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СATALOGUE / PHARMACEUTICAL PRODUCTION TECHNOLOGIES / Basic requirements for tablets

Basic requirements for tablets

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СATALOGUE / PHARMACEUTICAL PRODUCTION TECHNOLOGIES / Basic requirements for tablets

Basic requirements for tablets

The following requirements are imposed on tablets: dosing accuracy – homogeneity (uniformity) of distribution of the active ingredient in the tablet, correct weight of both the tablet itself and the drug substances included in its composition;
mechanical strength – hardness, brittleness, fragility – characterize the quality of tablets; tablets should have sufficient strength to remain undamaged by mechanical effects during packaging, transportation and storage;
disintegrability or solubility – the ability to disintegrate or dissolve within the time limits established by the relevant scientific and technical documentation (STD) for certain types of tablets. Dosing accuracy depends on the homogeneity of the tablet mass, which is ensured by thorough mixing of drug and excipients and their uniform distribution in the total mass. Accuracy of dosing also depends on the speed and reliability of filling the matrix slot of the tablet machine. If in the short time the funnel is above the matrix opening, less material is poured out than the matrix slot can accept, the mass of the resulting tablets will be insufficient. The required filling speed of the die slot depends on the shape of the funnel, the slope angle and whether the particles of the tabletting mass have sufficient slip. Often the friction forces between the individual particles are so great due to the roughness of their surface that the matrix nest is not filled completely or not at all due to the delay of the powder in the funnel.

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  • Information updated : 09 / 12 / 2024
  • In stock
  • Manufacturer : 1 year for Basic requirements for tablets

Model: Basic requirements for tablets.

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In such cases it is necessary to add substances with a higher cohesive force (solutions of starch, gelatine, etc.) and again it is necessary to resort to granulation in order to introduce binding agents into the tablet mass, which increase the plasticity of the drug substances; in this case the property called adhesion is manifested, which causes the adhesion of the particles to each other.
Disintegrability. The tablet should have the required disintegrability with adequate mechanical strength. Too high strength of the tablet affects its disintegration and release of the drug substance – disintegration time increases, which adversely affects the quality of the tablet. Disintegration depends on a number of reasons: on the amount of binding agents: tablets should contain as much of them as necessary to achieve the required strength; on the pressing pressure: excessive pressure worsens the disintegration of the tablet; on the quality of loosening agents that contribute to the disintegration of tablets; on the properties of the substances in the tablet, their ability to dissolve in water, wetting it, swelling; tablets with easily soluble substances will disintegrate faster and less loosening agents will be required.
The mass subjected to tabletting should have a set of properties that ensure the fulfillment of the above requirements: accuracy of dosing, mechanical strength and disintegration.

Pharmaceutical Glossary

Antifriction agents  — A group of materials that have a low coefficient of friction, or materials that can reduce the coefficient of friction of other materials.
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Technical specifications

In these cases, antifriction agents are added to the material to reduce friction between the particles by giving them a smooth surface. In general, fine powders have poor sliding properties and tend to stick to the funnel surface, so it is necessary to artificially increase the particle size to an optimum value by granulating the material.
Delamination causes a change in the weight of the tablets. In some cases delamination can be prevented by installing a small agitator in the funnel, but a more radical measure is to equalize the particle size by granulating the material. When speaking of the homogeneity of a material, one also means its homogeneity in particle shape. Obviously, particles having different spatial outlines at approximately the same mass will be placed in the matrix nest with different compactness.
This circumstance will also cause variation in the mass of the tablets. Particle shape equalization is achieved by the granulation process. It should be noted that it is quite difficult to achieve homogeneity of granules, so by varying the ratio of fractions of granulate by experimentation, it is possible to establish the optimal composition that meets the best bulkiness and high quality of tablets at a certain pressing pressure.
Mechanical strength. Mechanical strength is determined by the interlocking of the particles. At the beginning of the pressing process, the tablet mass is compacted, the particles are brought closer together and conditions are created for the manifestation of intermolecular and electrostatic interaction forces.

Additional information

Intermolecular interaction forces are manifested when the particles approach each other at a distance of 10″6-10″7 cm. The pressing process of the tablet mass can be divided into three stages. The mechanical strength depends on the amount of pressure in the pressing process and it is important to trace the pressure increase during pressing. In impact tablet machines (eccentric) the pressure builds up sharply, as a result of which the surface of the tablet under the impact of the punches is strongly heated (mechanical energy is converted into thermal energy) and the substances fuse to form a continuous cementitious layer.
In rotary tabletting machines, the pressure builds up gradually, which gives better results, as it provides a longer exposure of the tabletting mass to pressure. The longer the exposure, the more completely the air will be removed from the tabletting mass, which after the pressure is removed, expanding, can have a destructive effect on the tablets. In addition, the heating of the tablet near the surface is significantly weakened, which eliminates the harmful effect of increased temperature on the substances that make up the tablet.
Application of high pressure during pressing can adversely affect the quality of tablets and contribute to the wear of tablet machines. High pressure can be compensated by addition of substances possessing a large dipole moment and providing adhesion of particles at relatively low pressures.
Water, having sufficient dipole moment, is a “bridge” between these particles. Water will prevent the binding of particles of difficult to dissolve and insoluble drugs.

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