At present, automatic machines are widely used in industry for pouring suppositories, which produce suppositories in blister packs. This package is intended for packaging suppository mass in contour cells with subsequent sealing, encoding and cutting into strips of the required length. At medium-sized enterprises, suppository machines use a preformed tape, since the molding unit is quite expensive, difficult to set up, and has high operating costs. Therefore, the use of such a node in machines with low productivity is unprofitable. Using a preformed tape allows you to reduce the area occupied by the machine and simplify the production process, since there is no need to supply compressed air, water and ventilation, as well as to remove odors formed during molding. For pharmaceutical production of medium power, the Italian company Dott. BON APACE & S. produces machines of the BP series with productivity from ...
From the physicochemical 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 are medicinal substances. Depending on the properties of drugs, dispersed suppository systems can be either homogeneous or heterogeneous. Homogeneous systems are formed in those cases when the drug substance is dissolved in the base. Heterogeneous systems are formed in the case of the introduction of drugs into the base as an emulsion or suspension. In the structure of suppositories, the main (medicinal substances) and auxiliary (carriers or base) components are distinguished. A number of requirements are imposed on suppository bases: the bases must maintain sufficient hardness at room temperature; the melting temperature (dissolution) of the base should be close to the temperature of the human body; the bases should not irritate the rectal mucosa or cause undesirable effects, i.e. should be physiologically indifferent; suppository bases should not interfere ...
All suppositories produced must meet the requirements of the State Pharmacopoeia XI: Suppositories must have a uniform mass. The homogeneity of the suppository is checked visually on a longitudinal section by the presence or absence of inclusions, pieces of the base, particles of various colors, other inclusions; an air rod is permissible. Deviations in the mass of suppositories are allowed within 5%. Suppositories must have the same regular shape. In suppositories medicinal substances must be accurately metered in. Suppositories must have a hardness that provides ease of use.
There are several methods for manufacturing suppositories, among them: rolling out, pressing and pouring molten mass into molds. The rolling method is often used in pharmacy practice. This method is time-consuming, low-hygienic, and the resulting suppositories are slightly different in appearance. As packaging for suppositories, waxed capsules are used. The pressing method allows the production of suppositories like tablets in eccentric (crank) tablet machines using matrices and punches of the corresponding shape. The production of such suppositories is based on the conversion of fat suppository masses into a powder form, which allows it to freely sleep from a loading funnel. To achieve dosing accuracy and the necessary flowability, the suppository mass is cooled in a refrigerator to a temperature of 3-5 ° C, crushed and sieved through a sieve.
The stage of preparation of the suppository base begins with the weighing of its constituent components. In the first stainless steel reactor with a steam jacket, paraffin is melted, in the second reactor, the hydro fat is melted by supplying steam to the steam jacket. The heated hydro-fat is pumped into the pre-molten paraffin reactor using a pump. The mixture is heated to a temperature of 60-70 ° C and cocoa butter is added. In order to avoid changes in the modification of cocoa butter, the heating should not exceed 70 ° C and be continuous. After the base is completely melted, it is stirred for 40 minutes using a stirrer. In the finished basis, the melting temperature and the time of complete deformation are determined.
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