This presentation summarizes the process of manufacturing tablets. It discusses the key steps which include sieving and mixing the active ingredients and excipients, drying the granules in a fluidized bed dryer, milling to the desired size, blending, compression using tablet presses to form the tablets, coating for properties like taste-masking or controlled release, packaging in blisters or strips with secondary packaging like boxes, and quality control testing of the tablets. The presentation provides an overview of the various unit operations and equipment involved at each stage of tablet manufacturing.

1. INDUSTRIAL
TRAINING
PERSENTATION
PERSENTED BY: ASAD
REZA
DEPARMENT OF PHARMACY
MEWAR UNIVERSITY

2. MANUFACTURING OF TABLET
CONTENTS
 Introduction of tablet.
 Methods used in tablet formulation.
 Tablet manufacturing equipment/machines.
 Packaging of tablets.

3. INTRODUCTION OF TABLET
• A tablet (also known as a pill) is a pharmaceutical oral dosage form (oral solid dosage, or OSD) or solid
unit dosage form. Tablets may be defined as the solid unit dosage form of medicament or medicaments
with suitable excipients.
• Tablets :- API /Medicament +Excipients
 Tablets are present in a different-different shape and size.. Such as circular, flat biconvex etc.
 Advantage:
 Simplest oral dosage form.
 Easy to administered.
 Cheap (not expensive)
 Greatest dose precision.
 Unpleasant and bitter teste can be masked by sugar coating.
 Light in weight (easy to transport)
 Physically and chemically stable.

4. DISADVANTAGE
• Infant children’s and elder person can not easy administered.
• Not useful for unconscious patients.
• Not use in emergency ( slow action).
• Problem with compression to crystalline drugs.
• Tablets formation process consist of a series of steps (unit
processes)– weighing, milling, mixing, granulation, drying,
compaction, (frequently) coating and packaging. Regardless of
the method used the unit processes – weighing, milling and
mixing, are the same; subsequent steps differ.

5. Dispensing of API & Excipient
Sieving/ Screening
Mixing
Drying
Shifter(Milling)
Blender
Compression
Coating
(Packaging)-Tablet Dispatch in Market
Methodsusedintabletformulation.

6. SIEVING MACHINE

7. SIEVING
Separation of a mixture of various sized particles either dry or suspended in a liquid into
two or more portion by passing through screens of specified mesh sizes
Important of sieving
 The sieving process gives three fraction of granules
 Very coarse granules which return back to the milling process.
 Very fine Fraction which return back the compaction.
 Fraction with optimal dimensions for following manufacturing steps

8. SPECIFICATION
MODEL CAPACITY POWER
Shifter- 20 100-120 kg/Hr 1.0 HP
Shifter- 30 150-180 kg/Hr 2.0 HP

9. MIXING
• A process in which two or more than components are mixed in such a
way that each particle of any one ingredient lies as nearly as possible to
the adjacent particle of other ingredient.
• In pharmaceutical industry.
• Process of mixing is used in the formulation of solutions,
Emulsions, suspensions, powders, ointments and creams.

10. Instrument for granulation
 Rapid mixture granulator (RMG) is used in mixing, agitation, and shear mixing (to break internal molecular force). RMG is
used in pharmaceuticals to make granules. The components of the RMG (impeller and chopper) are highly responsible
for the wet granulation process.
Working principle of RMG:
 Rapid mixture granulator works on agitation, tumbling. The impeller is responsible for uniformly mixing wet granules,
and the chopper helps in a break or reduced particle size. At the starting process or during binder addition, the impeller
and chopper generally operate at low speed. Then after the formation of wet mass, they are operated at high speed to
make the desired granule size.
 Dry mixing is done at high speed after adding all dispensed materials into RMG.
 During batch validation, all the dry and wet mixing time parameters are set and applied in the batch manufacturing
records (BMR). All the parameters are set differently for every product, although it takes 3-5 minutes to mix the dry
granules and 5-10 minutes for wet mixing to get the desired 0.5mm to 1.5 mm sized granules.
COMPONENTS OF RMG
 Impeller
 Chopper
 Discharge port.

