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Pelletizing by layering

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Pelletizing by layering

Microspheres can also be produced by layering the drug substance onto inert microspheres. The layering process is the successive application of layers of drug substance from solution, suspension or dry powder onto cores. The cores can be crystals or granules of the same material or inert particles. In layering from solution or suspension, the drug substance particles are dissolved or suspended in a liquid. In powder layering, complete dissolution does not occur due to the small amount of liquid regardless of the solubility of the active ingredient in the liquid. In powder application, the drug is first atomized by spraying the binder solution onto inert cores and then the powder is applied. By adding a layer-forming component, the pellet is formed layer by layer to the desired size. Powder and binding agents, suspensions or solutions are suitable as layer-forming components. By moving the pellets in the rotor, dense layers are formed.

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  • Information updated : 09 / 11 / 2024
  • In stock
  • Manufacturer : 1 year for Pelletizing by layering

Model: Theory of pellet (microsphere) formation and growth.

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This process is usually used to increase the dissolution rate of the active ingredient and consequently increase the bioavailability of poorly soluble drug substances. Solidification is a process in which the drug is melted, dissolved or dispersed in hot resins, waxes or fatty acids and atomized in an air chamber where the temperature is maintained below the melting point of the formulation components to produce solidified microspheres. Depending on the physicochemical properties of the components, and the loading composition, this process can produce microspheres with conventional or modified release. Compression is one of the compaction technologies to produce microspheres. By compressing a mixture of active ingredients and excipients under pressure, microspheres of specific sizes and shapes can be obtained. The composition of the loading and the process conditions controlling the quality of the finished microspheres are similar to the parameters for the production of tablets.

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Technical specifications

A variety of layers with different characteristics can be applied. Pellets obtained by this technology have many positive characteristics such as spherical shape, good flowability, dosability, compact structure, low hygroscopicity, high bulk weight, dense and homogeneous surface layer, narrow particle size distribution, high resistance. External to abrasion, the ability to incorporate a large number of species of multilayer bioactive substances and optimal initial pellet shape for subsequent coating. With the rotor method, it is possible to apply the film in very thick layers. Pellets containing large amounts of bioactive substances (when necessary) can be produced with this technology. In layer-by-layer pelletizing, the biologically active substance can be: sprayed onto the initial nuclei as a solution with a concentration of up to 50%; sprayed as a suspension; dosed in powder form in combination with a solvent and binder feed.

Additional information

In this case, the mass gain during layer-by-layer pelletizing in the rotor can be up to 10-fold of the initial mass. The layering of drug on microspheres is also carried out in centrifugal granulators, which can be used to obtain multi-element products with conventional or modified drug release. Using such systems, the primary granules can be prepared, drug substance layered and coated in the same, equipment to produce spherical multilayer granules with the desired drug substance release. In addition to the methods described above, which are the most common, other methods of producing microspheres such as globulation, solidification and compression are used to a limited extent in the pharmaceutical industry. Globulation consists of two related processes: spray drying and solidification. Spray drying is a process in which a suspension or solution of a drug substance without excipients is atomized in a stream of hot air to produce dry spherical particles.

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