3.4) APIs Flashcards
What is an API
the biologically active part of aby medicine
Purpose of an API
to cause pharmacological activity or other direct effects in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure and function of human body
All medicines are made up of which 2 core components
- API
- Excipient
Define API
its the central ingredient that is meant to produce the desired effect in the body
Define Excipient
substance inside the medicine that helps deliver the medication to the human system
What is an excipient
they are inactive substances such as mineral oil and are not chemically active
Can there be more than 1 API
Yes, as these combination therapies have multiple AI to treat different diseases/symptoms
How is the relative strenth of an API measured
Manufacturers use specific standards and benchmarks to determine the relative strength of an API inside a specific medicine
Where are most API manufacturers located
In India and China
*mostly in Asia
What was introduced when most APIs started to be manufactured overseas
Significant changes in regulating medicines with more rigotous guidelines and inspections
Processes APIs are manufactured thru
-Chemical synthesis
-fermentation processes
-Recombinant DNA
-Isolation and recovery from natural sources
-a combination of these processes
Leading API manufacturer
TAPI
Quality of API has an effect on
efficacy and safety of a medication
*poorly manufactured or compounded APIs have been connected to severe issues such as illnesses and even death
