To acquire knowledge of topic.

1. Tablets
Miss. HarshadaR. Bafna
M.Pharmacy(QA)

2. CONTENT
 Introduction
 Advantages and disadvantages tablets
 Types of tablets
 Tablet Ingredients
 Tableting methods
 Direct compression
 Dry compression
 Wet compression
 Tablet compression machine
 Evaluation of tablet
 Problems in tableting & remedies thereof
 Advance granulation techniques.
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3. INTRODUCTION
1843 a patent was granted to Thomas Brockedon
(Englishman) for manufacturing pills and lozenges
1874 both rotary and eccentric presses
1885 Glyceryl trinitrate tablets was in the BP
until 1945 No other tablet monograph appeared
1980 nearly 300 monographs for tablets
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4. DEFINITION: According to the Indian
Pharmacopoeia Pharmaceutical tablets are
solid, flat or biconvex dishes, unit dosage form,
prepared by compressing a drugs or a mixture
of drugs, with or without diluents.
They vary in shape and differ greatly in size
and weight, depending on amount of medicinal
substances and the intended mode of administration.
It is the most popular dosage form and 70% of the total medicines
are dispensed in the form of Tablet.
All medicaments are available in the Tablet form except where
it is difficult to formulate or administer.
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5.  Production aspects
1. Large scale production at lowest cost
2. Easiest and cheapest to package and ship
3. High stability (chemical, mechanical & biological)
4. Lightest and most compact
 Formulation aspects
1. Greatest dose precision with least content variability
2. Lend to give special release profile products e.g. enteric or delayed
release tablets
3. Product identification is cheap – embossing or monogrammed
punch face
 Patient aspects
1. Ease of handling
2. Coating can mask unpleasant tastes & improve patient acceptability.
ADVANTAGES
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6. DISADVANTAGES
Some drugs resist compression into dense compacts owing to
amorphous nature, low density character.
Difficult to swallow in case of children, Old age patients and
unconscious patients.
Drugs with poor wetting & slow dissolution may be difficult or
impossible to formulate and manufacture as a tablet that provide
adequate or full drug bioavailability.
Bitter taste drugs, drugs with an objectionable odor, or sensitive
to oxygen or moisture may require encapsulation or entrapment
prior to compression or the tablets may require coating. 6
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7. General properties of Tablet dosage forms:
1.Atablet should have elegant product identity while free of defects
like chips, cracks, discoloration, and contamination.
2.Should have sufficient strength to withstand mechanical shock
during its production, packaging, shipping and dispensing.
3. chemical and physical stability
4.The tablet must be able to release the medicinal agents in a
predictable and reproducible manner.
5. Accurate dosage of medicament, uniform in weight, elegant
product, acceptable size & shape appearance and diameter 7
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8. DIFFERENT TYPES OF TABLETS
(A)Tablets ingested orally:
1. Compressed tablet, e.g. Paracetamol tablet
• Uncoated tablet
• Rapid disintegration & release
• Drug for local or systemic effect
•E.g. antacids, analgesics,
Antipyretics, etc.
• Tablets manufactured by any
of the three techniques - wet granulation,
dry granulation or direct compression. 8
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9. 2. Multiple compressed tablet
• e.g., Metformin & Gliclazide tab.
• Two types- layered tab. & compression coated tab.
• Tablet machine speed slower for this tab.
•separate physically or chemically
Incompatible ingredients or for repeat or
Prolonged action.
•One layer in layered tab. Or outer
Layer in compression coated tab. acts as
1st dose in stomach & other layer or
inner core material acts as 2nd dose in
intestine
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10. 3. Repeat action tablet
•Layered tab. or Compression coated tab. or Sugar coated tab.
may be used for this purpose.
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11. 4. Delayed release tablet or enteric coated tablet
• e.g. Enteric coatedAspirin tab.(irritates stomach on exposure)
• Intended to remain intact in stomach & release in intestine
• This tab. remains intact for 30 mins.
in USP Disintegration apparatus in gastric
media & then disintegrates as per time
specified in monograph plus 30 mins
•Enteric coating polymer: Cellulose
acetate phthalate, polyvinyl acetate
phthalate, HPMC phthalate.
• Mechanism of lose of integrity of this polymer film
(ASSIGNMENT)
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12. 5. Sugar coated tablet
• e.g. Multivitamin tablet
• elegant, glossy, easy to swallow tab.
•Used to separate incompatible ingredients
between core & coating
• Doubles tab. Wt.
• Required skilled labors
• Now-a-days water soluble polymer,
automated spray coating equipments &
High drying efficiency has made coating
more efficient & less time consuming & moreover coat wt. may
be 50% or less than core wt.
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13. 6. Film coated tablet
• e.g. Metronidazole tablet
• No drug incorporated in coat
•Polymer used along with plasticizer & surfactant
