Quantitative analysis to assess degrees of crystallinity is an essential step in the drug development process. Fully aware of its importance, service provider CRO â CD Formulation â recently announced to provide determination of crystallinity services for drug developers around the world.
The degree of crystallinity of pharmaceutical materials is recognized as a critical factor that can affect the dissolution rate of the drug, the physical compacting properties of the tablets, and the bioavailability of the drug.
âCrystallinity also plays an important role. Even a small amount of amorphous phase in a crystalline sample can dramatically change its physical and chemical properties, âexplains CD formulation marketing manager. âJust take the carbapenem antibiotics as an example, a low degree of crystallinity is linked to a lower chemical stability. Therefore, it is suggested that the extent of crystallinity be closely monitored during the shelf life of a pharmaceutical, from the scaling of bulk materials, from formulation development, from manufacture to production. intended shelf life, to ensure the safety and efficacy of medicines. . ”
With state-of-the-art expertise and facilities, CD Formulation is able to provide customers with crystallinity determination services for a wide range of active pharmaceutical ingredients (APIs). There are many analytical techniques to assess crystallinity, and the most commonly used methods are differential scanning calorimetry (DSC), FT-Raman spectrometry, X-ray powder diffraction (XRPD), near infrared spectroscopy ( NIRS) and more.
Different techniques are chosen for different occasions. X-ray diffraction analysis (XRD) will be the most definitive method to detect crystal forms. However, it is sometimes unsuitable for quantification analysis because the intensity of diffraction is affected by the dimensions of solid samples. Spectroscopic methods such as IR, Raman, and NIR spectroscopy are useful for quantifying amorphous and crystalline phases in solids. When an amorphous material crystallizes with changes in humidity, dynamic vapor sorption (DVS) detects the crystallization response of the amorphous material, where the extent of water sorption and desorption is related to the amorphous content. of the sample.
In addition to a detailed analytical report, CD Formulation’s scientific team will also provide customers with information on how to make a decision regarding the operational and procedural conditions that can ensure the physical and chemical stability and pharmacological activity of the product, while minimizing potential risks in drug formulation.
For more information on CD Formulation’s crystallinity determination services, please visit https://www.formulationbio.com/crystallinity-determination.html or send an email directly to [email protected]
About CD formulation
As a science-driven company, CD Formulation has accumulated rich experience in drug formulation and is qualified to serve the pharmaceutical industry by providing CRO services to develop, produce and design pharmaceutical excipients for solid dosage forms. , semi-solids and liquids. With an innovative mind and a down-to-earth attitude, the company is on a mission to solve the long-standing problem of developing new APIs. It has successfully completed several development projects and proudly extends its capabilities, which range from generic to innovative formulation with the ambition of improving the solubility and bioavailability of difficult-to-formulate compounds.