final compression to produce tablet.  Milling / Screening  Pre- blending  Slugging / roller compaction  Dry screening  Blending of lubricant  Compression
  • 28. Dry Granulation dies of large capacity tablet press and compacted using flat faced punches.  compacted masses are called slugs and process is called slugging.  Slugs milled or screened to produce good free flowing granules for compression.
  • 29. Dry Granulation Advantages  Good for moisture sensitive material  Compatible for heat sensitive material Disadvantage  Specialist equipment is required for granulation by roller compaction.  Slugging and roller compaction lead to the generation of considerable dust.  Does not permit uniform color distribution
  • 30. Wet Granulation Wet granulation is a widely employed method for the production of compressed tablets.  Weighing and blending the ingredients  Preparing a dampened powder or a damp mass  Screening the dampened powder or damp mass into pellets or granules  Drying the granulation (oven)  Sizing the granulation by dry screening  Adding lubricant. Dry binder, colorant or Disintegrants may be also added in this step  Forming tablets by compression
  • 31. Wet Granulation Advantages  To prevent segregation of the constituents of the powder blend.  To improve flowability of the powder mixture.  To improve the compaction characteristics of the powder mixture due to better distribution of the binder within the granules.  To improve homogeneity and thus ensure content uniformity
  • 32. Wet Granulation Advantages  Useful technique for the manufacture of tablets containing low and or high concentrations of therapeutic agent  Employs conventional excipients and therefore is not dependent on the inclusion of special grades of excipients
  • 33. Wet Granulation Disadvantages  Often several processing steps are required  Solvents are required in the process which leads to a number of concerns:  Drug degradation may occur in the presence of the solvent.  The drug may be soluble in the granulation fluid.  Heat is required to remove the solvent.
  • 34. Equipments There are 3 main stages/ operations in tablet production 1. Sizing 2. Mixing 3. Compression
  • 35. Equipments 1. Sizing  The sizing (size reduction, milling, crushing, grinding,  pulverization) is an important step in the process of tablet manufacturing.  A fine particle size is essential in case of excipients mixing with granules for its proper function.  Fluid energy mill  Colloidal mill  Ball mill  Cutting mill  Roller mill  Conical mill
  • 37. Equipments 2. Mixing  Successful mixing of powder is very crucial to achieve uniform dose content in each and every compressed tablet.  Each process of mixing has an optimum mixing time, and longer mixing may result in an undesired product.  Blender's optimum mixing time and mixing speed must be evaluated during mixing.  "V" blender  Oblicone blender  Container blender  Tumbling blender  Agitated powder blender
  • 39. Equipments 3. Compression  compression of powder for granulation  Compression of granules into tablet  compression of powder for granulation  Compaction of powder by means of pressure roll.  To prepare slug  To produce directly compressible excipients  Granulation of dry herbal drugs Eg. chilsonator
  • 41. Equipments 3. Compression  compression of powder for granulation  High Shear granulation:  Little ford Lodgie granulator  Little ford MGT granulator  Diosna granulator  Gral mixer
  • 42. Equipments 3. Compression  compression of powder for granulation  Granulator with drying facility:  Fluidized bed granulator  Day nauta mixer processor  Double cone or twin shell processor  Topo granulator
  • 43. Equipments 3. Compression  Compression of granules into tablet  Hopper for holding and feeding granules to be compressed  Dies that define the size and shape of the tablet  Punches for compressing the granules within the dies  Cam tracks for guiding the movement of the punches  Feeding mechanisms for moving granules from the hopper into the die  Tablet ejector
  • 44. Equipments 3. Compression A. Single punch machine  The compression is applied by the upper punch  making the single punch machine a “stamping press.”
  • 45. Equipments 3. Compression B. Multi-station rotary presses  The head of the tablet machine that holds the upper punches, dies and lower punches in place rotates  As the head rotates, the punches are guided up and down by fixed cam tracks, which control the sequence of filling  Then compression followed by ejection.
  • 47. Equipments 3. Compression B. Multi-station rotary presses  The portions of the head that hold the upper and lower punches are called the upper and lower turrets  The portion holding the dies is called the die table
  • 48. Tablet Tooling  Tooling means any industrial operation which is done with the help of a tool.  Use of suitable tools for an industrial process  Tablet tooling is a part/ set of machine  Which consists of a die & upper- lower punches
  • 50. Tablet Tooling  Name/ symbol/ design can be engraved into punch face to get the intended design on tablet.  Tooling damage can be avoided by calculating the pressure of compressive load & the pressure at punch tips.  The most common tools employed are refer as “BB TOOLING”.
