Generally active pharmaceutical ingredients can be defined as the chemicals that are used in manufacture of pharmaceutical drugs.
The AI abbreviates the active subststance(s) normally biologically active in the drug. It is this substance that is responsible for the specific desired effect in the person injecting the drug.
In normal cases, drugs feature two major components, the API and excipient. The API is definitely the major ingredient, whereas the excipient is inactive. The excipient simply acts as a vehicle for the active API. In the situation of a syrup for example it is the liquid in which the API is dissolved that acts as the excipient. API production is therefore a slow and tedious process requiring utmost precision.
API production companies follow a variety of manufacturing processes. Some of the commonly used processes include:
– Chemical synthesis
– Recombinant DNA
– Fermentation processes
– Isolation and recovery from natural sources.
– Combination of the above processes.
According to FDA, the major goal of APIs of course is to induce pharmacological activity, or other effects in diagnosis, cure, mitigation, prevention and treatment of diseases. Moreover, they may be administered to alter the function and structure of the human body.
There are some APIs however whose knowledge about is still limited. Such APIs therefore require to work with additional substances to yield the desired effect. Example of such APIs are notably many in herbal medicine. Most herbal APIs are a mixture of several substances which have to be used together to yield the desired pharmacological effect.
Whilst still focusing on API Production, it is important to draw distinctions between actual drugs and APIs. Why? It assists in specialization and pharmacists also find alignment of brand names with generic equivalents easy. This forms part of the most solid regulations and principles of pharmacy today.
API production requires highly skilled labor. Furthermore, skills have to be regularly updated since the field of diseases and API production is highly dynamic.