High shear mixer granulatorhigh speed mixer granulator. Scaleup of high shear wet granulation process has been studied extensively in the past with various. Granules prepared by the high shear wet granulation hswg process commonly exhibit the problem of overgranulation, a phenomenon characterized by a severe loss of the ability to form adequately strong tablet. High shear mixer granulator tapasyas high shear mixer granulator is designed to meet special needs of tablet formulation technology. The tip velocity, or speed of the fluid at the outside edge of the rotor, will be higher than the velocity at the center of the rotor, and it is this difference in velocity that creates shear. Difference between dry and wet granulation definition. Ten different formulations would probably require that the powders for each.
A mixer torque rheometer mtr was employed to evaluate the granulating solvents used water, isopropanol, and 1. It is another example of a wet granulation process. The present research mainly focuses on the high shear wet granulation of pharmaceutical powders. At 6% binder level in solution, fluidbed granulations from all products demonstrated excellent tablet hardness, in all cases better than low shear or high shear granulations. A discrete element method dem is a promising tool for the rational design and scaleup of high shear granulation, because the internal properties such as particle flow and stress field, which are hard to measure experimentally, can. A high shear mixer granulator was used to produce granola in a wet granulation process followed by. Defining scaling criteria in high shear granulation junfu huang, aijie yan, susan lum and kwok chow, pharmaceutical development services, patheon, inc. Chopper presence and then chopper speed was varied during wet high shear granulation of a placebo formulation using a pma1 granulator while also varying the impeller speed. It also shows the setup of a professional high shear granulator, aka high shear mixer and its key components. Wet granulation in laboratoryscale high shear mixers. The granules were extensively analyzed for differences due to the chopper. The main difference between dry and wet granulation is that dry granulation is the formation of granules without using any liquid solution whereas wet granulation is the formation of granules by.
Defining scaling criteria in high shear granulation. A formulation strategy for solving the overgranulation. High shear granulators gea engineering for a better world. High shear granulation is an effective way to turn powders into tiny, dense particles for tableting or coating. Above all, they are the first choice when the process needs high granulate density and rapid granulation. Granulation endpoint is predictable while using highshear granulator. However, some aluminosilicate wastes have low reactivity, which inhibits their usage as a strong geopolymer concrete precursor. The flexible concept behind the p 100 and p 150 are especially suited for pilot plants and small production batches.
A new approach to scaleup of a highshear granulation process. Handbook of pharmaceutical wet granulation sciencedirect. High shear mixer granulator r2t was introduced with the feature of direct drive technology. Methods contd single pot granulation high shear mixture granulation fluid bed granulation extrusion spheronization12720 satara college of pharmacy, satara. Pharmaceutical granulation processes, mechanism, and the use of binders 275 nozzle distan ce and posit ion, main impe ller speed, chopper speed an d time on, etc. Moreover, scaleup of high shear granulators is still difficult to perform. Single pot granulation the granulation is done in a normalhigh shear. Pharmaceutical granulation processes, mechanism, and the use of binders 271 where g is the surface tension of the liquid, q the contact angle, and r is the radius of the capillary.
The number of parts and design may vary depending on the type of machine. The scale itself had larger effects on the granule properties than the cpps, which demonstrated high robustness of formulation on the individual scale level. The spg2 is designed for accurate mixing and fine granulation. The effect of the chopper on granules from wet highshear.
High shear granulation high shear wet granulation process. A formulation strategy for solving the overgranulation problem in high shear wet granulation. This is achieved by reducing processing time, homogeneous mixing, even distribution of binder, wetting, nucleation and granule size growth with sampling provision for in process analysis and. Granulation is the process employed in the pharmaceutical industry whereby powder forms are made to bind together to form larger multiparticle entities or granules. Remember, this is the main subject of this article. The high shear granulation process combines the active powder with a binder solution using a high speed mixing blade and chopper. It consists of the agglomeration of different powders through the addition of a granulating fluid and a vigorous mixing.
However, as discussed in some detail in chapter 3, the two most common options associated with granulation are dry granulation roller compaction, and wet granulation fluidbed granulation or high shear granulation table 4. Three basic techniques are used to prepare powders for compression into a tablet. High shear mixer granulator r2t 11 high shear mixer granulator r2t tapasyas hsmg enjoys the trust and confidence of customers, the world over, for its unparalleled quality, unique features and reliable performance. Fundamentals of granule growth, granulation methods and equipments, granulation variables, scalingup and endpoint control. High shear wet granulation hswg is a shaping process for granulation that has been enhanced for application in the pharmaceutical industry. Granulation refers to the process in which primary dust particles are made to adhere to form larger entities of multiple particles called granules. It is the only granulator that not only meets all the stringent quality requirements of the fda cgmp, but also meets the specific needs of customers, with its, distinct torquebased granulation. High shear mixers for wet granulation from glatt have a history stretching back over decades in the pharmaceutical industry.
