Active Pharmaceutical Ingredients (APIs) are the components in medicines which provide the therapeutic effect. They interact directly in the body to treat a specific disease or condition.
The journey of an API begins with the identification of a potential target, typically a protein or enzyme. The researchers then design and synthesize various small molecules which could potentially interact with the target and produce a therapeutic effect. The molecules which show some level of activity against the target undergo further optimizations through chemical modifications to enhance their potency, selectivity and other pharmacological properties. The lead compound which exhibits the most promising characteristics becomes the basis for further development.
The chemical structure of the lead compound is then broken into manageable steps for synthesis. This results in the creation of several intermediary compounds, each of which represent a stage in the synthetic process. These intermediary compounds (intermediates) are produced in the laboratory through various chemical reactions. A process is identified for the large scale production of these intermediates. Factors such as reaction conditions, yields and purification methods are taken into consideration at this stage. Each batch of the intermediates undergoes rigorous quality control testing to ensure that it meets the required standards for purity, potency and other critical parameters. Various techniques like chromatography, spectroscopy and mass spectrometry are used to verify the characteristics of the transaction.
The API intermediates are then used in the formulation of final medication. Depending upon the medications intended use (i.e. oral tablets, injections etc.) they are combined with other active ingredients to create the final dosage form. Before a medication is approved for final use, it undergoes extensive clinical trials. If the clinical trials demonstrate safety and efficacy, the approval of the regulatory authorities is sought for commercial use. Once the required approvals are obtained, the medication is manufactured and distributed.
Ongoing monitoring of the medications safety and effectiveness continue, even after the commercial production. Any adverse events or issues related to the medication are reported/ addressed, as may be required.
DU Organics manufactures various API Intermediates which are used in pharmaceutical production. For obtaining more information with respect to the same, visit our website or contact us today.