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UNDERSTANDING ACTIVE PHARMACEUTICAL INGREDIENTS
Have you ever wondered how pharmaceutical drugs work? The ingredients in a pharmaceutical drug are responsible for the physiological reaction your body has to the medication. Many components are involved in the development of pharmaceuticals, but active pharmaceutical ingredients are the ingredients that produce the intended effects of the drug an individual is taking.Bala haholoanyane -
Active Pharmaceutical Ingredients (API)
Active ingredients are responsible for the beneficial health effects of drugs individuals consume. In pharmaceutical drugs, the active ingredient is known as the active pharmaceutical ingredient (API), like acetaminophen in pain relief tablets. In biological drugs, the active ingredient is a bulk process intermediate (BPI), such as insulin in insulin pen cartridges used by people with diabetes.Active Pharmaceutical Ingredients covers a significant part of the Science & Technology subject of the General Studies Paper-3 syllabus and current events of national importance in UPSC prelims.In this article, we will learn about Active Pharmaceutical Ingredients (API) and other associated details that the candidate can find helpful in all upcoming examinations and the UPSC CSE Exam. Candidates can also enrol in our UPSC Online Coaching program and get the best guidance for Science and Technology subjects.Bala haholoanyane -
Here’s Why Your Medication Contains Active and Inactive Ingredients
When you take medication, whether it’s over-the-counter or prescription, you might notice that your medicine contains active and inactive ingredients. You may wonder why these ingredients are there and what purpose they serve. Paul Thompson, PharmD, a clinical pharmacist with Banner Pharmacy Services, answered some common questions about them.Bala haholoanyane -
What is an API (Active Pharmaceutical Ingredient) in Pharma?
According to the World Health Organization (WHO) the definition of an API is established as any substance used in a finished pharmaceutical product (FPP), whose ultimate goal is to develop a pharmacological activity or generate some direct effect in the diagnosis, treatment or prevention of a disease in a patient.Bala haholoanyane -
Active Pharmaceutical Ingredients (APIs)
Active Pharmaceutical Ingredients or APIs are also known as bulk drugs and a term that is often heard in business news. Hence, it is important to understand what the term means and India’s production of APIs, for the IAS exam Indian economy segment.An active ingredient is the ingredient in a pharmaceutical drug or pesticide that is biologically active. The similar terms active pharmaceutical ingredient and bulk active are also used in medicine, and the term active substance may be used for natural products.Bala haholoanyane -
What is an API?
The safety and efficacy of a drug depend on the quality of its API. Poorly manufactured or unsafe APIs may result in harmful consequences, including death. Therefore, they are required to be regulated. APIs must adhere to strict safety and quality standards set by the manufacturing country. Even if the manufacturing is outsourced, APIs must follow the stringent rules of the concerned health authority. For example, if the API is manufactured in Korea or Japan for distribution in the US, it will still be inspected under the FDA guidelines.Bala haholoanyane -
WHAT ARE APIS?
While the number of available prescription or over-the-counter drugs (OTC) under different names increases daily, the situation differs in the case of APIs. Considering how expensive the steps to introducing a new drug to the market are, there isn’t a great number of new APIs being introduced. An API is sold under only one name: the nonproprietary name.To avoid confusion in this market, which potentially would have dangerous consequences, WHO, in cooperation with national drug safety agencies worldwide, came up with a list of non-proprietary names back in 1953. The organization revises the list regularly, and you can send them a request for new International Nonproprietary Names (INN).So, everywhere in the world, Ramipril is sold as Ramipril, and that API can’t be bought under any other name. Drug manufacturers can sell their drugs under any name they want, but they must put the API name right under the brand name.Bala haholoanyane -
Active pharmaceutical ingredient (API - Part II)
an extracted and purified active component of the cannabis plant (for example a cannabinoid)an extract of specified parts of the cannabis planta trituration of specified parts of the cannabis plantthe dried flower of the cannabis plant separated from leaves and stemThe term 'API starting material' refers to the starting material from which the API is made, not to the API.The manufacture of the API is required to be in compliance with Part II of the PIC/S Guide to GMP, as well as the relevant parts of the Annexes to the PIC/S Guide to GMP.Bala haholoanyane -
What are Active Pharmaceutical Ingredients (APIs) & Excipients?
API production is a highly sophisticated, technically demanding process and which is accomplished by chemical synthesis or biochemical methods. Active pharmaceutical ingredients are first obtained in the crude state. Subsequent production operations convert the crude material to the final API that meets the pharmacopoeial and/or similar requirements. Pharmaceutical manufacturing occurs in two general steps. First, raw materials are converted into Active Pharmaceutical Ingredients (APIs). The second step in pharmaceutical manufacturing is the final formulation of the drugs. Final formulations of API employs three major types of processes: organic chemical synthesis, fermentation and biological and natural extraction.Bala haholoanyane