The main reasons and solutions affecting the quality of tablets

The main reasons and solutions affecting the quality of tablets

main reason:

1. Compliance of raw material characteristics
2. Proportion of medicinal excipients and inconsistencies in excipients
3. Unreasonable formula relationship
4. Unreasonable mixing process, granulation process
5, the mold and equipment used in tableting are not good
6, poor tableting process
7. Unsuitable production environment

First, the difference in weight

Main reason
1. The length of the undershoot is inconsistent, the tolerance is poor, and the difference is within ±5μm.
2, particle layering to solve particle stratification, reduce the difference in particle size
3, the tablet machine shakes too large
A. The structure is loose and the assembly is unreasonable. Reassembly
B, material particles are uneven, mix, sieve
C, the pressure setting of the tablet press is too large, reduce the pressure
4, the scraping board is not flat or poorly installed
5. The clearance between the punch and the turret punch hole is too large.
6. Occasionally foreign matter in the particles causes the feeder to clog. Remove foreign matter.
7. Wear of the cam or track, the filling mechanism is unstable, replace, and stabilize
8, the pursuit of output, the speed is too high, reduce the speed
9, part of the undershoot is not pulled enough to ensure that all undershoot is pulled to the bottom
10, excessive particles of excessive wet powder, dry materials, reduce fine powder
11, the particle difference is large, uniform
12, the particle flow is not smooth, the feed is blocked, the flow aid is added, the formula is changed, and the hopper is dredged.
13. Smaller tablets use larger granules. Suitable granules.
14. The difference in material storage within the material is controlled within 50%.
15, double-sided tableting, feeding on both sides, the speed is inconsistent
16. With forced feeder, the forced feeder speed adjustment is consistent with the rotation speed of the runner.
17. The damping force of the undershoot damping screw is not good. Re-adjustment 2. Sticky punch: There is fine powder stuck to the surface of the punch and the die ring, which makes the sheet surface not smooth, uneven, and dent.

Main reason
1. The surface of the punch is damaged or the surface finish is reduced. Replace the punch to clean the surface of the punch.
2, engraved, rushed character design is not reasonable Replace the punch

3, the particles are too wet, dry particles
4, the drug contains easy moisture absorption components and moisture absorbent
5. Insufficient lubricant or improper selection. Increase dosage or replace new lubricant.
6, the environment humidity is too large, the humidity is too high, reduce the environmental humidity

Third, the split

Main reason

1. Air is present in the tablet during tableting. Adjusting pressure, slowing down the vehicle speed, increasing the preloading time or using a pre-pressing process.
2, the die is seriously worn, replace the die
3. Improper or insufficient selection of the binder. Replace the binder or add amount.
4, the water content of the particles is too low, increase the water content
5, the particles are too fine or too coarse to adjust the particle size
6, more oil components in the particles plus oil absorption agent
7. The mold gap is too small to be exhausted smoothly. Replace the mold.

Four, pine pieces

Main reason
1, the pressure is not enough to increase the pressure
2. The pressure is too low, the speed is fast, the pressure is extended, the preload is increased, and the speed is reduced.
3, the length of the punch is uneven, adjust the punch
4. The loosening of the active punching head is tightened.
5, the lower punch off the punch
6. The adhesive is not properly selected or too small. Replace the adhesive or add amount.
7. Improper proportion of lubricant in the granules
8, the particles are too dry to increase the moisture of the particles
9. The material is pulverized with insufficient particle size, fiber or high elasticity. The pulverized particle size is over 100 mesh and the adhesive is strengthened.
10. Many drugs or oils are mixed and unevenly mixed.
11. After the tablets are pressed, they are placed in the air for too long, and the damp is shortened.

Five, discoloration and spots

Main reason
1. The particles are contaminated by grease or other impurities to prevent oil and impurity pollution.
2, the particles are too hard or sugary varieties and colored to reduce the hardness of the particles, colored tablets are easy to appear with tablet particles. Ethanol is used as a lubricant for granulation.
3, the particles are too large or too small
4, rust spots appear on the surface of the model, remove rust spots
5. The surface of the feeder and the turntable is rubbed with fine metal powder. Adjust the height of the feeder to enter the die hole with the particles.
6. The friction between the punch and the inner wall of the die ring adjusts the die ring to cause the colored metal powder to enter the particle.

Six, slow disintegration

Main reason

1. The adhesive is too viscous or too much. Replace the adhesive or reduce the amount of particles.
2. Inappropriate selection of disintegrants, insufficient dosage. Replace disintegrants or add too much hydrophobic lubricant. Reduce hydrophobic lubricants.
3, the pressure is too large, the film is too hard, reduce the pressure

Seven, the main reason for lettering or lines is not clear
1. The character design and layout of the die are unreasonable. Replace the characters.
2. The surface of the punched surface is worn or damaged. Replace the die.
3. The die size is too large or not enough. Replace the die.
4, the pre-pressure is too large, reduce the pre-stress

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