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Current technologies for
solid dosage form
manufacturing
Presented by
Md Mehedi shah, Esrat Jahan
ID:161328, 161316
Dept of Pharmacy,
PUST
SOLID DOSAGE FORM
• Unshaped (without specific shape)
- Powders for external/internal use
• Shaped
 Tablets
 Capsules
 Implants (sterile disks inserted surgically into body
tissues and designed to release drug(s) over extended period of time)
 Transdermal patches
 Lozenges (consists of sugar and gum to medicate the mouth and throat)
Advantage
• Unit dosage forms.
• Suitable for large-scale production.
• Greatest chemical and microbial stability overall oral dosage form.
• Sustained release product is possible by enteric coating.
• Cost is the lowest of all oral dosage forms
• Lighter and compact.
Disadvantage
• Difficult to swallow in the case of children and unconscious patients.
• Some drugs resist compression into dense compacts, owing to their amorphous nature low-density character.
• may require encapsulation or coating.
• Hygroscopic drugs are not suitable for compressed tablets.
• may cause problem with in bioavailability.
MANUFACTURING PROCESS
PREPARATION OF GRANULES FOR COMPRESSION
A. Weighing of the ingredients
B. Mixing the powdered ingredients and excipients
C. Converting the mixed ingredients into granules
D. The granules can be prepared by the following methods:
A. Moist granulation method
B. Dry granulation
C. Granules by preliminary compression
Excipients used in formulation of tablets 1. Diluents 2. Granulating agents 3. Binding agents 4.
Disintegrating agents 5. Lubricants 6. Adsorbents 7. Coloring agents, Flavoring agents and
Sweetening agents.
Name of the Machine Function Capacity
Rapid Mixer Granulator
(RMG)
Mixing 300-350 Kg
(large) & 100-
150 Kg (small)
Paste Kettle Preparation of
slurry
600 Liter
Fluid Bed Dryer (FBD) Drying 200 Kg
Multimill Milling -
Machines used in the Granulation unit for the purpose of Granulation:
In each granulation unit, the following machines are present for granulation;
GRANULATION UNIT OF INCEPTA PHARMACEUTICALS LTD.
MACHINES USED IN THE BLENDING UNITS FOR THE PURPOSE OF BLENDING:
Name of the Machine Function Capacity Speed
(rpm)
Double Cone Blender
(DCB)
Blending 300-350 Kg (large)
150-200 Kg (small)
16 rpm
22rpm
Drum Blender Blending 65 Kg (large)
35Kg (small)
-
FITZ mill Milling - 4000
Machines used in the Blending unit
Octagonal blender Double cone blender
COATING OF TABLETS
Tablets are coated for following purposes:
To mask the unpleasant taste and odor
To improve the appearance of tablets
To prevent the medicament from atmospheric effects
To control the site of action of drugs (enteric coating)
To produce the sustained released product.
The tablet coating is generally done by using any of the following processes:
 Pan coating
 Press coating
MACHINES USED IN THE COATING UNIT FOR THE PURPOSE OF BOTH
FILM & ENTERIC COATING:
Name of the Machine Function
Perforated Coating Pan System Loading of Tablets
Spray Gun Spraying of coating solution
Coating Solution Manufacturing Vessel Manufacturing of Coating Solution
Homogenizer Manufacturing of Homogenous Solution of
Colorants
MACHINES USED IN THE COATING UNIT
Fluid bed granulator and coater
Fluid bed coater (enteric coating)
Name of the Machine Function
Automatic Capsule Filling Machine Filling of empty Capsule shell
Capsule Sorting Machine Removal of defected capsules
Dust Collector Removal of dust
Capsule Polishing Machine Polishing of Capsules after powder filling
Machines used in the Capsule Manufacturing unit
Machines used in the Capsule Manufacturing unit
Semi-auto capsule filling machine Fully automatic capsule filling machine
MACHINES USED IN THE TABLET PRESS UNIT FOR THE PURPOSE OF
COMPRESSION:
Name of the Machine Function
Automatic Powder Loader Loading of powder or granules to the hooper of the tablet
press
Tablet press machine (B-tooling/ D-tooling) Compression
Dust Collector Removal of dust
Electronic balance Weighing of tablets in regular intervals to maintain equal
weight
MACHINES USED IN THE TABLET PRESS UNIT FOR THE PURPOSE OF COMPRESSION:
Tablet press machine
Automatic powder loader
Machines used for blister packing
FOR BLISTER PACKING: ALU ALU BLISTER PACKING MACHINE IS A ROBUST AND GMP COMPLIANT MACHINE
FEATURING A MODULAR AND COMPACT CONCEPT. IT IS A SMALL SIZE MACHINE THAT OPTIMIZES BLISTER
PACKING PROCESS IN A LIMITED WORKING SPACE
Alu-alu blister packing machine
MACHINES USED FOR STRIP PACKING
• FOR STRIP PACKING: STRIP PACKING MACHINE IS EXTENSIVELY USED TO PACK TABLETS,
CAPSULES, CAPLETS, COATED TABLETS, SOFT GELATIN CAPSULES.