to facilitate spreading
• less time consuming & attractive method
• Water soluble polymers used are HPC,
HPMC used
• Better mechanical strength, less increase in tab.
Wt. as compared to sugar coating
• Less elegant than sugar coating 13
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14. 7. Chewable tablet
• e.g.Antacid tablet (Gelusil)
• Chewed in mouth & then swallowed
• Ease for administration in infants
(chewable aspirin) & people having difficulty in swallowing
• Not suitable for bitter & foul tasting drugs
• Dose of antacids is large so difficult to swallow tab. & lesser the
particle size of antacid dosage form in stomach better the acid
neutralization.
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15. (B) Tablets used in oral cavity:
1. Buccal tablet, e.g. Vitamin-C tablet
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16. 2. Sublingual tablet, e.g. Isosorbide dinitrate tablet,
nitroglycerin
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17. BUCCAL OR SUBLINGUALTAB.
• Intended to be held in mouth where the drug is released for
absorption directly in oral mucosa
• Small, flat tab. intended to be held between cheek & teeth or in
cheek pouch (Buccal), or beneath tongue (sublingual tab.)
• Drug absorbed from oral mucosa directly into blood circulation
& avoids first pass metabolism
• Rapid onset of drug action avoid drug degradation in GIT, nausea
produced due to swallowing of drug is avoided
• Should not disintegrate but slowly dissolve within 15-30 mins.
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18. 3. Troches or lozenges (pastilles or cough drops)
• e.g., Strepsils
• local effect in mouth & throat
•Commonly used to treat sore throat, or
to control coughing
• Lozenges made by incorporation of drug in
flavored hard candy sugar base prepared by
Fusion or candy molding method
• Troches made by compression
• Should not disintegrate in mouth but dissolve
or erode within 30 mins or less 18
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19. 4. Dental cone
•Minor tablet designed to be placed in empty socket remaining
after a tooth extraction to prevent multiplication of bacteria by
employing slow release of antibacterial
compound or to reduce bleeding by
using astringent or coagulant
• vehicles used are sodium Bicarbonate,
NaCl or amino acid
in presence of serum or
•Tablet should dissolve or erode slowly
fluid over 20 to 40 mins when loosely
packed in extraction site. 19
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20. (C) Tablets administered by other route:
1. Implantation tablet (depot tab.)
• e.g., nexlpanon implant
• Intended for subcutaneous implantation
• Prolong drug release from months
to year at constant drug release rate
•Tablets are small, cylindrical or Rosette
shaped & not more than 8 mm in length.
Kern injector (special injector with hollow needle & plunger) used
• Again surgery done to discontinue treatment, tissue toxicity at site
of implant can occur.
• E.g., Growth hormones administered in animals through ear
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21. 2. Vaginal tablet
• e.g. Clotrimazole tablet, nistan
• Slow drug release in vaginal cavity
• ovoid or peared shaped
• Used to release antibacterial,
antiseptic or astringent to treat vaginal infections or to release
steroids
•Tablets are buffered to promote pH favorable action of antiseptic
agent
• vehicles same as for buccal or sublingual tab.
• drug should be compatible with plastic tube inserter used to
place tab. in vaginal cavity
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22. (D) Tablets used to prepare solution:
1. Effervescent tablet
• e.g. Dispirin tablet (Aspirin)
•Intended to produce solution rapidly
with simultaneous release of CO2
•Tabs. prepared by compressing drug
with organic acids-such as citric acid or
tartaric acid & sodium bicarbonate
• When tab dropped in water chemical
reaction occurs within a min. or less between acid & NaHCO3 to
form sodium salt of acid & to produce CO2 & water
• pleasant flavored carbonated drink masks bitter taste of drugs
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Advantage:
1. Difficult to produce stable product
2. Moisture in air or water liberated from NaHCO3 can initiate
the reaction
3. Providing adequate protection of product in the hands of
consumer is another problem
 For this reason effervescent tablets are packed in hermetically
type foil pouches or stack packed in cylindric tubes with
minimal air spaces
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24. 2. Dispensing tablet, e.g. Enzyme tablet (Digiplex)
• Intended to be added in given volume of water by pharmacist or
consumer to produce a solution of a given drug conc.
• Drugs such as mild silver proteinate, bichloride of mercury,
merbromin & quaternary ammonium compounds are incorporated
in dispensing tab.
• Buffering & isotonicity adjusting agents also added in this tab.
• This tab. not used now a days as water used to prepare this
solution may not be of known quality to produce sterile solutions
• Material used is highly toxic & hazardous if as such swallowed
• Bichloride of mercury tab. Prepared in coffin shape with
skull & crossed bones embossed on it to emphasis toxicity
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25. 3. Hypodermic tablet
•Contain one or more readily water soluble
drug intended to be added to sterile water or
water for injection
