Health Care

How XRD improves drug formulation for pharmaceuticals

1:10:00 AM Dhanur Chauhan 0 Comments

X-Ray diffraction (XRD) analysis has become the accepted standard for analysis of materials particularly identification of crystals for formulating pharmaceutical drugs. Different types of Active Pharmaceutical Ingredients (API) are used in drug formulations. It is the APIs that make the medication effective for a particular disease or requirement. The APIs also help to determine the specialisation which is very important in modern pharmacy because sometimes a combination of APIs could be required to formulate an effective specialist medicine.

Since accuracy is of utmost importance in the formulation of these drugs therefore numerous pharmaceutical companies now use XRD-analysis as the standard for identifying the crystal forms of APIs. All APIs have different crystal forms, properties as well as stability factors. XRD helps determine which of these crystal forms should go into forming the pharmaceutical drug and which need to be controlled. Since APIshave different crystal forms they can easily be determined by XRD analysis in a testing lab that has XRD instrumentation since crystal forms all have different diffraction patterns.

The XRD instrumentation produces X-rays which are directed towards the crystalline samples. This interaction generates a diffraction pattern which is unique to the sample crystal. This unique pattern is referred to as the ‘fingerprint’ and when compared to the database of patterns and measurement it becomes easy to accurately identify the crystalline form. Unlike an amorphous material a crystal has well –defined properties like solubility, melting point etc. and these parameters help to control the final product.

Sometimes APIs are unknown and so they could require some additional substances to help them work in a required way. In herbal medicines particularly this is an important factor to keep in mind especially when there is some shortcoming in bioavailability. Through XRD analysis it is possible to ascertain which combination of APIs could best produce medication that will benefit patients. The knowledge about crystallinity is equally important as a crystalline form is the preferred form at the time the drug is being developed.

Determination of purity, particle size and stability are other aspects that are important in drug formulation. Correct particle size of substances ensures bioavailability therefore the particle size must be known so it can be controlled accordingly. Sometimes unknown and unwanted crystalline impurities can occur during the manufacturing process. XRD is therefore used for purity analysis so that unwanted crystalline impurities do not transform the pharmaceutical formulation either during manufacture or storage.

X-Ray diffraction or XRD analysis is becoming more and more important for medicine and pharmaceutical formulations as it helps to design new drugs. It is often used to identify APIs in medicines already in use so new medicine can be enhanced to work better to control disease and infection in the target. XRD analysis can be used to obtain critical knowledge from bulk material, tablets or amorphous components in raw materials during drug development in a cost effective and accurate manner. XRD analysis has therefore become crucial in all stages of drug discovery, design, development and manufacturing process.

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