Advanced strip packing machine
QUALITY CONTROL OF TABLETS
1. Shape of tablets
2. Appearance
3. Content of active ingredient in tablets
4. Uniformity of weight
5. Disintegration test for tablets
6. Dissolution test for tablets
7. Mechanical strength
8. Friability test
Thank you

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Solid dosage form/Incepta.pptx

  • 1. Current technologies for solid dosage form manufacturing Presented by Md Mehedi shah, Esrat Jahan ID:161328, 161316 Dept of Pharmacy, PUST
  • 2. SOLID DOSAGE FORM • Unshaped (without specific shape) - Powders for external/internal use • Shaped  Tablets  Capsules  Implants (sterile disks inserted surgically into body tissues and designed to release drug(s) over extended period of time)  Transdermal patches  Lozenges (consists of sugar and gum to medicate the mouth and throat)
  • 3. Advantage • Unit dosage forms. • Suitable for large-scale production. • Greatest chemical and microbial stability overall oral dosage form. • Sustained release product is possible by enteric coating. • Cost is the lowest of all oral dosage forms • Lighter and compact. Disadvantage • Difficult to swallow in the case of children and unconscious patients. • Some drugs resist compression into dense compacts, owing to their amorphous nature low-density character. • may require encapsulation or coating. • Hygroscopic drugs are not suitable for compressed tablets. • may cause problem with in bioavailability.
  • 5. PREPARATION OF GRANULES FOR COMPRESSION A. Weighing of the ingredients B. Mixing the powdered ingredients and excipients C. Converting the mixed ingredients into granules D. The granules can be prepared by the following methods: A. Moist granulation method B. Dry granulation C. Granules by preliminary compression Excipients used in formulation of tablets 1. Diluents 2. Granulating agents 3. Binding agents 4. Disintegrating agents 5. Lubricants 6. Adsorbents 7. Coloring agents, Flavoring agents and Sweetening agents.
  • 6. Name of the Machine Function Capacity Rapid Mixer Granulator (RMG) Mixing 300-350 Kg (large) & 100- 150 Kg (small) Paste Kettle Preparation of slurry 600 Liter Fluid Bed Dryer (FBD) Drying 200 Kg Multimill Milling - Machines used in the Granulation unit for the purpose of Granulation: In each granulation unit, the following machines are present for granulation;
  • 7. GRANULATION UNIT OF INCEPTA PHARMACEUTICALS LTD.
  • 8. MACHINES USED IN THE BLENDING UNITS FOR THE PURPOSE OF BLENDING: Name of the Machine Function Capacity Speed (rpm) Double Cone Blender (DCB) Blending 300-350 Kg (large) 150-200 Kg (small) 16 rpm 22rpm Drum Blender Blending 65 Kg (large) 35Kg (small) - FITZ mill Milling - 4000
  • 9. Machines used in the Blending unit Octagonal blender Double cone blender
  • 10. COATING OF TABLETS Tablets are coated for following purposes: To mask the unpleasant taste and odor To improve the appearance of tablets To prevent the medicament from atmospheric effects To control the site of action of drugs (enteric coating) To produce the sustained released product. The tablet coating is generally done by using any of the following processes:  Pan coating  Press coating
  • 11. MACHINES USED IN THE COATING UNIT FOR THE PURPOSE OF BOTH FILM & ENTERIC COATING: Name of the Machine Function Perforated Coating Pan System Loading of Tablets Spray Gun Spraying of coating solution Coating Solution Manufacturing Vessel Manufacturing of Coating Solution Homogenizer Manufacturing of Homogenous Solution of Colorants
  • 12. MACHINES USED IN THE COATING UNIT Fluid bed granulator and coater Fluid bed coater (enteric coating)
  • 13. Name of the Machine Function Automatic Capsule Filling Machine Filling of empty Capsule shell Capsule Sorting Machine Removal of defected capsules Dust Collector Removal of dust Capsule Polishing Machine Polishing of Capsules after powder filling Machines used in the Capsule Manufacturing unit
  • 14. Machines used in the Capsule Manufacturing unit Semi-auto capsule filling machine Fully automatic capsule filling machine
  • 15. MACHINES USED IN THE TABLET PRESS UNIT FOR THE PURPOSE OF COMPRESSION: Name of the Machine Function Automatic Powder Loader Loading of powder or granules to the hooper of the tablet press Tablet press machine (B-tooling/ D-tooling) Compression Dust Collector Removal of dust Electronic balance Weighing of tablets in regular intervals to maintain equal weight
  • 16. MACHINES USED IN THE TABLET PRESS UNIT FOR THE PURPOSE OF COMPRESSION: Tablet press machine Automatic powder loader
  • 17. Machines used for blister packing FOR BLISTER PACKING: ALU ALU BLISTER PACKING MACHINE IS A ROBUST AND GMP COMPLIANT MACHINE FEATURING A MODULAR AND COMPACT CONCEPT. IT IS A SMALL SIZE MACHINE THAT OPTIMIZES BLISTER PACKING PROCESS IN A LIMITED WORKING SPACE Alu-alu blister packing machine
  • 18. MACHINES USED FOR STRIP PACKING • FOR STRIP PACKING: STRIP PACKING MACHINE IS EXTENSIVELY USED TO PACK TABLETS, CAPSULES, CAPLETS, COATED TABLETS, SOFT GELATIN CAPSULES. Advanced strip packing machine
  • 19. QUALITY CONTROL OF TABLETS 1. Shape of tablets 2. Appearance 3. Content of active ingredient in tablets 4. Uniformity of weight 5. Disintegration test for tablets 6. Dissolution test for tablets 7. Mechanical strength 8. Friability test