7 Tablets Kebe Ours

Tablets
December 2022
February 4, 2023 Industrial Pharmacy 1

Manufacturing of pharmaceutical dosage forms
• Pharmaceutical dosage forms such as tablets, capsules,

solutions, etc contain both active ingredients and
pharmaceutical excipients.
• Active ingredients and excipients are raw materials for

pharmaceutical dosage forms.

DF = AI + E (one or more)
• And these raw materials are tested for quality

before production process.

• Raw materials procurement
• Storage of raw materials
• Quality testing of raw materials
• Production process

Introduction to Tablets
Definition
• Tablets are dosage forms containing one single dose
of one or more active ingredients.
• Tablets are prepared by compression of constant

volume of particle.
 Tablets are solid dosage forms containing medicinal

substances with or without suitable diluents.

• They may be classified according to the method of
manufacture as compressed tablets or molded tablets.
• Tablets can be non coated or coated with plain coat(sugar and

film) with enteric coating or polymers that provide extended
release.

Desirable attributes
Physical mechanical
• Acceptable elegance, lot-to-lot and tablet-to-tablet uniformity
• Defined appearance, size, shape, thickness, color, surface
texture, physical perfection, and legibility of any identifying
marking.
• Sufficient mechanical strength to with stand the mechanical
shocks encountered in their production, packaging, shipping
and dispensing.

Stability
• Tablets must have the chemical, microbiological and physical
stability to maintain their attributes over time, during their
shelf lives.

Advantages and disadvantages of tablets
• Advantages
1. Unit dose form: Offer the greatest dose precision and
least content variability. Accuracy of dose is maintained
as compared with other dosage forms like syrups,
suspensions …
2. Economical: Lowest cost of all oral dosage forms: as
they are amenable to high speed production and
cheapest to package and ship.
3. Ease of administration: Provide ease of swallowing
particularly for adults.

4. Product identification: Can easily be identified, requiring no
additional processing steps when employing an embossed or
monogrammed punch face.
5. Large scale production: Better suited for high speed machine
production than any other unit oral dosage form.
6. Tamper proof: Essentially tamper proof dosage forms
7. Stability: Have the best combined properties of chemical,
mechanical and microbiological stability. Thus tablets have
longer expiry period.
8. Special preparations: Lend themselves to controlled release
profile products, such as sustained release and enteric
products.

• Disadvantages
 Drugs having the following properties exhibit problem of
either compaction or bioavailability.
1. Amorphous, flocculent, low density: Such drugs exhibit low
compaction and hence resist compression
2. Poor wetting, slow dissolution and poor absorption in the
GIT: Such drugs if compressed into tablet may show how
bioavailability is affected
3. Intermediate/large doses having poor compaction: These
drugs may be difficult to formulate and manufacture
Capsule is alternative

 Bitter taste, objectionable odor, sensitiveness to oxygen or
atmospheric moisture: These drugs may require additional
manufacturing step-coating.
 Slow onset of action as compared to parental, liquid orals and

capsules.
 Difficulty in swallowing especially for geriatric, pediatric and

terminally ill patients.

Tablet Excipients
• Excipients means any component other than active
pharmaceutical ingredients (API) intentionally added
to the formulation of a dosage form.
• While selecting excipients for any formulation, the
following things should be considered wherever
possible:
– Keep the excipients to a minimum in number
– Minimize the quantity of each excipient
– Multifunctional excipients preferable over uni-functional
excipients

• Excipients are chosen in tablet formulation to perform a
variety of function like:-
o For providing essential manufacturing technology functions (binders,
Glidants, lubricant may be added)
o For enhancing patient acceptability (flavor, colorants may be added)
o For providing and in product identification (colorants may be added)
o For optimization or modifying drug release (Disintegrants, hydrophilic
polymers, wetting agents, biodegradable polymers may be added)
o For enhancing stability (antioxidants)

• Table excipients should be
– Non toxic, physiologically inert
– Commercially available in an acceptable grade/price
– Free of any unacceptable microbiologic load
– Physically and chemically stable/compatible
– Devoid of deleterious effect on bioavailability of drugs.

