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It was found that the compacted powders in capsules disintegrate 2 times longer than freely filled, but the difference becomes insignificant with the introduction of disintegrants. As such, aerosil (colloidal silicon dioxide), talc, calcium carbonate are mainly used. Thixotropics are substances that give the necessary flowability to excipients: they reduce the viscosity of pasty masses with permissible heating (ethanol) or increase the viscosity of easily flowing masses for filling capsules (polyethylene glycol wax, soya lecithin, etc.). Other additives may be added as adjuvants if necessary. Filling hard gelatin capsules is carried out in several stages: orientation of empty capsules; separation (opening) of empty capsules marriage); capsule scanner; filling the capsule body; removal of defective capsules; capsule closure; unloading capsules; capsule cleaning.
The pins are lowered into the molten gelatin mass, which solidifies on them with a thin shell. The shell is removed, filled, and then molded (fix the form by drying under a certain mode). The described method has found wide application in industry in the manufacture of shells of hard gelatin capsules, being, in fact, the only one. After the manufacture of shells of hard capsules, they are filled with medicinal and auxiliary substances. Filling hard gelatin capsules. In addition to the active substance, auxiliary ingredients are introduced into the composition for filling capsules (in order to give it the necessary technological characteristics and, if necessary, biopharmaceutical properties), which should be biologically indifferent, namely: Fillers, or diluents, - substances, giving the mass for filling capsules the necessary optimal volume.
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For these purposes, in the manufacture of drugs in molds? hard capsules are used milk sugar, microcrystalline cellulose (MCC), dibasic calcium phosphate and other substances that allow you to adjust bulk density and give the filler the necessary flowability. MCC, in addition, allows you to slow down the absorption process, which is important for the prolonged action of the drug. Moving substances - substances that give the mass for filling capsules the necessary flowability. Commonly used are calcium or magnesium stearate, stearic acid, talc. Their number, as a rule, is 0.5-2.0%. For example, the introduction of 0.1-0.3% aerosil or magnesium stearate with 0.5-1.0% talc may be sufficient. Disintegrants - substances that contribute to the deaggregation of encapsulated powder mass.