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What factors will affect the granulation products of wet mixing granulator?

The wet mixing granulator is a kind of mixing granulator, which can be used for mixing pharmaceutical ingredients. In terms of technology, the wet mixing granulator combines the two processes of mixing and granulation, which saves time and meets GMP requirements, reduces cross pollution, improves efficiency, and is a more rapid, better and more economical method, which is welcomed by users.

However, compared with the requirements of current preparation development, the traditional process of wet granulation has obvious shortcomings. It is reported that the auxiliary materials used in traditional wet granulation are usually limited to sugar powder, starch, dextrin, etc. The sugar powder has obvious hygroscopicity; Starch will gradually hydrolyze and lose its expansion when encountering acids, alkalis, or under humid and heated conditions; Dextrin interferes with the content determination of some drugs, so the traditional wet granulation has obvious limitations.

In addition, the traditional process often determines the amount of excipients by empirical judgment on the proportion and consistency of the extract, which affects the quality control standard of the preparation. For hygroscopic drugs and excipients, if the granules are prepared by wet granulation technology, the granules will be squeezed together, resulting in adhesions, strip soft materials, sticky nets, etc. The prepared granules are too hard, poor solubility, and unstable quality.

With the increasing requirements of the pharmaceutical industry on pharmaceutical technology, the wet granulation technology also needs to keep pace with the times. Only a more energy-saving, more environmentally friendly and safe granulation method can be applied in the market. The researchers found that the combination of dynamic and static drying, i.e. two-step drying method, could shorten the drying cycle of wet granules and improve the production efficiency.

It is understood that the granules made by wet mixing granulation are irregular in shape, uniform in particle size distribution, and more complete in structure than other traditional granulation processes, but their granulation products will be affected by many factors.

First, the rotation speed of the mixing paddle and the cutting knife. According to the industry, the size and distribution of particle size are directly related to the rotating speed of the agitator and the cutter. When the cutter rotates slowly, the particle size becomes larger, while when the rotating speed is fast, the particle size becomes smaller; When the rotating speed of the agitator is slow, the particle size is small, and when the rotating speed is faster, the particle size is large. The two play opposite roles.

Secondly, the influence of mixing and granulating procedures and time. Because the rotation of the stirring paddle causes the materials in the pot to roll towards space during the operation of the high-speed mixing and granulating machine, so that the materials at the bottom of the pot can be thrown up along the wall of the pot. This action pushes the soft materials to the fast cutting knife one after another, and is cut into particles of different sizes. As the particles roll over each other for a period of time, they are rounded and gradually become spherical. It can be seen that the speed and time of the agitator blade and the cutter blade affect the particle size of granulation.

Third, the influence of material and concentration. In the production of wet mixing granulation, alcohol granulation or dextrin adhesive granulation are commonly used, and there are certain differences between the two granulations. It is common to use alcohol to make granules. Because alcohol does not have viscosity, and it has a loose effect, this method is ideal for the granulation of traditional Chinese medicine with high viscosity. If dextrin is used to make granules, because dextrin has viscosity and polymerization, the granules produced are large and coarse, and the drying is slow. This method is ideal for western medicine without viscosity.

In addition, whether the concentrated extract is used as the material after dilution, or the material using dextrin or other adhesives, the slurry concentration of the material can be thinner when producing smaller particles, and it can be thicker when larger particles are needed.