Types of tablets
• With advancement in technology and increase in awareness
toward modification in standard tablet to achieve better
acceptability as well as bioavailability, newer and more
efficient tablet dosage forms are being developed.

• Reasons behind formulation of different types of
tablets
– To create a delivery system relatively simple
– Inexpensive to manufacture
– Provide the dosage form that is convenient from patients
perspective
• Tablets may be classified by
• Their route of administration
• The type of drug delivery system they represent within
that route and
• Their form and method of manufacture.

A. Classification based on route of administration
Oral tablets are meant to be swallowed intact along with a sufficient
fluid.
a. Compressed tablets
• Compressed tablets: over 90% of tablets manufactured today are
ingested orally; it shows this class of formulation is the most
popular . These classes of tablets are made by one of the standard
techniques. They are intended to provide rapid disintegration and
drug release for
– Local GIT effect  typically insoluble drugs
– Systemic effect

• Have some aqueous solubility and appreciable dissolution
rate in order to be absorbed.
b. Multiple compressed tablets
• Either layered tablets or compression coated tablets which
may be either two component or three component systems.
 Two or three layers of tablets
• Tablet within a tablet or a tablet within a tablet within a tablet
• Both types usually undergo double compression: Light
compression as each component is laid down and main
compression.

• Reason for layering
• To separate physically or chemically incompatible
ingredients
• To provide repeat action or prolonged drug action
c. Repeated action
• The core tablet is usually coated with enteric
polymer and second dose of drug is then
added in sugar coating.

d. Delayed action and enteric coated tablets
• Intended to release a drug after some time of delay or after
the tablet has passed through one part of the GIT into
another. Tablet may be sugar or film coated
Why tablet is coated?
Tablet coated for the following reasons
– To protect against external environment
– To protect against internal environment
– When local effect at intestine required
– Enteric coated tablets are the most common example of
delayed action tablet. Such tablet remains intact in the
stomach but quickly release their content in the upper
installing.

e. Chewable tablets
• Intended to be chewed in the mouth prior to swallowing. Not
to be swallowed intact.
Advantage of chewable tablets
• When doses are too large to swallow (antacids)
• Chewing increases surface area to hence activity
Limitations of chewable tablets
• Bitter or offensive tasting drugs are not candidate for this type
of tablet

2/ Tablet used in the oral cavity
• Tablets under this group are aimed to release API in oral cavity
or to provide action in this region.
a. Buccal and sublingual tablets

• Intended to be held in the mouth, where they release their
drug content for absorption directly through the oral mucosa.

• Buccal tablets are held between the cheeck and teeth while
sublingual tablets are held beneath the tongue.
o Tablets are small or flat in shape.
o Are meant for a systemic effect have good absorption properties

through oral mucosa directly to the general circulation;
o Avoid first pass metabolism.

These classes of tablets
• Should be formulated with non irritating or non
stimulating excipients.
• Which do not stimulate salivation in order to reduce the

fraction of drug is swallowed.
• Should be designed not to disintegrate but to slowly

dissolve.

i. Lozenges and troches
• Used is the oral cavity to control coughing in common cold, to
exert a local effect in the mouth and throat.
• Formulation may contain local anesthetics, antibacterial
agent, antitussive.
• Prepared by compression or molding (candy)
ii. Dental cones
• Designed to be placed in the empty socket remaining
following a tooth extraction to prevent multiplication of
bacteria in the socket.
• Intended to slow release of antibacterial compounds or
coagulant.
• Formulated to dissolve or erode slowly in presence of small
volume of serum or fluid.

3/ Tablets administered by other routes
• These tablets are administered by other routes so the drugs
are avoided from passing through gastrointestinal tract.
• These tablets may be inserted into other body cavities or

directly placed below the skin to be absorbed into systemic
circulation from the site of application.

a. Implantation tablets
• These are designed for subcutaneous implantation in animals
or man to provide prolonged and constant drug effect.
b. Vaginal tablets
• These are typically egg shaped to facilitate retention in the
vaginal cavity. Are designed to undergo dissolution and drug
release in the vaginal cavity. A plastic tube inserter used to
place the tablet in the upper lesion.

