Possible problems and solutions of tablet press in tablet preparation_Tablet press_high speed_single punch_double layer_flower basket_multifunctional rotary press

Possible problems and solutions of tablet press in tablet preparation

1. Tablet fragments

The phenomenon of tablet splitting is called splitting. If the split occurs at the top (or bottom) of the tablet, it is usually called capping. This is a common form of splitting. Inhomogeneous pressure distribution and the resulting difference in elastic recovery rate are the main causes of cracks. The key to solving the debris problem is to use auxiliary materials with low elasticity and high plasticity to reduce the overall elastic recovery rate of the material. In addition, there are too many fine powders in the granules, the granules are too dry, the cohesion is weak or the dosage is insufficient, and the tablet is too thick and compressed too quickly, which can also cause splitting.

2. Tablet loose tablet

Tablets that are not hard enough to break with the slightest touch are called tablet loosening.

3. Sticking punch when the tablet press is running

The surface of the tablet is stuck in a thin layer or small portion by the punch, resulting in a rough, uneven or depressed surface. Usually, it is sticky. If the tablet has rough or chipped edges, it can be called stick-on. The main reasons for sticking or sticking are: the particles are not dry enough or the material is not easy to absorb moisture, the lubricant is not selected correctly or the amount is insufficient, the surface of the punch is rusted or the lettering is rough and not smooth. The reason should be determined and resolved according to the actual situation.

4. The difference in tablet weight exceeds the limit

Indicates that the tablet weight exceeds the allowable range for tablet weight variance specified in the Pharmacopoeia. The causes and solutions are:

(1) The fluidity of the granules is not good. Sometimes the number of granules flowing into the die hole is small, resulting in a large difference in tablet weight. It should be re-granulated, or a better flow aid, such as fine powder silica gel, should be added to improve the fluidity of the granules. .

(2) There are too many fine powders in the particles or the size of the particles is very different, resulting in heavy and light materials flowing into the die holes. Excess fine powder should be removed or re-granulated;

(3) The granules in the hopper are usually too small, which will cause fluctuations in the feed weight and make the difference in tablet weight exceed the limit. Therefore, the pellets in the hopper should always be more than 1/3 full.

(4) The consistency of the punch and the die hole is not good. For example, there is a large amount of powder leakage between the outer periphery of the lower punch and the wall of the die hole, which will cause the phenomenon of 'squeezing punch' in the lower punch, which will inevitably lead to insufficient material filling. Therefore, the punch should replace the head die ring.

5. Slow disintegration

(PHARMA tablet press) Factors that affect tablet disintegration include:

(1) Compressibility of raw materials;

(2) The hardness of the particles. When the hardness of the granule (or material) is small, it is easy to break due to compression, so the porosity and pore size of the compressed tablet are small, and the disintegration of the tablet is slow.

(3) Compression force. Generally, the higher the pressure, the smaller the porosity and pore size of the tablet, and the slower the disintegration of the tablet.

(4) Surfactant. It cannot be assumed that the addition of surfactants to any tablet will accelerate its disintegration.

(5) Lubricant. Hydrophobic lubricants commonly used in tablets can also seriously affect tablet wettability. Therefore, in production practice, the type, dosage, mixing intensity and mixing time of the lubricant should be strictly controlled to avoid the slow disintegration of the tablet.

(6) The amount of adhesive. The molding of the tablet and the disintegration of the tablet must be considered comprehensively, and an appropriate binder and an appropriate dosage must be selected.

(7) Type and amount of disintegrant.

(8) Storage conditions of tablets. After the tablet is stored, the disintegration time usually prolongs, which is mainly related to the temperature and humidity of the environment.

6. Exceeding the solubility limit

(PHARMA tablet press) The tablet cannot dissolve the specified amount of medicine within the specified time, that is, the dissolution exceeds the limit or is called unqualified dissolution, which will make it difficult for the tablet to play its due role. After a tablet is taken orally, it must go through multiple processes, such as disintegration, dissolution and absorption, and any problems in any of these links will affect the actual efficacy of the drug. The above process can be explained as follows: