——Industry people talk about the status quo of China's related technology development and problems in its application
Film coating technology has been used in the production of pharmaceutical preparations for half a century, and it has been in China for more than 20 years. In recent years, with the rapid development of this technology, "film coating heat" has been set up in pharmaceutical companies. Then, what is the development status of this technology in China, and what problems should pharmaceutical companies pay attention to in the process of applying this technology? Not long ago, Wang Ran senior engineer of Tianjin Ailei Pharmaceutical Materials Co., Ltd. answered these questions for the reporter.
â– "Under class" of sugar coating has become a general trend
Film coatings are favored by pharmaceutical companies for their outstanding technical and cost advantages. As early as a few years ago, many large domestic pharmaceutical companies such as Baiyunshan Chinese Medicine Factory and Zhongxin Pharmaceutical Co., Ltd. had already started the “elimination†of their icings for their main products, and they were replaced with film coatings. At present, a considerable number of pharmaceutical companies in the country have introduced this technology, and replaced the original sugar-coated tablets or plain tablets with "new clothes."
Wang Ran Gaogong told reporters that the traditional sugar coating process generally requires four functional layers. It needs to be layer-dried and takes up to 10 hours or more. Each pot can only contain about 45 kilograms, and the weight gain often reaches 50% to 100%. And the sugar coating is prone to spots, lobes, and fading, and the waste rate is about 8%. The film coating is a continuous film with a thickness of 20~60 microns. The coating time is no more than 5 hours, most of which is about 2.5 hours. Each pot can be packed with 120~180 kg, and the weight gain is generally 1%~5. %, the volume of the core is almost unchanged. Therefore, the process saves packaging materials, is conducive to packaging, transportation, and is more conducive to taking. The film coating is made of natural lake, insoluble in water and alcohol, stable in color and beautiful in appearance, and can be coated on the tablet with the corporate logo or font.
According to Wang Ran, the film coating material not only has better functions than the sugar coating in the above application functions, but more importantly, it has a positive effect on the pharmacodynamic effect of the drug in the body - the film coating is easily collapsed. Solution, can improve the dissolution of the drug and bioavailability, especially suitable for the coating of proprietary Chinese medicine. In terms of standardization of operation, the film coating technology also meets the requirements of GMP: the sugar coating needs to be operated by an experienced master, otherwise the film rate is high; and the film coating only needs to adjust the temperature, rotation speed, wind speed, spray Operating parameters such as liquid volume can be completed by themselves.
Low cost is an important advantage of film coating. Wang Ran said that in terms of material cost, film clothing is more expensive than sugar coating materials, but considering the whole process, plus the economic and social benefits of the former, film coating has more development prospects than sugar coating. Gradually "out of the game" is an inevitable result. According to a statistic, as of 2003, 80% of tablets in Europe and the United States used film coating technology, and now film coating has basically replaced sugar coating. At the moment, in China, although the sugar coating has not been completely replaced by film coating, it is undoubted that being replaced is the general trend.
â– The coating material is looking forward to the "new army"
China's abundant Chinese herbal medicine resources and a large number of traditional Chinese medicine companies have provided a broad application horizon for film coating technology, which has led to the rapid development of this technology in the field of proprietary Chinese medicine preparations. At the same time, China's pharmaceutical excipients have also developed some film coating materials with new features.
According to reports, the solid film materials commonly used in domestic pharmaceuticals are classified into three categories according to different solubility and use requirements, namely hydroxypropyl methylcellulose, ethyl cellulose, and acrylic resin. These materials are either soluble in intestinal fluid or soluble in gastric juice and vary in nature. Based on these characteristics, various coatings such as water-soluble film coating, gastric-soluble film coating, enteric film coating and sustained-release film coating have been developed, which have injected new applications for film coating technology. "vigor".
However, Wang Ran Gaogong rationally evaluated that most of the research work of China's film coating material manufacturers is to provide pharmaceutical companies with "tailor-made" technical services. Although the applied formula research level has already had certain international competitiveness, the research limitations are large, and only minor adjustments are made when the factory conditions change, and no progress has been made in the development of new membrane materials.
