Research on Moisture Absorption of Microcrystalline Cellulose and Its Co-processing Excipient

The excipients have no separate official hygroscopic research methods.

The hygroscopicity of a drug refers to the ability or degree of moisture absorption of the substance under certain temperature and humidity conditions
.

The test product is a solid bulk drug that meets the drug quality standards, and the test results can be used as a reference for selecting appropriate drug packaging and storage conditions

Deliquescence: Absorb enough water to form a liquid
.

High moisture absorption: the weight gain is not less than 15%
.

Moisture absorption: weight gain is less than 15% but not less than 2%
.

Slight moisture absorption: the weight gain is less than 2% but not less than 0.

2%

No or almost no moisture absorption: the weight gain is less than 0.

2%

In fact, the hygroscopicity of APIs or excipients is not only used to screen suitable packaging materials and storage conditions.

Their hygroscopicity will also affect the results of certain test items of the product itself, such as excipients with high hygroscopicity.
It will cause deviations in the results of viscosity and moisture detection; in actual production, if the appropriate temperature and humidity are not set according to the moisture absorption characteristics of the raw materials and the raw materials are exposed to high humidity, the water-sensitive API will be generated.
Great influence, thereby affecting product quality

In this experiment, the above-mentioned guidelines are used as a reference basis to set up the experimental program, and the moisture absorption of microcrystalline cellulose produced by Dongchen Pharmaceutical and its co-processed auxiliary materials are studied.

The results are shown in the following text.

Hygroscopicity research

Test conditions

Temperature: 25℃±1℃
Relative humidity: 80%±2%

test results

Test Conclusions

It can be seen from the test data that the moisture absorption and weight gain rate of the test model samples are all less than 15% but not less than 2%.

According to the 2015 edition of the Chinese Pharmacopoeia, it can be determined that the test samples have hygroscopicity
.

Research under production conditions

Simulate production environment

Temperature: 25℃±1℃
Relative humidity: 55%±2% Test basis: literature method

test results

Test Conclusions

1.
Under the test conditions (temperature: 25±1℃, relative humidity: 55±2%), each test sample reaches moisture absorption equilibrium in about 8 hours;

2.
The 24 hours moisture absorption and weight gain rate of the test samples are all less than 3.
50%, of which the moisture absorption and weight gain rates of TC302 and TMT934 are both less than 2%, which is slightly hygroscopic under this condition; 3.
The test results show that the environmental humidity control can be effective Reduce the moisture absorption and weight gain rate of MCC and MCC co-processing auxiliary materials
.
Company: Shenzhen Youpuhui Pharmaceutical Co.
, Ltd.

Contact number: 18126405453