TECHNOLOGY OF DOSAGE FORMS IN PRODUCTION

Basic requirements of gmp soft dosage forms

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.

Technologies and equipment for the production of soft dosage forms

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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.