What is Pharmaceutical Drug Substance / API (Active Pharmaceutical Ingredient) And Pharmaceutical Drug Products?
This article is for understanding what is Pharmaceutical drug substance
/ Active Pharmaceutical ingredients (API) and drug product. These are two different
terms that can be easily understood by the picture depicting above. Drug
Substance i.e. API (Active Pharmaceutical Ingredient) is the Start point for
the manufacturing of any medicine which results the manufacturing of end
product i.e. Drug Product.
What is Definition of Drug substance (API)?
“An active pharmaceutical ingredient (API) is a substance which is used in the preparation of a drug product.
API and excipients (inert materials)
together form a drug product which is used for the treatment of diseases in
human beings. The API is also called as a drug substance.”
ICH definition of an Active Pharmaceutical Ingredient (API)
Any
substance or mixture of substances intended to be used in the manufacture of a
drug (medicinal) 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 effect in the diagnosis,
cure, mitigation, treatment, or prevention of disease or to affect the
structure and function of the body.
US FDA definition of an Active Pharmaceutical Ingredient (API)
"Active
Pharmaceutical Ingredient (API) (or Drug Substance): Any substance or mixture
of substances intended to be used in the manufacture of a drug (medicinal)
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 effect in the diagnosis, cure,
mitigation, treatment, or prevention of disease or to affect the structure and
function of the body".
European Medicines Agency definition of an Active Pharmaceutical Ingredient (API)
Active
Pharmaceutical Ingredient (API) (or Drug Substance) are the substances those
are responsible for the activity of medicines.
Types of API?
High Potent Active Pharmaceutical Ingredients (API)
An inbuilt
capacity of a drug substance to stimulate biological activity at a given amount
is the Potency. At very low concentration, micrograms (µg) these APIs will show
very high intensity of drug action. Hence, on OELs in µg/m3 (OQL = occupational exposure limit) has been selected for the establishment of the
potency of the highly potent active pharmaceutical ingredients. Lower the
value, the higher the potency of the compound. High Potent APIs are
specifically used for the treatment of cancer. Some good examples are listed
below.
1. Fentanyl
2. Alprazolam 3. Risperidone
4. Capecitabine 5.
Carbamazepine
Non-Potent Active Pharmaceutical Ingredients (API)
These
APIs do not have inherent capacity to stimulate biological activity at at a low
concentration level of micrograms (µg). These APIs have low potency and their
very low dose level does not alter the human beings DNA. Low potent APIs are
used for the treatment of various diseases in human beings and animals. Below
are some Common API lay in this category.
1.
Atorvastatin 2. Ketorolac 3.
Anastrozole 4. Tizanidine HCl 5.
Sumatriptan Succinate
What is Definition of Drug Product?
US FDA definition of Drug product
"A
Finished Dosage form (e.g. Tablet, Capsule or solution) that contains a drug
substance, generally but not necessarily in association with one or more other ingredients”
ICH definition of Drug product
A
formulated product manufactured with the combination of drug sustenance (APIs)
and excipient as applicable.
European Medicines Agency definition of Drug product
A
substance or combination of substances that is intended to treat, prevent or
diagnose a disease, or to restore, correct or modify physiological functions by
exerting a pharmacological, immunological or metabolic action.
We
hope this article of total pharmaceutical topic helps you to refreshing your
knowledge bucket; other useful articles may uplift the information stock of the
mind.
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