The next stage in the production of ointments is the introduction of medicinal substances into the ointment base. At the same time, it is necessary to pay attention to the following factors: the degree of dispersion of medicinal substances; their uniform distribution over the entire mass of the base; the method of administration of medicinal substances into the base; time, speed and order of mixing of components; temperature regime, etc. Medicinal substances are injected into ointments taking into account their quantity and physico-chemical properties. They come in three types: soluble in the base; easily soluble in water; insoluble neither in the base nor in water.
The main components in most finished dosage forms with a film coating are polymers, plasticizers, dyes and solvents (or the liquid phase). Polymers. Ideal properties for the polymer are solubility in a wide range of solvents for the variation of the composition of the finished dosage form, the possibility of creating a coating with suitable mechanical properties, and the corresponding solubility in gastrointestinal fluids - such as not to reduce the bioavailability of medicinal substances. The most suitable polymers for film coatings are cellulose esters, especially hydroxypropylmethylcellulose (HPC), hydroxypropylcellulose (HPC), with which slightly sticky coatings are obtained, and methylcellulose (MC), although this polymer can slow down the dissolution of the medicinal substance. Alternatives to cellulose esters are acrylic copolymers (such as methacrylic and methyl methacrylic...
One of the problems of tablet production is obtaining good granulate fluidity in feeding devices (funnels, bunkers). The resulting granules or powders have a rough surface, which makes it difficult for them to pour out of the loading funnel into the matrix sockets. In addition, the granules can stick to the walls of the die and punch due to friction developed in the contact zones of the particles with the press tool of the tablet machine. To remove or reduce these undesirable phenomena, antifriction substances are used, represented by a group of sliding and lubricating substances. Sliding substances, adsorbed on the surface of particles (granules), eliminate or reduce roughness, increasing their fluidity (flowability). Particles having a spherical shape have the greatest sliding efficiency.
The principal difference between the aerosol method and others is the presence of a gas dispersed medium and, as a consequence, with a significantly smaller size of interacting particles and formed microcapsules.
As noted earlier, the creation of effective medicines requires the use of a large number of excipients. Auxiliary substances in tablet production are intended to give the tablet mass the necessary technological properties that ensure: dosing accuracy, mechanical strength, disintegration, stability during storage. The effect of excipients on the effectiveness and quality of medicines, as well as the requirements for excipients. According to their functional purpose, the excipients are divided into six groups. Fillers (diluents) are added to obtain a certain mass of tablets. With a small dosage of LV (usually 0.01—0.001 g) or when tableting potent, toxic substances, fillers can be used to regulate certain technological indicators (strength, disintegration, etc.). Fillers determine the technological properties of the mass for tableting and the physical and...
Hydrophilic bases are mixed with water in any ratio. The following ointment bases are hydrophilic: solutions and gels of polysaccharides; solutions and gels of natural and synthetic polymers; phytosterol gels; gels of clay minerals; solutions and gels of proteins. The advantages of hydrophilic bases are: the possibility of introducing a significant amount of aqueous solutions of medicinal substances; ease of release of medicinal substances, which ensures their high bioavailability; good absorbency into the skin, the bases are easily removed from the application site and washed off with water from the skin. The disadvantages of hydrophilic bases include microbial contamination and rapid drying (this property does not apply to polyethylene oxides), as well as incompatibility with a number of medicinal substances and susceptibility to syneresis, a...
The next stage in the production of ointments is homogenization. This is a specific stage, since when mixing, the desired degree of dispersion of medicinal substances is not always achieved. For homogenization, various equipment is used, such as roller or disc masers, millstones and colloidal mills, as well as homogenizers-dispersants. Roller mazeterki have two or three rolls with a smooth surface, rotating towards each other at different speeds, ensuring the transition of ointment from shaft to shaft and increasing the friction between them. Rolls are made of porcelain, basalt or metal. To maintain the optimal temperature of the ointment entering the rolls, they are made hollow so that, if necessary, water can be supplied inside. Mazeterka is a system of three rolls in contact with...
The German-Swiss company FrymaKoruma, part of the Romaco group of companies, is well known in the world market of pharmaceutical equipment. In Russia, the equipment of this company is also widely represented at many enterprises. In particular, at one of the leading Russian pharmaceutical enterprises JSC Akrikhin, the production of ointments and creams is carried out at the Disho installation of FrymaKoruma. Vacuum is a production plant for liquid and pasty products FrymaKoruma MaxxD, which has the same principle of operation as the Disho installation, but is a more modern development of the company. FrymaKoruma MaxxD is a modular system for the production of emulsions and suspensions with a wide range of viscosity. The main advantages of the plant are high production efficiency, reduced operating...
Hydrophobic, or lipophilic, bases are chemically heterogeneous substances and their mixtures with pronounced hydrophobicity. This group includes: fat bases; hydrocarbon bases; silicone bases. Fat bases include animal, vegetable and hydrogenated fats, as well as waxes. Animal fats by chemical nature are triglycerides of higher fatty acids. By their properties, they are close to the fatty secretions of the skin. In addition, fats contain unsaponifiable components, among which cholesterol predominates. Of animal fats, pork fat is the most common — Adeps suillus seu Axungiaporcina (depurata). It is a mixture of triglycerides of stearic, palmitic, oleic and linoleic acids. Pork fat also contains a small amount of cholesterol. It is a white mass almost odorless with a melting point of 34-36 "C. Ointments on pork fat are...
Wet granulation is subjected to powders having poor flowability and insufficient ability to bond between particles. In both cases, binding solutions are added to the mass, improving the adhesion between the particles. Granulation, or wiping of the wet mass, is carried out in order to compact the powder and obtain uniform grains — granules with good flowability. Wet granulation includes successive stages: grinding of substances into a fine powder and mixing of dry medicinal substance with auxiliary substances; mixing of powders with granulating liquids; granulation; drying of wet granules; powdering of dry granules. Grinding and mixing is carried out in mills and mixers of various designs presented earlier. The resulting powder is sifted through a sieve.
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