With the development of tablet film coating technology, the application range of sugar coating has been gradually reduced, but some varieties are still using this coating process due to the patient's habits. For a period of time, sugar coatings have a range of applications that cannot be completely replaced by film coatings.
Many domestic pharmaceutical companies still use the process of making sugar coating in the crucible, and the use of the drum type high-efficiency coating machine to make the sugar coating is more automated, more efficient, more energy-efficient, suitable for mass production, and can meet the GMP. The more stringent the requirements, the more unparalleled advantages of the shabu-shabu.
The drum type high-efficiency coating machine is a very suitable equipment for the film coating. Although the roller-type high-efficiency coating machine is used to make the sugar coating, it has been used for many years in China and abroad, but whether it can be used for many years. The sugar coatings are packaged, and some of the managers and technicians of the pharmaceutical companies still have doubts. People's doubts mainly focus on the following aspects: coating efficiency, flatness and smoothness of the surface of the tablets.
The process of coating the sugar coating by the drum type high-efficiency coating machine is generally divided into the following stages: feeding, preheating, coating mixing, coating single syrup, coating color paste, glazing, discharging. Among them, the three stages of the mixed slurry, the single syrup, and the color paste are cycles of dropping, homogenizing, and drying. The coating and mixing stage takes the longest time and is the key to sugar coating. Coloring and glazing directly affect the aesthetics of the one-sided surface. After groping, we improved the high-efficiency coating machine and explored the coating process.
1. Delivery of syrup
The drip stage generally accounts for 1/5 to 1/4 of the total sugar coating time, and the syrup delivery flow rate can effectively improve the coating efficiency. High-efficiency coater coated sugar-coated tablets require the use of a mixture, a mixture of syrup and talc, which is one of the main differences between the sugar-coated icing. When coating, if syrup and talcum powder are added separately, because the traits of the two materials are different, two sets of conveying systems are needed, which undoubtedly increases the complexity of the equipment. This method has no practical application. Some pharmaceutical companies use artificial talc powder, which causes some talc to run out of the coating area through the small holes in the drum, causing waste and placing an excessive burden on the exhaust dust removal system. The use of mixing avoids the above problems.
When adding the slurry, in order to improve the efficiency, a large flow rate is required. The mixing is generally carried out in a 2:1 weight ratio of syrup to talc, and the viscosity is much larger than the syrup. In order to reduce the amount of syrup, the proportion of talc can be appropriately increased, the single viscosity is also increased, and the fluidity is deteriorated. Higher viscosity and poorer flow reduce the speed of mixing and reduce the efficiency of the coating. If you want to maintain a high flow rate, put forward higher requirements for the pump and pipeline.
As a syrup delivery pump, the peristaltic pump uses a lower viscosity and must use a hose with a large wall thickness and good resilience. Such a hose has good pressure resistance and rebound self-priming performance. Peristaltic pumps that can deliver higher viscosity liquids at higher flow rates are generally larger in size, so there are certain limits in use. The price of the fistula with good pressure resistance is high, and it is a consumable item. It should be noted when selecting.
2. Drip of syrup
Since the viscosity of the syrup is large, it is difficult to disperse it into a smaller droplet and spray it onto the sheet surface as with the film coating. Therefore, the high-efficiency coating machine generally uses a syrup dripping device to drip the syrup as evenly as possible onto the film bed, and then enters a homogenization process to make the syrup on the one side uniform and uniform. The uniformity of syrup dripping directly affects the efficiency of the homogenate, the more uniform the dripping, the shorter the homogenization time required.
In order to make the syrup drip more evenly and shorten the homogenization time, the dripping device should have a dripping width which is equivalent to the bed width, slightly narrower than the bed width, and the dripping width should be 70% to 90% of the width of the bed. Adequate supply flow is also a guarantee of consistent flow per syrup.
