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The wet mixing granulator is a kind of mixing and granulating equipment, which can be used to mix pharmaceutical ingredients. In terms of technology, the wet mixing granulator combines the two-step process of mixing and granulation, which not only saves time but also meets the requirements of GMP, reduces cross-contamination, and improves efficiency. The method is well received by users.

However, compared with the requirements of current formulation development, the traditional wet granulation process has obvious shortcomings. It is reported that the auxiliary materials used in traditional wet granulation are often limited to powdered sugar, starch, dextrin, etc. Among them, powdered sugar has obvious hygroscopicity; starch will gradually hydrolyze and lose its swelling effect when encountering acid, alkali, or under humid and heated conditions; dextrin interferes with the determination of the content of certain drugs, so the traditional wet granulation Has obvious limitations.

In addition, traditional techniques often use empirical judgments on the proportion of extracts and the consistency of extracts to determine the amount of excipients, which affects the quality control standards of the preparations. For hygroscopic drugs and excipients, if wet granulation technology is used to prepare granules, the granules will be squeezed together, causing adhesion, strip-like soft materials, sticky nets and other phenomena. The prepared granules are too hard and have poor solubility and unstable quality. .

As the pharmaceutical industry has higher and higher requirements for pharmaceutical processes, wet granulation technology also needs to keep pace with the times. Only more energy-saving, environmentally safe and safe granulation methods can be applied in the market. The researchers found that the combination of dynamic and static drying, two-step drying method used in the drying process of wet granulation, can shorten the drying cycle of the wet granules and increase the production efficiency.

Solid dosage forms are the general term for pharmaceutical preparations in solid forms, which are customarily called solid preparations. Due to the advantages of good stability and convenient storage, solid dosage forms are the most commonly used in clinical pharmaceutical preparations, accounting for about 2/3. At present, solid preparations commonly used clinically mainly include powders, granules, capsules, tablets, and so on.

The wet granulator is one of the most popular solid dosage forms, the wet granulator is to suck the material into the container by vacuum suction (or manual feeding) through the vortex effect generated by the rotation of the agitator to make it fully mixed. After adding the binder, in the intersection area, the granulating cutter will treat the churning material The dough is fully broken and cut into uniform and dense spherical particles. It integrates mixing and granulation. It is suitable for mixing and granulating powdery materials in the pharmaceutical, chemical, light industry and other industries, and it is also suitable for mixing dry powder. This machine can meet the requirements of the mixing and granulation of tablets and capsules in the pharmaceutical industry.

The wet mixing granulation process is completed in the same container by the two processes of mixing and granulating. The powdery material is put into the material container from the top of the conical hopper. After the cover is closed, the powder material rotates in the container due to the stirring effect of the stirring blade. At the same time, the material rolls from the outside to the center along the tapered wall, forming a semi-flow The material is sheared and diffused to achieve sufficient mixing. During granulation, the powder is gradually moistened due to the injection of the binder, and the properties of the material are changed, which strengthens the extrusion, friction, and kneading of the material by the blade and the barrel wall, and gradually forms a liquid bridge, and the material gradually turns into a loose soft These soft materials with agglomerated structure are not granulated by forced extrusion, but are cut by a pelletizing knife. The soft materials are cut into small and uniform particles in a semi-fluid state to realize the phase transformation of the materials. Finally, the discharge door is opened, and the wet particles are pushed out of the hopper under the centrifugal action of the paddle.

In the production of pharmaceutical tablets, granulation can be carried out before the tableting step to improve the flow and compaction properties of the powder. An alternative to traditional batch granulation for continuous tableting is continuous granulation using a twin screw extruder. Dirk Leister, Technical Marketing Manager for Process and Pharmaceutical Extruders at Thermo Fisher Scientific, said: “We continue to see demand in the pharmaceutical industry shift from batch to continuous production, as pharmaceutical production companies recognize its advantages, including reduced costs and smaller The equipment takes up space and minimizes the loss of materials and APIs.”

Online real-time monitoring of the continuous wet granulation process can not only ensure the production of high-quality finished products, but also improve the understanding of chemical and physical phenomena in the process, and reduce the risk of product failure and reduce waste.

Due to the current regulatory initiatives to improve product quality and reduce the risk of product defects, the market has great demand for continuous processing systems. The system generally has three modules: wet high-shear granulation module, segmented dryer module and particle adjustment module. In the granulation module, the system injects dry raw materials separately, or premixes the dry raw materials to the continuous high-shear granulator. After the small-scale dry mixing is completed, the granulation liquid is added so that each granule can absorb the same amount of liquid. The entire wet granulation process only takes a few seconds, and only a few grams of product are processed within a given time, so the start-up is faster without any loss. If you need to adjust the particle size, you can change the working level of the granulator; in this way, the wet granules with uniform quality and density can be produced, which continuously flow into the dryer. This process does not produce oversized agglomerates, so no wet grinding is required.

The dryer module is based on the principle of fluidized bed drying. It packs the constantly flowing particles into 1.5 kg, and then sends them to a separate section of the dryer for drying. After the particles in this section reach the desired moisture level, the dryer will send it to the particle adjustment module, and then load another package of wet particles for processing. The drying curve of each package of pellets is closely monitored. In the particle adjustment module, the system will measure the dried particles to meet key quality parameters such as particle size distribution, humidity, and composition uniformity. The system only processes 6-9 kg of raw materials at any time, so the risk of production loss can be minimized. The system’s small size and modular structure make it quick to deploy, easy to expand, and can be quickly integrated with existing equipment.

Drying is an important link in the pharmaceutical production process of pharmaceutical companies. For drying, the drying equipment used in different formulations, varieties, and process requirements is not the same, but one thing is the same, that is, the use of drying equipment to remove moisture (moisture or other liquids) from solid materials. There are many types of drying equipment. Among them, fluidized bed drying is a drying technology that has developed rapidly in recent years. The production practice proves that it is widely used in the pharmaceutical industry because of its applicability and superiority.

Fluidized drying is also called boiling drying, which is the application of fluidized technology in the drying process. When drying, the granular wet material is first added to the porous distribution plate, and the hot air is fed in from the lower part of the porous distribution plate. The airflow velocity is controlled between the settling velocity of the solid particles and the velocity of the airflow. When the gas velocity is low, the particle layer is still and the bed height remains unchanged, which is a solid bed; when the gas velocity increases, the particles begin to loosen, and the bed layer increases slightly; the gas velocity continues to increase, and the particles will move upward Floating and partially suspended in the air flow, the gas-solid mixture formed thereby is in a fluidized state in the bed, so it is called a fluidized bed.

Drying principle of fluidized bed dryer

During drying, the solid particles are suspended in the drying medium due to the countercurrent contact of the gas-solid two phases and vigorous agitation, with a large contact surface area. Fluidized bed drying technology involves two mutual processes of heat transfer and mass transfer. In the convection drying process, the hot air transfers heat energy to the surface of the material through contact with the wet material, and then from the surface to the inside of the material. This is a heat transfer process; when the wet material is heated, the surface moisture is first vaporized, and the internal moisture It diffuses to the surface of the material in liquid or gaseous state, and continuously vaporizes into the air, so that the moisture of the material is gradually reduced, and the drying is completed. This is a mass transfer process.