In recent years, spray drying technology has been widely used in the pharmaceutical industry. In the field of solid preparations, this technology is often used for drying highly thermally sensitive drugs and easily decomposed drugs during the concentration of feed liquids. In the application process, different APIs will have different special requirements for spray drying. How to meet these requirements, what details should be paid attention to are the issues of common concern for both equipment design producers and users. Guarantee cleanliness requirements The main process of some API production needs to be carried out in a 100,000-level clean environment. Spray drying is an important process for its quality control. In order to ensure the quality of the medicine, the part of the spray dryer that contacts the material should be made of stainless steel. For the material with strong acid corrosion, it is best to use 316L stainless steel. Drying chambers, cyclones, filters and other parts that directly contact the materials should have smooth inner walls, no dead corners, easy to disassemble, and easy to clean. Due to the huge system, the spray dryer cannot be placed in a clean area as a whole, and often only the part of the collected material is placed in a clean area. In this case, the system needs to have good sealing performance to prevent external pollution of the system. Avoid sticking to the wall In the spray drying process of solid preparations (especially traditional Chinese medicines), the sticking phenomenon is a prominent problem that hinders the normal operation of the spray dryer. The sticking of materials is not only not conducive to the collection operation, but with the extension of time, sensitive sticky materials will deteriorate into unqualified materials. From the process point of view, the solution includes selecting the appropriate solvent, adding auxiliary materials, and changing the process parameters. However, the room for adjustment of these methods is not very large, so it is necessary to seek a fundamental solution from the perspective of equipment. In recent years, experts at home and abroad have studied the problem of sticking walls and agglomeration during the drying process, and believe that the main reason for sticking walls is the wall temperature, thus summarizing five measures to prevent sticking walls: using a sandwich wall drying tower Use air cooling to keep the wall temperature below 50 ℃; the secondary air is introduced through the tower wall cyclone to cool the tower wall; the air broom composed of a row of nozzles is installed near the wall of the tower, and it is along the tower wall Rotate slowly; increase the air hammer on the tower wall, and force the sticky wall material to be separated by the hammering of the air hammer; increase the processing accuracy, and the inner wall polishing of the tower can also reduce the sticky wall. Improve self-control performance Spray drying is a continuous production process. The control points of the closed circulation system include: feed concentration, feed speed, air inlet speed, air inlet temperature, system pressure, pressure difference of each component, gas purity detection, etc., relying on traditional manual adjustment It is very difficult, so the self-control of the system must be strengthened. A good automatic control system can make the entire spray drying system run smoothly, reduce the unqualified rate of products, and reduce hidden safety hazards. Meet the requirements of different physical properties After the API is spray-dried, it is necessary to further complete the preparation process. Therefore, in terms of improving the preparation effect and the absorption effect of the final drug, different production requirements will place different requirements on the physical properties of the spray-dried product. The dispensing of drugs is generally controlled by volume, which requires a stable bulk density of the product, good fluidity of the product, and oral granules often require instant solubility. By changing the dispersion of atomization or appropriately changing the operating conditions to control the drying rate, products with different bulk densities can be produced, but the range of change is limited. At present, there is a new technology for improving physical properties-foam spray drying, that is, the feed liquid is foamed first and then spray dried. This method was originally proposed to improve thermal efficiency, and was later used to adjust the physical properties of the product. It has been proved that the foam spray-dried product has large particle size, porous, multi-sag, rough surface, and has good instant solubility. In addition, oral APIs will have some special requirements, such as particle shape. Production practice has proved that different shapes of particles can be obtained by changing the atomization method. Security measures are indispensable The particularity of certain medicines will also place higher requirements on the protection design of the equipment. For materials dissolved with organic solvents, the entire system must meet the explosion-proof requirements when drying, and at the same time, the explosion-proof type must be selected when designing accessories such as motors, meters, and control valves. In addition, in order to prevent the solvent and air from mixing into explosive gas, the system must use a closed circulation system, and the carrier should use inert gas, such as nitrogen. In addition, for the drying of some easily oxidized materials, a closed circulation system with nitrogen as a carrier should also be used. Environmental protection index must meet the standard The spray-dried products are fine particles, which are easy to form dust. In order to meet the requirements of environmental protection, it is not enough to separate the product and purify the exhaust gas with the cyclone separator currently equipped in the current configuration. A bag filter can also be added for purification, so that the dust content of the exhaust gas is less than 50 mg / cubic nanometer gas to meet the standard Or choose a wet scrubber to reduce the dust content of the tail gas to 15-35 mg / cubic nanometer gas. When using nitrogen as a carrier, the system should be sealed and the exhaust port should be led outdoors. Improving heat utilization is a top priority The inlet temperature of hot air is 250 ℃ ～ 500 ℃ in parallel flow operation and 200 ℃ ～ 300 ℃ in countercurrent operation. The outlet temperature after spray drying is generally controlled at 60 ℃ ～ 100 ℃, and its heat utilization rate is low, which is also The shortcomings of spray drying. At present, domestic industrial scale spray dryers generally have a thermal efficiency of 30% to 50%. Foreign spray dryers with waste heat recovery can achieve a thermal efficiency of 70%, but this equipment has economic significance only when the production capacity is greater than 100 kg (water) / hour. However, when a nitrogen carrier and organic solvent are used, a closed circulation system can be used to recycle nitrogen and use solvent condensation to effectively reduce production costs. But in general, the cost problem in the process of spray drying needs further research by equipment design and producers to find better countermeasures to reduce costs.
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Several Problems in Application Technology of Shanghai Guige Spray Dryer