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P R E S E N T E D B Y
M R . R A J E N D R A K . S U R A W A S E
Technological Advances in
Pharmaceutical Dosage form
Designing
Department of Pharmaceutics
Loknete Dr. J. D. Pawar College of Pharmacy
Manur, Kalwan, Nashik (M.S)
2/3/2020
1
R. K. Surawase
Content
 Concept of Preformulation
 Recent trends in drug delivery Development
 Types of tablet Formulations
 Conventional Method of tablet Manufacturing
 Recent advances in granulation process
 Concept of Microencapsulation
 Applications & Fundamentals of FBP
 Processing Variables of FBP
 Spray Drying
 Critical elements of Spray drying
2/3/2020
2
R. K. Surawase
Introduction
2/3/2020
3
PharmaceuticsDrug Dosage
Forms
R. K. Surawase
Concept of Pre-formulation
2/3/2020
4
Preformulation testing is the first step in the rational development
of dosage forms of a drug substance.
 It can be defined as study of physico-chemical properties of a
drug substance alone and combined with excipients.
 The overall objective of Preformulation study is to generate
information useful to the formulator in developing stable and
efficient, qualitative dosage forms.
R. K. Surawase
Preformulation Process
2/3/2020
5
 Physicochemical property:
 Organoleptic Property
 Particle characteristics
 Crystallinity
 Polymorphism
 Hygroscopicity
 Solubility analysis
 Thermal analysis
 Physicomechanical property:
 Flow property
 Angle of repose
 Percent compressibility
 Bulk density
 Spectroscopic method:
 Assay development:
 Stability testing:
R. K. Surawase
Recent Trends in Drug Delivery
Development
Recent
Trends
3 D
Printing
Technology
Co-
processing
of
Excipients
Quality by
Design &
DoE
Fluidized
Bed
Processing
Nanotechn-
ology
2/3/2020
6
R. K. Surawase
Types of Tablet Formulation
 Compressed tablet
 Sugar coated tablet
 Film coated
 Effervescent tablet
 Chewable tablet
 Mouth dissolving tablet
 Dispersible tablet
 Multilayer tablet
 Sublingual tablet
 Buccal tablet
 Micro tablet / Mini Tablet
 Osmoticaly active tablet (osmotic
Pump)
 3 D tablet
 SR/ CR tablet
 Fast disintegrating SR tablet
 Colon targeted Tablet
 Floating tablet
2/3/2020
7
R. K. Surawase
Conventional methods of tablet
Manufacturing
2/3/2020
8
WetGranulation
• Raw material
• Weigh
• Screen
• Mix
• Wet mass
• Mill
• Dry
• Mill
• Mix
• Compress
DirectCompression
• Raw material
• Weigh
• Screen
• Compress
DryGranulation
• Raw material
• Weigh
• Screen
• Mix
• Slug
• Mill
• Mix
• Compress
R. K. Surawase
Recent advancement in granulation
process
 Pneumatic Dry Granulation
 Steam granulation
 Melt granulation
 Moisture activated dry granulation
 Thermal adhesion granulation process
 Foam granulation
2/3/2020
9
R. K. Surawase
Microencapsulation
2/3/2020
10
Microencapsulation is a means of applying thin uniform
coatings to microparticles of core material in solid or
liquid droplets.
