What is an Active Pharmaceutical Ingredient?

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    Nov 15, 2012
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Introduction: Active Pharmaceutical Ingredient

An active pharmaceutical ingredient (API) is the substance in a pharmaceutical drug that is biologically active. Some medications may contain more than one active ingredient.In other words, it is the actual healing part of a medicine. Where there is more than one active ingredient in the drug, it is called a formulation drug, that is, the result of formulations. The traditional word for the API is pharmacon or pharmakon which originally denoted a magical substance or drug.

Drug Ingredients

A drug in the dosage form consists of two ingredients: One is the API, which is the drug itself, this is the ingredient that treats or relieves the symptoms of the specific medical conditions; the second ingredient is a substance that acts as filler in order to give volume and substance to the tablet or drug. It is called as an excipient, which is the liquid the API is suspended in or is the substance of the tablet. The excipient is a pharmaceutically inert substance. One important reason for which inert excipients or ‘fillers’ are added is that in their natural form, or in the form in which they are present in the medication; the base drug is extremely strong. Left to be consumed in this form; these ingredients will not work on the body the way they are intended to.

Every drug is defined based on its active pharmaceutical ingredient. It is important to understand the compatibility of API of one drug with that of the other, because when patients are on multiple medications, these API can interfere with each other. This could have effects ranging from minor side effects to serious repercussions such as life threatening complications.

Pharmaceutical Drugs vs. Herbal Medicines

The APIs are what differentiate a pharmaceutical drug from herbal medicines. In case of herbal medicines, the API are not identified, or there are more than one APIs and in most cases, these APIs although identified cannot be recreated through chemical or laboratory methods. This prevents standardization of herbal medicines; in many cases clinical trials do not provide substantial evidence of positive, or for that matter, any negative effect of a suspected API in herbal medicines.

The conventional wisdom associated with herbal or traditional medicines is the same as the one for dietary supplements: the process is the drug. Thus further leads to complications in labeling. Due to non-existence of a standard dosage or identified API, the drug effects are interpreted haphazardly and lose objectivity.

Importance of API

APIs are the essence of pharmaceutical market and, for that matter, global healthcare. While there are several challenges faced by API manufacturing companies in terms of standardization and compliance requirements, there is equally good number of opportunities such as improved credibility and ability to penetrate global markets.

API Awareness

Due to the increased awareness of APIs, and their importance, potential effects and side effects, several online services have come up with information identifying the APIs in pharmaceutical medication. An example is the following website.  The authenticity of information on this website is not guaranteed.

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