ppt for granulation technology

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In this power point of granulation technology, advanced techniques of granulation types and their description .

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GRANULATION TECHNIQUES:

GRANULATION TECHNIQUES M.Jyostna Assistant Professor Sri venkateswara College Of Pharmacy

INTRODUCTION:

INTRODUCTION Granulation process has been widely used in the pharmaceutical industry for the preparation of material for tabletting. Other Granulation process involves the granule formation includes microencapsulation, multi particulate system for modified release mechanism and to prepare granules to improve flow and compression characteristics of the blend.

NEED OF GRANULATION:

Increasing the bulk density of a product. Facilitating metering or volumetric dispensing. Controlling the rate of drug release. Improving product appearance. NEED OF GRANULATION

What is Granulation?:

Granulation may be defined as a size enlargement process which converts fine or coarse particles into physically stronger and larger agglomerates having good flow property, better compression characteristics and uniformity. The art and science for process and production of granules is known as Granulation Technology . What is Granulation?

ADVANTAGES:

It improves flow property and compression characteristics and increases density of granules. Better distribution of color and soluble drug if added in the binding solution. It reduces dust hazards. Prevents segregation of powders. Makes hydrophobic surfaces more hydrophilic. ADVANTAGES

DISADVANTAGES:

Process is expensive because of labor, space, time special equipment and energy requirement. Loss of material during various stages of processing. Moisture sensitive and thermo labile drugs are poor candidates. Any incompatibility between the formulation components is aggravated during the processing. DISADVANTAGES

PowerPoint Presentation:

Types of Granulation Granulation Technology can be broadly classified into 2 types based upon the type of processing involved: Dry granulation wet granulation Dry Granulation Dry granulation involves granule formation without using liquid solution as the product may be sensitive to moisture and heat. In this process dry powder particles may be brought together mechanically by compression into slugs or by roller compression to obtained flakes.

PowerPoint Presentation:

Dry Granulation API/Excipients Weighing Sieving Mixing Slugging Dry Screening Lubrication & Blending Compression Dry Granulation Equipment

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Wet Granulation Wet granulation is the most widely used process of granulation in the pharmaceutical industry. It involves addition of a liquid solution (with or without binder) to powders, to form a wet mass or it forms granules by adding the powder together with an adhesive, instead of by compaction . The wet mass is dried and then sized to obtained granules.

PowerPoint Presentation:

Types of wet granulation High shear mixture granulation Fluid bed granulation Extrusion-Spheronization Spray drying Advanced Granulation Techniques Steam Granulation Melt/Thermoplastic Granulation Moisture Activated Dry Granulation (MADG) Moist Granulation Technique (MGT) Thermal Adhesion Granulation Process (TAGP) Foam Granulation

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High shear mixture granulation High shear mixture has been widely used in Pharmaceutical industries for blending and granulation. Wet agglomeration in a high- shear mixer involves typically 3 phases: Dry Powder mixing ( 2-5 mins) Liquid binder addition (1-2 mins) Wet massing Advantages: Highly cohesive material can be granulated. Disadvantages: Mechanical degradation. Rapid Mixer Granulator (RMG)

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Fluid bed granulation Fluid bed granulation is a process by which granules are produced in single equipment by spraying a binder solution onto a fluidized powder bed. The material processed by fluid bed granulation are finer free flowing and homogeneous. Fludised Bed Granulator Advantages It reduces product loss. It improves worker safety . Disadvantages The Fluid Bed cleaning is labor-intensive and time consuming. Difficulty of assuring reproducibility .

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Extrusion-Spheronization This process is primarily used as a method to produce multi-particulates for controlled release application. It is a multiple step process involving at least 5 steps capable of making uniform sized spherical particles. 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 These dried rounded particles can be optionally screened to achieve a targeted mean size distribution.

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Extrusion Spheronizer Advantages 1. Two or more active agents can be easily combined in any ratio in the same unit. 2. Physical characteristics of the active ingredients and excipients can be modified. 3. Particles having high bulk density, low hygroscopicity, high spherocity, dust free, narrow particle size distribution and smoother surface can be produced. Disadvantages This process is more labor and time intensive than other commonly used granulation techniques.

