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DEFINATION:- Spheronization or maramuerization, is a rapid and flexible process where pharmaceutical products are made into small spheres, or spheroids of diameter ranging from about 0.5mm to 10 mm. 2


Advantages:- Optimum flow and handling characteristics:- The flow characteristics of spheres makes them suitable for transportation by most systems found in the pharmaceutical industry, including vacuum transfer. 2. More reproduceable packing into small container:- The packing into small containers, such as hard gelatine capsules, or larger packages is much more convenient than other drug form such as powders or granules. 3

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Eliminate quality problems with variable dosage due to packaging problems with powder. 3. Minimum surface area/volume ratio:- Spheres provide the lowest surface area to volume ratio and thus pharmaceutical compounds can be coated with minimum of coating material. Important for effective release of some drugs. 4. Optimum shape for coating and for controlled release:- Coating can provide controlled, targeted release at different location within the body. spheres are dense material that can easily be coated within a minimum of coating material. 4

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5.Easy mixing of non-compatible products:- spherical particles are easily mixed. 6.Elimination of dust:- Contamination is reduced. The amount of fines and dust will be reduced during transport and handling. 7.Improve hardness and friability:- Spheronization increases the hardness and reduces friability of granules. 5

Extrusion-Spheronization:- :

Extrusion-Spheronization:- It is commonly used to make uniformly sized spheroid. 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:- a standard mixer extruder spheronizer coater/dryer The powder mix The plastic mass the extrudate Wet sphere Coated sphere 6

Extrusion process:- :

Extrusion process:- It is first step in extrusion- spheronization process. Used to eliminate dust in formulations. There are three main type of extruders:- Screw extruders. Screen or basket extruder. Gear extruder. 1. Screw extruder:- Commonly used in industrial application. Higher pressure and heat can degrade pharmaceutical products. 7

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2. Screen or basket extruder:- Lower density extrudate . Relatively high throughput. 3. Gear extruder:- produces relatively high density. Gears are robust and last longer. 8

Type of extruder used in pharmaceutical industry:-:

Type of extruder used in pharmaceutical industry:- Equipment Description Main uses Extruder 20 Bench top screen extruder Laboratory experimental/small scale production(30-25kg/hr) Extruder 35 Production screen extruder Lab /production , low cost high out put (2kg/min) of less dense extrudate . Extruder 40 Production gear extruder Quality extrudate output 40-100kg/hr Extruder 100 Production gear extruder Quality extrudate output 100-500kg/hr 9

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1.The extruder 20:- Designed for pharmaceutical R&D process development work in lab. Few dead spaces where material can collect. Minimum effective load requirement is about 30g Can be easily dismantled for easy cleaning. 10

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The extruder 35:- The extruder 40:- 11

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The mini screw extruder:- for small quantity of material. Smallest batch size can be extruded is about 5g. Material loaded into it manually. Die hole size 0.7mm to 2.oomm. Minimum wastage of valuable product. Can be quickly dismantled for easy cleaning. 12


THE SPHERONIZATION PROCESS:- Basic configuration:- Machine consists of a rotating friction disk, designed to increase friction with the product, which spins at high speed at the bottom of cylindrical bowl. 13

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The ongoing action of particles colliding with the wall and being thrown back to the inside of the plate creates a “rope-like” movement of product along the bowl wall. When particle have obtained the desired spherical shape, discharge valve of the chamber is opened and the granules are discharged by the centrifugal force. 14

Key spheronization factors:-:

Key spheronization factors:- 1.Disc speed and load. 2.Disc groove geometry. 3.Disc diameter and speed. 4.Product parameters. 5.Retention time. 1.Disc speed & load:- There is an optimum disc speed and load for each disc diameter. Momentum too low:- Extrudate not densified sufficiently. No spheres formed. 15

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Momentum too high:- Too much force on the granules. Compression of particles within the granules. Minimum porosity. Granules fracturing. The spheronizer drum charge volume :- The optimum charging volume depends upon the machine size and the product characteristics. Ex-machine with a 380nm diameter disc, charged with a volume of 4 liters. Depending on the density of the spheres and smoothness of the granules. 16

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2.Disc groove geometry:- Square cross hatched design is most commonly used. 3. Product parameter:- The particles must be plastic enough to allow deformation during collisions, but also must be strong enough to withstand collision with the disc, other particles & the spheronizer wall without backing up. 4.Retention time:- Typical spheronization retention time necessary to obtaine spheres is from 3 to 8 min . 17

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5. Other factors:- Binders-binders can be used to increase the strength of granules and reduce the amount of dust. Lubricant-it will increase the plasticity but also increase the amount of fine dust. water can also be used as lubricant, but if too much water is used, sticking can occurs on the friction plate and bowl wall. Moisture content for spheronization is slightly less than for extrusion. 18

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Example of spheronizers:- Spheronizer 250:- Spheronizer380:- 19

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Spheronizer 500:- 20

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