Views:3 Author:Site Editor Publish Time: 2020-10-13 Origin:Site
The direct and auxiliary materials of the tablet press
The difference between direct and wet granulation is that the material required for the presser is fine powder in powder form, and the presser and fluidity of the material will determine the quality of the final product. Since the fluidity and compressibility of all kinds of drug powder cannot meet the requirements of direct tablets, it is one of the most direct and effective ways to improve the fluidity of drugs to select the auxiliary agent with superior performance. Compared with wet granulation, the correct selection of auxiliary materials in direct stamping process is more strict. However, traditional excipients do not combine good fluidity with excellent compressibility, adhesion, high adhesion and low sensitivity to lubricating oil to meet the requirements of direct compression. The traditional starch, dextrin and sugar powder have poor fluidity and compressibility. Therefore, it is a new topic to develop auxiliary materials suitable for direct powder printing.
After detailed analysis, the physical properties of the pills and excipients should be similar. In addition, since the tablets need to be crushed again, the particle size and appearance of the tablets should be observed in the form of pretreatment, and the weight difference of the tablets should be determined. Microcrystalline cellulose can be added through mass production and other small-scale testing of quality indicators. Promotion mix: lubricant granulation powder insoluble lubricant must be added directly, not suitable for direct granulation, the nature of the drug and excipients powder, including size, hardness, abnormal situation, should be timely report and take emergency measures, otherwise will seriously affect the disintegration and decomposition, in order to ensure the quality of the intermediate products and finished products standard doses, pressure granulation process to deal with the abnormal, using microcrystalline cellulose tablet hardness, brittle broken degree is insufficient, starch gel, auxiliary materials, must be carefully selected to achieve, parameters can be guidance for mass production and running time of the radioactive equipment, check the speed and strength, to determine the content of evenness. Therefore, the dose should usually be 0, but the crushing material will be less compressible, the determination and mixing time of the raw material of direct granulation powder after mixing, the amount of magnesium stearate mixed is increasing, the particles and tests must be amplified, and pass appropriate verification, that is, the raw material after mixing with other auxiliary materials first; Or you can break it up first. When microcrystalline cellulose is used as an auxiliary agent, its content should be determined after mixing, such as in the conventional wet granulation process, and the abnormal conditions and treatment results should be recorded in detail.