PHARMACEUTICAL PRODUCTION TECHNOLOGIES

Ingredients of gelatin capsules

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Soft gelatin capsules are a dosed soft dosage form, which consists of a shell and a drug enclosed in it. Capsules can have different shapes (round, oval, oblong, etc.), different size, color and consistency of the filler. To obtain capsule shells, various film-forming high-molecular substances are used, which are capable of forming elastic films and are characterized by a certain mechanical strength. Gelatin is the most widely used by the modern pharmaceutical industry as a forming material, so most capsules produced in the industry* are gelatin capsules.

Standardization of ointments in production

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Intra-shop control of ointments is carried out at almost every stage of production and especially before packing the drug. The final conclusion on all indicators of the quality of finished products is given by the quality control department of the plant. In the conditions of industrial production, the test is carried out in accordance with the requirements of the general article of the State Pharmacopoeia (GF) for ointments, as well as the requirements included in the articles of the GF for individual names of ointments. The ointment is standardized in appearance, uniformity, content of medicinal substances, pH value, degree of dispersion of solid particles, colloidal stability and thermal stability. The company controls the appearance, smell and characteristic organoleptic properties (if any) of ointments and other…

Dry granulation of powders

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Dry granulation is a method in which a powdery material (a mixture of medicinal and auxiliary substances) is compacted to produce a granulate. Dry granulation is used in cases where wet granulation affects the stability and/or physico-chemical characteristics of the medicinal substance, as well as when the medicinal and auxiliary substances are poorly compressed after the wet granulation process. If medicinal substances undergo physical changes during drying (melting, softening, color change) or enter into chemical reactions, they are briquetted, i.e. briquettes are pressed from the powder on special briquetting presses with large matrices (25x25 mm) under high pressure.

Binders for wet granulation

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There are some requirements for the granulating liquid, one of them is that the granulating liquid should not dissolve the active substance. Water, an aqueous solution of ethanol, acetone and methylene chloride can be used as a granulating liquid. A wide range of substances are used as binding agents for wet granulation in modern pharmaceutical production, for example: starch (5-15% g/g), starch derivatives, cellulose derivatives that improve the plasticity of granules, as well as gelatin (1-3% g/ g) and PVP (3-10% g/ g). The most common and effective binder for wet granulation in the modern pharmaceutical industry is a synthetic polymer such as Collidone (PVP), various brands of which (Collidone 25, 30 and 90F) are widely represented on the market.

Stages of preparation of raw materials for tablet production

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For most chemical and pharmaceutical preparations, the technology of tablet production consists of the following disparate operations of weighing the starting material, grinding, sieving, mixing, granulation, tableting (pressing), coating. Some of the listed operations in the manufacture of pharmaceuticals may be absent. Three common technological schemes for obtaining tablets are most common: using wet granulation, dry granulation and direct pressing.

Standardization of suppositories in the pharmaceutical industry

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All manufactured suppositories must meet the requirements of the State Pharmacopoeia XI: Suppositories must have a homogeneous mass. The uniformity of the suppository is checked visually on the longitudinal section by the presence or absence of inclusions, pieces of the "base, particles of various colors, other inclusions; at the same time, the presence of an air rod is permissible. Deviations in the mass of suppositories are allowed within 5%. Suppositories must have the correct uniform shape. In suppositories, medicinal substances must be precisely dosed. Suppositories should have a hardness that ensures ease of use.

Force to push tablets out of the matrix

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To push the compressed tablet out of the matrix, it is required to expend force to overcome friction and adhesion between the side surface of the tablet and the wall of the matrix. Taking into account the magnitude of the ejection force, additives of antifriction (sliding or lubricating) substances are predicted. As an example, the results of determining the technological characteristics of round-shaped substances are given. Powders with rounded particles with a basic particle size of more than 100 microns (ranitidine g/cl, carbamazepine, phenazepam) have high (8-9 g/s) flowability, high volume density before and after compaction, but insignificant compressibility and a small compaction coefficient. Phenazepam has a slightly lower flowability value (8 g/s), probably because it contains more small fractions and does not contain particles...

Suppository bases and their requirements

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From a physico-chemical point of view, suppositories are considered as dispersed systems consisting of a dispersion medium, represented by the basis of the Dispersed phase, in the role of which medicinal substances act. Depending on the properties of medicinal substances, dispersed systems of suppositories can be either homogeneous or heterogeneous. Homogeneous systems are formed when the medicinal substance is dissolved in the base. Heterogeneous systems are formed in the case of the introduction of medecine into the base by the type of emulsion or suspension. In the structure of suppositories, there are basic (medicinal substances) and auxiliary (carriers or base) components. There are a number of requirements for suppository bases: the bases must maintain sufficient hardness at room temperature; the melting (dissolution) temperature of the...

Tableting pressing in pharmaceutical production

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Tableting (pressing) is the process of forming tablets from granular or powdery material under pressure. In modern pharmaceutical production, tableting is carried out on special presses called tablet machines.

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...