Studying and discussing the problems that may occur during the tableting process is of great significance for ensuring the quality of the drug, improving the level of production technology, and innovating the operation technology. Based on the theory of tableting and the experience in practice, this paper reviews the various aspects of production factors (such as the physical properties of the particles, the mechanical conditions of the tablet press, and the air humidity), and summarizes the problems that are likely to occur in the tablet.
1. Physical properties of the particles
The physical properties of the granules are related to the properties of the pharmaceutical raw materials contained therein, the moisture content, the excipients used, and the like. These factors, together with the particle size ratio distribution after the pellets are produced, can affect the tableting process.
1.1 Properties of pharmaceutical raw materials Any crystal belonging to the cubic system can be directly compressed. The scaly, needle-like and spherical crystals are not easy to be directly compressed, and should be pulverized after 80-100 mesh sieve. Otherwise, it may be prone to cracks, loose pieces, and surface defects in the tablet. When the drug is a colored material, it is especially pulverized and sieved to granulate to prevent spots on the surface of the tablet, resulting in an undesirable appearance.
1.2 Moisture in the granules The proper amount of water can increase the plastic deformation of the friable particles and reduce the elasticity, which is beneficial to tableting and hardness. Practice has proved that the moisture content of vitamin C tablets is controlled between 1.5% and 2%, which is easy to compress, and when the water is reduced to less than 1%, it is prone to splitting and loosening. Even if the tablet is formed, 30% of the tablets may have a hairiness, a pockmark, and a looseness when the tablets are dispensed. On the contrary, when the moisture exceeds 3%, it is easy to cause sticking.
The general solution to excessive moisture particles is to use a dehumidifier and re-dry if necessary. For completely dry or insufficient water particles, according to the nature of the drug itself, it can be naturally hygroscopic or sprayed with a suitable concentration of ethanol, and it can be placed in a static or closed moisture for about 5 hours. For example, in the case of drug particles containing crystal water, cracks, loose pieces, slow disintegration, etc. which occur when the crystal water loses too much, can be solved by this method. However, berberine granules, due to their high viscosity, spray moisture absorption, tend to stick into a block, hard and not uniform, which will cause problems such as unstable tablet and damage to the tableting machine. In this case, it is better to naturally absorb moisture or re-granulate.
1.3 The granules used in the process of tableting, the phenomenon of cracks, loose pieces, and lack of corners, etc., are caused by improper selection or insufficient dosage of the adhesive. It is more pronounced when the drug is loose or fibrous. When there is a disintegration of the extruded film, it is necessary to consider whether the concentration and amount of the adhesive are too large, among other factors. Temporary solutions are to increase the amount of disintegrant and reduce the pressure on the tablet press. The appearance of lobes and pines is also related to the oil components contained in the granules. Absorbents can be used to overcome.
In the actual production, the amount of lubricant added, the degree of uniformity, has practical reference value for correcting the sticking, solving the difference in tablet weight, improving the appearance of the tablet and overcoming the disintegration.
1.4 The particle size of the granules is not properly proportional to the fine powder, and there may be a phenomenon of sluggish disintegration, lobes, loose pieces, difference in tablet weight or speckle on one side. According to experience, adjustments should be made in the selection of binders and in the granulation process.
2 mechanical conditions of the tablet press
2.1 Specifications of the tablet press The rotary tablet press has a higher pressure and uniformity than the impact tablet press, and the splitting phenomenon is easy to control. The rotary tablet press is available in a variety of models, monorail and dual rail. The double-track tablet press has a fast speed, and the particle pressing time is shorter than that of the single rail type, which is prone to cracking and loosening. At this point, you should pay attention to increase the pressure and slow down the speed. In addition, when the difference in sheet weight is found during the tableting process of the two-track tablet press, the sheet weight regulator and the pressure regulator of the double-sided rail should be adjusted separately, and the technical parameters of the rail gauge re-adjuster and the pressure regulator cannot be separately obtained. Consistent, but should be based on the actual adjustment of the data on each track.
