Novel Granulation Technologies

Thermoplastic granulation / Melt granulation:

In this process moldable binders are used which acts as solids in room temperature but melts down at temperature  between 50°C to 80°C and behaves as liquid binder, there is no drying phase. Dried granules are simply achieved by cooling them down at room temperatures.

3 phases are included.

1.  wetting and nucleation.

2. coalescence

3. Attrition and Breakage

1. Wetting and Nucleation

In this step liquid medium comes in contact with powder medium and small agglomerates are formed. Mathiesen and Schafer proposed 2 methods of nucleation 

A.  Immersion which includes deposition of solids onto molten binder.

B. Distribution includes formation of nuclei when particals comes in contact with binder, through collision method.

2.Coalescence

This stage has nuclei that has residual liquid for fusion of other nuclei

3.Attritution – breakage:

It refferes to have granulation fragmentation. It has greater effect on the resulting properties.

Meltable Binders:

• Must be solid at room temperature and melts between 40-80 °C.
• Must be physically and chemically stable at various ph and moisture.
• Its HLB ensures correct release of active ingredients.
• Safe applications in humans.

Foam Binder Granulation (FBG):

In this type of granulation aqueous foams are used in place of liquids. It has various benefits over other wet granulation techniques it requires less wetting agent i.e. foam, water sensitive compounds can be processed, drying time is reduced, no plugging problems, less binders are requires in case of CR and SR products.

Novel technologies:

Spray dry granulation:

It is a continuous process in which dried product is obtained in a process in which binding solution or suspention of active pharmaceutical ingredient with or without addition of excipients is feeded to the dried system which is then automized and dried out with the help of heated gas-stream and the product is subsequently separated from the stream. After that agglomeration of particles is achieved by spry of binding solution onto the powder bed in fluidized state by passage of hot air followed by drying. This technique is used in the preparation of dusting powders and dry syrups. It is continuous and cost effective process and the operator is less prone to dusting problems. It also have some disadvantages that the thermolabile products cannot be prepared. And particle size  variation can occur in case of improper spray. 

Freeze granulation:

This technique results in free flowing, homogenous and spherical granules. Spraying of powder containing suspension is involved into the liquid nitrogen, where the resultant drops are frozen instantaneously to form granules which upon freeze dying yields dry granules. This is used in production of granules for injectable purposes. By this process density of the granules can be controlled. Metals and non oxides can be treated well through this process. It yields solid granules with no cavaties. The organic solvent which is used in this process can be recycled. And cleaning of equipments is very easy. It also has some of disadvantages over other techniques i.e. degradation of drug can be occurred due to freezing temperatures.

Pneumatic Dry Granulation (PDG):

It is a novel granulation method which involves semi-automatic or complete automatic production of granules. This process was invented by Atacama labs of Finland. Compact mass is produced by roller compaction and then introduced into new designed fractionating device which separate granules and recycles the rejected fraction. It involve modification of disintegration time, hardness of tablet and drug loading. High drug loading is achieved it easily masked taste of the API and the difficult APIs combinations can be treated well, excellent flowabilty and compressibility characteristics can be achieved.

Extrusion-spheronization granulation process: 

As the name indicates Extrusion is the process which is used to create objects with a fixed cross-sectional profile. The material is passed through a die of  desired cross section. Spheronization is a process in which extrudates are shaped into the small spherical or rounded granules. This process is used to make uniform particles which are very much suitable for the manufacturing of controlled release or modified formulations. Tacky mass is passed through extruder and pellets are formed by apply hot melt or wet extrusion techniques. The parameters like pore size of extruder, speed of spheronization and operational conditions should be controlled which can influence the size of particles and granuler morphology. This technique is used in the manufacturing of capsules, dry suspensions, tablets and dry powders. It cannot be used for thermolabile and moisture sensitive materials.

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What is Thermoplastic granulation ?     What is Melt granulation?

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