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What are Active Pharmaceutical Ingredients (API)?


Drugs are composed of two major components: – Active pharmaceutical ingredient (API), and excipients. APIs vary from drug to drug and are responsible for creating the intended biological, physiological or therapeutic effect within the recipient's (patient's) body. A drug can contain one or more APIs depending on its purpose and the synergistic actions of the APIs.

Active pharmaceutical ingredients (APIs) are the therapeutically active substances or chemical components of drug products (capsules, tablets, syrups, etc.) that produce an intended pharmacological effect.

The APIs within drugs are conveyed into the body through inactive components known as excipients, which usually make up the bulk of the drug. They facilitate the ingestion, absorption, and distribution of the active ingredients. These excipients serve as vehicles and are usually inert or biologically inactive.


What is the purpose of APIs?

APIs are the primary ingredients contained in drugs and medicines. They play a significant role in drug production and produce pharmacological effects within the body. The pharmacological effects produced, directly or indirectly, influence the diagnosis, symptom relief, mitigation, treatment, cure, or prevention of diseases. APIs also modify, correct, or enhance the physiological function and structure of chemicals, cells, tissues, and organs within the body. In simple terms, they make the drug or medicine work.


How APIs are synthesized?

API synthesis is a complex multi-step process that involves a wide range of chemical processes and reactions of varieties of raw materials by physical and chemical means. Specialized professionals in API manufacturing companies perform the process of active pharmaceutical ingredient synthesis and manufacturing.

APIs can be synthesized through 3 major processes – Biological process, organic chemical synthesis, and extraction from a biological source. The method used depends on the raw material involved, steps of the process, and complexity of the API molecule.


How long does it take to synthesize APIs?

The length of the manufacturing process is majorly dependent on the complexity of the API molecule to be synthesized and the process used. API synthesis is a long and complicated process that may take months and sometimes, up to years to complete. The complexity of the structure influences the API synthesis period length, the number of steps in the synthesis route, type of synthesis, cost of the process, drug impurities present, number of APIs to be produced, and the number of isolation steps involved.

What is the goal behind the synthesis of APIs?

API synthesis facilitates the processing and manufacturing of pure pharmaceutical preparations (APIs) for clinical use. Through API synthesis, these active ingredients are extracted, purified, and packaged for treatment, diagnosis, cure, mitigation, and prevention of diseases. These APIs are synthesized and manufactured into biologically secure forms and substances to produce specific pharmacological effects within the recipient's body. Simply put, the primary goal of API synthesis is to create pure, potent, and safe APIs for drug development and production and administration to patients.



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