Wang Ran believes that the development of new membrane materials not only requires the development of new material materials in the original sense, but also the development of new uses of old polymer materials, so that "old drugs can be used newly."
Researchers abroad have found that polyvinyl alcohol (PVA), which is originally a composite packaging material, can be used as a new film coating material. Studies have shown that although the surface smoothness of PVA film is not good, the stretchability and elasticity of the film still need to be improved, but its advantages are obvious - its cost is very low, and the market has great potential for competition. Its emergence has provided new options for film coating technology materials. Compared with the current state of technological development in foreign countries, Wang Ran believes that China still has a lot of research work to do in the field of new membrane materials research and development.
â– Application misunderstanding
Wang Ran pointed out that although film coating technology has been popularized in China's pharmaceutical industry, many companies have many misunderstandings about the application of this technology.
Misunderstanding 1: The moisture-proof effect is pulled up. In the sales process of coating materials, because of improper publicity, many pharmaceutical companies believe that ordinary film coating materials have strong moisture-proof function, so they expect to use common coating materials to protect certain moisture absorption. The core of the drug, but often does not achieve the desired effect after application. It should be clear that ordinary coating materials may have some moisture-proof effect, but only have a small effect and should not be raised to the main role.
Misunderstanding 2: Do not pay attention to "tailoring tailoring." Some companies regard film coating technology only as an isolated link or a single process in the production of tablets, blindly expanding the scope of application of certain types of coated powder. In actual production, the production operating conditions are often changed, but the coating powder is not adjusted accordingly, resulting in unstable film coating quality.
Wang Ran pointed out that the coated powder may only be suitable for one or several cores. After the core has changed, the formula must be re-adjusted to find a suitable coating powder, which cannot be taken for granted. Film coating is a complete set of new technologies, including accessories, operation technology, production links, tablet coating and other production processes in a series of technical indicators and requirements adjustment and mutual support, and the production of traditional sugar-coated tablets is very different.
Misunderstanding 3: The quality of the coated powder was evaluated by the coating effect. "Evaluation of the quality of coated powder requires consideration of comprehensive factors, including particle size, color difference, degree of polymerization, solubility, and tensile strength, elongation, etc. of the film. The coating effect is not in one-to-one correspondence with the quality of the coated powder. Wang Ran said that although the coating powder is one of the factors affecting the coating effect, the mechanical properties of the core, such as hardness, friability, abrasion resistance and surface finish, have a decisive influence on the coating effect.
In addition, equipment factors are also important. The high-efficiency coating machine is easier to operate than the film coating pan modified by the ordinary sugar-coated pot. The computer-controlled high-efficiency pot has better effect than the ordinary high-efficiency pot, and the liquid-dispensing system, the hot air system, and the motor drive system also have a good fit.
If the operating conditions are different, the coating effect will be different. During the operation, the air volume, temperature, speed, liquid volume, and air volume should be dynamically balanced, and the core changes should be observed at any time to adjust various parameters.
In particular, for certain Chinese medicine tablets containing more fats and oils and more volatile components, it is necessary to comprehensively consider equipment, raw materials, auxiliary materials, and processes to achieve the desired coating effect.
â– Related links:
*film coating
The use of various chemically stable inert polymer compounds to distinguish their physical properties and their molecular arrangement and structural characteristics, activate specific groups of such molecules without changing the chemical properties, activate surface activity, and change the original single The molecular arrangement of the substances forms a new film-forming mixture - film coating powder. The film coating powder is added to a solvent (water or ethanol) to form a uniformly dispersed mixture, which is coated by a spray film to form a plastic film of several micrometers thick and coated on the processed product. This process is called a film. Coating.
* Classification of coated powder
According to different solvents, it can be divided into: all-water type, alcohol type, alcohol-water type; according to different parts and characteristics of film coating dissolved, disintegrated and dispersed in the human body, it can be divided into: gastric film, enteric film, oral solution Membrane, sustained release film, and controlled release film; according to the requirements of the coated powder for the plain film, it can be divided into ordinary type, moisture proof type, instant type, high adhesion type and the like.