3. Polishing
After the completion of the color paste newspaper, the polishing effect directly affects the appearance of the one-sided surface. The dense hole on the roller of the high-efficiency coating machine makes the surface of the enamel-type coating pan smooth, and the movement track of the tablet in the 包-type coating machine is more favorable. Throw a more beautiful look. After groping, the following points should be noted for polishing on the high-efficiency coating machine: the timing of the addition of the polishing wax, the amount of the addition, the temperature of the bed, the rotation speed of the drum, and the length of the polishing time. The above parameters will vary greatly depending on the packaged drug, but the parameters can be solidified in the standard operating procedures by groping. When polishing, the rotation speed of the drum is much higher than that of the coating. The higher linear speed of the drum drives the tablet, which increases the friction speed between the tablets and increases the friction probability, which is beneficial to the ideal one-sided effect. Increasing the rotation speed of the drum should be based on ensuring a smooth flow of the sheet bed, and avoiding the damage of the sheet surface caused by the splash of the core in the drum. The form of the agitator in the drum has a direct effect on the maximum rotational speed at which the bed is splashed. The amount of polishing wax added is more or less, which will reduce the brightness of the one side. The amount of addition is related to the total surface area of ​​the core. The total surface area is large, and more polishing wax needs to be added. Generally, the core is small and the total surface area is large.
When polishing, attention should be paid to monitoring the condition of the one-sided surface. The ideal surface appears in a short time interval, which can be completed from a few minutes to ten minutes. After the surface finishes the polishing effect, the drum rotation must be stopped immediately or the rotation speed of the drum should be reduced. Excessive and insufficient polishing can not achieve the desired surface requirements.
4. Coating environment control
The coating environment refers to the air environment inside the coating drum, air humidity, temperature and air volume. The two factors of temperature and air volume are not repeated here. The greater influence on the sugar coating is the air humidity, which is an important process parameter for sugar coating. The relative humidity of the air entering the drum has an effect on the drying speed and water content of the tablet. When the air humidity is too high, the efficiency of returning to the ten coatings is large, and even the sugar coating is not allowed. This situation occurs under high temperature and high humidity.
In order to ensure a good coating environment, the sugar coating should be equipped with a dehumidifying device in the offering. The suitable air relative humidity of the coating is between RH10 and 25%, and the air temperature is between 50 and 80 °C. The coating machine generally adopts condensing dehumidification, the refrigerant can use the refrigerant for the air conditioning of the pharmaceutical factory, or the refining machine itself is required to configure the refrigeration unit. After the air passes through the air cooler of the enshrining system, the temperature is lowered to about 14~15 °C. At this time, the air humidity is close to 100%. After the heat exchanger is heated, the temperature rises and the relative humidity decreases, the ideal environmental humidity can be obtained.
5. Coating process control
The high-efficiency coating machine can realize the automatic control of the sugar coating process, which is one of the advantages compared with the 包 type coating machine.
The process of sugar coating is more complicated than film coating, and there are many parameters to be controlled. Feeding, preheating, compounding, packaging, single syrup, coloring paste, glazing, cooling film, discharging Different process parameters need to be set at each stage. Due to the unstable factors in the sugar coating process, the operator is required to awaken the correction during the automatic control process. Therefore, human intervention should be allowed in the control of the program, and the human intervention should be an uninterrupted coating process.
The process parameter setting must be explored by the process parameters, and the process parameters are preset to the control system. Before each coating, the operator only needs to call the corresponding control program. Appropriate control parameters can reduce the probability of operator contact with the drug during the coating process and reduce the number of manual interventions. It ensures the stability and consistency of the quality of different batches of tablets, and reduces the dependence of the quality of the forgotten coating on the operators. These are in line with GMP requirements and are one of the main features of the crucible coating.
6. Conclusion
In summary, the equipment and process requirements for the coating of sugar-coated tablets using the drum-type high-efficiency coating machine are different from those of the 包-type coating machine. The pharmaceuticals explore a reasonable coating process for the high-efficiency coating machine, with reasonable Hardware facilities and control software, which has unparalleled advantages of the 包-type coating machine, can completely replace the è¸è -type coating machine to make sugar-coated clothes.
Cloud Storage Video Doorbell,Smart Camera,Wireless Night Vision Camera,Night Vision Camera
Shenzhen Zuomi Technology Co., Ltd. , https://www.bkvis.com