First, the reasons for the film weight difference and processing are as follows:
The film weight overshoot is the difference in weight between the tablets and the limits prescribed by the Pharmacopoeia.
1. The particle size distribution is uneven. The particle flow rate is different when the tablet is pressed, resulting in uneven grain thickness in the middle die hole. For example, the amount of coarse particles is light, and the fine particles are heavy. Solution: Mix the granules or sieve out too much fine powder.
2. If the fine powder adheres to the punch and causes the slamming, the difference in the weight of the sheet can be made larger. At this time, the undershooting rotation is not flexible, and it should be checked in time, the die is removed, and the undercut and the middle die hole are cleaned.
3. The particle flow is not good, and the amount of particles flowing into the die hole is often small, causing the difference in sheet weight to be too large and overrun. Solution: Re-granulation or adding a suitable glidant such as micro-silica gel to improve particle flow.
4. Particle stratification. Solve particle stratification and reduce the difference in particle size.
5. Smaller tablets use larger granules. Solution: Select the appropriate size of the particles.
6. The hopper is blocked. This phenomenon often occurs in drugs with strong viscosity or moisture permeability. The hopper should be dredged, the tableting environment should be kept dry, and the glidant should be added as appropriate.
7. The material storage in the material has a large difference and is controlled within 50%.
8. The feeder is unbalanced or not installed, resulting in uneven packing.
9. The scraping board is not flat or poorly installed. Solution: Leveling.
10. With the forced feeder, the forced feeder dial speed does not match the turntable speed. Solution: Adjust the consistency.
11. The punch has poor consistency with the middle die hole. For example, more powder is leaked between the outer periphery of the undershoot and the wall of the die hole, causing the phenomenon of "burdening" under the undershoot, resulting in insufficient material filling. Medium mold.
12. The length of the undershoot is different, and the tolerance is uneven, resulting in uneven filling. Solution: Correction, within ±5μm.
13. The undershoot is damped, and the damping force of the damper screw adjustment is not good. readjust.
14. The filling track is worn or the filling mechanism is unstable. Solution: Replace or stabilize.
15. Pursuit of production, the rotation speed of the turntable is too fast, and the filling amount is insufficient. In particular, when pressing large pieces, it is necessary to appropriately reduce the rotation speed to ensure that the filling is sufficient.
16. The tablet press is too large, the structure is loose, the assembly is unreasonable or reassembled; the pressure setting of the tablet press is too large to reduce the pressure.
Second, the reasons for the adhesion and treatment are as follows:
Adhesive punching refers to the adhesion of the fine powder on the surface of the tablet to the punch and the die when the tablet is pressed, so that the sheet surface is not only uneven, the uneven surface has a dent, and the lettering punch is more prone to sticking.
1. The surface of the punch is damaged or the surface finish is reduced. It may also have anti-rust oil or lubricating oil, the surface of the new die is rough or the lettering is too deep and angular. The punch can be wiped clean, replaced with a substandard die or rubbed with a trace of liquid paraffin on the surface of the lettering punch to lubricate the surface. In addition, if it is caused by mechanical heating, check the cause and repair the equipment.
2. The design of the engraved and rushed characters is unreasonable. Replace the punch or change the character design accordingly.
3. The moisture content of the particles is too much or the particles are unevenly wet and dry, resulting in sticking. Solution: Control the particle moisture in the range of 2% ~ 3%, strengthen the dry grain inspection.
4. Insufficient amount of lubricant or improper selection and excessive fine powder. Appropriately increase the amount of lubricant or replace with a new lubricant to remove excess fines.
5. The difference in fineness of the raw materials is large, resulting in uneven mixing or improper mixing time. Solution: The raw and auxiliary materials are crushed and sieved to make the fineness meet the quality requirements of the variety, and the mixing time is mastered and controlled.
6. The adhesive concentration is low or the adhesion is poor due to the quality of the adhesive, and the fine powder is too much (more than 10%) to stick. Solution: The fine powder is sieved with a 40-mesh sieve, regranulated, dried, and granulated, and the whole batch is uniformly mixed and then tableted.
7. Sticky due to the raw material itself (such as hygroscopicity). Solution: Add a certain amount of absorbent (such as adding 3% calcium hydrogen phosphate) to avoid sticking.
8. The ambient humidity is too high and the humidity is too high. Reduce ambient humidity.
9. The operating room temperature is too high and it is easy to produce sticking. Care should be taken to reduce the operating room temperature.
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