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Mahatma Gandhi Vidyamandir’s
Pharmacy college
Panchavati ,Nashik
Pharmaceutical Quality Assurance
Department
Sub : Pharmaceutical Manufacturing Technology
Prepared By Guided by
Mr. Kunal Anil Suryawanshi Dr. K.V. Bhambar Sir
Roll No:45
Presentation on
1
 VISION:
To be a Centre of professional excellence by contributing honestly
to the pharmacist moulding process’
 MISSION:
 Impart high quality education to graduates
 Contribute to all spheres of professional activities
 Uphold human values and ethics
 Nature them into globally competent professional
2
Content
• Introduction of granulation
• Advancement in granulation technology
• Pelletization
• Pelletization Techniques
• Conclusion
• References
3
Introduction
Granulation:
• Granulation is the process of collecting particles together by creating bond
between them.
• Bonds are formed by compression or by using binding agent.
• The granulation process combines one or more powder particles and forms a granule
that will allow tableting to be within required limits.
4
Advancement in granulation
1. Pneumatics Granulation
2. Freeze Granulation Technology
3. Foamed Binder Technology
4. Melt Granulation Technology
5. Steam Granulation
6. Moisture Activated Dry Granulation
5
Advancement in granulation
7 Thermal Adhesion Granulation Process
8 Moist Granulation Technique
9 TOPO Technology
10 Continuous Flow
6
Steam Granulation
• This process is modification of conventional wet granulation.
• Here steam is used as binder instead of water.
• Advantage:
 Uniformity distribution of the powder particles.
 Higher dissolution rate of granules because of large surface area generated and
Time saving.
 Maintain sterility.
7
Steam Granulation
• Disadvantages
 Requires special equipment for steam generation and transportation.
 Require high energy inputs.
 Thermolabile materials are poor candidates.
 More safety measures Required.
8
Melt Granulation
• Here granulation is achieve by the addition of meltable binder.
• Binder is in solid state at room temperature but melts in the temp range 50-
80°c. Melted Binder then act like a binding liquid.
• There is no need of drying phase since dried granules are obtained by
cooling it to room temperature Water soluble Binders E.g. polyethylene
glycol 2000 4000 6000 8000 (40-60°c)Water insoluble Binder E.g.
stearic acid (46-59°c).
9
• Advantages:
. Time and cost effective.
 Controlling and modifying the release of drug.
 Water soluble drugs are good candidates.
• Disadvantages:
 Heat sensitive material are poor candidates.
 Lower melting point Binder may melt soften during handling and storage.
Melt Granulation
10
Moisture Activated Dry Granulation
In MADG Moisture is use to activate granules formation without the need to
apply heat to dry the granules.
➤ Stages
Agglomeration: 1. Drug is blended with diluent and powder.
2. A small amount of water is sprayed.
3. Agglomerate formation.
Moisture distribution absorption: Moisture absorbent like microcrystalline
cellulose or silicon dioxide are added while mixing. Moisture redistribution
within the mixture Entire mixture become relatively dry. 11
• Advantages:
 Application to more than 90% of granulation need for pharmaceutical,
food and nutritional industries.
 Time efficient.
 Suitable for continuous processing.
Less energy involved during processing.
• Disadvantages:
 Moisture sensitive and high moisture absorbing API are poor candidates.
Moisture Activated Dry Granulation
12
Moist Granulation Technique
• A small amount granulation fluid is added to activate dry binder and to
facilitate agglomeration.
• Moisture absorbing material like microcrystalline cellulose is added to
absorb any excess moisture.
• Drying step is not necessary.
• Applicable for developing a controlled release formulations.
13
Thermal Adhesion Granulation Process
• It is Applicable for preparing direct tableting formulations.
• Mixture of API and excipients are heated to a temp 30-130°C, in a close
system until granulation.
• It provides granules with
 Good flow property
 Binding capacity to form tab of low friability.
 Adequate hardness
14
Foam Granulation
• Time efficient.
• Cost effective.
• IR, CR formulation.
• Water sensitive drugs.