4/ Tablets used to prepare solutions
• Tablets under this category are required to be dissolved first
in water or other solvents before administration or
application.

Effervescent tablets
• Designed to produce a solution rapidly with simultaneous
release of CO2.
• Active ingredients and mixture of organic acids (citric acid or
tartaric acid) and sodium bicarbonate are compressed in
moisture controlled environment. When administered, they
are placed in a glass of water where a chemical reaction takes
place between the acid and bicarbonate.
• R-COOH + NaHCO3  RCOONa + CO2 + H2O
• The formulation masks the taste of certain drugs

Tablet manufacturing process
Method of tablet manufacturing
• The manufacture of oral solid dosage forms such as tablets is
a complex multi-stage process under which the starting
materials change their physical characteristics a number of
times before the final dosage form produced.
Any tablet produced by one of the following method
1/ Wet granulation
2/ Dry granulation
3/ Direct compression

1. Direct compression
• After milling and mixing drug(s) and excipients, the blend is
compressed to tablet.

Ingredients Quantity (mg)
• Chlorpromazine 100 --API
• Avicel 125
• Dicalcium phosphate 125 Direct
compression diluents
• Cab-O-sil 1.74 – Glidant
• Mg-Stearate 5.25 – Lubricant

Procedure
1. Blend all ingredients except Mg Stearate
2. Screen in Mg-Stearate and blend for additional time
3. Compress to tablet.

2. Dry granulation
• Also called roller compaction
• For moderate dosage which water sensitive and heat sensitive
drugs
• Dry system because granules are prepared in dry system
Involve:-
 Milling and mixing of powder  Ribbon/ Slug  Granule 
Tablet

3. Wet granulation
• For large dose medication which is not sensitive for heat and
moisture

Typical unit operation involved in different tablet manufacturing process
Note: Regardless of whether tablet made by direct compression or granulation the

first step milling and mixing is same, subsequent step differ.
Unit operation involved in tablet manufacturing

Dispensing
• Weighing and measuring
• Dispensing is first step in any pharmaceutical manufacturing
process.
• Dispensing is one of most critical steps
• During this step the weight of each ingredient in the mixture
is determined according to the dose.
• Done by manually or automated dispensaries.

Granulation
• Following particle size reduction and blending, the
formulation may be granulated, which provides homogeneity
of drug distribution in blend.
Formation of granule (granulation) to provide spherical granule
which have two characters.

Have improved flow property
• Because we covert course particle to spherical particle
(granule) which has minimum contact surface with other
granule and machine.

Improve cohesion
• Help compressibility – indication of consolidation of two
phase solid and air.
The flow property of particles
• The flow property of particle measured by
By measuring angle of repose
 Static method

• Tan Ф = Opp/Adj
• Tan Ф = h/r
• If < 40o  good flow property
• As angle increases flow decreases
By measuring rate of flow
 Dynamic method
• Flow rate = Larger flow rate  good flow property
• To know compressibility you should know density and derived

properties of particle
Flow rate =
Mass
time
• A. Bulk density (ρb)- is ratio of mass of particles to
bulk volume.
M
ρb =
Vb
• Where: Vb – bulk volume which obtained by measuring
• M – Mass obtained by weighing
• B. True density (ρt) ratio of mass to true volume
M
ρtrue =
Vt
• True volume (Vtrue) obtained by displacement of liquid
or air

• Liquid pyconometer – equal volume of liquid is displaced but
there is some limitation which is liquid does not have ability to
enter to inner cracks.
• Air pyconometer-measure volume by displacing air
More efficient method because penetration of air is higher
than that of liquid, all space is occupied.
• C. Tapped density (ρtap) is ratio of mass to tapped volume.
ρtap = VtapM
Where: V tap- obtained by tapping powder in cylinder

• Indicate compressibility

Example
• Vb = 100ml
Vtap1= 75ml Vtap2= 50ml
• Which is more compressible (first or second)?
The second one (50ml)
Why?
• Carr’s index (CI)
CI = 100[(ρtap-ρb)/ρtap]

• Hausner’s ratio (HR)
HR = ρt/ρb
• CI < 20%
• HR < 1.25 indicates good flow property
and compensability

Drying
 It is important step in the formulation and development of

pharmaceutical product to keep the residual moisture
low enough to prevent product deterioration and ensure
free flowing properties.