Film coating technology has been used in the production of pharmaceutical preparations for half a century, and it has been in China for more than 20 years. In recent years, with the rapid development of this technology, "film coating heat" has been set up in pharmaceutical companies. Then, what is the development status of this technology in China, and what problems should pharmaceutical companies pay attention to in the process of applying this technology? Not long ago, Wang Ran senior engineer of Tianjin Ailei Pharmaceutical Materials Co., Ltd. answered these questions for the reporter.
â– "Under class" of sugar coating has become a general trend
Film coatings are favored by pharmaceutical companies for their outstanding technical and cost advantages. As early as a few years ago, many large domestic pharmaceutical companies such as Baiyunshan Chinese Medicine Factory and Zhongxin Pharmaceutical Co., Ltd. had already started the “elimination†of their icings for their main products, and they were replaced with film coatings. At present, a considerable number of pharmaceutical companies in the country have introduced this technology, and replaced the original sugar-coated tablets or plain tablets with "new clothes."
Wang Ran Gaogong told reporters that the traditional sugar coating process generally requires four functional layers. It needs to be layer-dried and takes up to 10 hours or more. Each pot can only contain about 45 kilograms, and the weight gain often reaches 50% to 100%. And the sugar coating is prone to spots, lobes, and fading, and the waste rate is about 8%. The film coating is a continuous film with a thickness of 20~60 microns. The coating time is no more than 5 hours, most of which is about 2.5 hours. Each pot can be packed with 120~180 kg, and the weight gain is generally 1%~5. %, the volume of the core is almost unchanged. Therefore, the process saves packaging materials, is conducive to packaging, transportation, and is more conducive to taking. The film coating is made of natural lake, insoluble in water and alcohol, stable in color and beautiful in appearance, and can be coated on the tablet with the corporate logo or font.
According to Wang Ran, the film coating material not only has better functions than the sugar coating in the above application functions, but more importantly, it has a positive effect on the pharmacodynamic effect of the drug in the body - the film coating is easily collapsed. Solution, can improve the dissolution of the drug and bioavailability, especially suitable for the coating of proprietary Chinese medicine. In terms of standardization of operation, the film coating technology also meets the requirements of GMP: the sugar coating needs to be operated by an experienced master, otherwise the film rate is high; and the film coating only needs to adjust the temperature, rotation speed, wind speed, spray Operating parameters such as liquid volume can be completed by themselves.
Low cost is an important advantage of film coating. Wang Ran said that in terms of material cost, film clothing is more expensive than sugar coating materials, but considering the whole process, plus the economic and social benefits of the former, film coating has more development prospects than sugar coating. Gradually "out of the game" is an inevitable result. According to a statistic, as of 2003, 80% of tablets in Europe and the United States used film coating technology, and now film coating has basically replaced sugar coating. At the moment, in China, although the sugar coating has not been completely replaced by film coating, it is undoubted that being replaced is the general trend.
â– The coating material is looking forward to the "new army"
China's abundant Chinese herbal medicine resources and a large number of traditional Chinese medicine companies have provided a broad application horizon for film coating technology, which has led to the rapid development of this technology in the field of proprietary Chinese medicine preparations. At the same time, China's pharmaceutical excipients have also developed some film coating materials with new features.
According to reports, the solid film materials commonly used in domestic pharmaceuticals are classified into three categories according to different solubility and use requirements, namely hydroxypropyl methylcellulose, ethyl cellulose, and acrylic resin. These materials are either soluble in intestinal fluid or soluble in gastric juice and vary in nature. Based on these characteristics, various coatings such as water-soluble film coating, gastric-soluble film coating, enteric film coating and sustained-release film coating have been developed, which have injected new applications for film coating technology. "vigor".
However, Wang Ran Gaogong rationally evaluated that most of the research work of China's film coating material manufacturers is to provide pharmaceutical companies with "tailor-made" technical services. Although the applied formula research level has already had certain international competitiveness, the research limitations are large, and only minor adjustments are made when the factory conditions change, and no progress has been made in the development of new membrane materials.