Fundamental of Microencapsulation:
Core Material
Coating Material
Manufacturing Vehicle Phase
R. K. Surawase
Microencapsulation methods
2/3/2020
11
1. Air suspension
2. Coacervation-phase separation
3. Spray drying
4. Congealing
5. Pan coating
6. Solvent evaporation techniques
R. K. Surawase
Microencapsulation Processes and
their Applicability
2/3/2020
12
Approximate Particle Size
(µm)
Applicable Core
Material
Microencapsulation
Process
35-5000SolidsAir suspension
600-5000SolidsPan coating
1-5000Solids & liquidsMultiorifice centrifugal
2-5000Solids & liquidsCoacervation-phase
separation
5-5000Solids & liquidsSolvent evaporation
600Solids & liquidsSpray drying and congealing
R. K. Surawase
Fluidized Bed Processor
2/3/2020
13
Microencapsulation by air suspension techniques using Fluidized
Bed Processor:
 Control panel
 Coating chamber
 Particles being treated
 Process airflow
 Air distribution plate
 Nozzle for applying film coatings
R. K. Surawase
Fluidized Bed Processor
Reduced
time
Cost
Processing
steps
2/3/2020
14
R. K. Surawase
Applications of FBP
2/3/2020
15
R. K. Surawase
Fundamentals on the Processes
2/3/2020
16
Fluid Bed Drying
Fluid Bed Granulation
Fluid Bed Coating
R. K. Surawase
Fluid Bed Coating (Air Suspension)
2/3/2020
17
R. K. Surawase
Advantages
2/3/2020
18
Rapid mixing
Liquid like behavior, easy to control
Applicable for large or small scale operation
Continuous operation
Ease of process control due to stable condition
R. K. Surawase
Disadvantages
2/3/2020
19
Pipe and vessel walls erode due to collisions by
particles.
Particle breakup is common
Difficult to predict non- uniform flow pattern
R. K. Surawase
Processing Variables
2/3/2020
20
 Density, surface area, melting point, solubility, crystalline nature,
flowability of core material.
 Coating material concentration
 Coating material concentration rate
 Volume of air required
 Inlet and outlet temperature
 Viscosity of coating solution
 Atomization pressure / Droplet size
 Position of Nozzle
R. K. Surawase
Industrial Applications
2/3/2020
21
Fluidized
Bed
Coating
Snack
Detregent
Enteric
coated
Formulation
Batery
Fertilizer
R. K. Surawase
Spray Drying
2/3/2020R. K. Surawase
22
Critical elements of spray drying:
 Atomizers
 Air flow
Co-current flow
Counter-current flow
Mixed flow
 Spray drying chamber
Critical Parameters of Spray Drying
2/3/2020R. K. Surawase
23
 Inlet temperature of air
 Outlet temperature of air
 Viscosity
 Atomization pressure
 Feed temperature
 Nozzle material
Application of Spray Drying in
Pharmaceutical Field
2/3/2020R. K. Surawase
24
 Powder properties
 Granulation
 Bioavailability
 Encapsulation
 Inhalation
 Controlled release product
2/3/2020
25
Thank You
R. K. Surawase

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Technological advances in pharmaceutical dosage form designing

  • 1. P R E S E N T E D B Y M R . R A J E N D R A K . S U R A W A S E Technological Advances in Pharmaceutical Dosage form Designing Department of Pharmaceutics Loknete Dr. J. D. Pawar College of Pharmacy Manur, Kalwan, Nashik (M.S) 2/3/2020 1 R. K. Surawase
  • 2. Content  Concept of Preformulation  Recent trends in drug delivery Development  Types of tablet Formulations  Conventional Method of tablet Manufacturing  Recent advances in granulation process  Concept of Microencapsulation  Applications & Fundamentals of FBP  Processing Variables of FBP  Spray Drying  Critical elements of Spray drying 2/3/2020 2 R. K. Surawase
  • 4. Concept of Pre-formulation 2/3/2020 4 Preformulation testing is the first step in the rational development of dosage forms of a drug substance.  It can be defined as study of physico-chemical properties of a drug substance alone and combined with excipients.  The overall objective of Preformulation study is to generate information useful to the formulator in developing stable and efficient, qualitative dosage forms. R. K. Surawase
