Difference Between the Wet Granulation and the Dry Granulation

Granulation is a critical process in the pharmaceutical industry, ensuring powders are transformed into granules to improve flowability and compressibility and ensure uniform dosage forms. 

The two main methods for granulation are wet granulation and dry granulation. Understanding the differences between these two methods is key to selecting the most suitable one for manufacturing.

What is Wet Granulation?

What is wet granulation? Wet granulation is the most commonly used method for producing granules, especially in the pharmaceutical industry. It involves adding a liquid binder to powder particles to promote adhesion, allowing them to form more uniform granules. The binder solution can be water or a solvent such as ethanol or isopropanol, depending on the material’s sensitivity to moisture.

• Process Overview: During wet granulation, the liquid binder is added to the powder while mechanical agitation is applied to mix and compact the particles. This process helps to bind the particles together, creating a more cohesive material. Once the desired granule size is reached, the wet mass is dried to remove the solvent, leaving behind solid, dry granules.
• Product Integration: Wet granulation is typically integrated into production processes that involve low-dose active ingredients or materials with poor compressibility. By improving particle adhesion, wet granulation produces granules better suited for high-speed tablet production, ensuring uniform weight and dosage.
  • Akışkan Yatak Granülasyonu: One of the most efficient wet granulation methods is fluid bed granulation. 

In this process, a stream of air fluidizes the powder particles while a liquid binder is sprayed into the fluidized bed. The particles bond as they are agitated in the air stream, and drying occurs within the same system, making it highly efficient for large-scale production.

• High Shear Granulation: Another commonly used method is high shear granulation. In this process, powders are rapidly mixed with a binding solution using a high-speed mixer. 

The intense agitation from the mixer blades forms granules quickly, which are then dried and milled to the required size. This method is ideal for producing dense granules and is commonly used when the product requires a more robust formulation.

What is Dry Granulation?

What is dry granulation? Dry granulation is a moisture-free granulation process, making it ideal for moisture-sensitive or heat-sensitive materials. This method uses mechanical forces to compress the powder into large, solid pieces called slugs or sheets, which are then milled into smaller granules. 

Dry granulation is often favored in situations where the formulation’s active ingredients cannot withstand moisture or heat exposure, and it offers a simpler, more energy-efficient alternative to wet granulation.

• Process Overview: Unlike wet granulation, no liquid is added in dry granulation. Instead, powders are compacted under high pressure to form solid aggregates. This compaction can be achieved through slugging (using a tablet press) or roller compaction, where the powder is compressed between two rotating rollers. The resulting compacted material is then broken down into granules using milling equipment.
• Product Integration: Dry granulation is typically integrated into manufacturing processes that involve high-dose APIs or formulations that are sensitive to heat or moisture. The simplicity of this method makes it ideal for smaller production scales or formulations where maintaining the material’s chemical stability is crucial.
  • Roller Compactor Granulation: One of the most common methods of dry granulation is roller compaction. In this process, a roller compactor applies high pressure to the powder mixture, forming a dense sheet or ribbon of material. These ribbons are then milled to produce granules of the desired size. 

Roller compaction is ideal for materials that do not need moisture for binding, providing a uniform and consistent particle size distribution.

Key Differences Between Wet and Dry Granulation

Use of Liquids

The most significant difference between wet and dry granulation is the use of liquid binders. Wet granulation requires the addition of a liquid solution to promote particle adhesion, while dry granulation uses mechanical forces like compression to achieve the same effect without the need for any liquid.

Application

Wet granulation is typically used for materials that benefit from enhanced compressibility, especially those that are difficult to bind or have poor flow characteristics. It is also more effective for formulations with low-dose APIs that require precise distribution within the granules. On the other hand, dry granulation is ideal for materials that are sensitive to moisture or heat, where the addition of liquids could compromise the stability of the product.

Process Complexity

Wet granulation involves additional steps such as mixing, drying, and milling, which can make it more labor-intensive and time-consuming compared to dry granulation. Dry granulation, in contrast, skips the drying phase, simplifying the process and making it faster and more efficient, especially in smaller production runs. However, roller compactors used in dry granulation require specialized equipment to apply the necessary pressure for compaction.

Equipment

Wet granulation typically requires fluid bed granulators, high-shear mixers, or other equipment capable of both granulating and drying. Dry granulation, particularly when using roller compactors, involves fewer pieces of equipment but requires precise control of pressure and feed rates to ensure proper granule formation.

Choosing the Right Granulation Method

Choosing between wet and dry granulation depends on several factors, including the characteristics of the material being processed, the desired properties of the final product, and the available manufacturing resources. Each method offers distinct advantages that make it suitable for specific types of formulations:

• Material Sensitivity: If the material is sensitive to heat or moisture, dry granulation is the preferred method. Roller compactors, for example, provide an effective way to produce granules without compromising the integrity of sensitive APIs.
• Compressibility and Uniformity: For formulations that require enhanced compressibility or those that need better content uniformity, wet granulation is generally more effective. The addition of a binder ensures that particles adhere more uniformly, resulting in more consistent granules and better tablet production outcomes.
• Scale of Production: Wet granulation is typically favored for large-scale production where high-speed tablet presses are used, as it provides a more uniform granule size and reduces the risk of product defects. Dry granulation, on the other hand, is more cost-effective for smaller batches and for materials that can be easily compacted.

World-Class Equipment for Your Granulation Needs

Whether using a roller compactor for dry granulation or a fluid bed granulator for wet granulation, both methods play a crucial role in the production of high-quality pharmaceutical products.

Bize Ulaşın today to learn more about how our roller compactor solutions and granulation expertise can enhance your manufacturing process.

Resources

• Wet Granulation in the Pharmaceutical Industry: Purpose, Advantages, and Manufacturers
• What Is Dry Granulation?
• Wet Granulation VS Dry Granulation