Wang Ran believes that the development of new membrane materials not only requires the development of new material materials in the original sense, but also the development of new uses of old polymer materials, so that "old drugs can be used newly."
Researchers abroad have found that polyvinyl alcohol (PVA), which is originally a composite packaging material, can be used as a new film coating material. Studies have shown that although the surface smoothness of PVA film is not good, the stretchability and elasticity of the film still need to be improved, but its advantages are obvious - its cost is very low, and the market has great potential for competition. Its emergence has provided new options for film coating technology materials. Compared with the current state of technological development in foreign countries, Wang Ran believes that China still has a lot of research work to do in the field of new membrane materials research and development.
â– Application misunderstanding
Wang Ran pointed out that although film coating technology has been popularized in China's pharmaceutical industry, many companies have many misunderstandings about the application of this technology.
Misunderstanding 1: The moisture-proof effect is pulled up. In the sales process of coating materials, because of improper publicity, many pharmaceutical companies believe that ordinary film coating materials have strong moisture-proof function, so they expect to use common coating materials to protect certain moisture absorption. The core of the drug, but often does not achieve the desired effect after application. It should be clear that ordinary coating materials may have some moisture-proof effect, but only have a small effect and should not be raised to the main role.
Misunderstanding 2: Do not pay attention to "tailoring tailoring." Some companies regard film coating technology only as an isolated link or a single process in the production of tablets, blindly expanding the scope of application of certain types of coated powder. In actual production, the production operating conditions are often changed, but the coating powder is not adjusted accordingly, resulting in unstable film coating quality.
Wang Ran pointed out that the coated powder may only be suitable for one or several cores. After the core has changed, the formula must be re-adjusted to find a suitable coating powder, which cannot be taken for granted. Film coating is a complete set of new technologies, including accessories, operation technology, production links, tablet coating and other production processes in a series of technical indicators and requirements adjustment and mutual support, and the production of traditional sugar-coated tablets is very different.
Misunderstanding 3: The quality of the coated powder was evaluated by the coating effect. "Evaluation of the quality of coated powder requires consideration of comprehensive factors, including particle size, color difference, degree of polymerization, solubility, and tensile strength, elongation, etc. of the film. The coating effect is not in one-to-one correspondence with the quality of the coated powder. Wang Ran said that although the coating powder is one of the factors affecting the coating effect, the mechanical properties of the core, such as hardness, friability, abrasion resistance and surface finish, have a decisive influence on the coating effect.
In addition, equipment factors are also important. The high-efficiency coating machine is easier to operate than the film coating pan modified by the ordinary sugar-coated pot. The computer-controlled high-efficiency pot has better effect than the ordinary high-efficiency pot, and the liquid-dispensing system, the hot air system, and the motor drive system also have a good fit.
If the operating conditions are different, the coating effect will be different. During the operation, the air volume, temperature, speed, liquid volume, and air volume should be dynamically balanced, and the core changes should be observed at any time to adjust various parameters.
In particular, for certain Chinese medicine tablets containing more fats and oils and more volatile components, it is necessary to comprehensively consider equipment, raw materials, auxiliary materials, and processes to achieve the desired coating effect.
â– Related links:
*film coating
The use of various chemically stable inert polymer compounds to distinguish their physical properties and their molecular arrangement and structural characteristics, activate specific groups of such molecules without changing the chemical properties, activate surface activity, and change the original single The molecular arrangement of the substances forms a new film-forming mixture - film coating powder. The film coating powder is added to a solvent (water or ethanol) to form a uniformly dispersed mixture, which is coated by a spray film to form a plastic film of several micrometers thick and coated on the processed product. This process is called a film. Coating.
* Classification of coated powder
According to different solvents, it can be divided into: all-water type, alcohol type, alcohol-water type; according to different parts and characteristics of film coating dissolved, disintegrated and dispersed in the human body, it can be divided into: gastric film, enteric film, oral solution Membrane, sustained release film, and controlled release film; according to the requirements of the coated powder for the plain film, it can be divided into ordinary type, moisture proof type, instant type, high adhesion type and the like.
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