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At the same time, the valley sterol contained in rice protein, can inhibit the role of cholesterol, the high content of cholesterol in the human body can play a role in regulation and balance.
KARAK , https://www.jsteva.com
I. Film Coating Process and Principle The film coating process is a new type of process developed in the 1940s. It was first produced in the pharmaceutical industry to protect drug films. Compared with sugar coating, it has the characteristics of short production cycle, less material consumption and strong moisture resistance. In the coating process, it can be divided into water-soluble coating process and organic solvent coating process depending on the solvent. The purpose of film coating is mainly to improve the appearance and to facilitate identification, masking bad odor, facilitating patient taking, reducing gastrointestinal reaction, controlling drug release, changing drug release curve, preventing moisture, protecting from light, and isolating air to increase drug stability. The pharmaceutical ingredients with the compatibility changes are placed in the core and the clothing layer respectively or separately after the coating, so as to avoid other changes.
1. Principle When the tablets are run in the coating machine, very fine droplets of the coating solution or suspension are sprayed onto the outer surface of the core, and when the droplets reach the core, they are contacted, spread, and droplets. Inter-joining, forming a film on the surface of the core, in the process of solvent and core between the two roles, namely the solvent on the core and the evaporation of the solvent, when the solvent evaporates The process of the coating is balanced when the amount is equal to the amount of solvent injected. Therefore, in the current research and development process of coating equipment, the main purpose of the improvement is to improve the evaporation efficiency to speed up the spraying speed and shorten the operation time.
2, prescription composition of film-forming materials: must have physicochemical properties such as film formation, solubility and stability. Among them, water-soluble ones include HPMC, Eudragit, L30D, Surelease, etc.; organic solvents include Eudragit, LSRC, HPMC, Shellac, PVAP, CAP, and the like.
Plasticizers include water-soluble propylene glycol, glycerin, polyethylene glycol; water-insoluble phthalates, castor oil, and the like.
Additional ingredients: such as talc, magnesium stearate, pigments, etc.
Solvent: Commonly used are water, ethanol, and the like.
3. Process parameters During the coating process, the parameters affecting the balance between spray and dry can be divided into two categories:
(1) Related to the spray: spray type, spray speed, nozzle diameter, spray gun height, spray pressure.
(2) Related to drying: inlet air temperature, air intake, drying time, batch size.
Another important parameter is the speed of the coating pan, which is not directly related to the spray and drying, but is related to the movement of the material. Adjust the speed to make the movement of the material as regular as possible.
Second, the choice of film coating production equipment is also an aspect of the process operation. There are three main equipments to choose from: traditional coating pans, high-efficiency coating machines, and fluidized beds. Traditional coating pans or non-perforated coating pans, sugar coating process are carried out in traditional coating pans, but the drying efficiency is not ideal, because the dry air flow is only in contact with the film on the surface of the bed, while still storing equipment needs Defects such as modification and inconvenience. Therefore, it is not appropriate to use such equipment for film coating production.
The high-efficiency coating machine is divided into two types: the perforated coating pan and the non-perforated coating pan. The perforated high-efficiency coating pan is a stainless steel fully enclosed structure with a vent hole on the wall of the pot, and the hot air is discharged from the vent hole of the pot wall through the material bed. There is no vent hole on the wall of the non-perforated coating pan, and the hot air outlet is in the material bed, and is discharged from the vent hole at the rear of the pot after passing through the material bed. Both of these methods increase drying efficiency. The coating pan usually has a mixing device to improve the uniformity of drug mixing. The installation of the liquid discharge system differs depending on the condition of the package to transport the spray coating liquid. The dry gas stream can pass through the drug tablet bed from top to bottom or from bottom to top. Such equipment is currently the main equipment for film coating production, mainly for water-soluble film coating and film coating of organic solutions.
Fluidized beds are often used for the coating of water-soluble or organic solvents of small particles, granules or pellets, but because of their strong mechanical force, the drug tablets are prone to wear and are therefore not commonly used.
Third, the problems often encountered in the coating and solutions 1, too wet and wet because the spray speed is too fast relative to the drying efficiency, there is no balance between spray and dry. This phenomenon is more likely to occur during the water-soluble coating process because water is more difficult to dry than organic solvents.
Due to excessive humidity, the tablets stick to the wall of the pot or the tablets stick to each other. This will cause the film to be damaged and uneven. To avoid over-wetting, the spray rate must be carefully controlled and the inlet air temperature can be increased. In addition, the addition of talc or magnesium stearate to the coating solution can improve this phenomenon.
2, the surface is rough, not smooth, in most cases, it is caused by spray drying, because the droplets are not spread when the drying is too fast. In addition, the dried polymer particles stick to the surface of the core, which is liable to cause a rough film. This can be improved by increasing the spray rate, lowering the inlet air temperature or shortening the distance between the spray gun and the bed.
3. Orange peel phenomenon This is a situation in which the surface of the film is rough. The droplets are not completely spread on the surface of the core, and dry polymer particles are irregularly distributed on the surface of the core. This is mainly caused by improper drying, which can be avoided by controlling the evaporation rate, increasing the spray speed or shortening the distance between the spray gun and the bed.
4, bridging and filling phenomenon When the outer surface of the tablet is irregular, engraved with the logo letters, the surface of these signs will disappear, filled with coating liquid. This is usually caused by the viscosity of the coating liquid being too large, increasing the amount of solvent or the amount of plasticizer, and this bridging or filling phenomenon will disappear.
5. Differences in film color In many formulations, there are pigments or dyes that are suspended in the polymer coating solution. If the agitation is too slow, it will cause precipitation, resulting in a difference in color between the batch and the batch. If the temperature is too high, the pigment will be easily diffused and the color of the film will be light. This phenomenon can be improved by reducing the amount of plasticizer and stirring the coating liquid.
6. Film rupture This is one of the problems that often occurs in coatings. The polymer film ruptures and cracks occur. This phenomenon may occur after the coating has been carried out for several hours when problems occur. This is due to the prescription. Adding a larger molecular weight polymer to the coating solution or increasing the amount of plasticizer will prevent this from happening.
In short, a successful coating depends on three main factors: the coating prescription: it must be determined according to the purpose of the coating, and it must be carefully selected, or the finished coating material can be used, and it can be prepared at the time of use; Surface finish, hardness and friability must meet the requirements; Equipment: The main process parameters must be well controlled throughout the coating process.
The film coating process is a novel process that is being widely used for the coating of pharmaceuticals, which is easy to develop and produce, and has a wide range of applications. In recent years, there has been a wealth of experience in the formulation and production of film coating processes. Although there are still some technical difficulties in the coating of traditional Chinese medicine pharmaceutical preparations, the application of this technology will be further expanded with the deepening of research on this technology.
Application of film coating technology in the production process of preparations
Coating means encapsulating a layer of material on the outer surface of the core, which may be powder, granules, pellets or tablets. The coating has various purposes, such as moisture resistance, mechanical resistance, taste masking, coloring or improved release properties of the active ingredient of the drug. The coating process mainly includes two types of sugar coating process and film coating process. The sugar coating process mainly sprays syrup, talcum powder and pigment onto the surface of the core to form a coating layer; the film coating process is to spray a polymer solution or a suspension onto the surface of the core to form a coating layer. The sugar coating process is an older pharmaceutical process. The film coating process is a rising star. Now it has been extensively researched. Different formulations and potential uses are being fully recognized and have attracted the attention of the pharmaceutical industry and rapid promotion.