Study on the Functionality of Microcrystalline Cellulose-Mannitol (TMT934) Co-processing Excipients

The vigorous development of foreign new excipients will certainly drive the introduction and independent research and development of these products in the domestic pharmaceutical industry, and will also promote the promulgation of relevant regulations and industry standards

Pre-mixed excipients (Pre-mixed excipients) refer to mixed excipients that are made by simple physical mixing of two or more pharmaceutical excipients that have certain functions and are uniform in appearance

Co-processed excipients (Co-processed excipients) are made from two or more pharmaceutical excipients processed by specific physical processing techniques (such as spray drying, granulation, etc.

TMT934 is produced by Dongchen Pharmaceutical.

Table 1.

1.

• Test sample: PH102 (direct pressure type MCC), TMT934, physical mixture (Physical Mixture) of microcrystalline cellulose and mannitol, referred to as mixture;

• Chuanbei equation: n/C=n/a+1/ab, a is the fluidity constant, b is the filling property constant, and the Chuanbei equation is used to determine the powder fluidity and filling performance;

• Test method: Use a measuring cylinder to perform an oscillation test on a certain volume of test powder, record the number of oscillations and the volume of the powder, and then compare the fluidity and filling properties of different samples through the analysis of the North Sichuan equation;

• test results:

Figure 2.

• Result analysis: TMT934 and direct pressure microcrystalline cellulose PH102 have similar fluidity and filling properties, and both are significantly better than simple physical mixtures

  
  

2.

• Test sample: PH102 (direct pressure type MCC), TMT934, physical mixture (Physical Mixture) of microcrystalline cellulose and mannitol, referred to as mixture;

• Compressibility study: tensile strength, tablet compression under the same pressure conditions, the larger the value, the better the powder compressibility;

• Compactness study: elastic recovery rate, tablet compression under the same pressure conditions, the smaller the value, the better the powder compaction;

Figure 3.