INTRODUCTIONHigh shear wet granulation process is extensively used in pharmaceutical industry to transform fine heterogeneus powders into homegeneus blend of granules with bigger size and density to improve flow and compactability for tableting operation.
The MIC Pharma, high shear granulator has the ability to control the four critical parameters of nucleation
A wide range of impeller and chopper speeds, sensitive liquid flow rate control and droplet size along with impeller torque help to keep the control over the granulation process.
The proper combination of these distinctive particular variables values and the quality of the raw materials shall determine the Nucleation and Coalescence, and hence, the final granule quality.
The tulip shape design of the bowl produces a roping action from the impeller into the high speed radically mounted chopper. The high shear forces result in intensive mixing of the components in a very short time period.
Liquid aspersion over the powder bed causes solid-liquid interaction producing densification. (End Point)
In simple way, granulation proceeds initially by a Nucleation mechanism, the solid particles agglomeration induced by liquid to produce the granule. With additional liquid to produce the granule. With additional liquid and time process individual granules, stick to each other by Coalescence yielding larger and dense granules.
Coalescence is a complete random process but Nucleation can be accurately controlled by adjusting the four critical parameters of the granulation process:
Liquid flow rate
Liquid drop size
DESIGN AND ENGINEERING
The MIC Pharma High Shear Granulator Line, meet the necessary requirements of geometric, kinematic and dynamic similarity for the Quantitive Scaling Up (QSU) feasibility. The Geometry in each scale (either Development or Production processes) obey the proportions of the critical linear dimensions.
The kinematic similarity in each scale is reproducible as it ensures the Tip Speed equality by means of a wide range of impeller speed. The dynamic of the granulation in each scale is reproducible as it ensures the Froude Number equality.
Characteristics of MIC Granulators
A. Densification curve: an Experimental Method
Powders are mixed at high impeller speed to uniform the components, then the speed is reduced and liquid is added; the granulation proceeds at high impeller speed
to reach the endpoint.
Too much time in this condition causes over-agglutination, dropping the torque and applying a negative effect on the granules properties.
The powders are moistened by liquid aspersion.
The impeller produces granulation while the chopper reduces the lumps. Motor shaft device measures torque to endpoint process.
MIC Pharma MACHINES USED AS MIXERS FOR COHESIVE POWDER MATERIALS
Besides Wet Granulation Process, High Shear Mixer Granulators MIC are suitable to carry out other important operation within manufacturing of Solid Pharmaceutical components: the Dry Mixing of cohesive powder materials.
Sometimes, the pharmaceutical powders mixtures have some cohesive features and it is difficult to make them uniform by means of the traditional tumbling blenders. However, the MIC mixers due to the high shear energy produced by the impeller and their bowl design, allow an homogeneous distribution of the formulation components in a very short time.
Graphic 1 shows the experimental results got in a powder formulation with cohesive features by means of a MIC Pharma, making a comparison with a Tumbling Blender. Active content uniformity in the blending at different times, was estimated by means of the Relative Standard Desviation %, for 10 samples at each mixing time, RSD %: less RSD % means better uniformity of active.
In 3 minutes of mixing, at 100 RPM, in a MIC P-100 model machine, the RSD % decreased below 2 %; while in 30 minutes of mixing, at 14 RPM, in a tumbling blender, the RSD % remains above 6 and it was impossible to fullfil the pharmacopoeia specification.
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