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Spray drying The spray drying process involves three fundamental steps- Atomization of a liquid feed into fine droplets. 2. Mixing of these sprays droplets with a heated gas stream, allowing the liquid to evaporate and leave dried solids. 3. Separation of the dried powder from the gas stream. Advantages 1. Rapid and continuous process. 2. Reduces overall cost by avoiding labor intensive drying and granulation steps. 3. Offers minimal product handling and operator exposure to dust. 4. Suitable for heat sensitive product.

Advanced Granulation Techniques:

Steam Granulation Advanced Granulation Techniques Pure steam is a transparent gas. At standard temperature and pressure, pure steam occupies about 1,600 times the volume of an equal mass of liquid water. This process is simply a modification of conventional wet granulation method. Here steam is used as a binder instead of water. Advantages 1. Uniformly distributed in the powder particles. 2. Higher diffusion rate. Disadvantages Requires special equipment for steam generation and transportation. 2. Requires high energy inputs. 3. Thermo labile materials are poor candidates.

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Melt Granulation Melt Granulation is also known as “Thermoplastic Granulation” as the granulation is achieved by adding a meltable binder which is in solid state at room temperature but preferably melts in the temperature range of 50 o C – 80 o C. Melt Granulation process has been widely used in the pharmaceutical industry for the preparation of both immediate and controlled release formulations such as pellets, granules, and tablets. This process has also been widely accepted for the enhancement of dissolution profile and bioavailability of poorly water soluble drugs by forming solid dispersion. Advantages Controlling and modifying the release of drugs. Disadvantages Heat sensitive materials are poor candidates.

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Moisture Activated Dry Granulation (MADG) MADG is a process in which moisture is used to activate granule formation, without the need to apply heat to dry the granules. There are two main stages in MADG: · Agglomeration · Moisture distribution/ Absorption Agglomeration In agglomeration, drug is blended with diluent's and binder in the powder form, to obtain a uniform mixture. The amount of water used in process is very small as compared to the other conventional wet granulation techniques. The particle size of the agglomerates generally falls in the range of 150–500 μm.

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Moisture distribution/ Absorption Moisture absorbents, such as microcrystalline cellulose or silicon dioxide, are added while mixing continues. When they come into contact, the moisture absorbents pick up moisture from the moist agglomerates, resulting in moisture redistribution within the mixture. When this happens, the entire mixture becomes relatively dry. While some of the moisture is removed from the wet agglomerates, some of these agglomerates remain almost intact and some usually the larger particles may break up. This process results in granulation with more uniform particle size distribution. Advantages Suitable for continuous processing Less energy involved during processing. Disadvantages Formulations with high drug loading are difficult to develop.

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Moist Granulation Technique (MGT) MGT works on the same principle as Moisture Activated Dry Granulation (MADG) described earlier. It involves binder activation by adding a minimum amount of liquid. Then, excess of moisture present in the blend is removed by adding moisture absorbing material like Microcrystalline Cellulose (MCC) which eliminates the drying step. It is applicable for developing a controlled release formulation.

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Thermal Adhesion Granulation Process (TAGP ) TGAP involves granulation by adding very less amount of water or solvent as compared to the traditional wet granulation methods. In this process drug and excipient mixture heated at a temperature range from 30 o C to about 130 o C in a closed system under mixing by tumble rotation until the formation of granules take place. Drying step is not required in most instances due to low amount of moisture added in the process. Granules of required particles size can be obtained after cooling and screening. It provides granules with good flow properties and binding capacity to form tablets of low friability, adequate hardness and have a high uptake capacity for active substances whose tableting is poor.

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Foam granulation Foam granulation technique involves addition of liquid binders as aqueous foam. The advantages of foamed binder and conventional binder addition method includes- 1. No spray nozzle is used. 2. Improve process robustness. 3. Less water required for granulation. 4. Time efficient drying. 5. Cost effective. 6. Uniform distribution of binder. 7. No over wetting. 8. Applicable for water sensitive formulation.

PowerPoint Presentation:

CONCLUSION Selection of appropriate technology for carrying out the granulation process is the key to achieve a targeted granulation and final product parameters. A systematic approach should be followed for selecting the suitable granulation process and to provide comprehensive information in this regard, which will be useful for the researchers and scientists involved at the product development stage.

PowerPoint Presentation:

Dilip M. Parikh, “Extrusion Spheronization as a Granulation Technique”, Handbook of Pharmaceutical Granulation Technology, Marcel Dekker INC, New York, 1997:334- 337. http://www.pharmaprdia.com/Tablet:manufacturing method/Granulation. www.wikipedia.com. REFERENCES

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