Active pharmaceutical ingredients

Active pharmaceutical ingredient or API is a term for the biologically active component of a pharmaceutical or nutraceutical product These products are usually made up of several components that make up their ‘formulation’. The Active Pharmaceutical Ingredient is the primary ingredient that delivers the desired results when consumed. The other ingredients are called excipients.  These are the substances that are always required make the products biologically safe and safe to consume. These often make up a variable fraction of these products.

The procedure for optimizing the mixture of such components used in the nutraceuticals is known as ‘formulation. If the API is a solid and the drug is required to have a liquid dosage form, such as a cough syrup, then the excipients will then be the liquid/s that are used to formulate the syrup. API molecules have many chemical functional groups. The API form that is used in a formulation is often the most thermodynamically stable crystalline form.  The hydration behavior of crystalline APIs is of particularly high importance within the pharmaceutical industry, and is vastly studied from every closely. The state of hydration has a direct effect on the physical properties of the API, which in turn has a large impact on the way the end-product is processed.  

New Method to Analyze APIs
Recently, a team of scientists in the department of Drug Product Science and Technology, at Bristol-Myers Squibb, USA have developed a supplementary technique to study the behavior of hydration in organic crystalline solids. This complements the more conventional analysis such as calorimetric studies, nuclear magnetic resonance and vibrational spectroscopy.

The team was able to gain more insights be performing single crystal X-ray diffraction experiments with the objective of being interpretation of the non-Bragg diffraction features, Chan et al, Acta Cryst. (2014). They were able to gain further insight into the mechanical and structural details of dehydration of the crystal. The scattering features were reproduced and studied using computer models and the results were able to show the mechanistic relationships between changes in the lattice structure as stages of the overall drying process. This is a first of its kind study to combine the mechanism of dehydration and non-Bragg scattering from a single API crystal.  The results will improve the knowledge, formulation and choice of API used in the manufacture of neutraceuticals.

New Guidelines
The APIC of ‘Active Pharmaceutical Ingrediencts’ Council has a new guide on meeting the WHO and European Union Guidelines.The guide deals with various aspects such as Storage, Cleaning and others. Find it here . 

API’s are one of the leading segments in the global nutraceutical market. With emerging technologies and new research, there seem to be more challenges and opportunities for anyone dealing with APIs. Watch this space for more on the latest in APIs.