• It is then used as parenteral solution
• Mostly used in olden days as physician
carried one bottle of this tab. & one bottle of sterile
water in rural area
• Not used now a days due to increase chance of administering the
drug in non-sterile water
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26. 4. Tablet triturates
• Small cylindric molded or
compressed tab.
• Potent drugs used
•Drug mixed with lactose & binder
such as powdered acacia, after which
the mixture was moistened to produce a moldable compactable mass.
This mass was forced into the holes of a mold board fabricated with
wood or plastic, after which tab. were ejected with pegboard, whose
pegs match with the holes in the mold.Alcohol used as solvent to
skip drying step. Drug migration may occur during evaporation
of alcohol so content uniformity problem may occur.
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27. Tablet Ingredients
In addition to active ingredients, tablet contains a number of inert
materials known as additives or excipients. Different excipients
are:
1. Diluent
2. Binder and adhesive
3. Disintegrants
4. Lubricants and glidants
5. Coloring agents
6. Flavoring agents
7. Sweetening agents
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28. 1. Diluent: Diluents are fillers used to make required bulk of the
tablet when the drug dosage itself is inadequate to produce the
bulk. Secondary reason is to provide better tablet properties
such as improve cohesion, to permit use of direct compression
manufacturing or to promote flow. A diluent should have
following properties:
1. They must be non toxic & acceptable to regulatory agencies
2. They must be commercially available in acceptable grade
3. There cost must be low
4. They must be physiologically inert
5.They must be physically & chemically stable by themselves
& in combination with the drugs.
6. They must be free from all microbial contamination.
7. They do not alter the bioavailability of drug.
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29. 8. They must be color compatible.
Commonly used tablet diluents
1. Lactose-anhydrous and spray dried lactose
2. Directly compressed starch - Sta Rx 1500
3. Hydrolyzed starch - Emdex and Celutab
4. Microcrystalline cellulose –Avicel {PH 101(powder)and PH
102(granule)}
5. Dibasic calcium phosphate dehydrate
6. Calcium sulphate dihydrate
7. Mannitol & sorbitol
8. Sucrose - Sugartab, DiPac, Nutab
9. Dextrose
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30. 30
Some drug interactions with diluent
• Tetracycline + calcium phosphate filler = bioavailability of
drug reduced to half than that of standard product
• Amines + lactose (in presence of Mg. stearate) = maillard
reaction causes browning or discoloration….. Not shown by
anhydrous lactose
• Spray dried lactose (used for direct compression) is prone to
darkening in presence of excess moisture, amines due to
presence of furaldehyde.
• Mannitol most expensive sugar but used in chewable tab.
Because of its negative heat of solution, its slow solubility & its
pleasant feeling in mouth. To reduce cost sorbitol (optical
isomer of mannitol) may be mixed with mannitol
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31. 2. Binders and Adhesives: These materials are added either in dry
or in wet form to form granules or to form cohesive compacts for
directly compressed tablet.
Example: 1.Acacia, tragacanth- Solution formed 10-25% Conc.
2. Cellulose derivatives- Methyl cellulose, Hydroxy propyl methyl
cellulose, Hydroxy propyl cellulose
3. Gelatin - 10-20% solution
4. Glucose - 50% solution
5. Polyvinylpyrrolidone (PVP) - 2% conc.
6. Starch paste -10-20% solution
7. Sodium alginate
8. Sorbitol
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32. 3. Disintegrants: Added to a tablet formulation to facilitate its
breaking or disintegration when it contacts water in the GIT.
Example: 1. Starch - 5-20% of tablet weight.
2. Starch derivative - Primogel and Explotab (1-8%)
3.Clays - Veegum HV, bentonite 10% level in colored tablet only as
this clays produce off white color
4. Cellulose
5.Cellulose derivatives -Ac-Di-Sol (sodium carboxy methyl
cellulose)
6. Alginate
32
7. PVP (Polyvinylpyrrolidone), cross-linked
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33. Superdisintegrants: Swells up to ten fold within 30 seconds
when contact water.
Example:
Crosscarmellose-cross-linked cellulose, Crosspovidone- cross-
linked povidone (polymer), Sodium starch glycolate- cross-linked
starch.
A portion of disintegrant is added before granulation and a
portion before compression, which serve as glidants or
lubricant.
Evaluation of carbon dioxide in effervescent tablets is also
one way of disintegration
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34. 4. Lubricant and Glidants:
Lubricants are intended to prevent adhesion of the tablet materials
to the surface of dies and punches, reduce inter particle friction and
may improve the rate of flow of the tablet granulation.
Glidants are intended to promote flow of granules or powder
material by reducing the friction between the particles.
Example:
Lubricants- Stearic acid, Stearic acid salt - Stearic acid,
Magnesium stearate, Talc, PEG (Polyethylene glycols), Surfactants
Glidants- Corn Starch - 5-10% conc., Talc - 5% conc., Silica
derivative - Colloidal silica’s such as Cab-O-Sil, Syloid, Aerosil in
0.25-3% conc.