  • 5. Preformulation Process 2/3/2020 5  Physicochemical property:  Organoleptic Property  Particle characteristics  Crystallinity  Polymorphism  Hygroscopicity  Solubility analysis  Thermal analysis  Physicomechanical property:  Flow property  Angle of repose  Percent compressibility  Bulk density  Spectroscopic method:  Assay development:  Stability testing: R. K. Surawase
  • 6. Recent Trends in Drug Delivery Development Recent Trends 3 D Printing Technology Co- processing of Excipients Quality by Design & DoE Fluidized Bed Processing Nanotechn- ology 2/3/2020 6 R. K. Surawase
  • 7. Types of Tablet Formulation  Compressed tablet  Sugar coated tablet  Film coated  Effervescent tablet  Chewable tablet  Mouth dissolving tablet  Dispersible tablet  Multilayer tablet  Sublingual tablet  Buccal tablet  Micro tablet / Mini Tablet  Osmoticaly active tablet (osmotic Pump)  3 D tablet  SR/ CR tablet  Fast disintegrating SR tablet  Colon targeted Tablet  Floating tablet 2/3/2020 7 R. K. Surawase
  • 8. Conventional methods of tablet Manufacturing 2/3/2020 8 WetGranulation • Raw material • Weigh • Screen • Mix • Wet mass • Mill • Dry • Mill • Mix • Compress DirectCompression • Raw material • Weigh • Screen • Compress DryGranulation • Raw material • Weigh • Screen • Mix • Slug • Mill • Mix • Compress R. K. Surawase
  • 9. Recent advancement in granulation process  Pneumatic Dry Granulation  Steam granulation  Melt granulation  Moisture activated dry granulation  Thermal adhesion granulation process  Foam granulation 2/3/2020 9 R. K. Surawase
  • 10. Microencapsulation 2/3/2020 10 Microencapsulation is a means of applying thin uniform coatings to microparticles of core material in solid or liquid droplets. Fundamental of Microencapsulation: Core Material Coating Material Manufacturing Vehicle Phase R. K. Surawase
  • 11. Microencapsulation methods 2/3/2020 11 1. Air suspension 2. Coacervation-phase separation 3. Spray drying 4. Congealing 5. Pan coating 6. Solvent evaporation techniques R. K. Surawase
  • 12. Microencapsulation Processes and their Applicability 2/3/2020 12 Approximate Particle Size (µm) Applicable Core Material Microencapsulation Process 35-5000SolidsAir suspension 600-5000SolidsPan coating 1-5000Solids & liquidsMultiorifice centrifugal 2-5000Solids & liquidsCoacervation-phase separation 5-5000Solids & liquidsSolvent evaporation 600Solids & liquidsSpray drying and congealing R. K. Surawase
  • 13. Fluidized Bed Processor 2/3/2020 13 Microencapsulation by air suspension techniques using Fluidized Bed Processor:  Control panel  Coating chamber  Particles being treated  Process airflow  Air distribution plate  Nozzle for applying film coatings R. K. Surawase
  • 16. Fundamentals on the Processes 2/3/2020 16 Fluid Bed Drying Fluid Bed Granulation Fluid Bed Coating R. K. Surawase
  • 17. Fluid Bed Coating (Air Suspension) 2/3/2020 17 R. K. Surawase
  • 18. Advantages 2/3/2020 18 Rapid mixing Liquid like behavior, easy to control Applicable for large or small scale operation Continuous operation Ease of process control due to stable condition R. K. Surawase
  • 19. Disadvantages 2/3/2020 19 Pipe and vessel walls erode due to collisions by particles. Particle breakup is common Difficult to predict non- uniform flow pattern R. K. Surawase
  • 20. Processing Variables 2/3/2020 20  Density, surface area, melting point, solubility, crystalline nature, flowability of core material.  Coating material concentration  Coating material concentration rate  Volume of air required  Inlet and outlet temperature  Viscosity of coating solution  Atomization pressure / Droplet size  Position of Nozzle R. K. Surawase
  • 22. Spray Drying 2/3/2020R. K. Surawase 22 Critical elements of spray drying:  Atomizers  Air flow Co-current flow Counter-current flow Mixed flow  Spray drying chamber
  • 23. Critical Parameters of Spray Drying 2/3/2020R. K. Surawase 23  Inlet temperature of air  Outlet temperature of air  Viscosity  Atomization pressure  Feed temperature  Nozzle material
  • 24. Application of Spray Drying in Pharmaceutical Field 2/3/2020R. K. Surawase 24  Powder properties  Granulation  Bioavailability  Encapsulation  Inhalation  Controlled release product