  • 51. Tablet Tooling  5.25 inches in length  0.75 inches barrel diameter  1 inch head diameter
  • 52. Tablet Tooling  Significance  To ascertain shape & size of the tablet  To fix identification mark on the tablet  Proper tooling helps to meet many provisional requirements to comply with the protocols of GMPs like  Dosage uniformity  Optimum production efficiency  Aesthetic appearance
  • 53. Processing Problems  An industrial pharmacist usually encounters number of problems during manufacturing.  Such problems bring about defects in tablets  Factors related to processing problems:- 1. Formulation related 2. Tableting process related 3. Machine related
  • 54. Processing Problems 1. Capping 2. Lamination 3. Cracking 4. Chipping 5. Sticking 6. Picking 7. Binding 8. Mottling 9. Double Impression 10. Wt. variation 11. Black marks on tablets 12. Delayed Disintegration
  • 55. Processing Problems 1. Capping  partial or complete removal of top or bottom portion of tablet. Reason Remedy Poorly finished dies Polish dies properly. Investigate other steels or other materials. Lower punch remains below the face of die during ejection. Make proper setting of lower punch during ejection. Damaged upper punch replace the tool Machine RPM too fast Speed adjustment
  • 56. Processing Problems 2. Lamination  Separation of a tablet into two or more distinct horizontal layers. Reason Remedy Air entrapment in granules improve granulation using tapered dies Rapid decompression Reduce turret speed and reduce the final compression pressure. Large amount of fines in the granulation Remove some or all fines through 100 to 200 mesh screen
  • 57. Processing Problems 3. Cracking  Small, fine flaws observed on the upper and lower central surface of tablets Reason Remedy Tablet expands on ejection due to air entrapment. Use tapered die. Deep concavities cause cracking while removing tablets Use special take-off Tablets expand. Improve granulation. Add dry binders. Granulation too cold. Compress at room temperature.
  • 58. Processing Problems 4. Chipping  Breaking of tablet edges Reason Remedy Sticking on punch faces. Dry the granules properly or increase lubrication. Too much binding causes chipping at bottom. Optimize binding, or use dry binders. Groove of die worn at compression point. Polish to open end, reverse or replace the die. Concavity too deep to compress powder blend. Reduce concavity of punch faces. Use flat punches.
  • 59. Processing Problems 5. Sticking  Tablet material adhering to the die wall Reason Remedy Granules not dried properly. Dry the granules properly. Make moisture analysis to determine limits. Too little or improper lubrication. Increase or change lubricant. Too little pressure. Increase pressure Compressing too fast. Reduce speed.
  • 60. Processing Problems 6. Picking  The material is removed or picked up by upper punch from the upper surface of the tablet. Reason Remedy Excessive moisture in granules. Dry properly the granules, determine optimum limit. Too much amount of binder. Reduce the amount of binder, change the type or use dry binders. Embossing or engraving letters on punch faces such as B, A, O, R, P, Q, G. Design lettering as large as possible. Plate the punch faces with chromium to produce a smooth and non-adherent face. Rough or scratched punch faces. Polish faces to high luster.
  • 61. Processing Problems 7. Binding  Sticking of the tablet to the die and does not eject properly out of the die. Reason Remedy Too moist granules and extrudes around lower punch. Dry the granules properly. Insufficient or improper lubricant. Increase the amount of lubricant or use a more effective lubricant. Poorly finished dies. Polish the dies properly. Rough dies due to abrasion, corrosion. Investigate other steels or other materials or modify granulation.
  • 62. Processing Problems 8. Mottling  An unequal distribution of colour on the surface of a coloured tablet. Reason Remedy Migration of dye in the granules during drying. Drying the granules at low temperature. Use of different coloration of medicaments and excipients. Using the dye which can mask the colour of all medicaments.
  • 63. Processing Problems 9. 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. Reason Remedy Free rotation of either upper punch or lower punch during ejection of a tablet. Newer presses have anti-turning devices, which prevent punch rotation.
  • 64. Processing Problems 10. Weight Variation  Weight variation occurs due to improper compression/ formulation of granules in a tablet machine Reason Remedy Granules are not in in uniform size. Provide uniform granules Restricted free flow of granules Add Glidant to improve flowability Variation in the speed of tablet machine. Calibrate machine speed Restricted hopper flow Adjust the hopper
  • 65. Processing Problems 11. Black mark on tablets  Unwanted mark on tablet due to presence of tiny particles Reason Remedy Granules having black particle Proper screening before compression Lubricant, grease or oil may contaminate the powder Inspect before using such materials Due to traces of any part of compression machine. Cleansing on daily basis can avoid this problem Manual error Check the material after each & every process
  • 66. Processing Problems 12. Delayed disintegration  When break down of tablets take more time than desired Reason Remedy Hard compression Optimize the compression pressure Over granulation Improve granulation Excessive blending time with lubricant Adjust the blending time
  • 67. References 1. Lachman L., Lieberman H.A., Theory And Practice of Industrial Pharmacy, (2009), Indian Edition, CBS Publication And Distributors, New Delhi. 2. Hayes S. Remington: The Science and Practice of Pharmacy, volume I and volume II. Journal of the Medical Library Association. JMLA 3. Tablets F. Indian Pharmacopoeia, 2010 Edition. Volume.;2: 4. Tripathi DK, Industrial Pharmacy: A Comprehensive Approach, (2018), Pharma Med. Press/BSP Books, Andhra Pradesh. 5. Kumar K.P. Sampath, A Text Book of Industrial Pharmacy (2019), Nirali Publication And Distributors, Maharashtra. 6. https://www.slideshare.net/sanjay2043/tablet-processing-problems