PHARMACEUTICAL PRODUCTION TECHNOLOGIES

Fluidized bed coating application

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The application of film coatings is carried out in apparatuses for combined granulation, drying and coating processes. A distinctive feature is the lower location of the nozzle. There are two possible ways of organizing the process: applying a film coating directly to crystals or granules containing a medicinal substance; conducting a preliminary stage — layering the medicinal substance on inert particles (pellets are most often used), after which a film coating is applied. During the coating process, a layer of particles is placed in a fluidized bed apparatus.

Filling gelatin capsules with powders and granules

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7590151

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The reproduction and accuracy of dosing depends on the characteristics of the filler, the filling method and the type of filling machine. Active substances for filling into solid gelatin capsules must meet the following requirements: the contents must be released from the capsule, providing high bioavailability; when using automatic filling machines, active substances must have certain physico-chemical and technological properties, such as: certain particle size and shape; the same particle size; mixing homogeneity; flowability (fluidity); moisture content; ability to form compactly under pressure. To fill solid gelatin capsules, machines of various companies are used, differing in performance, dosing accuracy and the structure of the dispenser.

Methods of industrial production of gelatin capsules

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There are three main methods of industrial production of gelatin capsules: immersion method, rotary matrix and drip. It should be noted that for the production of solid capsules, the dipping method has found wide application in industry, being essentially the only one. However, to obtain soft gelatin capsules (with drip sealing), the method is currently used only in laboratory conditions, as it is low-productivity and time-consuming. The stamping method, or rotary matrix, is used for the production of soft gelatin capsules and is the most rational for their production in industrial production. The principle of the method is to first obtain a gelatin tape, from which capsules are stamped on the rolls immediately after they are filled and sealed.

Soft gelatin capsules Basics of technology

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Soft gelatin capsules can also vary in capacity, although there is no clear standardization, unlike hard capsules. Suture soft capsules can hold up to 7.5 ml. The capacity of the rolls of the machine, with which the capsules are formed, filled and sealed, is measured in units called minim. At the same time, 1 minim is equal to an average of 0.062 ml, and the most commonly used roll cell sizes range from 2 to 80 minim. Larger capsules (up to 120 minim) have found application in the perfume industry.

Coating methods and equipment

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In modern pharmaceutical production, the following methods of applying film coatings are used.Coating in drums; coating in a fluidized bed (spraying from above, spraying from below, coating tangentially); technology of jet fluidization. Coating in drums has already been discussed in the section "Methods and equipment for coating".The technological parameters of the film coating process are: temperature, quantity and humidity of incoming and outgoing air, spray rate and pressure from the nozzle, layer temperature. At the same time, the technological parameters can be adjustable (temperature and amount of incoming air), unregulated (humidity at the inlet) and fixed (spray rate and duration of the process. DIOSNA has developed a vertical centrifugal coater VCC (from the English coater — coating plant). Unlike conventional drum-type coating systems, the VCC...

Classification of ointments by type of dispersed systems

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From the point of view of technology (production cycle), as well as the physico-chemical nature of the basis and the nature of the distribution of medicinal substances in the basis, the classification of ointments by the type of dispersed systems is of the greatest importance. According to this classification, homogeneous and heterogeneous ointments are distinguished. Homogeneous ointments are characterized by the absence of an interfacial interface between medicinal substances and the base. In such ointments, medicinal substances are distributed in the base according to the type of solution, i.e. brought to molecular or micellar dispersion. Depending on the method of preparation, these can be: ointments-alloys, which are a combination of several fusible mutually soluble components; ointments-solutions that contain medicinal substances dissolved in the base; extraction...

Classification of ointment bases

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Ointments contain medicinal and auxiliary substances that should be evenly distributed in the dosage form. Excipients form a simple or complex base. Thus, the ointment base is the carrier of the medicinal substance. Depending on the composition, it can have an effect on the release, bioavailability and therapeutic effect of the medicinal substance. The bases provide the necessary mass of ointment, proper concentration of medicinal substances, soft consistency and have a significant impact on the stability of ointments. The degree of release of medicinal substances from ointments, the speed and completeness of their resorption largely depend on the nature and properties of the base. For example, an ointment of 2% boric acid on a consistent emulsion basis exhibits the same therapeutic activity as a similar...

Ointments, requirements for ointments and their classification

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Of soft medicines for external use, ointments are most often used, which consist of an ointment base and a medicinal substance evenly distributed in it. Ointments are soft medicines for topical use, the dispersion medium of which, at a set storage temperature, has a non—Newtonian type of flow and high values of rheological parameters. They are highly viscous liquids capable of forming a smooth continuous film on the surface of the skin or mucous membrane. Ointments are the official dosage form intended for application to the skin, wound or mucous membranes. Despite the fact that ointments belong to the oldest medicinal forms mentioned in the Ebers papyrus, the works of Hippocrates, Galen and Avicenna, they have not lost their significance today, in modern medicine.

Classification of ointments by purpose

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Depending on the purpose of the ointment is divided into the following groups: medical ointments — ointments used for treatment, prevention, diagnosis in dermatology, ophthalmology, cardiology, dentistry, obstetrics, gynecology and other areas of clinical medicine. Cosmetic ointments — decorative, therapeutic, hygienic, for professional cosmetics - are used to soften and nourish the skin. The vitamins contained in them bring these ointments closer to therapeutic ones. Protective ointments — ointments used as personal protective equipment, ointments-films. They are used to protect hands and exposed parts of the body from the effects of chemical irritants in production and in everyday life. Electrode ointments are ointments and pastes for registering biological currents (physiotherapy, encephalography, electrocardiography, etc.). Their role is to fix the electrodes on the body, as well...

Classification of soft dosage forms

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Based on the above, the following classification of soft dosage forms is proposed: 1. Ointments by base type are divided into three groups: hydrophobic (lipophilic), hydrophobic absorption (emulsion) and hydrophilic ointments. Hydrophobic (lipophilic) ointments are prepared mainly on hydrocarbon bases (petroleum jelly, petroleum jelly oil, paraffin) and may contain other lipophilic excipients (vegetable oils, animal fats, waxes, synthetic glycerides and liquid polyalkyl-loxans). Only small amounts of water or aqueous solutions can be introduced into their composition. Hydrophobic ointments when used have an occlusive (preventing contact with air) effect, have a softening effect, are difficult to wash off with water and do not mix with exudate. Hydrophobic absorption ointments. Absorption ointments are hydrophobic, however, when rubbed into the skin, they can absorb (emulsify) exudate. The bases...