11. RAPID MIXER GRANULATOR

12. DRYING
 Drying is a ubiquitous process in the handling and preparation of pharma-ceuticals, and it may be defined as the
vaporization and removal of water or other liquid from a solution, suspension, or other solid-liquid mixture to form
a dry solid. The change of phase from liquid to vapor distinguishes drying from mechanical methods of separating
solids from liquids such as filtration. The latter often precede drying since, where applicable, they offer a cost-
effective method for removing a large part of the liquid
In the pharmaceutical sector the fallowing dryers are use:
1.Static Oven,
2.Rotary Drier,
3.Fluidized Bed Drier,
4.Vacuum Oven,
5.Microwave Drier,
6.Spray Drier,
7.Rotary Atomizer,
8.I.R Drier.

13. FLUIDIZED BED DRYER
 Fluidized bed dryer (also known as fluid bed dryers) are
commonly used in the pharmaceutical industry to
reduce the moisture content of pharmaceutical particles
and granules
Principle
FBD (fluidized Bed dryer) works on the fluidization
principle. A high-pressure Hot air from the supply is passed
through the perforated container containing a wet mass of
the granules,
 after some time granules, particles started to suspend
in the air to become dry (called (fluidized state), the
process is called fluidization.
FLUIDIZED BED DRYER
(FBD)

14. 1. Inlets Filters
2. Air preparatory unit.
3. Product container or Bowl.
4. Expansion chamber
5. Exhaust filter.
6. Exhaust blower.
7. Control panel (MMI).
8. Air distribution plate.
9. FBD bags (Finger Bags)
10.plenum
11.Gaskets
12.Body Stainless steel
Components of Fluidized-bed dryer

15. Separation of a mixture of various-sized particles
either dry or suspended in a liquid, into two or
more portions, by passing through screens of
specified mesh sizes.
Importance of sieving
The sieving process gives three fractions of
granules
 Very coarse granules, which return back to the
milling process.
 Very fine fraction, which return back to the
compaction.
 Fraction with optimal dimensions for following
manufacturing steps
Equipment used for sieving
 Industrial Sifter and Sieving Machine
SIFTER

16. Milling machine (Size reduction)
 Cutter mill is a size reduction equipment consisting of a series of
uniformly spaced knives (2 to 12 in number) attached to a
horizontal rotor (rotating knives) which act against a series of
stationary knives attached to the mill casing. The bottom of the
mill has a screen attached to control the residence time of the
particles inside the mill head.
 Size reduction process involves successive mechanical sheering of
the feed material with the help of sharp knife. Cutter mills produce
coarse particles from
1.Dried granulations before tableting and
2. Fibrous crude medicinal/roots, barks prior to extraction
 After the shifting of material of required size. The remaining
Material is of large sizes is Reduced by the milling machine and
after the size reduction material is collected in polythene Bags.
MULTI MILL

17. Blending
 Powders to be used for encapsulation or to be granulated
must be well blended to ensure good drug distribution.
 Inadequate blending at this stage could result in discrete
portion of the batch being either high or low in potency.
 Steps should also be taken to ensure that all the
ingredients are free of lumps and agglomerates.
 For these reasons, screening and/or milling of the
ingredients usually makes the process more reliable and
reproducible.
Equipment used for blending
1. V-blender.
2. Double cone blender.
3. Ribbon blender.
4. Slant cone blender.
BLENDER

18. COMPRESSION
 A tablet press is a mechanical device that compresses powder into tablets of uniform size and weight. A
press can be used to manufacture tablets of a wide variety of materials, including pharmaceuticals, illicit
drugs, cleaning products, and cosmetics. To form a tablet, the granulated material must be metered into a
cavity formed by two punches and a die, and then the punches must be pressed together with great force to
fuse the material together.
 Tableting procedure
 Filling
 Compression
 Ejection

19. Tablet Compression machine
 Hopper for holding and feeding granulation to be compressed.
 Dies that define the size and shape of the tablet
 Punches for compressing the granulation within the dies.
 Cam tracks for guiding the movement of the punches.
 Feeding mechanisms for moving granulation from the hopper into the dies.
The dies and the corresponding pairs of punches are arranged around a circular rotating turret.
 Each individual die with lower punch in its lowest position, passes under the powder bed which is contained within a
feed frame, which in turn is fed from a hopper.
 The die is completely filled under gravity, flow sometimes being assisted by rotating fingers in the feed frame.
 The quantity of solid in the die is adjusted by weight controlling cam.
 These punches then pass upper punch to descend and the lower punch to rise.
 Thus the powder is actively compressed from both top and bottom faces.
 The top punch then withdraws and the lower punch ascends as it passes over and ejection cam.