• Uniform binder distribution.
• No overwriting
15
Freeze Granulation Technology
• By spraying a powder suspension into liquid nitrogen the drops are
Instantly frozen.
• In a subsequent Freeze drying the granules are dried by sublimation of the
ice without any segregation effect.
• Finally it produces spherical, free flowing granules.
16
TOPO Technology
• It requires very small quantity of liquid to start the chain reaction. Pure
water or water ethanol mixture are used.
• Technology produce granules for tablet which contains at least one solid
crystalline, organic acid and one alkaline or alkaline earth metal carbonate
that react with the organic acid in aqueous solutions to form carbon
dioxide.
• As the result there is no solvent residue in the finish product, granules have
excellent hardness and stability.
17
Continuous Flow Technology
• The technology dose not need any liquid to start the chain reaction.
• Granulation is carried out in an inclined drum into which powder is fed at
one end and granulate is remove at other.
• The process produces granules with surface protected by inactive
components that do not harm to sensitive API.
• CF technology can produce up to 12 tones of granules every day.
18
Pelletization
• It is an Agglomeration process that converted fine powder or particles of bulk drug
and excipients into small free flowing more or less spherical unit and called
pellets.
• Advantages of pellets: Improved appearance of product.
 Improved flow properties and ease of packing resulting in uniform and
reproducible fill weight of tablets and capsules.
 Improved safety and efficacy of active ingredient.
Decreased handling hazards and easier transport.
 Pelletization can be used for taste masking of unpalatable drugs.
19
Pelletization
• Disadvantages of pellets:
Pellets are rigid and so cannot be pressed into tablets, So they have to
be encapsulated into capsules.
The production of pellets is quite an expensive process due to the
requirement of highly specialized equipment and trained personnel.
The control of production process is difficult. (e.g. the amount of water
added and time is critical for the quality of pellets as over-wetting can
occur very easily.)
20
Pelletization Techniques
1) Drug layering (dry powder layering & solution and suspension layering).
2) Pelletization by extrusion spheronization.
3) Cryopelletization.
4) Freeze Pelletization.
5) Globulation.
6) Compression.
7) Balling 21
Extrusion- Spheronization
• The method involves the following main steps: The dry mixing of the ingredients,
in order to achieve homogenous powder dispersions, Wet massing, in which the
powders are wet mixed to form a sufficiently plastic mass.
2. An extrusion stage, in which the wet mass is shaped into cylindrical segments with
a uniform diameter. The spheronization stage, in which the small cylinders are rolled
into solid spheres (spheroids)
3. The drying of the spheroids, in order to achieve the desired final moisture content
4. Screening (optional), to achieve the desired narrow size distribution 22
Extrusion- Spheronization
23
Extrusion
• Extrusion consists in applying pressure to a wet mass until it passes
through the calibrated openings of a screen or die plate of the extruder and
further shaped into small extrudate segments.
• The extrudates must have enough plasticity in order to deform, but an
excessive plasticity may lead to extrudates which stick to each other.
• The diameter of the segments and the final size of the spheroids depend on
the diameter of the openings in the extruder screen.
24
Spheronization
• Spheronization refers to the formation of spherical particles from the small
rods produced by extrusion.
• The essential part of the spheronizer is the friction plate.
• The indentation pattern on the plate can have various designs, which
correspond to specific purposes.
• In order to form spheroids, the extrudates are brought onto the rotating
friction plate of the spheronizer, which imparts a rolling motion to the
material.
25
Spheronization
• Following the collisions between the extrudates with each other and with
the friction plate and the stationary walls of the spheronization chamber,
the cylindrical segments change their shape and size.
• The movement of the product along the chamber and transition from the
almost cylindrical segments to spheres during the spheronization process
occurs in several stages.
26
Drug Layering
• In powder layering method, the binding liquid helps in forming successive layers
of dry powder of drug and other components on starting cores by forming liquid
bridges which are eventually replaced by solid bridges.
• In order to achieve the desired pellet size, successive layering of drug and binder
solution is continued.