2.2 If there is a difference between the lobes and the weight of the granules in accordance with the quality requirements, the rotation speed should be slowed down.
If the pressure is too large or insufficient, causing lobes, slow disintegration or loose pieces, the pressure should be adjusted. Due to the different heights of the loader device, the speed of the processed particles is different, and the feeder is clogged to affect the weight of the piece and cause a difference. The machine should be stopped for inspection to find out the cause. During the tableting process, sticking and flaking spots are found, and it should be considered whether it is caused by the excessive lubricating oil on the tablet press. The measure is to wipe the grease regularly and attach a rubber cap to the upper punch. For particles with poor fluidity and easy to cause difference in tablet weight, 2~3 large rubber caps can be attached to the upper punch to impact the lower hopper and help flow. For the sticking caused by abnormal heating of the machine, it is necessary to stop the maintenance.
2.3 Die is the part of the tablet that is particularly prone to problems. If the punch does not match the die ring or the punch is curled inward, causing the difference between the split piece, the loose piece and the piece weight, the die should be replaced in time. Due to the length of the punch, the piece weight should also be adjusted as soon as possible. . When the surface of the punch is rough or the lettering on the punch is too deep and sticks, in addition to wiping with oil yarn, it is also possible to use a small amount of liquid paraffin. If the temperature in the workshop is too high and there is moisture on the surface of the punch, it will also cause sticking. In this case, the punch and the die should be cleaned and then warmed up.
2.4 The cleaning of the tablet press has a direct relationship with the normal operation of the equipment. The clean-up is not clean, not only causes pollution, but also the source of the difference in color, adhesion and weight of the tablet.
3 environment and temperature
The production process requires that the tablet press be installed in a location that is light, warm, dry, and clean. This is because the sanitary conditions of the tableting workshop are not good, which will directly affect the quality of the tablet. In particular, the phenomenon that the air granules are too high and the wettability is relatively strong is obvious. Therefore, the relative humidity of the tableting workshop should generally be controlled by dehumidification equipment at around 65%.
1. Physical properties of the particles
The physical properties of the granules are related to the properties of the pharmaceutical raw materials contained therein, the moisture content, the excipients used, and the like. These factors, together with the particle size ratio distribution after the pellets are produced, can affect the tableting process.
1.1 Properties of pharmaceutical raw materials Any crystal belonging to the cubic system can be directly compressed. The scaly, needle-like and spherical crystals are not easy to be directly compressed, and should be pulverized after 80-100 mesh sieve. Otherwise, it may be prone to cracks, loose pieces, and surface defects in the tablet. When the drug is a colored material, it is especially pulverized and sieved to granulate to prevent spots on the surface of the tablet, resulting in an undesirable appearance.
1.2 Moisture in the granules The proper amount of water can increase the plastic deformation of the friable particles and reduce the elasticity, which is beneficial to tableting and hardness. Practice has proved that the moisture content of vitamin C tablets is controlled between 1.5% and 2%, which is easy to compress, and when the water is reduced to less than 1%, it is prone to splitting and loosening. Even if the tablet is formed, 30% of the tablets may have a hairiness, a pockmark, and a looseness when the tablets are dispensed. On the contrary, when the moisture exceeds 3%, it is easy to cause sticking.
The general solution to excessive moisture particles is to use a dehumidifier and re-dry if necessary. For completely dry or insufficient water particles, according to the nature of the drug itself, it can be naturally hygroscopic or sprayed with a suitable concentration of ethanol, and it can be placed in a static or closed moisture for about 5 hours. For example, in the case of drug particles containing crystal water, cracks, loose pieces, slow disintegration, etc. which occur when the crystal water loses too much, can be solved by this method. However, berberine granules, due to their high viscosity, spray moisture absorption, tend to stick into a block, hard and not uniform, which will cause problems such as unstable tablet and damage to the tableting machine. In this case, it is better to naturally absorb moisture or re-granulate.