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35. 5. Coloring agent: The use of colors and dyes in a tablet has three
purposes:
(1) Disguising of off-color drugs
(2) Product Identification
(3) Production of more elegant product
All coloring agents must be approved and certified by FDA. Two
forms of colors are used in tablet preparation – FD &C and D & C
dyes. These dyes are applied as solution in the granulating agent or
Lake form of these dyes. Lakes are dyes absorbed on hydrous
oxide and employed as dry powder coloring.
Example: FD & C yellow 6 - sunset yellow
FD & C yellow 5 - Tartrazine
FD & C green 3 - Fast Green
FD & C blue 1 - Brilliant Blue 35
FD & C blue 2 - Indigo carmine
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36. 6. Flavoring agents: For chewable tablet- flavor oil are used
7. Sweetening agents:
For chewable tablets: Sugar, mannitol.
1. Mannitol is 75% as sweet as sucrose
2. Saccharin (artificial): 500 times sweeter than sucrose
Disadvantage: Bitter aftertaste and carcinogenic
3. Aspartame (artificial):
Disadvantage: Lack of stability in presence of moisture.
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37. 37
ABSORPTION OF DRUG FORM TABLETS
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38.  Powders intended for compression into tablets must possess two
essential properties
 Powder fluidity
The material can be transported through the hopper into the die to
produce tablets of a consistent weight. Powder flow can be improved
mechanically by the use of vibrators, incorporate the glidant.
 Powder compressibility
The property of forming a stable, intact compact mass when pressure
is applied
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39. Granulation technology on large scale by various techniques
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40. • E.g., NaCl, KBr, NaBr
• Addition of other excipients like disintegrant reduces
compressibility
• Directly compressible diluent can be used that can be
compacted easily & even when quantities of drug is added to it
• LIMITATIONS:
1. Stratification within granulation due to difference in particle
size & bulk densities
2. Problem in compression of large dose drugs as again addition
of diluent in it will increase bulk
3. Interaction of diluent with drug e.g., amine & spray dried
lactose
4. Static charges buildup can occur on the drug during screening40
& mixing which can prevent uniform distribution of drug
DIRECT COMPRESSION
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41. 41
DRY GRANULATION(Compression Granulation)
• When the blend of powder is forced into dies of large capacity
tablet press & is compacted by flat faced punches, the compacted
mass is know as ‘slug’& the process is know as ‘slugging’
• This slugs are then screened or milled to produce a granular form
of tabletting material that has uniform flow
• On large scale, Roller compactor is used
• Capacity 500 kg/hr
• Produces ribbon like material that can be milled or screened
• Compression force in it is controlled by three variables:
a) Hydraulic pressure exerted on compaction rolls
b) Rotational speed of compaction rolls
c) Rotational speed of screw
• ADVANTAGE of roller compactor over slugging:
a) increased production capacity
b) greater control on compaction pressure & dwell time
c) no need for excessive lubrication of powder
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42. 42
Compacts
Powder to be
compacted
Size reduction of
compacts into
granules
Roller compactor "Chilsonator"
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43. 43
WET GRANULATION
• This technique employes the use of solution, suspension or slurry
of binder, which is usually added to powder mixture
• When small quantity of binder is used it is as such blended with
powder & when used in large quantity it is dissolved in liquid &
then added.
• End point of granulation is determined by pressing the mass in
palm of hand if the balls crumbles under moderate pressure then it
is ready for next stage
• Wet mass is then converted into coarse granular aggregates by
passing it through hammer mill or oscillating granulator
• Further drying process is done to remove solvent used to form
wet mass
• During drying interparticulate bonds results from fusion or
recrystallization & curing of the binding agent
• After drying screening is done.
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44. MECHANISM OF WET GRANULATION
Or droplet
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45. TABLET COMPRESSION MACHINE
Tablets are made by compressing a formulation containing a drug
or drugs with excipients on stamping machine called presses.
Tablet presses are designed with following basic components:
1) Hopper for holding and feeding granulation
2) Dies that define the size and shape of the tablet.
3) Punches for compressing the granulation within the dies.
4) Cam tracks for guiding the movement of the punches.
5)Afeeding mechanism for moving granulation from hopper into
the dies
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46. SINGLE PUNCH MACHINE
 The compression is applied by the upper punch
 Stamping press
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47. Upper and
Lower Collar
47
Collar locker
Single Punch Machine (Tablets)
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48.  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, compression
and ejection.
 The portions of the head that hold the upper and lower punches