Tablet compression
• After the preparation of granules (in case of wet granulation)
or sized slugs ( in case of dry granulation) or mixing of
ingredients (in case of direct compression) they are
compressed to get final product.

• Compression done by either single punch machine (stamping
press) or multi station machine (rotary press).
Tablet compression and machines
• Tablets are made by compressing a formulation containing a
drug or drugs with excipients on stamping machine called
presses.

Historical background
• In 1843, a British patent No 9977 was issued -William
Brockedon
• Its object was shaping pills, lozenges by pressure in dies.
• Brockedon’s punch and die assembly

Brockedon’s punch and die assembly
• When a tablet to be made the upper punch was removed and
material was filled into the die cavity.
• The punch was there replaced and strike with a mallet.

• For tablets to meet pharmacopoeia specifications tablets
must have properties fall within accepted limits (weight,
hardness, friability, disintegration, dissolution, etc).
• Such requirements were unknown in brockedon’s time.
• Now a day, neither the formulation nor the subsequent

process control would be possible without the use of
adequate instrumentation.

Tablet processes
• Are two types
– Single punch machine
– Multi station rotary press

1. Single punch machine
• All of the compression is applied by the upper punch making
it a stamping press.

Basic components
• Hopper (s) – for holding and feeding granulation to be
compressed
• Dies – that define the size and shape of tablet
• Punches – for compressing the granulation within the dies
• Cam tracks – for guiding the movement of the punch
• Feeding mechanism – for involving granulation from the
hopper into the dies (hopper shoe)

• Compression cycle of a tablet machine
– Collection and filling
– Compression
– Ejection

a) Collection and filling
During collection and filling of granule
• Upper punch moves up
• Lower punch moves down
 Empty die cavity produced
 Hopper shoe feeds die cavity the amount of delivered to die
cavity determined by the depth of lower punch with die
cavity.

b) Compression
During compression
• Hopper shoe moves back
• Upper punch descends
• Lower punch remain stationary
 The amount of pressure exerted is controlled by distance
which the upper punch penetrate the die.
• Tablet is compressed

c) Ejection
During ejection
• Both punches (upper and lower) move up
• Tablet is ejected by the lower punch and
kicked by hopper shoe and it feeds the die.

Single-punch Tablet Press: - (eccentric press)

Multi-station rotary presses
• The head of the tablet machine that holds the upper punches,
dies, and lower punches in the 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.

• Output of tablet machine regulated by three basic
characteristics of its design.
– Number of tooling sets
– Number of compression station
– Rotational speed of the presses
• In general, all rotary presses are engineered for past and
economical production of all kinds of tablets.

Compression machine tooling
• Tooling set must satisfy dosage requirement, i.e. dosage
uniformity, esthetic appearance. The size (length, width) and
shape of tablet as well as certain identification marking are
determined by the compression machine tooling.
• Each tooling set consists of die, upper and lower punches.
Hopper is used to hold powder or granules. Feed frame used
to feed the powder into the die.

 Small rotary press punches has 60 or more dies and 60 or
more pairs of punches, which can produce above 330,000
tablets/hour.

The Tablet compression machine

Cont’d

Tablet Compression Cycle

Compression cycle of multi-station rotary presses

Auxiliary Equipments
• Are equipments which increase the efficiency of a tablet
compression operation
Include
• Mechanized feeders
• Granulation level sensors
• Devices for continuous monitoring of tablet weight
• Tablet de-duster

i. Mechanized feeders
• To force granulation into the dies
• To prevent weight variation due to improper filing of a poorly
flowing granulation.

• Means for replenishing (filling of hopper at constant interval;
mechanized equipment to load granulation into the hoppers)
ii. Granulation level sensors

• To stop the press automatically when the granulation level
drops to a critical level in the hopper.

iii. Derives for continuous monitoring of tablet
weight
• Monitor the force of each compression station, which
correlates with tablet weight
• The monitories are capable of initiating corrective actions
• Altering the amounts of die fill to maintain a fixed force
• Ejecting tablets that are out of specifications
• Counting
• Documenting the machine operation throughout the run

iv. Tablet de-duster
• Tablets coming off a tablet machine bear excess powder and
are run through a tablet de-duster to remove the excess
powder.