A high shear granulator is a process array consisting of an inline or batch highshear mixer and a fluidbed dryer. Measurement control corporation east hanover, new jersey, usa what is an endpoint. A high shear mixer received 19 may 2011 granulator was used to produce granola in a wet granulation process followed by oven received in revised form. Powder can be also kept in movement by the rotation of the container pan, disk or drum granulation. Now, let me go straight to the main differences of wet granulation vs.
Particularly, this research aims at closing the gap in understanding the role of. This is achieved by reduced processing time, more homogeneous mixing, uniformity of granule size and above all maintaining improved hygiene compliant to cgmp norms. Glatt high shear granulation by high shear granulator. Saizoner mixer granulator is designed to meet special needs of tablet manufacturing technology. High shear granulation is an effective way to turn. High shear granulation is an effective way to turn powders into dense granules for tableting or coating. Pdf effect of high shear granulation process parameters on the. Bonds between the primary particles are formed by compression, or by using a binding agent. The aims of the study were to evaluate the effect of high shear mixer hsm granulation process parameters and scaleup on wet mass consistency and granulation characteristics. Diosna pharma mixers p 100 and p 150 are tailored down to the very last detail to fulfill every practical requirement.
Again, this system allows full integration with upstream and downstream equipment, and even includes a wet. Pdf effect of high shear granulation process parameters. High shear granulators use an impeller to vigorously agitate the powder and produce highdensity granules. The lci high shear granulator model spg2 is a benchtop device that allows researchers and new product developers to intimately and efficiently mix small batches of powders and liquids to produce homogeneous mixtures. High shear granulator p 100 and 150 diosna pharmacuetical mixers p 100 and p 150 are designed for efficient mixing and wet granulation of tablet masses. High shear granulation was performed at different scales. The low shear granulation is performed using low shear mixers and was a popular method for wet granulation before high shear mixers became available for the pharmaceutical industry. Dry granulation is done with a tablet press swaying high shear mixergranulators. Scaleup of high shear granulation has been an important yet challenging issue in the pharmaceutical industries. Improved understanding of the high shear wet granulation. Highshear granulator produces less compressible granules when compared to low shear granulator. Endpoint can be defined by the formulator as a target particle size mean or distribution. Alternatively, the endpoint can be defined in rheological terms. High shear granulators glatt integrated process solutions.
Scaleup of high shear wet granulation process has been studied extensively in the past with various different methodologies being proposed in the literature. However, study of hswg is complex and challenging due to the relatively poor understanding of hswg, especially for sticky powderlike herbal extracts. Extremely high shear forces compared with other granulators. Granulation technologies like roller compaction, spray drying, supercritical fluid, low high shear mixing, fluid bed granulation, extrusionspheronization, etc. In some cases, increasing impeller speed will lead to higher granule growth. It may be applicable to powders which can not be processed in low shear.
So far, the main application of alkaliactivated materials has been concreteor bricktype monolithic products. A high shear granulation is a perfect choice for highly cohesive material. To create the particles, powders are added and sealed inside of a mixing bowl, and a large rotating device spins the powder into a lowspeed vortex. Both high and low shear wet granulation utilize mixer with a bowl and an impeller that agitates the powder while adding the granulating liquid. A high shear mixer uses a rotating impeller or high speed rotor or both to create flow and shear. High shear wet granulation is a complex process that in turn makes scaleup a challenging task. This design of granulation is for high shear wet granulation, pelletization, etc.
The type of process selection requires thorough knowledge of physicochemical properties of the drug, excipients, required flow and release properties, etc. The powder of the compound is aggregated using a high pressure. Today, robust and reliable glatt vertical granulators are setting a new standard in the pharmaceutical industry. The mechanism of granulation formation and methods. The mipro high shear granulator allows working at different scales, keeping similar ratios between bowl, impeller and chopper and can be seen as a scaled down. Realtime assessment of granule densification in high shear wet granulation and application to. The choice of granulation process typically depends on the ease of blending, powder flowability, and blend uniformity. Chapter 1 high shear granulation request pdf researchgate. Nevertheless, to achieve the desired flow and compaction, the values of the cpps. High shear wet granulation is a complex process that, in turn, makes scaleup a challenging task. In a granulation process, only the solid component of the mixture is required. Pdf pharmaceutical granulation processes, mechanism and. This article explains in simple terms the fundamentals of the granulation process.
Normally, a low shear mixer granulator machine cannot process such materials because they have a high amount of hydrophilic polymer. Extended release guaifenesin tablets containing mid and high levels of carbopol 971p nf polymer 10% or 20% as a matrix forming excipient could be produced by high shear aqueous granulation in two bottomdrive granulators with different capacities 4l vs. With plants installed around the world and literally thousands of tests performed, we have established a solid base of expertise related to the needs of the pharmaceutical manufacturing industry. Pdf on jan 1, 2017, ramadan alshdefat and others published highshear granulation process. Highshear granulator minimizes the exposure of drug dust to workers due to reduced process dust generation.
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