TECNOLOGÍAS DE PRODUCCIÓN FARMACÉUTICA

Requisitos básicos para tabletas

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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...

Organización de la producción moderna de ungüentos

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General recommendations for the selection of pharmaceutical equipment. The right choice of equipment is one of the most important issues of the organization of modern industrial production. Reliable, optimally selected and well-proven equipment largely determines the quality of the manufactured product, its competitiveness, and is also a guarantee of the successful development of production as a whole. The selection of equipment (for the pre-modern production of pharmaceutical products is carried out on the basis of many criteria. First of all, the equipment must be designed and optimally suited for the technological processes of production of a particular pharmaceutical product. Usually, preference is given to production machines and installations that allow several technological operations to be carried out at once, since their structural elements and operating...

Prensado directo de polvos en producción

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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...

Polimerización y policondensación

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When microencapsulating solid particles by polymerization and polycondensation methods, a polymerization initiator is pre-grafted onto the surface of the encapsulated substance.

Peletización en la producción farmacéutica

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To study the formation of pellets (microspheres), it is necessary to understand the mechanisms of formation and growth of granules. Some theories were derived from experimental data, others were derived from visual observations. Conventional granulation as the most fully studied and classified process of formation of microspheres, carried out using different equipment, was divided into three successive stages: the stage of core formation, the transitional stage and the stage of sphere growth. However, based on experiments to study the mechanism of formation and growth of microspheres, the following mechanisms of microspheres growth have been proposed: core formation, joining, layering and transfer of material by friction.

Producción industrial de yesos

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Adhesive plasters "Uniplast fixing", "Bactericidal Veropharm" and "Uniplast bactericidal" Modern industrial production of plasters is characterized by a wide range of products. Therefore, it is not possible to consider in detail in one section the production of all types of plasters. In order to understand the specifics of the technological production of plasters, as well as to get acquainted with the main types of equipment used, as an example, consider the production of adhesive plasters "Uniplast fixing", "Bactericidal Veropharm" and "Uniplast bactericidal", organized at the Voronezh Chemical and Pharmaceutical Plant, which is part of JSC "VEROPHARM". The adhesive plaster "Uniplast fixing" is produced in accordance with international quality standards. It is hypoallergenic, has high breathability, is easily and painlessly removed, easily tears without using scissors...

Peletización por capas

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Microspheres can also be made by layering a medicinal substance on inert microspheres. The layering process is a sequential application of layers of a medicinal substance from a solution, suspension or dry powder to the nuclei. The nuclei can be crystals or granules of the same material or inert particles. When layered from a solution or suspension, the particles of the medicinal substance are dissolved or suspended in a liquid. When the powder is layered, complete dissolution does not occur due to the small amount of liquid, regardless of the solubility of the active component in the liquid. When powder coating of the drug, the binder solution is first sprayed onto the inert nuclei, and then the powder is applied. By adding a layer-forming component,...

Máquinas rotativas de comprimidos

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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…

Requisitos básicos de las formas farmacéuticas blandas gmp

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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.

Cribado de polvo en producción

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When grinding solid materials on the equipment discussed earlier, a homogeneous product is practically not obtained, Therefore, such an operation as sieving is necessary to separate larger particles. Sieving is an integral part of grinding to obtain a mixture with a certain granulometric composition. Sieving eliminates soft conglomerates of powders by rubbing them through perforated plates or sieves with a certain size of holes. Sieving, or screening, is the process of separating a mixture of grains of various sizes using sieves into two (or more) groups. The size of the grains passing through the sieve cells is characterized by a number. There are 16 different sieves, which correspond to 7 degrees of grinding.