PHARMACEUTICAL PRODUCTION TECHNOLOGIES

Rotary tableting machines

8235

7652405

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Rotary tablet machines (RTM), unlike eccentric ones, have a large number of matrices and punches. The matrices are mounted in a rotating matrix table. The pressure in the RTM increases gradually, which ensures a soft and uniform pressing of the tablets. rTMS have high productivity (up to 0.5 million tablets per hour). The technological cycle of tableting on RTM consists of a number of sequential operations: Filling the matrices with tableted material (volumetric dosing method). Actually pressing. Ejection. Dropping pills. The operations are performed sequentially in automatic mode. The upper and lower punches slide along the guides (caps) and pass between the pressing rollers, exerting simultaneous pressure on them. The pressure increases and decreases gradually, which leads to uniform and soft pressing of the tablet…

Basic requirements of gmp soft dosage forms

8178

7651837

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In the production of ointments, creams and other soft dosage forms, there is a particularly high risk of microbial and other contamination. Therefore, special measures are needed to prevent any contamination. Soft dosage forms have specific rheological properties and in most cases are heterogeneous dispersed systems. Therefore, in order to avoid heterogeneity of the product due to uneven distribution of components, formation of gas emulsions and destabilization of dispersed systems, special attention should be paid to the proper conduct of the technological process, the equipment used and the temperature conditions of product storage. Requirements for production facilities and equipment. The environment of the premises, taking into account all measures to protect production, should pose a minimal risk in terms of contamination of materials and products.

Equipment for combined processes

8234

7652396

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The SG type apparatus manufactured by NPO "Pharmedobrazovanie" is used for granulation of powders in a fluidized bed, subsequent drying and dusting. This process is periodic. The body of the device is made of three all-welded sections, sequentially mounted with each other. The principle of operation is as follows: 30 kg of tablet mixture to be granulated is loaded into the food tank in accordance with the recipe. The trolley with the initial components is rolled into the machine and lifted. The air temperature required for fanulation is set, the mixing, fanulation and drying time is set, as well as the cyclicity and frequency of shaking of bag filters. The fan is turned on with the help of a gate that regulates the flow of...

Spray drying method (physicochemical microencapsulation method)

8250

7652553

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The method of spray drying of the dispersion or emulsion of the encapsulated substance containing polymer and solvent (both organic and aqueous) consists in their dispersion into the flow of a coolant gas. As a result of heat and mass transfer, the solvent is removed from the system and dense particles are formed, the encapsulated substance in which is distributed throughout the volume, and not concentrated in the capsule core. The most widespread groups of substances used for encapsulation by spray drying are carbohydrates, including modified and hydrolyzed starches, cellulose derivatives, gums and cyclodextrins; proteins, including whey proteins, casein and gelatin; biopolymers. The type of shell material used affects not only the encapsulation efficiency, but also the morphology of the product particles.

Extrusion method (physical microencapsulation method)

8253

7652584

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During microencapsulation by extrusion, a thin viscous film of film-forming material is formed on the surface with small diameter holes, through which the encapsulated substance is pressed. The shell formed in this way is further stabilized by cooling or polymerization of its constituent monomers. For microencapsulation by extrusion, forming devices are also used, which are two coaxially arranged tubes of different diameters (a "pipe in a pipe" device). The encapsulated material is fed into the inner hole of the tube under pressure, and the shell material is fed into the inter—tube space.

Method based on the use of polymers and crosslinking agents

8256

7652616

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Crosslinking of polymer chains is carried out by introducing special substances into the system, which, as a result of ion exchange, form bonds between two neighboring chains. In this case, the process takes place at the interface of the phases. It is possible to use oil-in-water systems containing a hydrophilic polymer and, for example, lower aldehydes as crosslinking agents. In this case, the interaction of the polymer with the aldehyde occurs in the aqueous phase, resulting in the formation of a new phase deposited on oil droplets, since the higher aldehydes dissolve in the non-polar phase.

Microspheres and pellets technology basics

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7652234

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Microspheres (pellets) are a new type of solid dosage form. Recently, in the pharmaceutical industry, drug manufacturers have been producing microspheres, or pellets (from the English pellet — ball, pellet, pellet), as the final or intermediate type of dosage form for the production of finished dosage forms. Microspheres are increasingly being used in the production of finished medicines, as they have a number of significant and undeniable advantages. Pellets can be tableted with the addition of suitable excipients, they can be the contents of capsules, as well as be part of suspensions. Microspheres (pellets) are agglomerates of fine powders or granules, which, in turn, may consist of medicinal and auxiliary substances. Microspheres are small, spherical or hemispherical solid particles with a diameter of 0.5 to...

Equipment for wet granulation process

8233

7652385

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The granulate is obtained in the process of granulation of wet mass on special granulator machines. The principle of operation of granulators is that the material is wiped with blades, springy wolves or other devices through a perforated cylinder or mesh. To ensure the wiping process, the machine must operate at an optimal mode without overload so that the wet mass passes freely through the holes of the cylinder or mesh. If the mass is sufficiently moistened and moderately plastic, then it does not seal the holes and the process goes without difficulty. If the mass is viscous and seals the holes, the machine works with overload and it is necessary to periodically turn off the motor and rinse the drum blades. The granulator contains...

Fluidized bed coating application

8104

7651099

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The application of film coatings is carried out in apparatuses for combined granulation, drying and coating processes. A distinctive feature is the lower location of the nozzle. There are two possible ways of organizing the process: applying a film coating directly to crystals or granules containing a medicinal substance; conducting a preliminary stage — layering the medicinal substance on inert particles (pellets are most often used), after which a film coating is applied. During the coating process, a layer of particles is placed in a fluidized bed apparatus.

Filling gelatin capsules with powders and granules

8081

7650866

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The reproduction and accuracy of dosing depends on the characteristics of the filler, the filling method and the type of filling machine. Active substances for filling into solid gelatin capsules must meet the following requirements: the contents must be released from the capsule, providing high bioavailability; when using automatic filling machines, active substances must have certain physico-chemical and technological properties, such as: certain particle size and shape; the same particle size; mixing homogeneity; flowability (fluidity); moisture content; ability to form compactly under pressure. To fill solid gelatin capsules, machines of various companies are used, differing in performance, dosing accuracy and the structure of the dispenser.