PHARMACEUTICAL PRODUCTION TECHNOLOGIES

Industrial production of suppositories

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There are several methods of making suppositories, among them: rolling out, pressing and pouring the molten mass into molds. The rolling out method is often used in pharmacy practice. This method is labor-intensive, low-hygienic, and the resulting suppositories differ slightly in appearance. Waxed capsules are used as packaging for suppositories. The pressing method makes it possible to produce suppositories like tablets in eccentric (crank) tablet machines using matrices and punches of the appropriate shape. The production of such suppositories is based on the transformation of fat suppository masses into powder form, which allows it to pour out freely from the loading funnel. To achieve the accuracy of dosing and the necessary flowability, the suppository mass is cooled in the refrigerator to a temperature of 3-5...

Direct pressing of powders in production

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Direct pressing is the process of pressing non—granulated powders. From the technological scheme for obtaining tablets, it can be seen that direct pressing allows you to exclude 3-4 technological operations from the production process. The direct pressing method has a number of advantages, including: reduction of the production cycle time due to the abolition of a number of operations and stages; use of less equipment; reduction of production areas; reduction of energy and labor costs; production of tablets from moisture-, thermolabile materials and incompatible substances. The disadvantages of the direct pressing method include: the possibility of delamination of the tablet mass; changing the dosage when pressing with a small amount of active substances; the need to use high pressure. Some of these disadvantages are minimized...

Method based on the use of polymers and crosslinking agents

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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.

Equipment for combined processes

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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)

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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)

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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.

Methods of industrial production of gelatin capsules

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There are three main methods of industrial production of gelatin capsules: immersion method, rotary matrix and drip. It should be noted that for the production of solid capsules, the dipping method has found wide application in industry, being essentially the only one. However, to obtain soft gelatin capsules (with drip sealing), the method is currently used only in laboratory conditions, as it is low-productivity and time-consuming. The stamping method, or rotary matrix, is used for the production of soft gelatin capsules and is the most rational for their production in industrial production. The principle of the method is to first obtain a gelatin tape, from which capsules are stamped on the rolls immediately after they are filled and sealed.

Soft gelatin capsules Basics of technology

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Soft gelatin capsules can also vary in capacity, although there is no clear standardization, unlike hard capsules. Suture soft capsules can hold up to 7.5 ml. The capacity of the rolls of the machine, with which the capsules are formed, filled and sealed, is measured in units called minim. At the same time, 1 minim is equal to an average of 0.062 ml, and the most commonly used roll cell sizes range from 2 to 80 minim. Larger capsules (up to 120 minim) have found application in the perfume industry.

Coating methods and equipment

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In modern pharmaceutical production, the following methods of applying film coatings are used.Coating in drums; coating in a fluidized bed (spraying from above, spraying from below, coating tangentially); technology of jet fluidization. Coating in drums has already been discussed in the section "Methods and equipment for coating".The technological parameters of the film coating process are: temperature, quantity and humidity of incoming and outgoing air, spray rate and pressure from the nozzle, layer temperature. At the same time, the technological parameters can be adjustable (temperature and amount of incoming air), unregulated (humidity at the inlet) and fixed (spray rate and duration of the process. DIOSNA has developed a vertical centrifugal coater VCC (from the English coater — coating plant). Unlike conventional drum-type coating systems, the VCC...

Coating of pellets, pellets and tablets

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After the tableting process, the finished tablet most often needs to be coated. In the modern pharmaceutical industry, the importance of tablet coating is increasing.