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GRANULATION. DR. MOHAMMAD KHALID ANWER Assistant Professor. CONTENTS. INTRODUCTION METHODS OF GRANULATION ADVANCED GRANULATION TECHNIQUES CONCLUSION. Introduction. Granules Granulation Granulation Technology. Why we prepare granules when we have powders….?.
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GRANULATION DR. MOHAMMAD KHALID ANWER Assistant Professor COLLEGE OF PHARMACY, PRINCE SATTAM BIN ABDULAZIZ UNIVERSITY
CONTENTS • INTRODUCTION • METHODS OF GRANULATION • ADVANCED GRANULATION TECHNIQUES • CONCLUSION
Introduction • Granules • Granulation • Granulation Technology
To avoid powder segregation. • To enhance the flow of powder. • To produce uniform mixtures. • To produce dust free formulations. • To eliminate poor content uniformity. • To improve compaction characteristics of mix.
Contd... • To avoid powder segregation. -Segregation may result in weight variation. SATARA COLLEGE OF PHARMACY, SATARA.
Contd... • To enhance the flow of powders. • (Higher flowability gives better filling of the dies or containers) • To produce uniform mixtures. • (Mixtures of various particles tend to segregate in transport or handling because of differences in particle size, shape and density)
Dust free formulations. • (Decrease dust generation and reduce employee exposure to drug product) • To eliminate poor content uniformity.
Methods of granulation • DIRECT COMPRESSION • COMPRESSION GRANULATION • WET GRANULATION
When To Choose DRY method? • Drug dose is too high. • Do not compress well after wet granulation. • Heat sensitive drugs. • Moisture sensitive drugs. • e.g. Aspirin , Vitamins
Contd… How can we do it………?
Contd… By two ways SLUGGING ROLLER COMPACTION Powder is squeezed between two rollers to produce sheet of material e.g. Chilsonator Large tablet produced in heavy duty tablet press.
Contd… Equipments Has two parts, • Machine for compressing dry powder to form compacts. • Mill for breaking these intermediates to granule. • e.g. CHILSONATER • HAMMER MILL
COMPRESSION granulation • It mainly involves three steps - • Milling of drug and excipients • Mixing of drug and excipients • Tablet compression
wet granulation In this, powdered medicament and other excipients are moistened with granulating agent.
Steps in wet granulation Contd…
Methods Contd… • Single pot granulation • High shear mixture granulation • Fluid bed granulation • Extrusion- Spheronization
Single pot granulation • The granulation is done in a normal high shear processor and dried in same equipment. • e.g. Single Pot Processor / One-Pot Processor
ADVANTAGES Contd.. DISADVANTAGES • Short processing time. • Lesser amount of liquid binders required compared with FBG. • Highly cohesive material can be granulated. • Increase in temperature may cause chemical degradation of thermolabile material. • Over wetting of granules can lead to large size lumps formation.
Fluid bed granulation • Fluidization is the operation by which fine solids are transformed into a fluid like state through contact with a air/gas. • Granulating and drying can be completed in one step inside the machine.
Contd… -Homogeneous granules.---Gentle product handling.--Uniform spraying of all particles in the fluid bed.
Contd… • Advantages • 1.It reduces dust formation during processing • 2. It reduces product loss • 3. It improves worker safety. • Disadvantages • The Fluid Bed cleaning is labor-intensive and time consuming. • 2. Difficulty of assuring reproducibility.
Extrusion-Spheronization 1.Dry mixing of materials to achieve homogeneous dispersion. 2. Wet granulation of the resulted mixture to form wet mass. 3. Extrusion of wet mass to form rod shaped particles. 4. Rounding off (in spheronizer) 5. Drying
Extrusion-Spheronization Different steps involved in the Extrusion- Spheronization process
Advanced Granulation Techniques • Steam Granulation • Melt Granulation • Moisture Activated Dry Granulation (MADG) • Moist Granulation Technique (MGT) • Thermal Adhesion Granulation Process (TAGP) • Foam Granulation • Pneumatic Dry Granulation (PDG)
Contd… • Freeze granulation Technology • Steam Granulation • Melt Extrusion Technology • Liquisolid Technique • TOPOTechnology • Continuous Flow Technology