Drug crystal form research is an important field in drug research and development, which runs through the whole process of drugs from APIs to drug products. Molecular backbone types such as steroids, alkaloids, terpenes, coumarins, flavonoids, macrolides, etc., these different backbone types of drug molecules may produce polymorphic phenomena. The study of crystal form is very important for pharmaceutical companies, and it is also a key link in the consistency evaluation of generic drugs.
Different crystal forms of the same drug may be significantly different in terms of appearance, solubility, melting point, dissolution, bioavailability, etc., which affects the stability, bioavailability and efficacy of the drug, and directly or indirectly affects the clinical performance of the drug.
At present, the detection methods applied to the field of crystal form can be roughly divided into the following types according to their technical principles.
(1) Diffraction analysis: It is the most commonly used crystal form detection method, including single crystal X-ray diffraction analysis and powder X-ray diffraction analysis, and the crystal form of the drug can be determined by comparing the diffraction pattern obtained from the experiment with the pattern of the known standard crystal form;
(2) Thermal analysis: including differential scanning calorimetry analysis, thermogravimetric analysis, melting point analysis, etc.;
(3) Spectral analysis: mainly including infrared spectroscopy, near-infrared spectroscopy, Raman spectroscopy, etc.;
(4) Spectral analysis: such as solid-state magnetic resonance spectroscopy;
(5) Microscopic analysis: including optical microscope, scanning electron microscope, polarizing microscope, etc.
The study of drug polymorphs is crucial for pharmaceutical companies. In the early stage of drug development, the optimal drug crystal form is found and screened through experimental methods, and in the production process of the drug, ensure that the drug exists in the desired crystal form, avoid the appearance of bad crystal form, study the stability of the drug crystal form under storage conditions, ensure the quality of the drug during the expiration date, study the solubility and dissolution rate of different crystal forms of drugs in the body, and how they affect the absorption and efficacy of the drug.
In order to meet these requirements, companies need to establish comprehensive and rigorous quality standards for crystalline drugs. A combination of techniques is used to comprehensively determine the drug crystal form to ensure the accuracy and reliability of the results. For the effective detection and analysis methods of different crystal forms of drugs, the micro-source testing laboratory provides professional analysis and testing services for impurities and crystal forms that affect the efficacy and quality of drugs, and uses X-ray diffraction (XRD), differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), infrared spectroscopy (IR) and other testing methods to help enterprises complete qualitative and quantitative methodological research on drug crystal forms to ensure the authenticity and reliability of data. If you have relevant testing needs, please call for consultation!
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