Granulations (Dry and Wet)
We specialize in powders for nutraceuticals and pharmaceuticals.
Compaction & Granulation
Compaction:
The primary goal of compaction is to increase the density of bulk materials. Small, fine particles are compressed into larger particles, and any air fractions in the material are removed, resulting in lower volumes.
Roller compaction is an efficient method where bulk material is compacted by two counter-rotating rollers. Depending on the material’s plastic deformability, this process can produce endless slugs or fine needle agglomerates, such as during the compaction of silicates. Afterward, the slugs are comminuted into granules of the desired shape. The result is bulk materials with higher densities and improved flow properties.
Granulation:
Granulation is used in nutraceutical applications to transform fine, poorly flowing powders into larger, more manageable particles called granulates. In the pharmaceutical industry, granulation is crucial for achieving good meterability of bulk materials, which allows for easier tablet formation in subsequent processes.
There are two main methods of granulation:
Wet Granulation
Weighing & Mixing: Ingredients (active and excipients) are mixed together to ensure uniformity.
- Binder Solution: A liquid binder (water or alcohol-based) is prepared.
- Adding Binder: The binder is gradually added to the powder mixture, causing particles to agglomerate into larger particles (granules).
- Wet Massing: The mixture is stirred or mixed to enhance granule formation.
- Granulation: The wet mass is processed through a granulator to form uniform granules.
- Drying: The granules are dried in our fluid bed dryer to remove excess moisture.
- Sieving: Dried granules are screened to achieve consistent size.
The process improves blend uniformity, helps powder fit into capsule because of increased density of powder, increase flowability, compressibility, and uniformity for tablet or capsule production.
- Poorly flowing powders that need improved flowability and density.
- Ingredients that require better compressibility for tablet formation.
- Poorly mixed ingredients that need improved uniformity and consistency.
- Heat-sensitive actives (with controlled moisture and drying processes).
- Granules that require coating, encapsulation, or improved size consistency.
- Compaction: Powders are compressed under high pressure to form a solid mass, typically using a roller compactor or tablet press. This step is crucial for creating the initial granules.
- Milling: The compacted mass is then broken down into granules using an integrated milling process. This step results in particles with a uniform size and shape.
- Screening: Granules are sifted (3 size sives) to remove fine particles and oversized granules, ensuring the desired particle size distribution.
- Recycling: Any fines or oversized granules are recirculated back to the compactor for further granulation using a pneumatic conveying system.
Questions and Answers About Wet and Dry Granulation
What is wet granulation, and how does it improve the blend uniformity?
Wet granulation is a process where a liquid binder is added to powders to agglomerate them into larger granules. This process helps improve blend uniformity by ensuring that the active ingredients and excipients are evenly distributed in the final mixture. The binder creates cohesive bonds between particles, which minimizes segregation and enhances the homogeneity of the blend, making it easier to handle and process in subsequent steps.
How does wet granulation improve the flowability of powders?
Wet granulation helps improve the flowability of powders by transforming fine, poorly flowing powders into larger, more uniform granules. These granules have a larger particle size and improved cohesion, making them less prone to clumping and more capable of flowing smoothly during filling processes like tablet or capsule production. The increased size and reduced surface area of granules also help them move more easily through processing equipment.
How does dry granulation help increase powder density and improve tablet/capsule filling?
Dry granulation uses compression to densify powders, creating granules with increased density and reduced volume. This is particularly helpful when working with fine powders that are difficult to handle. The higher density of the powder means it fits better into capsules and tablets, improving the fill consistency and ensuring accurate dosing. This process eliminates the need for binders or moisture, making it suitable for heat-sensitive ingredients.
What role does granulation play in improving compressibility for tablet production?
Granulation, whether wet or dry, improves the compressibility of powders by forming larger granules that can be compressed into solid tablets more easily. These granules have better interparticle bonding and are less likely to crumble under compression, resulting in stronger tablets with fewer defects such as cracks or capping. The uniformity in granule size ensures that the tablet matrix holds together during pressing.
How does granulation affect the uniformity of tablets or capsules?
Granulation ensures that the powder or granules used for tablet or capsule production are uniform in size, which directly impacts the uniformity of the final product. Whether using wet or dry granulation, the process creates consistent granules that allow for accurate and uniform compression into tablets or filling into capsules. This leads to consistent weight and dosing, ensuring that each tablet or capsule contains the correct amount of active ingredient.
How does wet granulation help prevent ingredient segregation?
Why is dry granulation preferable for heat-sensitive ingredients?
Dry granulation is preferable for heat-sensitive ingredients because it does not require moisture or heat to create granules. The process relies on mechanical compression, which minimizes the risk of damaging sensitive compounds. This makes dry granulation an ideal choice for ingredients that may degrade or lose potency when exposed to heat or moisture during wet granulation.
Can granulation improve the shelf life of tablets and capsules?
Yes, granulation can improve the shelf life of tablets and capsules by reducing moisture content and improving ingredient stability. Wet granulation, for example, helps control the amount of moisture in the granules, reducing the potential for microbial growth or ingredient degradation. In dry granulation, the absence of moisture also helps prevent issues like mold or degradation. Granules formed through either method are more stable and durable, leading to longer-lasting products.
How does granulation improve powder handling during manufacturing?
Granulation improves powder handling by transforming fine, fluffy powders into larger, more manageable granules that are easier to handle during manufacturing. This enhances the flowability and dosing accuracy during tablet or capsule filling, reducing issues like dusting, clumping, or inconsistent powder flow. Granules are less likely to segregate and provide a more consistent and predictable material for processing.
What are the main advantages of using both wet and dry granulation in the industry?
The main advantage of using both methods is the flexibility they offer in handling a wide range of formulations. Wet granulation is ideal for improving the uniformity, flowability, and compressibility of powders that need to be formed into tablets or capsules, especially for poorly flowing materials. Dry granulation, on the other hand, is preferred for heat-sensitive materials and offers a faster, more efficient solution without the need for moisture or drying. Both methods ensure that powders meet the necessary quality standards for pharmaceutical and nutraceutical applications.