are called the upper an lower turrets
 The portion holding the dies is called the die table
 The pull down cam (C) guides the lower punches to the bottom,
allowing the dies to overfill
 The punches then pass over a weight-control cam (E), which
reduces the fill in the dies to the desired amount
 A swipe off blade (D) at the end of the feed frame removes the
excess granulation and directs it around the turret and back into48
the front of the feed frame
MULTI-STATION ROTARY PRESSES
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49. 49
 The lower punches travel over the lower compression roll (F)
while simultaneously the upper punches ride beneath the upper
compression roll (G)
 The upper punches enter a fixed distance into the dies, while
the lower punches are raised to squeeze and compact the
granulation within the dies
 After the moment of compression, the upper punches are
withdrawn as they follow the upper punch raising cam (H)
 The lower punches ride up the cam (I) which brings the tablets
flush with or slightly above the surface of the dies
 The tablets strike a sweep off blade affixed to the front of the
feed frame (A) and slide down a chute into a receptacle
 At the same time, the lower punches re-enter the pull down
cam (C) and the cycle is repeated
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50. 50
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51. EVALUATION OF TABLET
1.General Appearance: The general appearance of a tablet, its
identity and general elegance is essential for consumer acceptance,
for control of lot-to-lot uniformity and tablet-to-tablet uniformity.
The control of general appearance involves the measurement of
size, shape, color, presence or absence of odor, taste etc.
2.Size & Shape: It can be dimensionally described & controlled.
The thickness of a tablet is only variables. Tablet thickness can be
measured by micrometer or vernier caliper. Tablet thickness
should be controlled within a ± 5% variation of standard value.
3.Unique identification marking: These marking utilize some
form of embossing, engraving or printing. These markings include
company name or symbol, product code, product name etc.
4.Organoleptic properties: Color distribution must be uniform
with no mottling. For visual color comparison compare the color of
sample against standard color. 51
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52. Efforts to quantitate color evaluations have used reflectance
spectrophotometry, tristimulus colorimetric measurement &
microreflectance photometer to measure color uniformity & gloss on
tablet surface.
5. Hardness and Friability:
•Tablet requires strength or hardness
and resistance to friability to withstand
mechanical shakes of handling in
manufacture, packaging and shipping.
Hardness generally measures the tablet
Crushing strength.
• Tablet hardness may be defined as
the force required to break a tablet in a Roche’s friabilator
diametric compression test.
• Hardness measured in terms of Kg or Strongcobb
•WHISKERING in tablet caused due to concave or deep concav5e2or
worn out punches. Such tabs. have friability higher than normal value
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53. 53
Pfizer
Strongcobb
Erweka Schleuniger
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54. Average weight of tablet (mg) Maximum
percentage
difference allowed
As per USP As per IP
130 or less 80 or less 10
130-324 80-250 7.5
More than 324 250 or more 5
2. Drug Content and Release:
(I)Weight Variation test (U.S.P.): Take 20 tablet and weighed
individually. Calculate average weight and compare the individual
tablet weight to the average. The tablet pass the U.S.P. test if no
more that 2 tablets are outside the percentage limit and if no tablet
differs by more than 2 times the percentage limit.
TABLE: Weight variation tolerance for uncoated tablet
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55. (II)Content Uniformity Test: Randomly select 30 tablets. 10 of
these assayed individually. The tablet pass the test if 9 of the 10
tablets must contain not less than 85% and not more than 115% of
the labeled drug content and the 10th tablet may not contain less than
75% and more than 125% of the labeled content. If these conditions
are not met, remaining 20 tablet assayed individually and none may
fall outside of the 85 to 115% range.
(III)Disintegration Test (U.S.P.):
Disintegration is defined as breakdown of the tablet into smaller
particle or granules.
The U.S.P. device to test disintegration uses 6 glass tubes that are 3”
long; open at the top and 10 mesh screen at the bottom end.
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56. To test for disintegration time, one tablet is placed in each tube and
the basket rack is positioned in a 1-L beaker of water, simulated
gastric fluid or simulated intestinal fluid at 37 ± 20 C such that the
tablet remain 2.5 cm below the surface of liquid on their upward
movement and not closer than 2.5 cm from the bottom of the beaker
in their downward movement. Move the basket containing the
tablets up and down through a distance of 5-6 cm at a frequency of
28 to 32 cycles per minute. Floating of the tablets can be prevented
by placing perforated plastic discs on each tablet.
According to the test the tablet must disintegrate and all particles
must pass through the 10 mesh screen in the time specified. If any