• The first equipment used to manufacture pellets on a commercial scale was the
conventional coating pan, but it has significant limitations as Pelletization
equipment. 27
Drug Layering
• The degree of mixing is very poor, and the drying process is not efficient.
• Other equipment's used for powder layering process are:
a. Tangential Spray granulator.
b. Centrifugal Fluid Bed granulator.
28
Cryopelletization
• Cryopelletization is a process whereby droplets of a liquid formulation are
converted into solid spherical particles or pellets by using liquid nitrogen
as the fixing medium at -160°C.
• The procedure permits instantaneous and uniform freezing of the material.
• The rapid heat transfer that occurs between the droplets and liquid nitrogen
is responsible for the same.
• The pellets are dried in conventional freeze dryers. Generally, 3-5 kg of
liquid nitrogen is required for preparation of 1 kg pellets. 29
Compression
• Compression is one of type of compaction technique for preparing pellets.
• Pellets of definite sizes and shapes are prepared by compacting mixtures or
blends of active ingredients and excipients under pressure.
• The formulation and process variables controlling the quality of pellets
prepared are similar to those used in tablet manufacturing.
30
Balling
• Balling is the Pelletization process in which pellets are formed by a
continuous rolling and tumbling motion in pans, discs, drums or mixers.
• The process consists of conversion of finely divided particles into spherical
particles upon addition of appropriate amounts of liquid.
31
Conclusion
• It can be concluded that due to their good technological and
biopharmaceutical advantages, tablet improvement has gained and
importance in modern pharmaceutical science and are expected to play a
major role in design and fabrication of many novel granulation and
pelletization techniques in the future. Influence of process improvement on
minimizing process time, labor and cost reduction performance.
32
Reference
• Roop k Khar, SP Vyas, Farhan k Jain. Lachman/Liberman's the theory and
practice of industrial pharmacy. CBS publisher& distributor pvt ltd, 2013.
• Michael E. Aulton, K. M. (n.d.). Aulton's pharmaceutics the design and
manufacture of medicines. Churchill Livingstone Elsevier.
33
THANK YOU
34

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Improve tablet Production, Granulation and Pellitization techniques.pptx

  • 1. Mahatma Gandhi Vidyamandir’s Pharmacy college Panchavati ,Nashik Pharmaceutical Quality Assurance Department Sub : Pharmaceutical Manufacturing Technology Prepared By Guided by Mr. Kunal Anil Suryawanshi Dr. K.V. Bhambar Sir Roll No:45 Presentation on 1
  • 2.  VISION: To be a Centre of professional excellence by contributing honestly to the pharmacist moulding process’  MISSION:  Impart high quality education to graduates  Contribute to all spheres of professional activities  Uphold human values and ethics  Nature them into globally competent professional 2
  • 3. Content • Introduction of granulation • Advancement in granulation technology • Pelletization • Pelletization Techniques • Conclusion • References 3
  • 4. Introduction Granulation: • Granulation is the process of collecting particles together by creating bond between them. • Bonds are formed by compression or by using binding agent. • The granulation process combines one or more powder particles and forms a granule that will allow tableting to be within required limits. 4
  • 5. Advancement in granulation 1. Pneumatics Granulation 2. Freeze Granulation Technology 3. Foamed Binder Technology 4. Melt Granulation Technology 5. Steam Granulation 6. Moisture Activated Dry Granulation 5
  • 6. Advancement in granulation 7 Thermal Adhesion Granulation Process 8 Moist Granulation Technique 9 TOPO Technology 10 Continuous Flow 6
  • 7. Steam Granulation • This process is modification of conventional wet granulation. • Here steam is used as binder instead of water. • Advantage:  Uniformity distribution of the powder particles.  Higher dissolution rate of granules because of large surface area generated and Time saving.  Maintain sterility. 7
  • 8. Steam Granulation • Disadvantages  Requires special equipment for steam generation and transportation.  Require high energy inputs.  Thermolabile materials are poor candidates.  More safety measures Required. 8
  • 9. Melt Granulation • Here granulation is achieve by the addition of meltable binder. • Binder is in solid state at room temperature but melts in the temp range 50- 80°c. Melted Binder then act like a binding liquid. • There is no need of drying phase since dried granules are obtained by cooling it to room temperature Water soluble Binders E.g. polyethylene glycol 2000 4000 6000 8000 (40-60°c)Water insoluble Binder E.g. stearic acid (46-59°c). 9