22. The coating in tablets, which is additional step in the manufacturing
process.
OBJECTIVE
o To makes the taste, odor, or color of the drug.
o To provide physical and chemical protection for the drug.
o To control the release of the drug from the tablet.
o To protect the drug from the gastric environment of the stomach
with an acid resistant enteric coating.
TYPE OF COATING
1. Film coating
2. Sugar coating
3. Press coating
4. Functional Coating
a) Enteric coating
b) Control release coating
COATING

23. PACKAGING
 Packaging is the science, art and technology of enclosing or protecting
products for distribution, storage, sale, and use. Packaging also refers to
the process of design, evaluation, and production of packages. Package
labeling or labeling is any written, electronic, or graphic
communications on the packaging or on a separate but associated label.
 Packaging machines e.g., blister packing machine, aluminium foil
packaging machine, etc. Machine name Dph-220/260 High Speed Blister
Packing machine.

24. TYPES OF PACKAGING
 There are two types of packaging-
1. Primary packaging
2. Secondary packaging

25. 1-PRIMARY PACKAGING: -
It is the packing which is in contact with medicament (capsule or tablet).
A. Blister packaging: -
 In this PVC and Al Foil is used for packaging.
 Sometimes Al foil is used wholly for packaging-
 Thickness of Al foil = 0.025mm ± 10%
 Thickness of PVC = 0.25 mm ±10%
 The blister package is formed by heat- softening a sheet of thermoplastic resin and vacuum drawing the softened
sheet of plastic into a contoured mold
 Blister packaging machine consist of-
 Feeder (vibrator).
 A guide tracks.
 A forming die.
 Forming heater
 Sealing heater.
 Cutter.
 Printing registration controller.

26. Temperature: -
 Forming heater = 140º-170º C.
 Sealing heater = 170º-200º C.

27. B) Strip packaging: -
 The strip package is form by feeding to webs of a heat sealable flexible film through either a heated
crimping roller or a heated reciprocating platen. In this the product is drop into the pocket formed
prior to forming the final set of seals.
Machine:
 It consists of: -
 Hopper.
 Disc.
 Channel (chute).
 Two rollers (for Al foil).
 Cutter (center cutter).
 Conveyer belt.
 Thermostat.
 Selector.

28. When primary (strip & blister) packaging is done. The strips &
blisters are subject for secondary packaging.

29. SECONDARY PACKAGING
It is the packaging which is in contact with the primary packaging.
It involved –
 Cartoons (printed).
 Corrugated boxes (CB)
 White board box
 Corrugated boxes consist of 3 ply or 5 ply or 7 ply as per requirement.
When secondary packaging is complete a BOPP tape (Bio Oriented Poly
Propylene Tape) is use for sticking

30. Packaging machines
A choice of packaging machinery includes, technical
capabilities, labor requirements, worker safety,
maintainability, serviceability, reliability, ability to integrate
into the packaging line, capital cost, flexibility (change-over,
materials, etc.), energy usage, quality of outgoing packages,
qualifications (for food, pharmaceuticals, etc.), throughput,
efficiency, productivity, High speed conveyor with bar code
scanner for sorting transport packages.

31. BLISTER PACKAGING MACHINE

32. STRIP PACKAGING MACHINE

33. EVALUATION OF TABLETS
Official tests:
• Content of active ingredient/ absolute drug content test/ assay of
active ingredient.
• Weight uniformity test/ weight variation test.
• Friability Test.
• Hardness Test.
• Thickness Test.
• Disintegration time test.
• Dissolution test.

34. Tablets/QC test Equipment
•Weighing Balance
•Friability Tester
•Hardness Tester
•Disintegration time tester
•Dissolution tester

35. Disintegration testing condition
Sr.
NO
Type of
Tablets
Medium Temperature Limit
1 Uncoated Water/buffer 37°±2 °C 15 min or as per individual monograph
2 Film coated Water 37°±2 °C 30 min or as per individual monograph
3 Sugar coated Water/0.1 N HCL 37°±2 °C 60 min or as per individual monograph
4 Dispersible tablets Water 25°±1 °C 03 min or as per individual monograph
5 Effervescent
Tablets
Water 25°±5 °C 05 min or as per individual monograph
6 Enteric-coated
Tablet
0.1 M HCL mixed
phosphate buffer
Ph 6.8
37°±2 °C 02 hour in HCL: no disintegration
60 min in buffer : disintegrate
7 Soluble Tablets Water 20°±5 °C 03 min