Quantitative analysis to evaluate degrees of crystallinity is an indispensable step in the drug development process. The degree of crystallinity in pharmaceutical materials is recognized as a critical factor that may affect drug dissolution rate, physical properties of tablet compaction and drug bioavailability.
Crystallinity also plays an important role. Even a small amount of amorphous phase in a crystalline sample may significantly change its physical and chemical properties, just take carbapenem antibiotics as an example, a low degree of crystallinity is related to poorer chemical stability. Therefore, it is suggested that the extent of crystallinity should be closely monitored during the lifetime of a pharmaceutical product, from bulk material scale-up, formulation development, manufacturing to its intended shelf-life, so as to ensure the safety and efficacy of drugs.
With expertise and state-of-the-art facilities, CD Formulation is capable of providing customers with crystallinity determination services for a wide range of active pharmaceutical ingredients (APIs). There are numerous analytical techniques to assess crystallinity, and the methods that are most commonly employed 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 of detecting crystalline forms. However, it is sometimes unsuitable for quantification analysis because diffraction intensity is affected by the dimensions of solid samples. Spectroscopic methods such as IR, Raman and NIR spectroscopy are useful for quantifying both 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.
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, semi-solid and liquid dosage forms. With an innovative spirit and a down-to-earth attitude, the company is missioned to address the long-standing issue of new API development. It has successfully completed several development projects and proudly extends its capability, which covers generic to innovative formulation with an ambition to enhance the solubility and bioavailability of difficult-to-formulate compounds.