  • 10. • Advantages: . Time and cost effective.  Controlling and modifying the release of drug.  Water soluble drugs are good candidates. • Disadvantages:  Heat sensitive material are poor candidates.  Lower melting point Binder may melt soften during handling and storage. Melt Granulation 10
  • 11. Moisture Activated Dry Granulation In MADG Moisture is use to activate granules formation without the need to apply heat to dry the granules. ➤ Stages Agglomeration: 1. Drug is blended with diluent and powder. 2. A small amount of water is sprayed. 3. Agglomerate formation. Moisture distribution absorption: Moisture absorbent like microcrystalline cellulose or silicon dioxide are added while mixing. Moisture redistribution within the mixture Entire mixture become relatively dry. 11
  • 12. • Advantages:  Application to more than 90% of granulation need for pharmaceutical, food and nutritional industries.  Time efficient.  Suitable for continuous processing. Less energy involved during processing. • Disadvantages:  Moisture sensitive and high moisture absorbing API are poor candidates. Moisture Activated Dry Granulation 12
  • 13. Moist Granulation Technique • A small amount granulation fluid is added to activate dry binder and to facilitate agglomeration. • Moisture absorbing material like microcrystalline cellulose is added to absorb any excess moisture. • Drying step is not necessary. • Applicable for developing a controlled release formulations. 13
  • 14. Thermal Adhesion Granulation Process • It is Applicable for preparing direct tableting formulations. • Mixture of API and excipients are heated to a temp 30-130°C, in a close system until granulation. • It provides granules with  Good flow property  Binding capacity to form tab of low friability.  Adequate hardness 14
  • 15. Foam Granulation • Time efficient. • Cost effective. • IR, CR formulation. • Water sensitive drugs. • Uniform binder distribution. • No overwriting 15
  • 16. Freeze Granulation Technology • By spraying a powder suspension into liquid nitrogen the drops are Instantly frozen. • In a subsequent Freeze drying the granules are dried by sublimation of the ice without any segregation effect. • Finally it produces spherical, free flowing granules. 16
  • 17. TOPO Technology • It requires very small quantity of liquid to start the chain reaction. Pure water or water ethanol mixture are used. • Technology produce granules for tablet which contains at least one solid crystalline, organic acid and one alkaline or alkaline earth metal carbonate that react with the organic acid in aqueous solutions to form carbon dioxide. • As the result there is no solvent residue in the finish product, granules have excellent hardness and stability. 17
  • 18. Continuous Flow Technology • The technology dose not need any liquid to start the chain reaction. • Granulation is carried out in an inclined drum into which powder is fed at one end and granulate is remove at other. • The process produces granules with surface protected by inactive components that do not harm to sensitive API. • CF technology can produce up to 12 tones of granules every day. 18
  • 19. Pelletization • It is an Agglomeration process that converted fine powder or particles of bulk drug and excipients into small free flowing more or less spherical unit and called pellets. • Advantages of pellets: Improved appearance of product.  Improved flow properties and ease of packing resulting in uniform and reproducible fill weight of tablets and capsules.  Improved safety and efficacy of active ingredient. Decreased handling hazards and easier transport.  Pelletization can be used for taste masking of unpalatable drugs. 19
  • 20. Pelletization • Disadvantages of pellets: Pellets are rigid and so cannot be pressed into tablets, So they have to be encapsulated into capsules. The production of pellets is quite an expensive process due to the requirement of highly specialized equipment and trained personnel. The control of production process is difficult. (e.g. the amount of water added and time is critical for the quality of pellets as over-wetting can occur very easily.) 20
  • 21. Pelletization Techniques 1) Drug layering (dry powder layering & solution and suspension layering). 2) Pelletization by extrusion spheronization. 3) Cryopelletization. 4) Freeze Pelletization. 5) Globulation. 6) Compression. 7) Balling 21
