Hydroxylopyolin (HPMC) is a widely used polymer in the pharmaceutical industry and is an important formula. It is mainly used as an adhesive in solid dosage (such as tablets, capsules, and particles), viscosity enhanced agent and decomposition.
In the drug preparation, the dissolution of active ingredients is important to absorb and produce the treatment effect. However, the dissolution of active ingredients may be hindered by the formula. Therefore, it is important to understand the dissolving behavior of HPMC in the drug formula because it affects the performance of the dosage type.
HPMC’s dissolution method
US Pharmacy (USP) has standardized a test method for dissolving HPMC. This method usually involves the use of dissolving equipment, which simulates and measures the solubility of the dosage type in the medium of solution medium. The test involves placing the dosage in a basket or paddle, and the basket or paddle rotates in a container containing the dissolved medium.
The solubility medium must be selected according to the expected use of the dosage (such as gastric or intestinal dissolving). Common solubility medium for HPMC includes water, phosphate buffer solution and simulation gastric juice (SGF) or analog intestinal fluid (SIF).
In order to ensure repetitiveness and accuracy, test parameters must be standardized, such as rotation speed, temperature, and dissolving medium volume and sampling time. Then use the appropriate analysis method to analyze the sample solution obtained by different time intervals to determine the amount of HPMC dissolution.
Prevention measures When performing HPMC dissolving tests
1. Selection of the right dissolving medium: The selection of dissolving medium is based on the expected use of the dosage form. Choosing an appropriate dissolution medium is very important because it will affect HPMC’s dissolving behavior.
2. Correctly verifying the solubility method: Verifying the solubility method to ensure that it is appropriate and it is important to meet the requirements of the regulatory agency. Verification should involve the robustness and repeatability of the measurement.
3. Standardization of test parameters: Test parameters, such as rotation speed, temperature, and dissolved medium volume affect the result of dissolving tests. Therefore, these parameters must be standardized to ensure reappearance and accurate analysis.
4. Sample: Careful sampling is important for obtaining representative samples from dissolving medium. Pay attention to timing and sampling points to ensure that the sample is collected in a unified interval.
5. Analysis method: Select the analysis method for analysis shall be verified, and should have appropriate sensitivity, selectivity and accuracy.
In short, the dissolving test of HPMC is an important tool in drug development and drug formula. The quality control laboratory is conducted regularly to ensure the correct release of the active ingredients, and the drug is safe and effective. The error in the appropriate test method may lead to misunderstandings and false statements on the efficacy of drugs. Therefore, it is important to follow the standards and preventive measures during the dissolution test.
Post time: Jun-29-2023