Dry granulation is a widely used pharmaceutical manufacturing process that transforms powdery materials into free-flowing granules. This technique offers numerous advantages, including enhanced flowability, compressibility, and dissolution rates of final dosage forms. Various equipments play crucial roles in achieving successful dry granulation, each serving specific functions to optimize the process.
Purpose: Uniformly combine raw materials to ensure consistent distribution of active ingredients and excipients.
Types:
* Tumble Blenders: Rotate on a horizontal axis, gently tumbling the materials for efficient mixing.
* Ribbon Blenders: Feature a helical agitator that creates a shearing force for thorough blending.
* V-Blenders: Have a V-shaped design, allowing materials to cascade and mix effectively.
Purpose: Convert blended powders into granules by applying pressure and shear forces.
Types:
* Roller Compactor: Utilizes two counter-rotating rollers to compress and granulate materials.
* Slugging: Involves moistening the powder blend and compressing it into "slugs" using a tablet press, which are then broken down into granules.
Purpose: Separate granules by size to obtain desired particle size distribution.
Types:
* Sieves: Consist of mesh screens with different pore sizes, allowing smaller particles to pass through while retaining larger ones.
* Sifters: Employ vibrating or shaking motions to separate particles based on size.
Purpose: Remove moisture from granules to achieve desired moisture content.
Types:
* Fluidized Bed Dryers: Suspend granules in a stream of hot air, facilitating rapid and uniform drying.
* Tray Dryers: Place granules on trays and expose them to warm air for gradual drying.
Purpose: Apply lubricants to granules to improve their flowability and prevent sticking.
Types:
* Spraying: Uses a雾化器to distribute lubricant evenly over granules.
* Blending: Incorporates lubricant powder into the granules during mixing.
Purpose: Fill and seal granules into appropriate containers to ensure stability and protect against moisture and contamination.
Types:
* Filling Machines: Automatically fill granules into bottles, capsules, or other containers.
* Sealing Machines: Seal containers to prevent moisture penetration and maintain product integrity.
In recent years, the dry granulation industry has witnessed several advancements and innovations. These include:
Equipments used for dry granulation form the backbone of this vital pharmaceutical manufacturing process. By carefully selecting and utilizing appropriate equipment, manufacturers can ensure consistent production of high-quality granules for various dosage forms. Continued advancements in technology and innovation will further enhance the efficiency, reliability, and quality of dry granulation operations in the years to come.
Granule Size Range | Application |
---|---|
<100 µm | Injectable suspensions |
100-500 µm | Oral tablets and capsules |
500-1000 µm | Oral sachets and granules |
Granulation Method | Advantages | Disadvantages |
---|---|---|
Roller Compaction | High efficiency, good granule properties | Can produce fines |
Slugging | Good for moisture-sensitive materials | Time-consuming |
Fluidized Bed Granulation | Continuous process, uniform granules | Requires specialized equipment |
Equipment | Key Parameters |
---|---|
Blenders | Mixing time, fill level |
Granulators | Roll pressure, speed |
Sifters | Screen size, vibration frequency |
Dryers | Temperature, airflow rate |
Lubrication Systems | Lubricant type, application rate |
Material | Application |
---|---|
Lactose | Filler, diluent |
Starch | Binder, disintegrant |
Microcrystalline Cellulose | Binder, disintegrant |
Magnesium Stearate | Lubricant |
Talc | Glidant |
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