General terminology of tooling (sets of upper and
lower punches and dies) for rotary tablet presses

There are two main standards:
1) B-tools with subcategories EU19 (Europe)/TSM 19

(USA)/Japan Norm;
2) D-Tooling, also called EU1, TSM 1, which

are classified according to the dimensions of the barrel
diameter, overall length, and the overall diameter of the
punch head.
D-tooling is thicker than B-tooling; European toolings

(both B- and D-types) are longer
compared to TSM types.

Examples of well-known tablet shapes

• To avoid tooling damage, compressive loads or pressures
at the pressure rolls must be translated into a calculation
of the pressure at the punch tips.
•As tablet, punch diameter decrease, less force is required
to produce the same pressure at the punch face, since the
face represents a smaller fractions of unit area (square
inch).
•The formula for the area of a circle is πr2 where r is radius
of the circle.
•Given the flat punch face, the area of a ¼-inch-diameter
punch would thus be 3.14× (1/8)2 or 3.14×1/64, or
approximately 1/20 square-inch.
•If a 1-ton load is being applied by the pressure roll, this
area is translated as 2000 pounds on 1/20 square inch, or
40,000 pounds on 1 square inch, a gross overload.

Embossing/debossing of engravings on tablets
and punches.
Tablet processing problem
• An ideal tablet should be free from any visual defect.
• An industrial pharmacist usually encounters a number of

problems during manufacturing.

• Solving many of the manufacturing problems requires an in-
depth knowledge of granulation processing and tablet presses
and is acquired through an exhaustive study and a rich
experience.

Prior to tablet compression operation the following are verified
• Identify the granulation
• Set-up of the proper tableting machine
• Proper tooling
The source of processing problem could be :-
• The formulation,
• The compression equipment, or
• A combination of the two.

Processing problems are
A. Capping and lamination
• Capping – partial or complete separation of the top or bottom
crowns of a tablet from the main body of the tablet. Capping
can exist immediately up on ejection or hours or weeks after
ejection
• Lamination – separation of a tablet into two or more distinct

layers
• Both problems are due to the deformational properties of the

formulation during and immediately following compression

Causes for capping and lamination
• Entrapment of air during compression  pre compression
required
• Granulation that are light or contain large amount of powder
 reduce or remove powder by sieving
• Granulation may be too dry  addition of hygroscopic
material maintain proper moisture
• Both die and punch  use flat punches

• Carelessness in setting up the press
• Develop of wears in area of compression dies
• Tablet shape
• Granulation may contain lower amount of binders  increase
amount of binder
• Increase in CF or decrease in CF => cause lamination
eg CF above max CF  hardness decrease  tablet laminate
• Increase dwell time up in the die

B. Picking and sticking
Picking
• Picking- 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
• Problem is more prevalent on the upper punch faces than on
the lower ones
• Due to engraving or embossing letters and the granular
material is improperly dried and improperly lubricated
granules.

Solution
• Dry properly the granules
• Increase lubricant
• Compress at room temperature
• Polish faces
• Use high melting substances
• Design lettering as large as possible
• Use flat punch face

Sticking
• Refers to the tablet material adhering to the die wall
• Due to improperly dried or improperly lubricated granules
Solution:
• Increase or change lubricant
• Dry granules properly
• Decrease amount of binders or used different binder

C. Mottling
• Mottling is the term used to describe non uniform distribution of
color on a tablet
Due to
• Colored drugs, whose color differs from the color of excipients or
• Drug whose degradation products are colored.
• Use of poor colorant
• Migration of color during mixing or drying
• Poor mixing of drug and excipients

Solution:
• Use of appropriate colorants
• Mix properly
• Reducing drying temperature
• Grinding to a smaller particle size
• Changing the solvent system

D. Weight variation
• The weight of a tablet being compressed is determined by the
amount of granulation in the die prior to compression
• Any thing that can alter the die filling process can alter tablet
weight and cause weight variation

Possible reasons for weight variation
• Variation in granule size and size distribution before
compression
• Ratio of small to large granules
• Magnitude of difference between granule sizes (influence
how void space between particles are filled)
• Different proportions of large and small particles may change
the weight of fill in each die.
Solution: maintain uniform size distribution.

