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.
The process of making ointments can be periodic or continuous. The periodic process can be one-, two-, three-stage, etc., depending on the number of devices in which separate stages of the process of obtaining ointments are consistently carried out. The technology of manufacturing ointments at pharmaceutical enterprises is carried out in accordance with the regulations. It includes the following stages: sanitary treatment of premises and equipment; preparation of raw materials (medicinal substances, ointment base, packaging containers, etc.); introduction of medicinal substances into the base; homogenization of ointments; standardization; packing and storage of ointments. Sanitary treatment of premises and equipment is aimed at preventing microbial contamination during the production, storage and transportation of ointments, at creating safe working conditions and protecting the health of workers.
According to the composition of the adhesive masses, plasters are divided into ordinary and rubber. Ordinary plasters (Emplastra Ordinarid) are divided into lead, lead-resin, lead-wax and resin-wax depending on the substances prevailing in the plaster base. These patches contain lead soap as a mandatory component, which has the following positive properties: it has no hardness, is easily fused with resins, waxes and various medicinal substances, and is also stable during storage.
A negative property of lead soaps is their non-indifference. A simple lead plaster (Emplastrum Plumbi simplex). The group of lead patches includes a simple lead patch, which is chemically a mixture of lead salts of higher fatty acids (stearic, palmitic and oleic), and also contains traces of unsaponified fats and no more than 3% water. The patch consists of 10 parts of sunflower oil, 10 parts of purified pork fat, 10 parts of lead oxide in the smallest powder and distilled water in the amount necessary for the formation of a homogeneous plastic mass. The basis for obtaining this patch is the reaction of saponification of fats with lead oxide in the presence of water at the coating point of the mass in a st...