residue remains, it must have a soft mass.
Disintegration time:
Uncoated tablet: 5-30 minutes
Coated tablet: 1-2 hours
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58. 3.Dissolution Test (U.S.P.): Two set of apparatus:
Apparatus-1: A single tablet is placed in a small wire mesh basket
attached to the bottom of the shaft connected to a variable speed
motor. The basket is immersed in a dissolution medium (as
specified in monograph) contained in a 1000 ml flask. The flask is
cylindrical with a hemispherical bottom. The flask is maintained at
37±0.50C by a constant temperature bath. The motor is adjusted to
turn at the specified speed and sample of the fluid are withdrawn at
intervals to determine the amount of drug in solutions.
Apparatus-2: It is same as apparatus-1, except the basket is
replaced by a paddle. The dosage form is allowed to sink to the
bottom of the flask before stirring. For dissolution test U.S.P.
specifies the dissolution test medium and volume, type of apparatus
to be used, rpm of the shaft, time limit of the test and assay
procedure for. The test tolerance is expressed as a % of the labeled
amount of drug dissolved in the time limit. Sinkers (non
reactive wire helix) are used to avoid floating of tablet or capsule.
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61. PROBLEMS IN TABLETING & REMEDIES
THEREOF
1. Capping
2. Lamination
3. Chipping
4. Cracking
5. Sticking
6. Picking
7. Binding
8. Mottling
9. Weight variation
10. Punch variation
11. Poor flow
12. Poor mixing
13. Hardness variation
14. Double Impression
61
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62. CAPPING
Capping is a term used to describe the partially or completely
separation of the top or bottom crown of the tablet from the
main body of a tablet.
Reason: Capping is usually due to the air–entrapment in a
compact during compression, and subsequent expansion of
tablet on ejection of a tablet from a die or due to incorrect set
up at press.
62
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63. CAPPING RELATED TO ‘FORMULATION’ (GRANULATION)
Sr.No. CAUSES REMEDIES
1.
Large amount of fines
in the granulation
Remove some or all fines through 100 to 200
mesh screen
2.
Too dry or very low
moisture content
(leading to loss of
proper binding action).
Moisten the granules suitably. Add
hygroscopic substance e.g.: sorbitol, methyl-
cellulose or PEG-4000.
3.
Not thoroughly dried
granules.
Dry the granules properly.
4.
Insufficient amount of
binder or improper
binder.
Increasing the amount of binder OR
Adding dry binder such as pre-gelatinized
starch, gum acacia, powdered sorbitol, PVP,
hydrophilic silica or powdered sugar.
5.
Insufficient or improper
lubricant.
Increase the amount of lubricant or change
the type of lubricant.
6.
Granular mass too cold
to compress firm.
63
Compress at room temperature.
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64. CAPPING RELATED TO ‘MACHINE’ (DIES, PUNCHES
AND TABLET PRESS)
Sr.No CAUSES REMEDIES
1. Poorly finished dies
Polish dies properly. Investigate
other steels or other materials.
2.
Deep concave punches or
beveled-edge faces of punches.
Use flat punches.
3.
Lower punch remains below
the face of die during ejection.
Make proper setting of lower punch
during ejection.
4.
Incorrect adjustment of sweep-
off blade.
Adjust sweep-off blade correctly to
facilitate proper ejection.
5. High turret speed.
Reduce speed of turret (Increase
dwell time). 64
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65. LAMINATION / LAMINATING
Definition: ‘Lamination’is the separation of a tablet into two
or more distinct horizontal layers.
Reason: Air–entrapment during compression and subsequent
release on ejection.
The condition is exaggerated by higher speed of turret.
65
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66. LAMINATION RELATED TO FORMULATION (GRANULATION)
LAMINATION RELATED TO MACHINE (DIES, PUNCHESAND
TABLET PRESS)
Sr. No CAUSES REMEDIES
1.
Oily or waxy materials in
granules
Modify mixing process. Add adsorbent
or absorbent.
2.
Too much of hydrophobic
lubricant e.g.: Mg stearate.
Use a less amount of lubricant or
change the type of lubricant.
Sr. No. CAUSES REMEDIES
1.
Rapid relaxation of the
peripheral regions of a tablet,
on ejection from a die.
Use tapered dies, i.e. upper part of
the die bore has an outward taper of
3° to 5°.
2. Rapid decompression
Use pre-compression step. Reduce
turret speed and reduce the final
compression pressure. 66
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67. CHIPPING
Definition: ‘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
take-off.
67
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68. CHIPPING RELATED TO FORMULATION (GRANULATION)
CHIPPING RELATED TO MACHINE (DIES, PUNCHESAND
TABLET PRESS)
Sr. No CAUSES REMEDIES
1. Sticking on punch faces
Dry the granules properly or
increase lubrication.
2. Too dry granules.
Moisten the granules to plasticize.
Add hygroscopic substances.
3.
Too much binding causes chipping
at bottom.
Optimize binding, or use dry
binders.
Sr. No CAUSES REMEDIES
1.
Groove of die worn at compression
point.
Polish to open end, reverse or
replace the die.
2.
Barreled die (center of the die wider
than ends)
Polish the die to make it cylindrical
3.
Edge of punch face turned
inside/inward.
Polish the punch edges
68
4.
Concavity too deep to compress
properly.
Reduce concavity of punch faces.
Use flat punches.
8/5/2022

