MANUFACTURING OF EFFERVESCENT FORMS IN PHARMACEUTITAL INDUSTRY Part 2: “Granulation method – Process of single-step granulation”

This single-step granulation process provides effervescent granules directly by granulating the acid and the alkaline materials together. It is possible to use only water as the granulating liquid, thus controlling the effervescent reaction to granulate, or using a nonreactive liquid, like absolute ethanol or isopropanol, but in this case, it is necessary to use a binder to get the agglomeration of the particles of the raw material. There are two type of equipment complying with this technology

 

1. Single-pot equipment – Mixer, granulator and vacumm dryer TMG

After mixing and granulation, this machine is possible to suddenly switch to drying phase by creating vacuum inside the bowl. Vacuum is created in a few seconds, which immediately provokes the decrease of the water boiling point. At the same time, the bowl is heated up to provide more energy for water evaporation. In a few seconds, the water released on the granules surface will be removed and the effervescent reaction will stop.

The big advantage of this machine is that material or intermediary product is not necessary to transfer between machines, so that it is much suitable to effervercent dosage which is always sensitive to the humidity of air. The disadvantage is that this technology provides low capacity for every batch while the investment cost is high.

Tien Tuan Pharmaceutical Machinery Limited Company has succesfully made the Mixer, granulator and vacumm dryer TMG, and is willing to serve the customers.

The mixer & granulator TMG made by TTP

 

2.Fluid-bed dryer, spray & Granulator FBDG is the more popular choice

In the fluid-bed technology, the vacuum inside the machine helps to raw materials scattering better. After that, granulation occurs when water is sprayed on the fluidized bed, initiating the effervescent reaction. The reaction is stopped when water is not sprayed anymore and drying phase is carried out with warm dry air. It is quite understandable that this method is difficult to control, and if possible, the investment cost for automatic system is very high. The reproducibility is also the big challenge and almostly dependent on the skill of operators because of this reason. An other big problem is handling the humidity of air (the only agent for drying granules in fluid-bed technology), normally is required very low to get good results in drying efferverscent granules. Therefore, the effective of the process is much dependent to the technical competence of machinery – technology provider. With our technical competence, TTP always has optimum solutions to handle the difficulties mentioned above.

Organic solvents: Because the effervescent reaction is only started if the materials come into contact with water — and not if they come into contact with organic solvents — one possibility is to use such solvents as a granulation fluid. However, the equipment is required a more complex design to prevent the explosion. All processing equipment made by TTP had the exposion-proof function in their design and were certified according to CE, ATEX, PED standards. This is an optional selected by customers.

Tien Tuan Pharmaceutical Machinery Limited Company has succesfully made the Fluid-bed dryer, spray & Granulator FBDG, and is willing to serve the customers.

(The fluid-bed technology helps gnanules boiled evenly and quickly comparing with eventional drying)

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