this presentation slide has been prepared to add valuable information about tablet (solid dosage form). I hope that it will surely help the pharma aspirants for their examination.
The most common method of drug delivery is oral dosage
form of which tablet and capsule are predominant.
Tablet is more accepted as compared to capsule due to
many reason such as cost, tamper resistance, ease of
handling, ease of identification and manufacturing efficiency.
Tablet compression process understanding is resulted in
development of formulation.
Recent advances in the design of tablet compression
equipment has conducted resulted in higher efficiency,
minimized tablet variation, greater flexibility.
pellets can be defined as multi particulate system or multiunit system
They are spherical particulates manufactured by agglomeration of the powder granules containing drug substance and excipients.
Pellets can be prepared by a special technique called Pelletization.
This technique is referred to an agglomeration process that convert fine powder or granules of bulk drug or excipient in to small , free flowing , spherical or semi spherical pellets .
Multi particular drug delivery system especially suitable for achieving controlled delay released oral formulation with low risk of dose dumping, flexibility of blending to attain different release patterns as well as reproducible and short gastric residence time.
Multi particulate drug delivery system are mainly oral dosage form consisting of a multiplicity of small discrete units each exhibiting some desire characteristics.
The most common method of drug delivery is oral dosage
form of which tablet and capsule are predominant.
Tablet is more accepted as compared to capsule due to
many reason such as cost, tamper resistance, ease of
handling, ease of identification and manufacturing efficiency.
Tablet compression process understanding is resulted in
development of formulation.
Recent advances in the design of tablet compression
equipment has conducted resulted in higher efficiency,
minimized tablet variation, greater flexibility.
pellets can be defined as multi particulate system or multiunit system
They are spherical particulates manufactured by agglomeration of the powder granules containing drug substance and excipients.
Pellets can be prepared by a special technique called Pelletization.
This technique is referred to an agglomeration process that convert fine powder or granules of bulk drug or excipient in to small , free flowing , spherical or semi spherical pellets .
Multi particular drug delivery system especially suitable for achieving controlled delay released oral formulation with low risk of dose dumping, flexibility of blending to attain different release patterns as well as reproducible and short gastric residence time.
Multi particulate drug delivery system are mainly oral dosage form consisting of a multiplicity of small discrete units each exhibiting some desire characteristics.
“Pellets Technology: Special focus on Wruster Coating and Extruder
spheronization”
Basic introduction, various methods of pellets technology, Wruster process, equipments, various process parameters and equipment parameters, Extrusion-Spheronization, Equipments, process and equipment parameters
“Pellets Technology: Special focus on Wruster Coating and Extruder
spheronization”
Basic introduction, various methods of pellets technology, Wruster process, equipments, various process parameters and equipment parameters, Extrusion-Spheronization, Equipments, process and equipment parameters
Tablet, Tablet as a dosage form, tablet as a solid unit dosage form, tablet t...RajkumarKumawat11
Tablet, Tablet as a dosage form, tablet as a solid unit dosage form, tablet topic for pharma student, presentation of tablet, tablet by raj kumar kumawat
The most common tablet manufacturing process techniques are wet granulation, dry granulation, and direct compression.
Your active pharmaceutical ingredients’ (APIs) physical and chemical stability influences manufacturing.
For successful tablet manufacturing, you need granulators, mixing equipment, drying machinery, and coating systems.
Even if you’re using the right equipment to manufacture your product, there is a wide range of common tablet defects that can occur that affect quality.
There are several goals to aim for during the tablet manufacturing process:
Develop tablets that are strong and hard enough to hold up against mechanical shock during manufacturing, packaging, shipping, and dispensing
Formulate tablets that are uniform in weight and drug content
Manufacture bioavailable products according to indication requirements
Create chemically and physically stable tablets that last over long periods
Formulate products that are free of defects and have an elegant finish
Tablet coating engineering is one of the prominent topics in pharmaceutical field.
This slide will help pharmacy student to become familiar with coating technology
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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
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
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)
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
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