McMurritique (Shanghai) Instrument Co., Ltd.
Micromeritics Instrument (Shanghai) Ltd.
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Mike Powder Fluidity Application-Powder Characterization Technology for Tablets
2019-12-06 点击320次 McMurritique (Shanghai) Instrument Co., Ltd.
Easy-to-take tablets play an important role in daily life. Production of tablets has a long history, dating back a century, but failures still occur in production today. In order to achieve more efficient production, the use of more powerful active ingredients, and more complex tablet structures, all present pharmaceutical companies face huge challenges. From this, knowing how to control the characteristics of the mixture is essential to achieve good processability and obtain high quality end products . The various stages of the tablet manufacturing process expose powder mixtures to different environmental conditions. First, the mixture must be transferred from the hopper to the shoe, and then rotated on the table to flow into the die. The continuous travel of the shoe allows the powder to completely fill the die. The subsequent "small step" is pre-pressing, and the punch advances to compress a certain amount of powder in the die to a preset depth to form a stable tablet. Finally, the sheet is ejected from the die to complete the entire process.
Figure 1-Tablet press
Figure 2-Compaction process of tablets Tablet manufacturers generally use a single parameter or single behavior to describe the powder behavior of a mixture. Take the Karl Index, which is a measure based on loose characteristics, or a cut-box analysis. However, the characterization of powders has developed rapidly over the past decade. Modern instruments such as the FT4 are based on dynamic testing, removing the characterization of loose fit and complementing automated and sophisticated shear testing. At the same time, it can analyze the powder in the state of motion, which is very effective for process-related research and quantification of the fluidity under the influence of viscosity and aeration. For tableting applications, the dynamic flow characteristics quantify the ease with which the mixture can entrain air or enter a partially filled die. In fact, it also includes the possibility of separation between API small particles and excipients and eventual segregation. It is also possible to directly study the air permeability. In an ideal situation, after the powder mixture enters the die, the air should be released as soon as possible to ensure that the filling is complete. Otherwise, the entrained air will be compressed, which will cause lumbar or top crack after compaction. Compressibility is another loose feature that is extremely relevant to the compaction step. For highly compressible mixtures, the thickness, hardness, and mechanical integrity of the tablet will be affected; however, for powders that are not easily compressed, the pressure applied by the punch will be uniformly transmitted, resulting in a more uniform and stable tablet . Shear box and wall friction data are also useful if you need to predict whether the mixture is likely to "build up" or the adhesion of powder to processing equipment. This simple analysis emphasizes the correlation between different powder performance parameters and different stages of the process. Providing a series of properties of the mixture rather than a single parameter makes it easier for the R & D or producer to see this "overall picture". When formulating prescriptions, this type of information also makes for a more comprehensive approach that, combined with good processing characteristics, can be used as a guide for success. In the subsequent process design phase, this data also helps to fully understand and reduces the need for debugging or changes. Finally, in the daily production process, detailed and sensitive powder characteristics can minimize variations between batches of raw materials or intermediates and better troubleshoot. In these methods, investing in the most suitable analytical instrument in the early stage will bring benefits to each stage of the tablet production cycle, thereby ensuring that the powder and equipment are well adapted and have the best long-term stability. It can be seen that focusing on powder measurement can also bring rich benefits.
Vendor Address: Room 1505-1509, Ship Research Building, 600 Minsheng Road, Shanghai 联系人：美国麦克仪器 电话：400-630-2202 传真： Zip code: 200135 Contact person: Mike Instruments, USA Phone: 400-630-2202 Fax: email: Website: www.micromeritics.com.cn Designed by China Powder Net http://astramp.com