X-Ray Diffraction (XRD) has now become a well-established technique that has numerous applications in the pharmaceutical industry. Data can easily be generated about crystalline materials, like unknown minerals and inorganic compounds which make it a key technique for pharmaceutical drug analysis. Since XRD analysis can be relied upon to be quite accurate it is extensively used for drug research, development and quality control of active pharmaceutical ingredients (API) excipients and final product.
Pharmaceutical testing labs understand that drug moiety not only has different forms but they also have varied physical properties. These differences can affect the quality and efficacy of a new pharmaceutical formulation. With the help of X-ray diffraction, pharmaceutical testing labs screen the API and the final dosage as any change can affect the final outcome. Screening can detect even very minor changes in the diffraction pattern and so the formulation can be adjusted accordingly during the developmental stage.
Pharmaceutical industry is wary of even minor changes as this leads to batch to batch inconsistency. XRD analysis can resolve the inconsistency in final product by understanding where the formulation is showing disparity. Other applications of XRD in drug formulation are the ability to arrive at the correct dosage form, ensure drug stability, bioavailability and quality in all formulations. XRD techniques are being used so extensively in pharmaceutical industry that a relevant data base has been generated which the pharmaceutical companies can use for drug discovery, development, and manufacture.
XRD has become an indispensible technique in characterisation of pharmaceutical substances because it can reveal unique structural details which might not be able to be observed by any other method of analysis. XRD is frequently used for solid-state drug analysis because it can unequivocally characterise the composition of pharmaceuticals. The parameters of a crystal structure can be assessed and compared to the existing indexed XRD pattern data. If the formulation has multiple-components even then the pharmaceutical testing labs can analyse the actual percentage of the API as also any other amorphous ingredients that have been used in the formulation.
XRD analysis of pharmaceutical substances is advantageous because it can identify the more stable form of the substances as opposed to the any kind of polymorphism. All the various forms that any pharmaceutical substance can have are analysed with X-ray diffraction for solid-state characterization. With the help of X-ray diffraction or XRD it is possible to carry out
- Non-destructive analysis as the samples do not need to be dissolved, destroyed or digested to get to their essential characteristics
- Determination of the integrity of the API in the finished product
- Detection of any crystalline impurities
- Detection of changes in pharmaceutical substances during processing and manufacturing
XRD is an accepted methodology for new product registrations and patent applications. XRD makes it very feasible to determine the single crystal pattern structure that is required for a patent. Once the API has been isolated then the pharmaceutical company can apply for the patent because the unique diffraction pattern cannot be disputed.