Manufacturing Basics - Tablets

1. MANUFACTURING BASICS
Solid Orals – Tablets
- Jhony Sheik

2. Introduction:
• Tablet is a pharmaceutical dosage form.
• It comprises a mixture of active Pharmaceutical
Ingredients and excipients.
• It is pressed or compacted from a powder into a
solid dose.

3. Advantages:
Advantages afforded to the manufacturer
1- simplicity
2- economy of preparation
3-stability
4-convenience in packaging, shipping and dispensing
Advantages to the patient
1-accuracy of dosage
2-compactness
3-portability
4-blandness of taste
5-ease of administration.

4. Disadvantages:
DISADVANTAGES
• THE MANUFACTURE OF TABLETS REQUIRES A SERIES OF UNIT OPERATIONS AND THEREFORE
THERE IS AN INCREASED LEVEL OF PRODUCT LOSS AT EACH STAGE IN THE MANUFACTURING
PROCESS.
• THE ABSORPTION OF THERAPEUTIC AGENTS FROM TABLETS IS DEPENDENT ON PHYSIOLOGICAL
FACTORS, E.G. GASTRIC EMPTYING RATE, AND SHOWS INTER PATIENT VARIATION.
• THE COMPRESSION PROPERTIES OF CERTAIN THERAPEUTIC AGENTS ARE POOR AND MAY
PRESENT PROBLEMS IN THEIR SUBSEQUENT FORMULATION AND MANUFACTURE AS TABLETS.
• THE ADMINISTRATION OF TABLETS TO CERTAIN GROUPS, E.G. CHILDREN AND THE ELDERLY MAY
BE PROBLEMATIC DUE TO DIFFICULTIES IN SWALLOWING. THESE PROBLEMS MAY BE
OVERCOME BY USING EFFERVESCENT TABLET DOSAGE FORMS.

5. Tablet Type:
TABLET TYPES AVAILABLE INCLUDE
• CONVENTIONAL COMPRESSED TABLETS
• MULTIPLE COMPRESSED TABLETS
• ENTERIC-COATED TABLETS
• SUGAR-COATED TABLETS
• FILM-COATED TABLETS
• CHEWABLE TABLETS
• EFFERVESCENT TABLETS
• BUCCAL AND SUBLINGUAL TABLETS

6. API
Filler Mixing of
granulation blend
GranulationBinder(s)
Preparation of
binder solution
Drying
Milling
LOD
Disintegrant
screening
screening Initial Blending
lubricant Final Blending
Compression
Solvent
Film coating agent Preparation
Film Coating of Tablets
Packaging
and Labelling
Weight
Hardness
Friability
screening
Flow Chart:

7. Process Steps:
• Dispensing
• Milling/Screening
• Granulation
• Drying
• Blending
• Compression
• Coating
• Packaging

8. Dispensing:
• One of the most critical steps in pharmaceutical manufacturing
– manual weighing on a weight scale with material lifting assistance like vacuum
transfer and bag lifters
– automated weighing

9. Milling / Screening:
• Principle: Mixing or blending is more uniform if ingredients are of similar size
• The sizing (size reduction, milling, crushing, grinding, pulverization) is an important step
(unit operation) involved in the tablet manufacturing.
• In manufacturing of compressed tablet, the mixing or blending of several solid
ingredients of pharmaceuticals is easier and more uniform if the ingredients are
approximately of same size. This provides a greater uniformity of dose. A fine particle
size is essential in case of lubricant mixing with granules for its proper function
What are the Equipments:
 Fluid energy mill
 Co-mil
 Ball mill
 Hammer mill
 Cutting mill etc.

10. Granulation:
• Granulation: A size enlargement process that converts small particles into physically
stronger & larger agglomerates
Type of Granulations:
1. Wet Granulations
2. Dry Granulations
3. Direct Compression
What are the Equipments:
 Wet Granulation (Sifter, Rapid Mixer Granulators & Fluid Bed Dryer)
 Dry Granulator (Roller compactor, Tableting machine)
 Direct Compression (Sifter & Blender)

11. Drying:
• Purpose: To reduce the moisture level of wet granules
What are the Equipments:
 Vacuum tray dryers
 Fluid Bed Dryer

12. Blending:
• Blending is the most difficult operation in the manufacturing process since perfect
homogeneity is practically impossible due to differences in size, shape and density of
particles
What are the Equipments:
 “V” Blenders
 Octagonal Blenders
 Bin Blenders
 Double cone Blenders
V cone blender
Octagonal blender
Double cone blender

13. Compression:
• Principle: : Powder/granules are pressed inside a die and compressed by two punches
into required size, shape and embossing.
What are the Equipments:
 Tablet Compression Machine

14. Coating:
• Principle: Application of coating solution to a moving bed of tablets with concurrent use
of heated air to facilitate evaporation of solvent.
What are the Equipments:
 Pan (standard/perforated) Coating Machines
 Fluidized Bed Coating Machines
 Spray Coating Machines
 Vacuum, Dip & Electrostatic Coating Machines

15. Inspection:
• Major defects:
 Broken tablets, cracks or fragments.
 Capping/ lamination.
 Crack or porous surface.
 Excess surface powder
 Foreign odor
 Tablet with illegible or missing embossing.
 Sticking.
 Non-uniform color (Mottling).
• Minor defects:
 Adhering surface spots
 Picking
Chips
 Surface not smooth
Poor embossing (shallow , broken)Projected edges.

16. Packaging:
• Pharmaceutical packaging has to be carried out for the purpose of the safety of the pharmaceutical
preparations in order to keep them free from contamination, prevent microbial growth, and ensure
product safety throughout the shelf life for the pharmaceuticals. Packaging is done in a contamination
free environment or Clean room.
What are the Equipments:
 Blister Packing Machine
 Bottle Filling Machine
 Strip Packing Machine
 Pouch Packing Machine

17. THANK YOU