Poor flow
• The die fill process is based on a continuous and uniform flow of
granulation from the hopper through the faced frame.
Problems:
• Dies are incompletely filled when the granulation does not flow
readily and machine speed is in excess of the granulation flow
capabilities
Possible solution:
• Addition of glidant or an increase in the amount already present
such as talcum
• Use of induced die feeders – mechanically force granulation down
into die cavities.
• Attaching vibrators to the hopper sides to induce the granulation
flow

Poor mixing
• If the lubricants and glidants are not thoughly distributed,
flow of particle impaired and the granule do not move
efficiently into the dies.
• Solution: optimum mixing times
Punch variation
• When lower punches are of unequal length, the volumetric fill
in each die varies.

Hardness variation
• Depending on the weight of granulation in the dies and the
space between the upper and lower punches at the
movement of compression results in hardness variation. i.e.
variation in volume of material and distance between
punches.

Evaluation of Tablets
i) General appearance
• Overall elegance, batch to batch or lot to lot uniformity and
tablet to tablet uniformity
• Control size, shape, color, presence or absence of an odor,

taste, surface texture, physical constancy, legibility of any
identifying marking.

ii) Uniformity of weight
• Sample of 10 tablets are randomly taken and weight
throughout the compression process.
• Appropriate test for bulky drugs, where tablets consist of all
or essentially all (90 – 95%) active ingredients.

E.g. USP weight variation test
• 20 tablets weighed individually, the average weight
calculated and the individual tablet weight is compared
to the average.
• The tablets meet the USP test if no more than 2 tablets
are outside the percentage limit and if no tablet differs
by more than 2 times the percentage limit.

iii) Uniformity of content/potency test
• For moderate or low-dose drugs
• Excipients make up the bulk of the tablet weight

• A composite sample of the tablets are taken, ground-up,
mixed and analyzed to produce an average potency value.
• Potency test for tablets of low dose drugs
• 30 tablets are randomly taken, 10 of them are assayed
individually 9 of the 10 tablets must contain not less than 85%
or more than 115% of the labeled drug content.

• The 10th tablet may not contain less than 75% or more than
125% of the labeled content
• If these conditions are not meet, the tablets remaining from
the 30 must be assayed individually and non fall outside of
the 85% to 115% range.
• Factors that contribute to content uniformity problems in
tablets
 Non uniform drug distribution .
 Separation of drug during the various manufacturing
processes.
 Tablet weight variation.

iv) Mechanical Strength (hardness and friability)
Tablet hardness
• Force required to break the tablet in a diametric compression
test
• Force required to break measured in terms of neuton (N)
• Minimum allowed 5kg or 50N but it varies depending on
preparation.

Friability
• Tendency of capping, chipping, fragmenting on attrition
• Another measure of a tablet strength
• Test: 10 tablets placed in plastic chamber (Roche friability
tester) that revolves at 25 rpm
• Dropping the tablets a distance of 6 inches with each
revolution
• Operation for 100 revolution (4 minutes)
• Tables then dusted and reweighed
• Maximum allowed loss of weight is 1%.

• Eg: Initially taken = 5gm
• Find wt = 4.9gm
• Loss of wt = 0.1gm
• Thus, Friability = 100(5gm-4.9gm)/5gm =
0.1gm/5gm x 100% = 2%
•  Tablet is not acceptable

• When capping is observed on friability testing, the tablets
should not be considered for commercial use, regardless of
the %age of loss.
• Moisture content may influence friability a low but acceptable
moisture level (2.4%) frequently acts as a binder. Very dry
granulation often produce more friable tablets

v) Disintegration test
• Conventional tablets must disintegrate into granules and
primary particles in specified time
• Tablet  granules  particles
• 6 glass tube, 3 inch long, open at top, bottom 10 mesh screen
• Medium: 1 liter beaker of water, simulated gastric fluid or
simulated intestinal fluid at 37 + 2oC

• Tablets remain 2.5cm below the surface of the liquid on their
upward movement and descend not closer than 2.5cm from
the bottom of the beaker.
• Tablets move up and down through a distance of 5 to 6 cm at
a frequency of 28 to 32 cycles per minute.
• Perforated plastic discs may also be used for tablets that float.