69. CRACKING
Definition: Small, fine cracks observed on the upper and lower
central surface of tablets, or very rarely on the sidewall are
referred to as ‘Cracks’.
Reason: It is observed as a result of rapid expansion of tablets,
especially when deep concave punches are used.
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69

70. CRACKING RELATED TO FORMULATION (GRANULATION)
CRACKING RELATED TO MACHINE (DIES, PUNCHES & TABLET PRESS)
Sr. No. CAUSES REMEDIES
1. Large size of granules. Reduce granule size. Add fines.
2.
Too dry granules. Moisten the granules properly and add
proper amount of binder.
3. Tablets expand. Improve granulation. Add dry binders.
4. Granulation too cold. Compress at room temperature.
Sr. No. CAUSES REMEDIES
1.
Tablet expands on ejection due
to air entrapment.
Use tapered die.
2.
Deep concavities cause cracking
while removing tablets
Use special take-off.
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70

71. STICKING
Definition: ‘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.
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71

72. STICKING RELATED TO FORMULATION
(GRANULATION)
Sr.
No.
CAUSES REMEDIES
1.
Granules not dried
properly.
Dry the granules properly. Make moisture
analysis to determine limits.
2.
Too little or improper
lubrication.
Increase or change lubricant.
3. Too much binder
Reduce the amount of binder or use a
different type of binder.
4.
Hygroscopic granular
material.
Modify granulation and compress under
controlled humidity.
5. Oily or waxy materials Modify mixing process. Add an absorbent.
6.
Too soft or weak
granules.
Optimize the amount of binder &
granulation technique. 72
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73. STICKING RELATED TO MACHINE (DIES,
PUNCHES AND TABLET PRESS)
Sr. No. CAUSES REMEDIES
1. Concavity too deep for granulation. Reduce concavity to optimum.
2. Too little pressure. Increase pressure.
3. Compressing too fast. Reduce speed.
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73

74. PICKING
Definition: ‘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.
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74

75. PICKING RELATED TO FORMULATION
(GRANULATION)
Sr.No CAUSES REMEDIES
1. Excessive moisture in granules.
Dry properly the granules, determine
optimum limit.
2. Too little or improper lubrication.
Increase lubrication; use colloidal silica as
a ‘polishing agent’, so that material does
not cling to punch faces.
3.
Low melting point substances,
may soften from the heat of
compression and lead to picking.
Add high melting-point materials. Use
high meting point lubricants.
4.
Low melting point medicament in
high concentration.
Refrigerate granules and the entire tablet
press.
5.
Too warm granules when
compressing.
Compress at room temperature. Cool
sufficiently before compression.
6. Too much amount of binder.
Reduce the amount of binder, change the75
type or use dry binders.
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76. PICKING RELATED TO MACHINE (DIES,
PUNCHES AND TABLET PRESS)
Sr.No CAUSES REMEDIES
1.
Rough or scratched punch
faces.
Polish faces to high luster.
2.
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.
3.
Bevels or dividing lines too
deep.
Reduce depths and sharpness.
4.
Pressure applied is not
enough; too soft tablets.
Increase pressure to optimum.
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76

