Active Pharmaceutical Ingredients (API)
Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical dosage form and that, when used, so becomes an active ingredient of that pharmaceutical dosage form.
Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease of disease or to affect the structure and function of the body (World Health Organization (WHO)).
API can be divided into:
- Inorganic substance
- Organic substances (isolated from material of animal or human origin)
- Organic substances (synthetic or semi-synthetic or isolated from herbal sources or micro-organism)
Any drug is composed of two components or aspects. The first is the actual API or Active Pharmaceutical Ingredients, which is the central ingredient.
The second is known as an excipient. This refers to the substance inside the drug or tablet. If it is in syrup form, then the excipient will be the liquid that has been used. Thus, excipients are the inactive or inert substances present inside a drug while the Active Pharmaceutical Ingredients is the chemically active substance, which is meant to produce the desired effect in the body.
Certain Active Pharmaceutical Ingredients are unknown and hence require additional substances, which can work in conjunction with the API to produce the required medicinal effect. For example, in the case of herbal medicines, the API is usually a combination of several mixtures and substances, which when used together become active and act on the body.
Thus, in such situations, the Active Pharmaceutical Ingredients are not singular substances but the culmination of several herbs and ingredients.
Manufacturers usually use certain standards and benchmarks of calculation in order to determine the relative strength of Active Pharmaceutical Ingredients inside a medicine or drug.
However, the methods of standardizing the strengths of APIs within a medicine differ from one brand to another. While one manufacturer may use a certain standard for evaluating the strength of Active Pharmaceutical Ingredients, another manufacturer may use a different standard altogether.
As described above, in the case of herbal medicines the Active Pharmaceutical Ingredients are a combination of several different substances. According to the particular herbal supplement the active ingredient will differ significantly.
Since Active Pharmaceutical Ingredients are used in different proportions for virtually all the herbal medicines, suppliers procure poor quality batches of such Active Pharmaceutical Ingredients. By poor quality, it means that the strength of the API is lesser than what it should be. This automatically entails that the resultant herbal medicine does not combine the full properties of the Active Pharmaceutical Ingredients as it ideally should.
When contacting Active Pharmaceutical Ingredients suppliers it is essential to ensure high quality of the substances. In addition, the documentation, regulatory compliance, storage of Active Pharmaceutical Ingredients as well as packaging, labeling, repackaging, release and production should all be as per the standards set by the FDA.
Client confidentiality is critical and suppliers need to maintain complete confidentiality while dealing with their clients. The supplier should have a suitable system to accept or reject all intermediate materials, raw materials, labeling or packaging materials as per their discretion.
All the manufacturing records must be thoroughly evaluated to ascertain all the important process steps have been followed. Only then should the Active Pharmaceutical Ingredients be released.