PHARMACEUTICAL PRODUCTION TECHNOLOGIES

Modern capabilities of tablet presses

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Many companies producing pharmaceutical equipment are constantly working on improving the tablet presses and their components used. Recently, the company FETTE (Germany) has improved the rotary tablet press, using a segmented matrix disk instead of traditional matrices. Instead of 47 matrices and 47 screws, only 3 segments are used, which gives clear advantages, such as: high productivity — up to 311 thousand tablets per hour; less time spent to change the product — there is no need to adjust individual matrices; reduced cleaning time, as the number of parts decreases and there are no holes that are difficult to clean; lower tablet ejection force due to reduced friction against the matrix walls; increased service life by 5-6 times due to segments made of high—alloy steel...

Leukoplasty production process

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A band-Aid (Leucoplastrum), or a sticky elastic band-aid smeared (Emplastrum adhaesivum elasticum externum). It is used to hold bandages, to bring the edges of wounds closer together, to stretch the limb in case of fracture, etc. It consists of the following components: 25.7 parts of natural rubber, 20.35 parts of rosin, 32 parts of zinc oxide, 9.9 parts of anhydrous lanolin, 11.3 parts of liquid paraffin and 0.75 parts of neozone D. The adhesive plaster production process includes several stages: the dissolution of natural rubber and rosin in gasoline, the preparation of an alloy of lanolin with liquid paraffin, mixing it with finely ground zinc oxide and the preparation of a paste of anti-oxidant rubber. The application of the finished mass of adhesive plaster to...

Production of hard gelatin capsules

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As noted above, encapsulated dosage forms are becoming increasingly important due to their obvious advantages over other dosage forms. This section will consider the technology of production of solid gelatin capsules, which are most widely used in the modern pharmaceutical industry, as well as the equipment on which their manufacture is carried out. Characteristics of the main and auxiliary substances included in the composition of solid gelatin capsules. To obtain capsule shells, film-forming high-molecular substances capable of forming elastic films characterized by a certain mechanical strength are used. Such materials include casein, zein, cellulose esters and esters, fats and wax-like substances, as well as some synthetic polymers (for example, a copolymer of methacrylamide and methacrylic acid, etc.). However, these substances have not found wide practical...

Manufacture of pepper patches

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Pepper plaster (EmplastrumCapsici) is a homogeneous sticky mass of yellow-brown color with a peculiar smell, applied to a fabric and covered with a protective layer of cellophane. Currently, a wide range of patches of various sizes is available: 12x18 cm, 10x18 cm, 8x18 cm, 10x15 cm, 4x10 cm, 6x10 cm, etc.The pepper patch has the following composition: 8% thick extract of capsicum, 0.6% thick extract of belladonna, 0.6% tincture of arnica, 22% natural rubber, 21% pine rosin, 18% anhydrous lanolin, 24% petroleum jelly oil and other components.

Preparation and filling of gelatin capsules

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The calculated amount of purified water is poured into the container, which is heated to a temperature of + 65 ° C in a gelatin mass preparation apparatus, and a stirrer is turned on. Then glycerin is poured with nipagin and gelatin is filled in. The gelatin mass is mixed for 1.5 hours until the gelatin is completely dissolved, then, with the agitator turned off, it settles for 0.5—1.5 hours. After that, the gelatin mass is filtered through a sieve and its viscosity is measured using a viscometer. If the viscosity indicators do not correspond to the norm, the ratio of water and gelatin is recalculated. The filler solution is prepared according to the technological instructions. The prepared gelatin mass and filler in the required...

Film coatings of tablets

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A film coating is a thin shell formed on the surface of a microsphere (pellets). Tablets or granules after drying of the film-forming substance solution applied to their surface. The thickness of the film coating layer is approximately from 5 to 50 microns. The droplets of the coating liquid are sprayed onto the initial particles. The supplied process air evaporates the liquid and dries the film layer on the surface of the particles. The small droplet size and low viscosity ensure uniform distribution of the film on the particle surface. An important point when applying the coating is a very uniform application of the coating material. The coatings must be dense, without mechanical damage and cracks. Film coating is an effective way of applying protective...

Film coatings for modified-release applications

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Modified release film coatings can be applied to pharmaceutical products to achieve modification, control the release of a medicinal substance. All coatings on the kinetics of drug release can be divided into the following four types: Coatings that provide periodic release of LV (intermittent release). This type includes coatings resistant to the effects of gastric juice — intestinal soluble coatings. Coatings that provide instant release of LV. Coatings that provide a steady (continuous) release of LV. Coatings that provide delayed (delayed) release of LV. Let's look at each type of coatings in more detail. Coatings that provide periodic release of the medicinal substance. This type of coating provides a prolonged effect of the dosage form, when injected into the body, LV is released in portions,...

Coatings that provide medicine substance release

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With this type of coating, the medicinal substance from the tablets can be released instantly. These types of coatings include polymers developed by BASF: polyvinyl alcohol (PVA), Kollicoat IR white and Kollicoat Protect. PVS-based films are very elastic, but the coating process is possible only in a narrow range of varying technological parameters. This polymer is rapidly dispersed in water during the preparation of the dispersion for the film coating, forms shiny, non-sticky and very flexible films that do not crack during storage. The addition of a plasticizer is not required to create a coating. Kollicoat IR can be replaced by GPMC and other coatings with immediate release of LV in new tablet preparations. The use of Kollicoat IR increases the cost-effectiveness of the coating...

Problems encountered during coating application

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As in the case of sugar coatings, problems may arise after or during the application of the film coating. Tablets, Pellets and granules on which the coating is applied may not be strong enough or delaminate during the coating process. Due to the fact that film coatings are relatively thin, their ability to hide defects is significantly lower than that of sugar coating. When using a film coating, various problems may arise. One example is sticking, which occurs when the fluid flow rate exceeds the drying rate, which causes the gluing of tablets, pellets and granules and their further destruction.

Basic requirements for tablets

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The following requirements are imposed on tablets: dosing accuracy — uniformity (uniformity) of the distribution of the active substance in the tablet, the correctness of the weight of both the tablet itself and the medicinal substances included in it; mechanical strength — hardness, brittleness, fragility — characterize the quality of tablets; tablets must have sufficient strength to remain intact under mechanical influences during packaging, transportation and storage; disintegration or solubility — the ability to disintegrate or dissolve within the time limits established by the relevant scientific and technical documentation (NTD) for certain types of tablets. The accuracy of dosing depends on the uniformity of the tableted mass, which is ensured by careful mixing of medicinal and auxiliary substances and their uniform distribution in the total...