AGITATION-
Agitation is also known as spherical agglomeration.
In spherical agglomeration process, suitable quantity of liquid is added before or
during agitation to the finely divided particles to convert into spherical particles by
a continuous rolling or tumbling action.
Spherical agglomeraåon can be divided into liquid-induced and melt induced
agglomeration.
Since many years spherical agglomeraåon is carried out in horizontal drum pelletizer,
inclined dish pelletizer, and tumbling blenders.
CRYOPEllitisation-
In the process of repalletization, liquid nitrogen is used as a fixing medium to
convert the droplets of liquid formulations into solid spherical
particles or pellets.
Technology initially developed for lyophilization can be used to produce drug-
loaded pellets in liquid nitrogen at 1600C temperature.
The procedure allows instantaneous and uniform freezing of the processed material
due to the rapid heat transfer between the droplets, and thus the large surface area
facilitates the drying process.
The amount of liquid nitrogen required for In Manufacturing a given quantity
depends on the solid content and temperature of the solution or suspension being
processed.
0 Involves deposition of successive layers of powdered drug and excipient or both on
preformed cores with the aid of binding liquid.
Both are added simultaneously in a controlled manner.
In the initial steps, the drug particle is bound to the core to form the pellet by
forming a liquid bridge.
These liquid bridges are solidified to form solid bridges during solidification.
This leads to the formation of successive layers of a drug and the binder solution
until the desired pellet size is reached.
• A tangential spray granulator & centrifugal bed granulator are used
SOLUTION OR SUSPENSION LAYERING-
This techniques involves the deposition of successive layers of solution or
suspension of drug substances and binders on the starter nuclei.
Which maybe a inert material or granule of the same drug.
Drug particles and other components are dissolved or suspended in the binding
liquid.
Droplets stick on the core and spread evenly when the solution or suspension is
sprayed on to the nuclei.
During drying, solid bridges are formed between the nuclei and the initial layer and
between the successive layers of drug substances.
Extrusion — Spheronization-
Extrusion spheronization is a pharmaceutical technique used to produce uniformly
sized, spherical pellets for drug delivery, involving four steps:
-mixing dry powders with a binder to form a moist mass
- extruding this mass into cylindrical strands
-breaking these strands and rounding them into spheres in a spheronizer
- and finally drying the pellets. This process results in pellets with excellent flow, high
drug loading capacity, and uniform size, which are ideal for coating to achieve
controlled or sustained drug release profiles.
Globule or droplet formation-
Spray drying :- It is a process in which drug (in solution or suspension), with or
without excipients are sprayed into a stream of hot air to generate dry, highly
particles. This process is used to enhance the dissolution rates and bioavailability
of poorly soluble drugs.
Spray congealing :- It is the process in which a drug is allowed to melt, disperse
or dissolve in hot melts of gums, waxes, fatty acids etc. then it is sprayed into an
air chamber where the temperature below the melting points of the
formulation. No source of heat is used here
.
Freeze pelletisation-
Freeze pelletization is a pharmaceutical technique where droplets of a molten, drug-
containing carrier are introduced into an inert liquid column, causing the droplets to
solidify into spherical pellets. This method produces pellets that are solid at room
temperature, eliminating the need for a separate drying step and making it ideal for
water-sensitive drugs. The process results in spherical pellets with a narrow size
distribution, which is beneficial for drug absorption and release control.
Equipments used in pelletisation technique-
1. SUPPLY BINS
The supply bins located ahead of the pellet mill, should store a sufficient quantity of
feed to provide a continuous operation of the pelleting unit and also a continuous
operation of the mixer which provides mash to the pelleting unit.
The supply bin constructed from stainless steel should have at least two bins, results in
an efficient mixing as well as pelleting.
2. Pellets mills-
' The thoroughly mixed ingredients flow into a flow
rate regulator called a feeder under gravity.
It is equipped with speed controlling devices,
provides a constant, controlled and uniform flow
of feed to the mixing and pelleting operation, and
variation in this flow leads to poor conditioning
and a variable product.
3. COOLERS
' The pellets from the pellet mill flow under gravity into a device for cooling and drying.
When pellets leave pellet mill, they are at very high temp.
(1900F) & also have high moisture content (17- 18%).
4. SHAKER
The product (either whole or crumblised) from crumbling device is passed to a shaker
(screening device) that extracts the undesirable undersized portions of product from
correctly sized material.
The undersized product is returned to the pellet mill for repelletisation and is termed
recycle or fines.
5 . Pelleting dyes –
Die thickness and hole size varies with the type of product to be pelleted, Releived dies
have an enlarge diameter on the discharge side of hole .Releif length is the distance of
the hole with a gteater diameter than the other holes
The following types of dies diagram are mentioned below-
1- Standard die- in this type all the holes have same effective thickness.
2-Standard relieve die- In this type also holes have the same effective thickness but
discharge sie of hole is enlarged to a depth of 1/4 (relieved) . This die is used for adding
the strength of die without increase the thichness of hole depth.
3. Standard variable relief die- In this type all the holes are same except the two or
three outside rows of the die which are relieved by ¼. This loses 25 % of the die
effectiveness
4. Staggered relief die- This type serves as the std variable re;eif die except that the two
or three outside rows are relieved by ½ and next two three are reeived by ½.