Active pharmaceutical ingredients

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Active pharmaceutical ingredients
Drug class


Active Pharmaceutical Ingredients (APIs) are the biologically active components of a pharmaceutical drug that produce the intended effects. APIs are essential in the development and production of pharmaceuticals, as they are the primary ingredients responsible for the drug's therapeutic effects.

Definition[edit | edit source]

An Active Pharmaceutical Ingredient (API) is any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical drug product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effects in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure and function of the body.

Production[edit | edit source]

The production of APIs involves various sophisticated processes including chemical synthesis, fermentation, recombinant DNA technology, or isolation and recovery from natural sources. The process chosen depends on the complexity of the molecule required.

Synthesis[edit | edit source]

Chemical synthesis is one of the most common methods used in the production of APIs. It involves the step-by-step addition of reagents in controlled conditions to build a compound with the desired chemical structure.

Biotechnology[edit | edit source]

Biotechnological methods such as recombinant DNA technology or fermentation are used to produce APIs that are difficult to synthesize chemically. These methods are commonly used for the production of proteins and peptides used in biologic drugs.

Extraction[edit | edit source]

Extraction from natural sources is another method of API production, particularly for substances that are complex and difficult to synthesize in the laboratory. Plants, marine organisms, and microorganisms are common sources.

Regulation[edit | edit source]

APIs are heavily regulated by governmental agencies to ensure their safety, efficacy, and quality. In the United States, the Food and Drug Administration (FDA) requires that all APIs meet strict manufacturing standards according to Good Manufacturing Practices (GMP). Similar regulations are enforced in Europe by the European Medicines Agency (EMA) and in other regions by respective regulatory bodies.

Challenges[edit | edit source]

The development and production of APIs present several challenges, including the optimization of yield, purity, and scale-up processes. Environmental concerns also play a significant role, as the synthesis of APIs can generate significant amounts of waste.

Future Trends[edit | edit source]

The future of API manufacturing lies in the advancement of green chemistry principles to reduce environmental impact, the adoption of continuous manufacturing processes, and the exploration of novel drug delivery systems.

See also[edit | edit source]


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Contributors: Prab R. Tumpati, MD