Film coating is a new kind of coating technology, which refers to a relatively stable thin-layer polymer film on the core of the core. Since the 1930s, there have been successive technological explorations concerning film coating. However, due to the fact that film materials, coating processes, and equipment have not yet been adapted to production requirements, practical applications have been limited. By the 1950s, Abbott Lab first produced a new type of film tablet and patented it under the trademark â€œFilmtabâ€. After nearly 40 years of research and development, the continuous improvement and improvement of production equipment and technology, and the advent of polymer film materials, the film coating technology has been rapidly developed. Foreign countries basically replaced the sugar coating with a film coating. China has only started to develop in recent years. The application of film coating based on foreign drugsâ€”new drugsâ€”general drugs has developed rapidly and has become a â€œnew hot spotâ€ in the pharmaceutical industry.
Film coating process can be widely used in tablets, pills, granules, especially for the hygroscopicity, easy cracking, piebald Chinese medicine tablets show its superiority, compared with film coating and sugar coating, the main advantages are as follows: :
1. Good quality. Because the film former and most of the auxiliary additives are high-molecular materials with excellent physical and chemical properties, the film-coated tablets can not only prevent moisture, light, taste, taste, abrasion, but also are not easy to mold, easy to disintegrate, and greatly improved. The dissolution, bioavailability, and drug expiration date of drugs greatly expand the countries and regions where drugs can be sold, effectively promoting the export of drugs, especially proprietary Chinese medicines.
2. Less weight gain. Only increase the core weight of the tablet by 2% to 4%, and the sugar-coated tablets (in which the main excipients are foreign talcum powder) can often increase the weight of the core by 50% to 100%.
3. Fast drying. Coating operation time is short, generally only 2 ~ 3h, and sugar coating generally takes 16h, easy to operate, easy to grasp, especially for high temperature easy to destroy the Chinese and Western medicine is better to save the quality.
4. Image beauty. Beautiful appearance, bright color, fresh logo, vivid image. The drug core can adopt various flat music shapes. The company's trademarks and logos can be directly punched on the drug core, and the film clothing is still clear and obvious. This can not only enhance the corporate image, but also can play a security role.
5. Many varieties. The film coating has a large number of materials to choose from. Through the design of the coating prescription, the film clothing with different characteristics can be made to change the release position of the drug core and the release characteristics of the drug. In addition to stomach and enterosoluble membranes, there are also oral and continuous membranes, sustained-release membranes, controlled-release membranes, and composite membranes (in addition to the drug core, the membrane also contains another main drug) as well as the most recent ones. Lamellar membranes, microporous membranes, osmotic pump coatings, and targeted dosing coatings greatly increase drug efficacy.
6. Wide application. Now film coating has been widely used not only in tablets and pills, but also in small tablets, pills, granules, soft and hard capsules and even pharmaceutical powders. Film-forming materials can also be used directly. In the film agent (such as a contraceptive membrane, the film containing the main drug without a drug core), suspension and hydrophobic drug dispersant.
7. standardization. The design, process, materials, and quality of film coated tablets can be standardized and then computerized, which is particularly important for GMP management and access to international markets.
8. Little pollution. The process can reduce or avoid the dust flying in the workshop, which is conducive to environmental protection and labor protection. At the same time, it can prevent the pollution in the workshop, which is of great significance to meet the GMP cleanliness requirements under the dynamic conditions.
9. More solvents. The coating agent is generally used as a solvent to prepare the coating solution. This not only reduces the cost, but also makes the operating environment more comfortable and safe. However, it can only use non-aqueous solvents for certain drugs that absorb water quickly or can easily decompose and deteriorate in water. Many solvents are available for this option.
10. low cost. Although film coating materials are more expensive than sugar and talcum powder, due to the small amount and labor saving (1 to 2 operators), there is less need for plant and equipment (only one standard workshop and one coating pan), Saving materials and energy, so the overall calculation is not higher than the cost of icing.
Based on these advantages, with the acceleration of the implementation of GMP, the application of domestic film coating technology is in an accelerating process, the market prospect of film coating is very broad, and the improvement of coating materials and coating technology is also increasing the trend of innovation. Imperative, we have made some explorations in the selection of coating materials, prescription design, and coating technology.
Due to the current international and domestic film coating materials are synthetic or semi-synthetic polymer materials, the serious pollution to the environment caused by the synthesis process and the harm to the human body has attracted people's attention. Returning to nature and advocating green has become fashionable. It is inspired by natural fruit peels, protected by delicate fruit, bright color, and fruity taste. According to the natural skin, it is rich in plant fibers, mucilage, pectin, etc. It has a good filming effect. Pure natural macromolecules, after the structural transformation of these natural macromolecules, the optimized design of the coating prescriptions and processes, the development of a pure natural fruit coating agent, and the national patent has been reviewed (Patent No. is 00128159 Â· 3), has been applied to the film coating of solid preparations, in addition to the advantages of the above synthetic polymer film coating agent, but also has the following characteristics:
1. Pure natural film-forming material. The natural cellulose in the fruit is a linear chain molecule composed of an anhydroglucose unit loop.
2. Perfect fruit mask agent formula design. The combination of orthogonal test design and computer-aided simulation of film coating formulations simulates specific formulations and is easy to use. It also allows formulators to study the results of changing the variables and thus optimize the formulation.
3. Medicinal food dual-use natural raw materials, safe and non-toxic. At present, the international and domestic film coating materials are synthetic and semi-synthetic macromolecules. The hazards to the human body and the environmental pollution during preparation are worrisome. This prescription is mainly made from natural peels and processed through special processes. With the current human body advocates green, return to nature, and green consumption.
4. The natural fruit is pleasant and refreshing. Due to the fact that the synthetic macromolecules always give people a sense of discomfort, the use of a fruit coating agent shows the natural fruit coat color, smooth and delicate, fruity and pleasant.
Tablet quality is the main technical factor affecting film coating. The mechanical properties of the core, in particular hardness, wear resistance, profile and surface regularity, play a major role in the effectiveness of the film coating, which involves adhesive formulation, particle size, moisture, tableting of tablet formulations. The mechanical properties, such as pressure and other studies related to physical chemistry and chemical engineering, especially Chinese medicine tablets are mostly made by extracting extracts and fine powders of medicinal herbs, which are more difficult than chemical pills, so emphasizing the service of the drug core, everything To meet the requirements of the drug core to the maximum extent, this is the latest concept advocated by experts at home and abroad on film coating technology.
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