Views:0 Author:Site Editor Publish Time: 2020-12-22 Origin:Site
Application of powder press
The properties of drugs and excipients should be similar. When pressing powder directly, the physical properties of drugs and excipients, such as heap density, particle size and particle size distribution, should be similar, so as to facilitate the even mixing. In particular, for drugs with small specifications and the uniformity of content, all kinds of excipients must be carefully selected.
Insoluble lubricants used for powder direct pressing must be added later, that is, the raw materials and other auxiliary materials mixed evenly, then add insoluble lubricants, and to control the mixing time, otherwise it will seriously affect the disintegration or dissolution. In addition, when pregelatinized starch and microcrystalline cellulose are used as excipients, the dosage of stearin magnesium is large and the mixing time is long, and the tablet tends to soften, so the general dosage should be less than 0.75%, and the mixing time, rotation speed and strength should be verified.
After mixing, the content determination shall be carried out, just like the production process of conventional wet granulation, and the content determination shall be carried out after the mixing of raw and auxiliary materials of direct powder pressing tablets, so as to ensure the quality of intermediate products and finished products meet the stipulated standards.
After the small test must be fully tested amplification under general circumstances, the direct powder pressing process to suppress the unqualified tablets should not be reworked. Because the tablet has to be pulverized again after rework, the compactability of the crushed material will be significantly reduced, so it is not suitable for direct tablet pressing. Therefore, from small trial to large-scale production, pilot test must be carried out and fully verified, and the pilot test should use the same type of equipment as the large-scale production in the future, so that the determined parameters can play a guiding role in large-scale production.
When the tablet hardness and fragility of microcrystalline cellulose are not up to standard, microcrystalline cellulose can be added with the dosage up to 65%. Can also be used to crush into a large, and then broken into sound grains, and then pressed pieces of the method, you can get satisfactory results.
Timely processing of the abnormal situation of tablet in the process of tablet, according to standard operating procedure should be timely sampling, observe the appearance of the tablets and determination of weight difference, degree of hardness, brittle broken, disintegration time, slice thickness and other quality index, and watch the running status of equipment, abnormal situation should be timely report and take emergency measures, detailed record abnormal phenomenon and the processing results, a detailed analysis, in order to ensure product quality. With the introduction of new pharmaceutical excipients from abroad, the development and marketing of new varieties of pharmaceutical excipients in China, and the constant updating, improvement and perfection of tablet pressing equipment, the application of direct tablet pressing method of powder in China will increase gradually.