1.3 The granules used in the process of tableting, the phenomenon of cracks, loose pieces, and lack of corners, etc., are caused by improper selection or insufficient dosage of the adhesive. It is more pronounced when the drug is loose or fibrous. When there is a disintegration of the extruded film, it is necessary to consider whether the concentration and amount of the adhesive are too large, among other factors. Temporary solutions are to increase the amount of disintegrant and reduce the pressure on the tablet press. The appearance of lobes and pines is also related to the oil components contained in the granules. Absorbents can be used to overcome.
In the actual production, the amount of lubricant added, the degree of uniformity, has practical reference value for correcting the sticking, solving the difference in tablet weight, improving the appearance of the tablet and overcoming the disintegration.
1.4 The particle size of the granules is not properly proportional to the fine powder, and there may be a phenomenon of sluggish disintegration, lobes, loose pieces, difference in tablet weight or speckle on one side. According to experience, adjustments should be made in the selection of binders and in the granulation process.
2 mechanical conditions of the tablet press
2.1 Specifications of the tablet press The rotary tablet press has a higher pressure and uniformity than the impact tablet press, and the splitting phenomenon is easy to control. The rotary tablet press is available in a variety of models, monorail and dual rail. The double-track tablet press has a fast speed, and the particle pressing time is shorter than that of the single rail type, which is prone to cracking and loosening. At this point, you should pay attention to increase the pressure and slow down the speed. In addition, when the difference in sheet weight is found during the tableting process of the two-track tablet press, the sheet weight regulator and the pressure regulator of the double-sided rail should be adjusted separately, and the technical parameters of the rail gauge re-adjuster and the pressure regulator cannot be separately obtained. Consistent, but should be based on the actual adjustment of the data on each track.
2.2 If there is a difference between the lobes and the weight of the granules in accordance with the quality requirements, the rotation speed should be slowed down.
If the pressure is too large or insufficient, causing lobes, slow disintegration or loose pieces, the pressure should be adjusted. Due to the different heights of the loader device, the speed of the processed particles is different, and the feeder is clogged to affect the weight of the piece and cause a difference. The machine should be stopped for inspection to find out the cause. During the tableting process, sticking and flaking spots are found, and it should be considered whether it is caused by the excessive lubricating oil on the tablet press. The measure is to wipe the grease regularly and attach a rubber cap to the upper punch. For particles with poor fluidity and easy to cause difference in tablet weight, 2~3 large rubber caps can be attached to the upper punch to impact the lower hopper and help flow. For the sticking caused by abnormal heating of the machine, it is necessary to stop the maintenance.
2.3 Die is the part of the tablet that is particularly prone to problems. If the punch does not match the die ring or the punch is curled inward, causing the difference between the split piece, the loose piece and the piece weight, the die should be replaced in time. Due to the length of the punch, the piece weight should also be adjusted as soon as possible. . When the surface of the punch is rough or the lettering on the punch is too deep and sticks, in addition to wiping with oil yarn, it is also possible to use a small amount of liquid paraffin. If the temperature in the workshop is too high and there is moisture on the surface of the punch, it will also cause sticking. In this case, the punch and the die should be cleaned and then warmed up.
2.4 The cleaning of the tablet press has a direct relationship with the normal operation of the equipment. The clean-up is not clean, not only causes pollution, but also the source of the difference in color, adhesion and weight of the tablet.
3 environment and temperature
The production process requires that the tablet press be installed in a location that is light, warm, dry, and clean. This is because the sanitary conditions of the tableting workshop are not good, which will directly affect the quality of the tablet. In particular, the phenomenon that the air granules are too high and the wettability is relatively strong is obvious. Therefore, the relative humidity of the tableting workshop should generally be controlled by dehumidification equipment at around 65%.
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