Tablet Manufacture 1

Tablet Manufacture 1
Lecture 6
Granulation
 Granulation is a unit operation in which small
powder particles are gathered together to
form agglomerates called granules.
 To achieve cohesion between the powders, it
is necessary to include adhesive substances

called binders or granulating agents within
the formulation.
Reasons
 There are several reasons for converting powders
or blends of powders into granules including:
 To enhance the flow properties of powder mix.
 To increase the bulk density of powder so that
required volume of powder can be filled into dies
 To reduce the incidence of dust production.
 To improve the compression characteristics/
compact ability of powder by the addition of
binder
 To ensure homogeneity of ingredients by use of
mixing.
Types of manufacture
 Wet granulation
 Dry granulation
 Direct compression
Mechanism of wet granulation
Steps of wet granulation
It is divided into following steps:
1. Weighing and mixing of formulation
ingredients
2. Damp mass preparation (Agglomeration)
3. Wet screening
4. Drying
5. Dry screening
6. Lubrication
7. Compression
1. Weighing and mixing of
formulation ingredients
 This step involves the weighing and
introduction of specified quantities of drug
substance(s), bulking agent, filler or diluent,
and disintegrant into a powder mixer.
 These ingredients are mixed using either a
planetary bowl mixer, ribbon/ trough mixers,

rotating drum mixer or high-speed mixer
until a uniform powder mix is achieved.
2. Damp mass preparation
(Agglomeration)
 Here, the binder solution is mixed with the powder
mixture to form an adhesive mass which can be
granulated.
 The amount of binding agent used as well as the quantity
of fluid required to form a damp and coherent mass is
part of the operator’s skill; however, the resulting binder-
powder mixture should compact when squeezed in the
hand.
 The use of insufficient binder tends to poor adhesion,
capping and soft tablets. Excessive binder solution yields
hard tablets with slow disintegrating properties.
 Colorants or flavoring agents may be added to the binding
agent to prepare a granulation with an added feature.
3. Wet screening
 The wet massed powder blend is screened
using 6- to 12- mesh screen to prepare wet
granules. This may be done by hand or with
suitable equipment that prepares the
granules by extrusion through perforations in
the apparatus. The granules formed are
spread evenly on trays and dried in an oven.
4. Drying
 The screened moist granules are dried in an
oven at a controlled temperature not exceeding
550C to a consistent weight or constant
moisture content.
 The drying temperature and the duration of
drying process depend on the nature of the
active ingredient and the level of moisture
required for the successful production of
satisfactory tablets. Shelf or tray drier and
fluidized-bed drier can be used for this
purpose.
5. Dry Screening
 The dried granules are passed through a
screen of smaller size than that used to
prepare the moist granules. The size of the
final granules is dependent on the size of the
punches (and hence the final tablet size).
Screens of 14- to 20- mesh size are generally
used for this purpose.
6. Lubrication
 After dry screening, the dried and screened
granules are separated into coarse and fine
granules by shaking them on a 250 mesh
sieve. Appropriate quantity of lubricant is
passed through a 200 – mesh sieve. This is
mixed with the fine granules before the coarse
granules are incorporated. The quantity of
lubricant used varies from one formulation
scientist to another but usually ranges from
about 0.1% to 5% of the weight of the
granulation.
6. Lubrication
 It is worth noting that disintegrant may be added
in step 1 (intragranular) or in step 6
(extragranular) and sometimes in both steps
(intragranular – extragranular).
 Intragranular – extragranular incorporation
appears to be the best method of incorporation
because the extragranularly added portion causes
immediate disruption of the tablet into the
previously compressed granules while the portion
added intragranuarly cause further erosion of the
granules to the original powder particles.
7. Compression
 Here, the mixed granules are compressed in a
single punch or multi-station tablet press
fitted with the appropriate punches and dies.
Dry Granulation
Dry granulation is typically used in the manufacture
of tablets if the formulation ingredients are too fluffy or
too susceptible to flowability problems for direct
compression to be a viable processing option and/or too
susceptible to degradation from heat and/or moisture
for wet granulation to be a viable processing option for
densification. The process is sometimes chosen as an
alternative to wet granulation when direct compression is
not feasible, not because wet granulation is not feasible
but because the manufacturer is more experienced with
dry granulation or to reduce processing time and/or
equipment requirements to reduce costs.
Methods of Dry granulation
 Slugging technique
 This process involves compression of primary powder
particles into large flat tablets or pallets using a tablet
press or, more usually, a large heavy-duty rotary press.
The resultant compact is then milled using a hammer
mill or other conventional milling equipment. The milled
slugs are passed through a screen of desired mesh for
sizing. Lubricant is added in the usual manner, and the
granules compressed into tablets.
 Slugging results in considerable dust production which
poses a problem for good containment and reduction of
cross-contamination.
 Roller compaction
 Roller compaction (also referred to as ribbon blending) is a
relatively simple, more efficient and inexpensive form of dry
granulation. It is a process where formulation ingredients are
continuously passed between two counter-rotating rollers where
it is densified and consolidated into a sheet of solid mass.
Depending on the type of rollers used, the feed material may be
compacted into dense ribbon-like materials known as flakes
(smooth rolls) or dense briquettes (almond or stick-shaped) if the
rollers have grooved or etched surfaces. The compacted materials
are further milled, sized, lubricated and compressed into tablets.
 Roller compaction offers distinct advantages over wet granulation,
particularly for moisture-, solvent-, or heat sensitive formulation
ingredients.
Thank You

Tablet Manufacture 1

Uploaded by

Copyright:

Available Formats

Tablet Manufacture 1

Uploaded by

Document Information

Original Description:

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Tablet Manufacture 1

Uploaded by

Copyright:

Available Formats

Tablet Manufacture 1

is necessary to include adhesive substances

planetary bowl mixer, ribbon/ trough mixers,

You might also like