Compliance
• The tablets must disintegrate, and all particles must pass
through the 10 mesh screen in time specified.
• Many tablet’s disintegration time = 15 minute
• Enteric coated tablets should show no evidence of
disintegration after 1 hour in simulated gastric fluid some
tablets disintegrate in simulated intestinal fluid in 2 hours.

vi) Dissolution test
• Disintegration test offers on assurance that resultant particles
will release the drug in solution at an appropriate rate.
• Thus rate of dissolution is determined which is related to drug
availability

• In vivo-bioavailability measurement (direct assessment)
• In vitro-dissolution test (indirect measurement of drug
availability)
• Appropriate medium, volume are chosen according to the
equilibrium solubility of cp under investigation

• Dissolution test done by
– Basket method
– Paddle method
• We periodically sample 5ml and replace 5ml of dissolution
medium to maintain the volume. Sampling taken up to 60min
for conventional tablet and 8/12 hrs for sustain release tablets
• Its concentration is determined by using UV or HPLC

Tablet coating
 Coated tablets are defined as tablets covered with one or
more layers of mixture of various substances. Substances used
for coating are usually applied as solution or suspension
under condition where vehicle evaporates
 The application of coating to tablets which is an additional
steps in the manufacturing process. It increases the cost of
product therefore the decision to coat a tablet is usually
based on its objective.

Reasons for coating
• To protect against deterioration by environment factors
(external and internal environment)
• To increase shelf life
• To facilitate swallowing and mask taste and odor
• To enhance aesthetic appeal and brand image
• To prevent wastage during packaging and handling and cross
contamination
• To provide functional film coating
• To avoid esophagus and stomach irritation

Types of tablet coating
• Film coating
• Sugar coating
• Press coating

1- Film coating
• Film coating is deposition of a thin film of polymer surrounding the
tablet core by spraying.
• The polymer is solublized in solvent, resulting solution is sprayed
onto a notated tablet bed.
• The drying conditions causes removal of the solvent giving thin
deposition of coating material each tablet core.
• Coating liquids (solution, suspension) contains
– Polymer
– Plasticizer
– Colorants
– Solvents

• Commonly used polymers include: Hydroxypropyl methyl
cellulose (HPMC), Methyl cellulose, ethyl cellulose,
Hydroxypropyl cellulose (HPC), Eudragits (polymethacrylates),
etc
• Plasticizers are used to modify physical property of polymer
and to decrease film brittleness.
E.g. Polyols: polyethylene glycol (PEG) > 100 (600)
Organis esters: diethyl phthalate (10 -13%)
oils/glycerides: coconut oil

Colorants use should be
• FDA approved quality, safety
• Chemically stable
• Provide better opacity
• Good covering power
• Insoluble colorants are preferable than soluble one because soluble
one migrate in the formulation and result in non uniform color.
E.g. Iron oxide pigment
Fe2O3 – yellow red
Fe2O3.H2O – yellow
FeO.Fe2O3 – Brow black
Titanium dioxide
Aluminum lakes

Solvents
• Organic solvents are used in early period but now it is
replaced by aqueous solvent
• Draw back of organic solvents
 Environmental hazard (ecologically unacceptable)
 Safety (explosion, fire, toxic hazards)
 Financial (cost)
 Solvent residues in the film

Basic process required for film coating
a) Adequate means of atomizing the spray liquid for application
to the tablet core
b) Adequate mixing and agitation of the tablet bed.
c) Sufficient heat input in the form of drying air to provide the
latent heat of evaporation of the solvent
d) Good exhaust facilities to remove dust and solvent laden air

Ideal properties of film coated tablets
• Even coverage of film and color
• No abrasion of tablet edge and crowns
• Logos and break lines should be distinct and not filled in
• Coated tablets must be compliant with finished product
specification

Coating faults
• Coating faults either from process or formulation
• Processing – during manufacturing
– Inadequate drying
– Sticking of tablets (formation of twins)
• Solved by: Increasing mixing rate
• Increasing drying rate
• Formulation
• Film cracking due to excess drying and using inadequate plasticizer
• Bridging of break lines due to viscosity and solved by increasing
solvent amount.

