The Role of High Shear Mixer Granulation in Tablet Formulation

Tablet formulation is a multi-step, intricate procedure, with each stage considerably influencing the end result of the finished product. Granulation, which turns tiny powders into granules to enhance flow characteristics, content consistency, and compressibility, is a crucial step in the production of tablets. In the pharmaceutical business, high shear mixer granulation is a widely used method for this. The crucial function of high shear mixer granulation in tablet formulation will be examined in this blog post, with an emphasis on elements including binder choice, particle size distribution, and granule properties.

High Shear Mixer Granulation:

An Overview

High-speed mixing of powders and a liquid binder results in cohesive granules during the wet granulation process known as high shear mixer granulation. This process is preferred because it makes granules that are great in flowability and compressibility, making them perfect for making tablets. Let's explore the reasons why this method is so crucial for tablet formulation.

Binder Selection

The choice of binder is an important factor in high shear mixer granulation. The final qualities of the tablet and the production of granules are substantially influenced by the binder used. Water, alcohol, and solutions of polymers like hydroxypropyl cellulose (HPC), polyvinylpyrrolidone (PVP), and hydroxypropyl methylcellulose (HPMC) are examples of common binders. The decision is made in light of various elements, including production limitations, desired release profile, and pharmacological properties.

Application of water as a binder

As water is affordable and readily available, it is a flexible binder that is frequently utilised. It functions well with a variety of excipients and can be used with other binders to produce the best results. Drugs that are sensitive to water, however, could need different binders.

Polymer Binders

PVP, HPC, and HPMC polymers provide improved control over granule characteristics. They can improve tablet stability and change release profiles. However, they should take processing needs and drug-polymer compatibility into account while making their decision.

Organic Solvents

Organic solvents like ethanol or isopropanol can be utilised when water is unsuitable due to medication instability. These solvents can need special handling techniques and precautions.

Dispersion of Particle Size

For tablet formulation, achieving the proper particle size distribution in granules is essential. This parameter can be controlled precisely with high shear mixer granulation.

Homogeneity 

Granules of constant size and content are produced as a result of the high shear mixing process, which ensures uniform distribution of the binder. This improves the finished tablet's consistency of content.

Target Granule Size

To obtain the appropriate granule size, the mixer speed and processing time can be changed. This affects the rate of tablet dissolving and disintegration.

Particle Size Distribution Analysis

During the granulation process, particle size distribution is frequently monitored and controlled using laser diffraction or sieve analysis.

Characteristics of Granules

Several granule qualities that are essential for tablet formation are influenced by high shear mixer granulation:

Flowability: High-shear mixer granulation results in granules with outstanding flowability, ensuring consistent tablet filling and rapid tablet filling.

Compressibility: Because the granules created in this technique are cohesive, they have good compressibility, allowing for the creation of sturdy tablets with low friability.

Densification: Granule density can be increased through high-shear granulation, producing tablets with favourable hardness and disintegration profiles.

Granule porosity: By modifying the process variables, tablet dissolution and drug release kinetics can be affected.

Conclusion

By offering precise control over the choice of binder, particle size distribution, and granule properties, high shear mixer granulation plays a crucial role in tablet formulation. This procedure guarantees the creation of tablets with a consistent level of quality, homogeneity of content, and desirable performance traits. Because of its adaptability and efficiency in enhancing tablet formulations, pharmaceutical producers continue to rely on high shear mixer granulation. The quality of tablets and the effectiveness of drug administration will probably continue to improve as the business develops thanks to developments in granulation technology.