1. The properties of the drug and the auxiliary materials should be similar. When the powder is directly compressed, the physical properties such as bulk density, particle size and particle size distribution of the drug and the auxiliary material are similar, so as to facilitate uniform mixing, especially the specification is small, and the content uniformity needs to be determined. For drugs, various excipients must be carefully selected.
2, insoluble lubricants must be added after the insoluble lubricant for direct compression of the powder must be added after the Zui, that is, the raw materials and other auxiliary materials are mixed evenly, then add insoluble lubricant, and control the mixing time, otherwise Will seriously affect disintegration or dissolution. In addition, when pregelatinized starch, microcrystalline cellulose, etc. are used as auxiliary materials, if the amount of magnesium stearate is large and the mixing time is long, the tablet has a softening phenomenon, so the general dosage should be below 0.75%, and The mixing time, speed and intensity are verified.
3. The content measurement after mixing is the same as the conventional wet granulation production process. After mixing the raw materials of the direct compression of the powder, the content is determined to ensure that the quality of the intermediate product and the finished product meets the prescribed standards.
4. Sufficient test amplification after small test In general, unqualified tablets pressed by powder direct compression process should not be reworked. Since the tablet is re-pulverized after rework, the compressibility of the material after pulverization is remarkably lowered, so that it is not suitable for direct compression. Therefore, from small test to large production, it must be piloted and fully verified, and the pilot should use the same type of equipment as the large production in the future, so that the determined parameters can guide the large production.
5, the use of microcrystalline cellulose when the tablet hardness and friability is unqualified, microcrystalline cellulose can be added, the amount can be as high as 65%; can also be used to first press into a large piece, then broken into particles, and then tablet The method can get satisfactory results.
6. Handling the abnormal conditions in the tablet in time. During the tableting process, samples should be taken in time according to the standard operating procedures. Observe the appearance of the tablet and measure the difference in weight, hardness, friability, disintegration time, thickness and other quality indicators. And observe the operation of the equipment, the abnormal situation should be reported in a timely manner and take emergency measures, detailed records of abnormal phenomena and processing results, detailed analysis to ensure product quality.
With the introduction of new foreign pharmaceutical excipients, the continuous development and listing of new varieties of domestic pharmaceutical excipients, the continuous updating, improvement and improvement of tablet presses, the application of powder direct compression method in China will gradually increase.
2, insoluble lubricants must be added after the insoluble lubricant for direct compression of the powder must be added after the Zui, that is, the raw materials and other auxiliary materials are mixed evenly, then add insoluble lubricant, and control the mixing time, otherwise Will seriously affect disintegration or dissolution. In addition, when pregelatinized starch, microcrystalline cellulose, etc. are used as auxiliary materials, if the amount of magnesium stearate is large and the mixing time is long, the tablet has a softening phenomenon, so the general dosage should be below 0.75%, and The mixing time, speed and intensity are verified.
3. The content measurement after mixing is the same as the conventional wet granulation production process. After mixing the raw materials of the direct compression of the powder, the content is determined to ensure that the quality of the intermediate product and the finished product meets the prescribed standards.
4. Sufficient test amplification after small test In general, unqualified tablets pressed by powder direct compression process should not be reworked. Since the tablet is re-pulverized after rework, the compressibility of the material after pulverization is remarkably lowered, so that it is not suitable for direct compression. Therefore, from small test to large production, it must be piloted and fully verified, and the pilot should use the same type of equipment as the large production in the future, so that the determined parameters can guide the large production.
5, the use of microcrystalline cellulose when the tablet hardness and friability is unqualified, microcrystalline cellulose can be added, the amount can be as high as 65%; can also be used to first press into a large piece, then broken into particles, and then tablet The method can get satisfactory results.
6. Handling the abnormal conditions in the tablet in time. During the tableting process, samples should be taken in time according to the standard operating procedures. Observe the appearance of the tablet and measure the difference in weight, hardness, friability, disintegration time, thickness and other quality indicators. And observe the operation of the equipment, the abnormal situation should be reported in a timely manner and take emergency measures, detailed records of abnormal phenomena and processing results, detailed analysis to ensure product quality.
With the introduction of new foreign pharmaceutical excipients, the continuous development and listing of new varieties of domestic pharmaceutical excipients, the continuous updating, improvement and improvement of tablet presses, the application of powder direct compression method in China will gradually increase.
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