Granulation Process in Pharmaceutical Manufacturing : Pharmaceutical Guidelines

Granulation Process in Pharmaceutical Manufacturing

Granulation is the main manufacturing process for the manufacturing of tablets. It is of two types wet and dry that is adopted on the basis of the API used in the manufacturing.
Granulation is a process of producing granules generally. In pharmaceutical manufacturing, granulation process implies the techniques that are, used to combine powdered particles to form relatively bigger ones called granules. This process is used for commercial production of tablets.

Why is Granulation Necessary?

The granulation process allows particles to stick together more firmly. It increases the particle size of the constituents used, which are mostly very fine powders. The greater the particle size of a constituent, greater will be its compressive or binding ability.

Granulation ProcessGranulation process in Pharmaceutical Manufacturing for tablet production is mainly of two types:
1. Wet Granulation
2. Dry Granulation


1. Wet Granulation

In wet granulation technique, following steps are involved:
Sifting: Active Pharmaceutical Ingredient (API) and excipients are sifted, usually through a 40 mass or 60 mass sieve. When API and excipients are sifted they mix together.
Mixing: In order to mix them up more thoroughly, the dry mixing process is utilized. Once the mixing is complete, granulating fluid is added to rapid mixture granulator or RMG.
Drying: The materials are then dried in a dryer, usually a fluid bed dryer or a tray dryer. When the constituents have dried, they are then milled using 16 mass or 20 mass sieves.

Lubrication: The final step is lubrication in order to make the particles adhere firmly together. This is done with the addition of a lubricating agent. The use of lubricating agents is particular to the types of API and excipients used. The most commonly used lubricating agent is magnesium stearate. The material formed is thus ready for further compression and manufacturing.

2. Dry Granulation

Dry granulation does not involve the use of a liquid lubricating agent. This is because constituents utilized might chemically react with the agent used, thus dry granulation equipment technique is used.
Dispensing: The first step in dry granulation is dispensing of the API and excipients used, in specified amounts.
Dry Mixing or Blending: Once both the constituents are dispensed, API and intragranular excipients are mixed together through dry mixing.
Compaction: After dry mixing of the materials, they are passed through roller powder compactors for compaction. This results in the formation of slugs. Slugs are the rough form of tablets, usually quite large in size.

Milling or Crushing: The slugs are then milled or crushed until the required granule size is obtained. Depending upon the product requirement, sieves are used to attain granules of the right size. At this stage, further mixing is done with the addition of extragranular excipients. Extragranular excipients do not form the part of the main mixture; instead, they are added after the granulation has taken place. Extragranular excipients include diluents, disintegrating agents, and others. The materials are then ready as a result of the granulation process in pharmaceutical manufacturing for further compression.





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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9 comments: Post Yours! Read Comment Policy ▼

  1. I want to read all your past blogs about pharmaceutical industry.please provide me link.

    ReplyDelete
    Replies
    1. Visit the blog www.pharmaguideline.com

      Delete
  2. Dear sir,

    I am big follower of your blog and sir i want to carry out product hold time study in our plant and there are more than 300+ product in our plant,so is it necessary to study all the product or by API wise.
    So is there any other way or not pls give me the details data.

    thanks in advance

    ReplyDelete
  3. Hold time study for 300+ products individually is really a big task. You can do it in groups by API used/ preservatives added (if any)or not/ water used in manufacturing or not and so on. Alternatively you can create a matrix including all factors and select the products accordingly.
    Please note that hold time study 8s done for inprocess samples but not for final product.

    ReplyDelete
  4. Dear sir,

    I want to know about the coating of tablets having Friability more than 1%.

    ReplyDelete
  5. How much Ratio of granules and fines for best compression

    ReplyDelete
  6. I think there are no such specific guideline for the ratio of fines and granules. It purely depend upon F&D study and at the time of study following main criteria should be in mind--

    1. Physical and chemical characteristics of the API and Recipients to be used.
    2. What should be the final specification of the product e.g- Assay,CU,DT,DISSO etc as it mentioned in followed pharmacopoeia.
    3. Type of release of the drug(SR,CR etc).
    4. Moisture sensitivity of the product.
    5. Depend upon issues found during compression stage of F&D study and result coming after the problem short out.
    6. Depending upon what are the process facility can provide a company and by this F& D will short out the issues and will provide the any other process way to achieve the product final specification.

    So there are also so many criteria which may be briefly described by a rich experienced F&D person..

    But above mentioned criteria are somehow directly or indirectly alter the process flow and it could be better understanding by following way-

    ** Final product specification------->Compression Parameters(F&D Stage)------>Result in Granulation type and its parameters(F&D Stage).

    I think it will help you...

    ReplyDelete


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