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Scope
Introduction
Advantages and disadvantages of
compressed tablets
Types of tablets
Tablet compression machine
Tableting methods
– Direct compression
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
No other tablet monograph appeared until 1945
1980 nearly 300 monographs for tablets
Advantages
Production aspect
– Large scale production at lowest cost
– Easiest and cheapest to package and ship
– High stability
User aspect (doctor, pharmacist, patient)
– Easy to handling
– Lightest and most compact
– Greatest dose precision & least content variability
– Coating can mark unpleasant tastes & improve pt.
acceptability
Disadvantages
Some drugs resist compression into dense compacts
Drugs with poor wetting, slow dissolution, intermediate
to large dosages 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
Absorption of
drug form
tablets
Ingredients used in tablet formulations
Drugs
Fillers, diluent, bulking agent
– To make a reasonably sized tablet
Binders
– To bind powders together in the wet granulation process
– To bind granule together during compression
Disintegrants
– To promote breakup of the tablets
– To promote rapid release of the drug
Lubricants
– To reduce the friction during tablet ejection between
the walls of the tablet and the walls of the die cavity
Glidants
– Reducing friction between the particles
– To improve the flow properties of the granulations
Antiadherants
– To prevent adherence of the granules to the punch faces
and dies
Dissolution (enhancers and retardants)
Wetting agents
Antioxidants
Preservatives
Coloring agents
Flavoring agents
Essential properties of tablets
Accurate dosage of medicament, uniform in weight,
appearance and diameter
Have the strength to withstand the rigors of mechanical
shocks encountered in its production, packaging,
shipping and dispensing
Release the medicinal agents in the body in a predictable
and reproducible manner
Elegant product, acceptable size and shape
Chemical and physical stabilities
Types of tablets
Route of administration
– Oral tablets
– Sublingual or buccal tablets
– Vaginal tablets
Production process
– Compressed tablets
– Multiple compressed tablets
Tablet within a tablets: core and shell
Multilayer tablet
– Sugar coated tablets
Protect tablets from moisture
Mask odor and flavor
Elegance
Children drug
– Effervescent tablets
Dissolve in the water before drink
Tablet production
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
Upper and
Lower Collar
Collar locker
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, compression and
ejection.
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
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 into
the front of the feed frame
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
Although tablet compressing machinery has undergone numerous
mechanical modifications over the years, the compaction of
materials between a pair of moving punches within a stationary die
has remained unchanged
The principle modification from earlier equipment has been an
increase in production rate which is regulated by
– Number of tooling sets
– Number of compression stations
– Rotational speed of the press
Special adaptations of tablet machines allow for the compression of
layered tablets and coated tablets
A device that chills the compression components to allow for the
compression of low-melting point substances such as waxes i.e.
suppositories
Tableting methods
Dry methods
– Direct compression
– Dry granulation
Wet methods
– Wet granulation
Direct compression
Tablets are compressed directly from powder blends
of the active ingredient and suitable excipients
No pretreatment of the powder blends by wet or dry
granulation procedures is necessary
Advantages
– Economy
Machine: fewer manufacturing steps and
pieces of equipment
Labor: reduce labor costs
particle state
– Uniformity of particle size
– Greater stability of tablet on aging
Color
Dissolution rate
(amorphous lactose)
Much more compressible
Highly fluid
Non hygroscopic
Tablets are three to four times harder than
regular spray dried
– Tabletose: aggromerate form of lactose
More compressible than spray dried but less
fluidity
Poor color stability
Dextrose
– Emdex: spray crystallized
90-92% dextrose, 3-5% maltose and the
product
Excellent compressibility
occur
Sorbitol
– Exists in a number of polymorphic crystalline
forms and amorphous form
– Widely used in sugar-free mints and as a vehicle
in chewable tablets
– Cool taste and good mouth feel
– Forms a hard compact
– Hygroscopic and will clump in the feed frame and
stick to the surfaces of the die table when tableted
at humidities > 50%
– Lubricant requirements increase when the MC of
the sorbitol drops below 0.5% or exceeds 2%
Mannitol
– Exists in a number of polymorphic forms
– Not make as hard a tablet as sorbitol
– Less sensitive to humidity
– Widely used where rapid and complete solubility is
required
– Use as a filler in chewable tablets
– Cool mouth feel but expensive
Maltodextrin
– Maltrin
Highly compressible
Completely soluble
Reworkability
in modern times
Derived from a special grade of purified alpha
lubricant requirement
When >20% of drugs or other excipients are
humidities
This softening is reversible when tablets are
Good fluidity
Slightly alkaline with a pH of 7.0 to 7.3
Precludes its use with AI that are sensitive to