77. BINDING
Definition: ‘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.
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77

78. BINDING RELATED TO FORMULATION
(GRANULATION)
Sr.No CAUSES REMEDIES
1.
Too moist granules and
extrudes around lower punch.
Dry the granules properly.
2.
Insufficient or improper
lubricant.
Increase the amount of lubricant or use
a more effective lubricant.
3. Too coarse granules.
Reduce granular size, add more fines,
and increase the quantity of lubricant.
4.
Too hard granules for the
lubricant to be effective.
Modify granulation. Reduce granular
size.
5.
Granular material very
abrasive and cutting into dies.
If coarse granules, reduce its size.
Use wear-resistant dies.
6.
Granular material too warm,
sticks to the die.
Reduce temperature.
Increase clearance if it is extruding.
78
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79. BINDING RELATED TO MACHINE (DIES,
PUNCHES AND TABLET PRESS)
Sr.No
.
CAUSES REMEDIES
1. Poorly finished dies. Polish the dies properly.
2.
Rough dies due to abrasion,
corrosion.
Investigate other steels or other
materials or modify granulation.
3.
Undersized dies. Too little
clearance.
Rework to proper size.
Increase clearance.
4.
Too much pressure in the
tablet press.
Reduce pressure. OR
Modify granulation.
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79

80. MOTTLING
 Definition: ‘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.
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80

81. CAUSES AND REMEDIES OF MOTTLING:
Sr.No. CAUSES REMEDIES
1.
A coloured drug used
along with colourless or
white-coloured excipients.
Use appropriate colourants.
2.
A dye migrates to the
surface of granulation
while drying.
Change the solvent system,
Change the binder,
Reduce drying temperature and
Use a smaller particle size.
3.
Improperly mixed dye,
especially during ‘Direct
Compression’.
Mix properly and reduce size if it is of a
larger size to prevent segregation.
4.
Improper mixing of a
coloured binder solution.
Incorporate dry colour additive during
powder blending step, then add fine
powdered adhesives such as acacia and
tragacanth and mix well and finally add81
granulating liquid.
8/5/2022 Tablet ( HRB )

82. WEIGHT VARIATION
• The weight of tablet being compressed is determined by the
amount of in die prior to compression. Therefore, anything that
can alter the die filling process can alter the tablet weight &
weight variation.
PUNCH VARIATION
• When lower punches are of unequal lengths- the fill in each die
varies because the fill is volumetric.
• So only a good punch & die control program can provide a
tooling of uniform dimension.
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82

83. • Die fill process is based on a continuous & uniform flow of
granulation from hopper through feed frame.
• When granulation do not flow properly it leads to incomplete &
improper filling of die.
• In this case use of glidants like talc or colloidal silica or
increase in amount if already present is helpful.
• Poor flow may lead to ‘rat-holing’ & ‘Bridging’or ‘arching’
POOR FLOW
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83

84. • Sometimes the lubricant or glidant may not be thoroughly
distributed due to which the flow of powder or granules may be
impaired
HARDNESS VARIATION
• Hardness depends on the weight of material and space between
the upper & lower punches at the moment of compression.
• So if anyone of this varies as a result hardness will vary.
POOR MIXING
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84

85. DOUBLE IMPRESSION
Definition: ‘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.
85
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86. CAUSES AND REMEDIES OF DOUBLE
IMPRESSION:
Sr.
No.
CAUSE REMEDIES
1.
Free rotation of
either upper punch
or lower punch
during ejection of a
tablet.
-Use keying in tooling, i.e. inset a
key alongside of the punch, so that it
fits the punch and prevents punch
rotation.
-Newer presses have anti-turning
devices, which prevent punch
rotation.
86
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87. 87
FLUID BED SPRAY GRANULTOR
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88. 88
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89. 89
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90. 90
TWIN S H E L L B L E N D E R
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91. DAY-NAUTA MIXER
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91

92. TOPO GRANULATOR
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92

93. CF GRANULATOR
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93

94. DIOSNA MIXER
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94

95. PLANETARY MIXER
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95

96. COLLET GRAL MIXER
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96

97. COLLET GRAL MIXER
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97

98. COLLET GRAL MIXER
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98

99. OSCILLATING GRANULTOR
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99

100. SPRAY DRYER
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100

101. EXTRUDER
A) SCREW FEED EXTRUDER
101
RADIAL
AXIAL

102. B) GRAVITY FEED EXTRUDER
CYLINDER GEAR 102
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103. SPHERONIZER
103
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104. THANK YOU
Tablet ( HRB )
8/5/2022