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Granulation Process Basic Understanding

Granulation is a process that increases the size of particles by agglomeration and is commonly used in pharmaceutical manufacturing. It converts small particles into larger granules through either wet or dry granulation methods. Wet granulation is most widely used despite being more complex and time-consuming. Granulation improves properties like flow, content uniformity, and compaction for tablet production. The characteristics of the granules depend on factors like the ingredients, binders, granulation time and equipment used.

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RainMan75
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Topics covered

  • toxic exposure,
  • moisture content,
  • hardness,
  • tablet manufacturing,
  • wet granulation,
  • crystallization,
  • attrition,
  • API uniformity,
  • agglomeration,
  • sintering
234 views3 pages

Granulation Process Basic Understanding

Granulation is a process that increases the size of particles by agglomeration and is commonly used in pharmaceutical manufacturing. It converts small particles into larger granules through either wet or dry granulation methods. Wet granulation is most widely used despite being more complex and time-consuming. Granulation improves properties like flow, content uniformity, and compaction for tablet production. The characteristics of the granules depend on factors like the ingredients, binders, granulation time and equipment used.

Uploaded by

RainMan75
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd

Topics covered

  • toxic exposure,
  • moisture content,
  • hardness,
  • tablet manufacturing,
  • wet granulation,
  • crystallization,
  • attrition,
  • API uniformity,
  • agglomeration,
  • sintering

Granulation techniques and technologies

Granulation, a technique of particle enlargement by agglomeration, is one of the

most significant unit operations in the production of pharmaceutical dosage

forms, mostly tablets and capsules.1 During the granulation process, small fine

or coarse particles are converted into large agglomerates called granules.

Generally, granulation commences after initial dry mixing of the necessary

powder ingredients along with the active pharmaceutical ingredient (API), so

that a uniform distribution of each ingredient throughout the powder mixture is

achieved. Although granules used in the pharmaceutical industry have particle

size in the range of 0.2-4.0 mm, they are primarily produced as an intermediary

with a size range of 0.2-0.5 mm to be either packed as a dosage form or be

mixed with other excipients before tablet compaction or capsule filling. 1,2

Granules are produced to enhance the uniformity of the API in the final product,

to increase the density of the blend so that it occupies less volume per unit

weight for better storage and shipment, to facilitate metering or volumetric

dispensing, to reduce dust during granulation process to reduce toxic exposure

and process-related hazards, and to improve the appearance of the


product.2 Consequently, the ideal characteristics of granules include spherical

shape for improved flow, narrow particle size distribution for content

uniformity and volumetric dispensing, sufficient fines to fill void spaces

between granules for better compaction and compression characteristics, and

adequate moisture and hardness to prevent breaking and dust formation during

process.

Granulation is an exemplary of particle design and the properties of the

particles acquired after granulation depend on particle size of the drug and

excipients, the type, concentration, and volume of binder and/or solvents,

granulation time, type of granulator, drying rate (temperature and time), etc.

The primary methods by which the agglomerated granules are formed include

solid bridges, sintering, chemical reaction, crystallization and deposition of

colloidal particles.1,3 Besides, binding can also be accomplished through

adhesive and cohesive forces by utilizing high viscous binders. The series of

mechanisms by which granules are formed from the powder particles

encompass wetting and nucleation, coalescence or growth, consolidation, and

attrition or breakage.3-5

Blend of powders containing pharmaceutical excipients and API can be

compressed into tablets either by direct compression or after making granules


by agglomeration or granulation techniques (Fig. 1). The granulation technique

may be widely categorized in to two types, dry granulation and wet granulation,

based on the type of method used to facilitate the agglomeration of powder

particles (Fig. 1). Dry granulation uses mechanical compression (slugs) or

compaction (roller compaction) to facilitate the agglomeration of dry powder

particles, while the wet granulation uses granulation liquid (binder/solvent) to

facilitate the agglomeration by formation of wet mass by adhesion. Among these

two techniques, wet granulation is the most widespread granulation technique

used despite the fact that it involves multiple unit processes such as wet

massing, drying and screening, which are complex, time consuming, and

expensive requiring large space and multiple equipment

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