Active Pharmaceutical Ingredients: Biological Active Drug Components for Effective Results

August 2019
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The pharmaceutical industry has emerged as a profitable industrial sector with remarkable potential to offer innovative drugs for the treatment of life-threatening diseases. The sector also provides economical generic alternatives that boast of high quality. Therefore, this sector strives to not only provide the much-desired health benefit to the society, particularly in the developing countries, but it is also marked with competitiveness and high profits from a business perspective. At present, the main focus of the pharmaceutical sector is to raise the bar in terms of safety, quality as well as the efficacy of the drugs.

What are Active Pharmaceutical Ingredients?

Active pharmaceutical ingredient (API) refers to the biologically active component present in a drug product like tablets and capsules. Drug products generally contain various components where API is a primary ingredient. Other ingredients present in the drug are usually called excipients, and such substances should always be biologically safe, often accounting for variable fraction of the drug. The procedure that involves optimizing as well as compositing these components’ blend utilized in the drug is called formulation.

As per FDA, APIs are used for causing pharmacological activity along with various other effects in the cure, diagnosis, treatment or prevention, mitigation of disease. It is also used for altering the structure as well as the function of the human body. However, there are few APIs that are unknown, and therefore, they need additional substances that work alongside the API to get the needed effect. This is quite apparent in herbal medicines wherein API is mostly a combination of different mixtures or substances which cause pharmacological activity when used together. In these cases, API is not exactly a single substance but a mixture of several ingredients.

Often, patients find it difficult to identify the active ingredients present in their medication, and are generally unaware of what a certain active ingredient represents. In cases when the patients are prescribed multiple medications, active ingredients are known to cause hindrance with each other, which can lead to severe or even life-threatening problems.

Few Examples of Drugs with Active Pharmaceutical Ingredients


Paracetamol is also called acetaminophen (APAP) refers to a medication that is used for treating pain and fever. It is generally used to relieve mild to moderate pain. It is generally sold in conjunction with various other medications, including in several cold medications. Paracetamol is generally also used for finding relief from severe pain including pain after surgery and cancer pain along with opioid pain medication. It is mostly used either rectally or by mouth, but it can also be injected into a vein.


Crocin is made out of dicarboxylic acid crocetin and disaccharide gentiobiose. In cases when it is isolated as a pure chemical compound, it forms crystals with a melting point of 186 °C and comes in deep red color. After it is dissolved in water, an orange solution is formed.


North America is the largest consumer of active pharmaceutical ingredients, owing to the rising incidence of preventable chronic diseases and growing government focus on generic drugs. Mounting demand for biologics as well as specialty drugs along with technological advancements in the manufacturing processes of APIs also augments the product demand. The ratio of economic and healthcare severity measures coupled with the introduction of low-cost and generic-based drugs elevates the demand for APIs in the region.

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