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Granulation in Pharmaceutical Industry

Granulation is a critical and most important part of pharmaceutical manufacturing. The aims of granulation process is to provide a more homogenous mixture with formation of granules by agglomeration of fine particles.

Granulation is the process of particle enlargement by agglomeration technique. Where fine powders transform into free-flowing, dust-free granules that are easy to compress.

Types of Granulation in Pharmaceutical Manufacturing

There are numerous granulation technique available in pharmaceutical manufacturing. These are different from each other by their principle of granulation process. Frequently used granulation technique are mentioned below – 

  • Roller compaction,
  • High shear mixing, 
  • Fluid bed granulation

Roller compaction: this technique is commonly used for dry granulation. Where granules are formed without presence of any liquid solution. It is a relatively simple, inexpensive and more efficient method of dry granulation. In this method formulation ingredients are continuously passed between two counter-rotating rollers and produce a sheet of solid mass.

High shear mixing: this technique is an established and more user-friendly technology of granulation process in pharmaceutical industry. But long time for changeover and large number of operators are required for this process.

Fluid bed granulation: using this technique granulationis achieved by suspending the powder in the fluidized bed air and then binder solution is sprayed from nozzles that are either positioned above or below the powder bed depending on the type of the granulator. For this granulation technique limited number of operators are required.

Process flow of wet granulation

  • Dispensing
  • Sieving/Blending
  • Charging
  • Dry-mixing
  • Binder solution addition
  • Wet mixing
  • End point determination 
  • Drying
  • Blending

Process flow of dry granulation

  • Dispensing
  • Sieving & Blending
  • Slugging
  • Milling & Sieving
  • Blending

Importance of Granulation

Granulation process is necessary for several reasons, including:

  • Improving flow properties: Granulation improves the flow properties of powders, making them easier to handle and process.
  • Enhancing compressibility: Granulation enhances the compressibility of powders, making it possible to compress them into tablets.
  • Improving dissolution: Granulation can improve the dissolution rate of a drug, which is important for oral administration.
  • Enhancing stability: Granulation can enhance the stability of a drug, preventing it from degrading or losing its potency.
  • Masking taste: Granulation can be used to mask the taste of a bitter or unpleasant-tasting drug.
  • Improve Uniformity: Granulation helps to improve the uniformity of a drug's dose in a final product, ensuring consistent and accurate dosing for patients.

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