2- Sugar coating
• Compressed tablets may be coated with colored or uncolored sugar
layer. The coating is water soluble and quickly dissolves after
swallowing.
Advantage
• Protect drug from environment
• Mask objectionable taste
Disadvantages
• Take time for coating
• Require expertise
• Increase weight and size

• Sugar coating process involves fire separate operations
i- Sealing/water proofing of the tablet core
• To prevent entry of water into core tablet
• Sealing means applying water impermeable polymer around tablet
like shellac, …
ii- Sub-coating
• Rapid build up to round off the tablet edges (to increase volume)
• Bulking agents (calcium carbonate, talc, gum acacia)
iii- Smoothing/Grossing
• Smoothes out the irregularity on the sub-coated surface
• Smoothly coats of sucrose syrup

iv- Coloring
• Gives the tablet its color and finished size.
v – Polishing
• Produces the characteristic glossy
• Used to achieve a final elegance
• Done by applying mixture of wax
vi- Printing of manufacturer logo or code
• For identification purpose
• Note: Steps 4, 5, 6 are optional

Difference between sugar and film coating
Film coating Sugar coating
Weight increment because of coating 2 – 3% 30 -50%
Logo or break lines Possible single Not possible
Process stages Process is automatic Multiple
Operator training Easy training of operator Require expertise

• Film coating is more favored over sugar coating. Comparison
between film coating and sugar coating film coating is used
i- To prevent degradation of acid sensitive drugs or API
E.g. Erythromycin
ii- To prevent irritation of stomach by certain drugs
E.g. Aspirin
iii- Delivery of API or drug into intestine
E.g. Anti-helmintics

• Press coating
• It is compression coating and prepared by pressing coating material
around core. It is also purpose of preparation of multilayer tablet
(tablet within tablet). Require specialized tablet machine
• Application: used to separate chemically incompatible materials.
Incompatibility reduced by placing inert material between two
chemicals
• Problem:
• Equipments – require sophisticated equipment
• Difficult in precision coating
• Difficult to apply thin layer.

• Coating equipments
• Tablet coating can be done by any of the
following equipments.
Pan coating principle (coating pans: standard or
perforated)
Acceta cota
Hi-coater
Dria coater
Fluidized – bed (air suspension) principle

Standard pan coating
• Consists of circular metal pan mounted some what angularly
on the stand (45o).
• Heated air directed into the pan and on to the tablet bed
surface and exhausted by means of duct positioned through
the frnt of the pan.

• Coating solution are applied to the tablet by leading or
spraying
• Spraying the solution using atomizing system lead to
 Faster and more even distribution of solution or suspension
 Reduce drying time
• The most important coater that has improved drying
efficiency are
o Immersion sword
o Immersion tube system

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Tablets

February 4, 2023 Industrial Pharmacy 1

• Pharmaceutical dosage forms such as tablets, capsules,

• Active ingredients and excipients are raw materials for

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• And these raw materials are tested for quality

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• Storage of raw materials

• Quality testing of raw materials

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• Tablets are prepared by compression of constant

 Tablets are solid dosage forms containing medicinal

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• Tablets can be non coated or coated with plain coat(sugar and

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 Slow onset of action as compared to parental, liquid orals and

 Difficulty in swallowing especially for geriatric, pediatric and

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a. Buccal and sublingual tablets

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o Tablets are small or flat in shape.

o Are meant for a systemic effect have good absorption properties

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• Which do not stimulate salivation in order to reduce the

• Should be designed not to disintegrate but to slowly

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• These tablets may be inserted into other body cavities or

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Note: Regardless of whether tablet made by direct compression or granulation the

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• To know compressibility you should know density and derived