Successfully reported this slideshow.
You’ve unlocked unlimited downloads on SlideShare!
Pellet Production Technologies
Areej Abu Hanieh
Introduction: • Pelletization can be defined as an
agglomeration process that
converts fine powders or particles
of bulk drugs and excipients into
small, free flowing, more or less
spherical units, called pellets.
• This technique enables the
formation of spherical beads or
pellets with a mean diameter
usually ranging from 0.5 to 2.0
• It can be coated and usually used
in controlled release dosage
Pelletization vs. granulation.
• The general terms “granulation” and
“Pelletization” are sometimes used
synonymously and no clear distinction
is made between them.
• generally if agglomerates size
distribution within the range of 0.1 to
2.0 mm and a high porosity (about 20-
50%), this process may be called
•But if the agglomerates
have a narrow size
range, usually with mean
size from 0.5 to 2.0mm
and have a low porosity
(about 10%) with free
flowing properties then
it is called Pelletization.
Smith kline and French
improve the pellet and
tablets , capsules and
• Improvement of the uniformity of the content
• Prevention of dust formation.
• Increasing bulk density and decreasing bulk volume.
• The defined shape and weight improves the
appearance of the product.
• Improvement of the handling properties, due to the
free-flowing properties .
• Improvement of the hardness and friability of pellets.
• Controlled release application of pellets due to the
ideal low surface area-to-volume ratio that provides an
ideal shape for the application of film coatings.
• Pellets can disperse freely throughout an area
of the gastrointestinal tract
• Pellets reduce peak plasma fluctuations and
minimize potential side effects
• Avoiding the irritant effect of some drugs on
the gastric mucosa
• Modified-release multiparticulate delivery
systems are less susceptible to dose dumping
than single-unit dosage forms
• Often pellets can not be pressed into tablets
because they are too rigid. In that case, pellets
have to be encapsulated into capsules.
• The production of pellets is often an expensive
process and / or requires highly specialized
• The control of the production process is difficult
(e.g. the amount of water to be added is critical
for the quality of the pellets and overwetting can
occur very easily).
• Extrusion is necessary first step in the extrusion-spheronization process.
• The size of the sphere are determined by the diameter of the extrudate used.
The extrusion-spheronization process can be broken down into following steps:-
• Commonly used in industrial application.
• Higher pressure and heat can degrade
Screen or basket
- Gears are
• spheronization is a process of forming a spherical particles
from different rod shapes , by extrusion , that has a diameter
ranging from 0.5 to 1 mm .
• The size of the spheres are determined by the diameter of the
extrudate used for the spheronization process. For example,
in order to obtain spheres with a diameter of 1 mm, a 1 mm
screen is used on the extruder.
Spheronization machine design
• In principle the basic machine consists of a rotating friction disk, designed to increase
friction with the product, which spins at high speed at the bottom of a cylindrical bowl.
The spinning friction disc has a carefully designed groove pattern on the processing
surface. This is most often crosshatched, but several sizes and other types are
Spheronization mechanism of action
• as the machine rotate , rods move in rotationary movement or woven rope
movement , and the most important point that rods should not be friable but
it should have a plastic properties to have the ability to spheronized.
Key Spheronization Factors:
• Disc speed and load
• Disc groove geometry
• Disc diameter and speed
• Retention time
• Product paramaters
• Other factors
There is an optimum disc speed and load for each disc diameter:
- Momentum too low:
Extrudate not densified
No spheres formed.
- Momentum too high (from under
loading or disc speed too high):
Too much force on the
Compression of particles
within the granules.
Disc Groove Geometry:
• Both radial and cross hatched will work effectively.
• Radial disc had gentler and more controlled action.
• Radial not suitable for large diameter discs.
Cross Hatched Disk Radial Disk
• Typical retention time to obtain spheres range
from 2 to 6 minutes.
• The edges of cylindrical granules are the most
fragile part and they will generate dust during
• Spheronization with short retention time can
help to reduce dust significantly.
Table summarizing the different types of caleva
spheronizers for pharmaceutical production and
Equipment Description Main use
Micro spheronizer A Bench Top Laboratory
Spheronizer-120 Bench top Laboratory/experimental
Spheronizer-250 Lab scale bench top Low cost high output
Spheronizer-380 A Production or Pilot Plant
Quality spheroids output
Spheronizer-500 A Production or Pilot Plant
Quality spheroids output
Types of fluid bed technologies
Top spray Bottom spray Tangential spray
Tangential Spray(Rotor Process)
•Liquid addition rate
•Inlet air temp.
•Atomization air pressure
•Binder type and
Rotogranulation is one of the most recent methods for the
production of spheroids. The single-unit spheronizing system
can be described using terms like centrifugal granulator, rotary
fluidized-bed granulator, rotary fluid bed, rotary processor or
rotor granulator :
1)The preblending of the formulation powder, including the
active ingredients, fillers, disintegrants, in a flow of air.
2)The granulation of the mixture by spraying a suitable
liquid binder onto the fl uidized (suspended) powder bed.
3) The drying of the granulated product to the desired
• During processing, three mechanical forces cause particle
movement, mixing, and granulating.
• First, the spinning of the disk generates a centrifugal force.
• Second, a lifting force is generated by the hot air passes
through the adjustable disk gap.
• Third, gravitational force causes material to fall down onto
• These forces provide good mixing and result in granules,
drying, coating with good content uniformity.
During spraying-drying, a drug is solution or
suspension is sprayed, with or without
excipients, into a hot-air stream, generating
dry and highly spherical particles.
Spray-drying represents another process
based on globulation.
Inlet air temperature: 180-
250 Co .
Outlet air temperature:
Inlet moisture content:
outlet moisture content:
• This technique is suitable for
development of controlled-released
• It is generally employed to improve
dissolution rates and bioavailability of
poor soluble drugs.
• This method is applied for heat
sensitive pharmaceuticals: amino acids,
antibiotics, ascorbic acid, liver
extracts, pepsin and similar enzymes,
protein hydrosylate and thiamine.
• Particle size and size distribution, bulk
density, porosity, moisture content,
flowability and friability can be easily
controlled by the design and operation
of the spray drier.
powder particles are
uniform in size.
Spray-congealing is similar to
spray-drying, it is also called
In spray-congealing the drug is
allowed to melt, disperse or dissolve
in hot melts of gums, waxes, fatty
acids, or other melting solids.
The dispersion is them sprayed into a
stream of air and other gases with a
temperature below the melting point
of the formulation components,
under appropriate processing
conditions, spherical congealed
pellets are obtained.
Mar. 23, 2021
Mar. 2, 2021
Feb. 1, 2021
Jan. 28, 2021
Jan. 26, 2021
Dec. 22, 2020
Dec. 10, 2020
Dec. 8, 2020
Nov. 19, 2020
Nov. 16, 2020
Oct. 26, 2020
Oct. 3, 2020
Sep. 23, 2020
Sep. 19, 2020
Sep. 3, 2020
Aug. 24, 2020
Aug. 1, 2020
May. 3, 2020
Feb. 5, 2020
Jan. 28, 2020
Pellet production Technologies
Birzeit University - Palestine