Introduction Of An Active Pharmaceutical Ingredient (API)
"Active pharmaceutical ingredient (API) is the driving force of the pharmaceutical industry. Combination of API and excipients makes a medicine. An API is a propeller of the healthcare industry. Manufacture of Active Pharmaceutical Ingredient (API) involves high-end technologies and strategies. Production of an API is a very critical task due to the necessary action of execution of hazardous chemical reactions.
Definition Of An Active Pharmaceutical Ingredient (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.
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".
- From Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Guidance for IndustryHigh Potent Active Pharmaceutical Ingredients (API)
Potency refers to the inherent capacity of a drug substance to stimulate biological activity at a given amount.
The intensity of drug action in high potent APIs will be very high even at the lowest concentration level, micrograms (µg). Hence, the establishment of the potency of the highly potent active pharmaceutical ingredients is based on OELs in µg/m3.
The 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 are the APIs which have low potency and their very low dose level does not alter the human beings DNA. It means that the drug substances do not have the inherent capacity to stimulate the biological activity at a low concentration level of micrograms (µg).
Low potent APIs are used for the treatment of various diseases in human beings and animals.
Below are some illustrations that you might have seen.
1. Atorvastatin
2. Ketorolac
3. Anastrozole
4. Tizanidine HCl
5. Sumatriptan Succinate
Note:
Potency and toxicity both are different terms. Potency refers to the inherent property to induce biological activity and altering of DNA at a very low concentration level of a dose, whereas, toxicity refers to adverse effects of a chemical substance on the whole organism such as animal and plant.
Manufacture of Active Pharmaceutical Ingredients
The preparation of an Active pharmaceutical ingredient (API) is a multi-step organic synthesis. Critical steps of the manufacturing process may be purification, crystallization, drying, milling and packing. Understand organic synthesis. That will give you more insight into APIs.
Manufacturing Facility of High Potent APIs
Production of high potent APIs needs special equipment and design. The fermentation process also is one of the techniques used to prepare this kind of APIs.
Accurate operational instructions and safety measurements are the crucial factors in the manufacturing process.
Perfect installation of airlocks, 100% single-pass air and exit showers are the basic needs to fulfill.
These steps are necessary due to their inherent property of intense biological activity which can harm the people even at microgram level concentrations if presented in the surrounding atmosphere.
Dedicated suits are also one of the protective equipment of personnel that to be maintained mandatorily. Failure in taking up this care will harm the people and can cause cancer in humans who exposed to it.
It is the major responsibility of manufacturers to ensure failsafe procedures are in place.
Manufacturing Facility of Non-Potent APIs
The design of the plant should be in line with the laid down compliance systems by WHO and government agencies.
Maintenance of facilities, clean rooms, hygiene, handling and storage of materials should be clearly defined and maintained.
Manufacturers of APIs should build the plant in an appropriate environment.
Operations should not be conducted in an open air system where the dust resides as a source of contamination.
The major source of fatal incidents is contamination and cross-contamination. Procedures should be in place to prevent this kind of contaminations of active pharmaceutical ingredients from other materials.
General safety measures and handling procedures of hazardous reactions are necessary requirements to avoid fatal incidents due to hazardous reactions.
Top 10 API Market Vendors
Many survey reports and industry research reports are indicating that the below-mentioned companies are the top 10 global API Suppliers.
The list presented here has been taken from the source given below.
Global Active Pharmaceutical Ingredients Market 2017-2021
1 Aurobindo Pharma
2 Cipla
3 Dr. Reddys Laboratories
4 Sun Pharmaceutical Industries
5 Teva Pharmaceutical Industries
6 Abbott Laboratories
7 Albemarle
8 Amgen
9 BASF
10 Biocon
Summary
An Active pharmaceutical ingredient (API) is a main active ingredient in drug product and is biologically active substance. APIs only would act in the human body, not the excipients, in the treatment of diseases with pharmaceutical drugs.
There are two types of APIs which are potent and non-potent. Potent API can stimulate biological activity, even with a very low concentration of dose (microgram level). Plant design for high potent APIs is a very critical task and involves vigorous safety measures.
Non-potent APIs cannot stimulate biological activity with a low concentration of doses. Safety and quality are the two main factors to take into account while designing an API plant.
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Author Profile
Ram Kumar Reddy
Ram Kumar Reddy is the founder of Pharma Times Now. Helping students of Pharmacy and Chemistry and employees in pharma industry in learning pharmaceutical scince. Ram Kumar Reddy has 24 years rich experience in Pharmaceutical industry and well versed in quality systems. He worked with Dr.Reddys and Sai Life Sciences. He lives in Hyderabad, India.
Sir I have a question what is the types of API, different name of API ,and most demanded or profitable API
ReplyDeleteWhat type of APIs drug purchase from China. We have to produce Made in India APIs drugs. Please guide us.
ReplyDeleteSir,
ReplyDeletewhat is the types of API.
I Like to add one more important thing here, The Active Pharmaceutical Ingredients Market is expected to be around US$ 238.5 Billion by 2025 at a CAGR of 6% in the given forecast period.
ReplyDelete