  • 22. Extrusion- Spheronization • The method involves the following main steps: The dry mixing of the ingredients, in order to achieve homogenous powder dispersions, Wet massing, in which the powders are wet mixed to form a sufficiently plastic mass. 2. An extrusion stage, in which the wet mass is shaped into cylindrical segments with a uniform diameter. The spheronization stage, in which the small cylinders are rolled into solid spheres (spheroids) 3. The drying of the spheroids, in order to achieve the desired final moisture content 4. Screening (optional), to achieve the desired narrow size distribution 22
  • 24. Extrusion • Extrusion consists in applying pressure to a wet mass until it passes through the calibrated openings of a screen or die plate of the extruder and further shaped into small extrudate segments. • The extrudates must have enough plasticity in order to deform, but an excessive plasticity may lead to extrudates which stick to each other. • The diameter of the segments and the final size of the spheroids depend on the diameter of the openings in the extruder screen. 24
  • 25. Spheronization • Spheronization refers to the formation of spherical particles from the small rods produced by extrusion. • The essential part of the spheronizer is the friction plate. • The indentation pattern on the plate can have various designs, which correspond to specific purposes. • In order to form spheroids, the extrudates are brought onto the rotating friction plate of the spheronizer, which imparts a rolling motion to the material. 25
  • 26. Spheronization • Following the collisions between the extrudates with each other and with the friction plate and the stationary walls of the spheronization chamber, the cylindrical segments change their shape and size. • The movement of the product along the chamber and transition from the almost cylindrical segments to spheres during the spheronization process occurs in several stages. 26
  • 27. Drug Layering • In powder layering method, the binding liquid helps in forming successive layers of dry powder of drug and other components on starting cores by forming liquid bridges which are eventually replaced by solid bridges. • In order to achieve the desired pellet size, successive layering of drug and binder solution is continued. • The first equipment used to manufacture pellets on a commercial scale was the conventional coating pan, but it has significant limitations as Pelletization equipment. 27
  • 28. Drug Layering • The degree of mixing is very poor, and the drying process is not efficient. • Other equipment's used for powder layering process are: a. Tangential Spray granulator. b. Centrifugal Fluid Bed granulator. 28
  • 29. Cryopelletization • Cryopelletization is a process whereby droplets of a liquid formulation are converted into solid spherical particles or pellets by using liquid nitrogen as the fixing medium at -160°C. • The procedure permits instantaneous and uniform freezing of the material. • The rapid heat transfer that occurs between the droplets and liquid nitrogen is responsible for the same. • The pellets are dried in conventional freeze dryers. Generally, 3-5 kg of liquid nitrogen is required for preparation of 1 kg pellets. 29
  • 30. Compression • Compression is one of type of compaction technique for preparing pellets. • Pellets of definite sizes and shapes are prepared by compacting mixtures or blends of active ingredients and excipients under pressure. • The formulation and process variables controlling the quality of pellets prepared are similar to those used in tablet manufacturing. 30
  • 31. Balling • Balling is the Pelletization process in which pellets are formed by a continuous rolling and tumbling motion in pans, discs, drums or mixers. • The process consists of conversion of finely divided particles into spherical particles upon addition of appropriate amounts of liquid. 31
  • 32. Conclusion • It can be concluded that due to their good technological and biopharmaceutical advantages, tablet improvement has gained and importance in modern pharmaceutical science and are expected to play a major role in design and fabrication of many novel granulation and pelletization techniques in the future. Influence of process improvement on minimizing process time, labor and cost reduction performance. 32
  • 33. Reference • Roop k Khar, SP Vyas, Farhan k Jain. Lachman/Liberman's the theory and practice of industrial pharmacy. CBS publisher& distributor pvt ltd, 2013. • Michael E. Aulton, K. M. (n.d.). Aulton's pharmaceutics the design and manufacture of medicines. Churchill Livingstone Elsevier. 33