What are the common sources of active pharmaceutical ingredients?
On the basis of origin, active pharmaceutical ingredients can be divided into four main categories as follows:
1. Synthetic organic chemistry as a source of drug substances
This group mainly includes small chemical substances, typically with a molecular weight of under 500 Daltons. The largest category of drug substances in use today are synthetic organic substances.
Examples of APIs obtained via synthetic organic chemistry include paracetamol (Panadol® – Glaxo) and artovastatin (Liptor® – Pfizer).
With better technology, it is also now possible to synthesise peptides having up to 20 amino acid residues in the laboratory for use as drug substances. Synthetic peptides include Somatostatin, Calcitonin (Fortical – )and Vasopressin (VASOSTRICT – Parpharm)
2. Natural organic molecules as sources of drug substances
From the time immemorial, humans have resorted to the nature as a source of therapeutic substances. This remains the case today.
For example, many antibiotics such as erythromycin and anticancer agents like paclitaxel (ABRAXANE® – BMS) are isolated from nature.
3. Recombinant DNA technology as a source of drug substances
Simply put, recombinant DNA technology is the process of altering gene of an organism and using the change to produce a biological molecule such as a large protein or chemical compound.
In just over a period of 40 years, recombinant DNA technology has grown to become one of the main sources of new drug substances today. Many important actives such as Human Insulin, Human Albumin, Erythropoietin and Human Growth Hormone are obtained this way, as are many vaccines and monoclonal antibodies.
4. Whole or Extractions from natural sources (animals)
There are still many therapeutic substances that can only be obtained from natural sources either as whole organisms or extracts from organisms.
Examples of these include blood and plasma, attenuated or live viruses used in vaccines and human immunoglobulins. The same applies to cells, tissues and organs used various in biotechnology modalities.
The table below summarises the main types of active pharmaceutical ingredients arranged by their source or origin:
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