New accessories make the application of powder direct compression method more and more widely
Zyzhan guide: At present, China's tablet production is still the most widely used wet pellets, but the application of powder direct compression technology in domestic and foreign pharmaceutical companies is gradually receiving attention. At present, domestic wet pellets are the most widely used. However, with the development of new excipients, the application of powder direct compression method has become more and more widespread.
At present, tablets are the most widely used dosage form, and their preparation can be divided into two types: particle tableting method and direct tableting method. The granule tableting method can be divided into two types according to the process of preparing granules: wet granule tableting method and dry granule tableting method; and direct tableting method is divided into powder direct compression method and crystallization directly due to different main drug properties. Tableting method.
Direct tableting of the powder means that the powder of the drug is separately sieved and mixed with a suitable excipient, and then directly compressed into tablets without being subjected to granulation (wet granules or dry granules).
In the traditional wet granulation, factors such as the amount of binder added, the drying time of the granules, the granulation time of the granules of the granules, etc., the number of machines required for production is large, the space is large, and some factors need to rely on experience judgment, which may result in Product quality is unstable, and there are large differences between batches.
The most significant advantage of direct compression technology is that it reduces the cost of equipment and operation: its production process is simple, no granulation, sieving, drying, sizing and intermediate sampling testing are required, which reduces the investment in the corresponding equipment factory and Inspection cost and labor intensity, saving time and energy, and not determining the quality of the product due to the experience of the worker, making the final product quality stable, small difference between batches, operability, continuous production guaranteed, especially suitable for GMP production management.
The drug for direct compression of the powder should have a certain thickness or crystal form; the drug powder should have good fluidity, compressibility and lubricity. However, most drugs do not have these characteristics, which need to be solved by improving the performance of the material and improving the performance of the tablet press.
At present, direct compression equipment is constantly being updated and improved. By improving the feeding device and dust removal device, the company can improve the pre-compression mechanism to help ensure the smooth progress of the entire direct compression process. The flowability of the fine powder is not as good as that of the granules. It is easy to appear in the powder feeder or the flow is fast and slow, resulting in a difference in the weight of the tablets. The use of the oscillating feed or the forced feeding device allows the powder to flow evenly into the die hole.
Since the air present in the powder is more than the particles, it is easy to produce a top crack when the tablet is pressed, and the tableting speed is lowered, or the second compression is performed, that is, the first compression is performed for the first time, and the second compression of the tablet is solved for the second time. This problem, and because of the increased compression time, is conducive to the discharge of air in the powder, reduce the phenomenon of splitting, increase the hardness of the tablet; in addition, because the powder is flying, when the powder is directly compressed, more dust will be generated. Sometimes there is a phenomenon of powder leakage, so the tablet press should have an automatic closed feeding device, a good dust removal device and a tight joint between the duster and the turntable.
At present, tablets are the most widely used dosage form, and their preparation can be divided into two types: particle tableting method and direct tableting method. The granule tableting method can be divided into two types according to the process of preparing granules: wet granule tableting method and dry granule tableting method; and direct tableting method is divided into powder direct compression method and crystallization directly due to different main drug properties. Tableting method.
Direct tableting of the powder means that the powder of the drug is separately sieved and mixed with a suitable excipient, and then directly compressed into tablets without being subjected to granulation (wet granules or dry granules).
In the traditional wet granulation, factors such as the amount of binder added, the drying time of the granules, the granulation time of the granules of the granules, etc., the number of machines required for production is large, the space is large, and some factors need to rely on experience judgment, which may result in Product quality is unstable, and there are large differences between batches.
The most significant advantage of direct compression technology is that it reduces the cost of equipment and operation: its production process is simple, no granulation, sieving, drying, sizing and intermediate sampling testing are required, which reduces the investment in the corresponding equipment factory and Inspection cost and labor intensity, saving time and energy, and not determining the quality of the product due to the experience of the worker, making the final product quality stable, small difference between batches, operability, continuous production guaranteed, especially suitable for GMP production management.
The drug for direct compression of the powder should have a certain thickness or crystal form; the drug powder should have good fluidity, compressibility and lubricity. However, most drugs do not have these characteristics, which need to be solved by improving the performance of the material and improving the performance of the tablet press.
At present, direct compression equipment is constantly being updated and improved. By improving the feeding device and dust removal device, the company can improve the pre-compression mechanism to help ensure the smooth progress of the entire direct compression process. The flowability of the fine powder is not as good as that of the granules. It is easy to appear in the powder feeder or the flow is fast and slow, resulting in a difference in the weight of the tablets. The use of the oscillating feed or the forced feeding device allows the powder to flow evenly into the die hole.
Since the air present in the powder is more than the particles, it is easy to produce a top crack when the tablet is pressed, and the tableting speed is lowered, or the second compression is performed, that is, the first compression is performed for the first time, and the second compression of the tablet is solved for the second time. This problem, and because of the increased compression time, is conducive to the discharge of air in the powder, reduce the phenomenon of splitting, increase the hardness of the tablet; in addition, because the powder is flying, when the powder is directly compressed, more dust will be generated. Sometimes there is a phenomenon of powder leakage, so the tablet press should have an automatic closed feeding device, a good dust removal device and a tight joint between the duster and the turntable.
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