High Potency Active Pharmaceutical Ingredients; Effective at Much Smaller Dosage Levels than Traditional APIs

 

High Potency Active Pharmaceutical Ingredients

High potency active pharmaceutical ingredients (HPAPIs) are compounds that elicit a biological response at a very low dose/concentrations, such as a daily therapeutic dose of <10 mg or an occupational exposure limit (OEL) of < 10 μg/m3 at an eight-hour time-weighted average. High potent drugs represent a growing proportion of medicines, including therapies in development and those commercially available. The active ingredient in a pharmaceutical drug is called an API. An example of an API is the acetaminophen contained in a pain relief tablet.

The active ingredient in a biological drug is called a bulk process intermediate (BPI). Demand for High Potency Active Pharmaceutical Ingredients is increasing at a rapid pace due to its ability to target diseased cells more precisely and selectively than other APIs. A highly potent drug (bisoprolol, bumetanide, risperidone, alprazolam, and fentanyl) evokes a given response at low concentrations, whereas a drug of lower potency (metoprolol, furosemide, ziprasidone, diazepam, and meperidine) evokes the same response only at higher concentrations.

High potency active pharmaceutical ingredients are compounds that elicit a biological response at a very low dose. However, any type of compound can be highly potent if it causes a response at a low dose. A substance with high potency will have a big effect on the body, and something with low potency will have a smaller one. Many of these drugs have accelerated timelines for approval & commercial development. HPAPI services by Piramal Pharma offer manufacturing of HPAPIs through its FDA-approved cGMP state-of-the-art facility in the U.S.

Potency is an expression of a drug's activity in terms of the concentration or amount of a drug needed to produce the defined effect, while clinical efficacy judges a drug's therapeutic effectiveness in humans. High potency active pharmaceutical ingredients (HPAPI) represent an increasingly significant share of the pharmaceutical drug pipeline.

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