Tablets are currently one of the most widely used dosage forms, with the largest output and the most widely used. The traditional wet granulation process is still the mainstream process in the production of pharmaceuticals. It has mature production processes, good particle quality, high production efficiency, and compression molding. Good and other advantages, it is the most widely used in the pharmaceutical industry.
The manufacturing process of tablets can generally be divided into the processing of raw and auxiliary materials, weighing, granulating, drying, mixing, tableting, coating, etc. There is a saying in the industry: granulation is the leader, tableting is the core, and packaging is Phoenix tail, it can be seen that the granulation process plays a pivotal role in the entire tablet production, but how to make soft materials and obtain granules, so far there is only a very deep meaning in the textbooks "holding into a ball, touching and dispersing" , Has not been elaborated. Based on the author's personal experience in actual production, this article analyzes several common factors affecting the stability of the tablet wet granulation process, and proposes relevant control measures to ensure the quality of drug production.
Pretreatment of raw materials
The raw and auxiliary materials generally need to be crushed and screened before wet mixing and granulation production. Some unqualified phenomena that often occur in the process of tableting, such as uneven mixing, splitting, sticking or dissolution, etc., are closely related to the insufficient pulverization fineness of the raw materials during pretreatment. If the raw materials are scaly or needle-shaped crystals, the possibility of the above deviations will be more obvious. The screen for pretreatment, crushing and sieving in the traditional process is generally 80 mesh or 100 mesh screen, but with the advancement of equipment and raw material technology, most of the raw materials that have been crushed through the 80 mesh screen in the traditional process can now exceed 100. The probability of the above phenomenon is greatly reduced for the fine powder that has been crushed through the 100-mesh sieve. Therefore, the fineness of the raw and auxiliary materials through the 100-mesh sieve is gradually replacing the 80-mesh sieving process.
The manufacturing process of tablets can generally be divided into the processing of raw and auxiliary materials, weighing, granulating, drying, mixing, tableting, coating, etc. There is a saying in the industry: granulation is the leader, tableting is the core, and packaging is Phoenix tail, it can be seen that the granulation process plays a pivotal role in the entire tablet production, but how to make soft materials and obtain granules, so far there is only a very deep meaning in the textbooks "holding into a ball, touching and dispersing" , Has not been elaborated. Based on the author's personal experience in actual production, this article analyzes several common factors affecting the stability of the tablet wet granulation process, and proposes relevant control measures to ensure the quality of drug production.
Pretreatment of raw materials
The raw and auxiliary materials generally need to be crushed and screened before wet mixing and granulation production. Some unqualified phenomena that often occur in the process of tableting, such as uneven mixing, splitting, sticking or dissolution, etc., are closely related to the insufficient pulverization fineness of the raw materials during pretreatment. If the raw materials are scaly or needle-shaped crystals, the possibility of the above deviations will be more obvious. The screen for pretreatment, crushing and sieving in the traditional process is generally 80 mesh or 100 mesh screen, but with the advancement of equipment and raw material technology, most of the raw materials that have been crushed through the 80 mesh screen in the traditional process can now exceed 100. The probability of the above phenomenon is greatly reduced for the fine powder that has been crushed through the 100-mesh sieve. Therefore, the fineness of the raw and auxiliary materials through the 100-mesh sieve is gradually replacing the 80-mesh sieving process.
