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Granulation techniques include wet granulation in which the binder is added in the form of a solution or
suspension, and dry granulation/slugging in which the binder is added as a dry powder.
For both solution and dry binders, the compounds are added in low concentrations - typically about 2-10% by
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weight. Common traditional binders include sucrose, gelatin and starch. More recently introduced binders include
polymers such as cellulose derivatives and polyvinylpyrrolidone, which have improved adhesive properties. - Terms
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The most common and means of adding binder to powder that is to be granulated, is as a solution. Although the
solution method is considered the most e ective way of adding binder, an important issue is the compatibility of
binder with the API & other tablet components. This is traditionally found by choosing an appropriate stability study
design.
Drug characteristics such as compressibility, particle size, surface area, porosity, hydrophobicity and solubility in
binder are all important when assessing granulation. A poorly compressible drug formulation will requires a strong
binder such as liquid glucose, sucrose, etc., whereas drugs that exhibit good compressibility can be successfully
handled using a weak binder (starch paste etc.). Fine and porous powder particles require higher amounts of liquid
binder in contrast to coarse particles which require lsee. Hydrophilic drug/excipients also require a higher volume
of binder compared to hydrophobic drug/excipients. The granule quality (size, friability) is governed by the solubility
of the drug in the granulation solution.
The uniformity of the particle size, hardness, disintegration and compressibility of the granules depends on the type
and quantity of binder added to formulation. For example hard granulations that require excessive force during
tabletting may be the result of using a stronger binder or a highly concentrated binder solution. On the other hand,
fragile granulations may be due to an insu cient quantity of binder in which particles segregate easily. Larger
quantities of granulating liquid tend to produce a narrower particle size range of coarse and hard granules, i.e. the
proportion of ne granulates is less. Therefore the optimum quantity of liquid needed to obtain a given particle size
should be determined before setting up the granulation process so as to keep batch to batch variations to a
minimum.
Sr. Recommended
No. Binder %
10 Hydroxy propyl methyl cellulose with water, hydro alcohol, methylene chloride 2 to 5%
etc.
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Compression, directly compressible binders are required which should exhibit adequate powder compressibility
and owability. Direct compression binders should therefore be selected on the basis of compression behaviour,
volume reduction under applied pressure and ow behaviour in order to have optimum binding performance. The
choice and selection of binders is extremely critical for Direct Compression tablets. It is possible to use pre
formulated pill powder mix like Firmapress (https://www.lfatabletpresses.com/ready-mix- rmapress).
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