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The lobes, also known as apical fissures, refer to the phenomenon that a thin layer of the upward facing rupture is split and detached due to vibration or the like after the tablet is pushed out of the die hole; sometimes even the tablet is split into two pieces, but Less happens. The reason for the occurrence of cracks in the tableting process of the tablet press is that the fine powder in the particles is large, and there is air in the pores of the particles before compression. Because of the faster compression speed, the gap between the punch and the die wall is small, and the compression is small. During the process, the air cannot be smoothly discharged and is enclosed in the gap in the sheet; when the pressure is released, the air expands and the split occurs. According to the above explanation, the fine powder in the granules should be removed or the pre-pressing equipment should be added to the tableting machine to make the air easy to escape. However, there are many phenomena that cannot be explained. For example, direct compression of a powder of 100 mesh or more with microcrystalline cellulose and compressible starch does not cause cracking; and if a crack occurs at a high pressure, appropriately lowering the pressure can prevent the split. The particles are too dry to be easily cracked, and the water content can be adjusted to overcome the problem of cracking. Some of the lobes were pelleted by a tablet press placed in a vacuum system, and lobes still appeared.
An important reason for the rupture of the tablet press during the tableting process is that the compression behavior of the granules is unsuitable because of the strong elasticity of the granules, the high elastic recovery rate of the pressed tablets, and the uneven distribution of pressure. When the tablet is pressed by a single punch tablet, the pressure on the upper surface of the tablet is relatively large; when the tablet is pressed by the rotary tablet press, the pressure on the upper and lower surfaces of the tablet is large; since the elastic recovery rate is related to the pressure, The elastic recovery of the upper surface or the upper and lower surfaces of the tablet is high; the upper surface of the tablet is pressed for a short time and is first removed from the die hole and released from the die hole, so that it is easily split by the top. Using this mechanism as a guide, you can scientifically design prescriptions to prevent lobes, and make reasonable answers to the problems listed above, such as adjusting prescriptions, increasing plasticity of excipients, improving the compression molding of granules, acetaminophen tablets are prone to lobes, and adding appropriate amounts. Compressible starch can solve this problem and the like. Properly reducing the pressure can prevent the split, because the pressure is small, and the elastic recovery rate is also small; increasing the compression time can increase the tendency of plastic deformation and prevent the split; the particles contain appropriate amount of water, which can enhance the plasticity of the particles and have a lubricating effect. Improve pressure distribution to prevent lobes. In addition, the addition of high quality lubricants and glidants to change the pressure distribution is also an effective means of overcoming the problem of splitting.
Other causes of the lobes, such as deformation and wear of the die hole, medical education, the damage of the punch of the tablet press, and the lowering of the punch is not raised to the level of the upper edge of the die hole.
Crack-tabler problems that often occur during tableting
In the process of pharmaceutical testing, we often use the tablet press. I believe many of my friends have encountered the same problem, that is, there are often cracks and cracks. What are the reasons for this: