High potency active pharmaceutical ingredients (HPAPIs) are pharmacologically active substances that exhibit biological activity at extremely low concentrations. Generally, high potency active pharmaceutical ingredients works well even in daily therapeutic dose of <10 mg or an occupational exposure limit (OEL) of < 10 μg/m3 at an eight hour time-weighted average.
A few examples of commercial products that fall into the highly potent category are digoxin (Linoxin capsules, 100 µg per capsule) and alprazolam (Xanax tablets, 250 µg per tablet).
HPAPIs is a quite a buzz word in API market. There is a huge demand and growth in the oncology market, including the development of antibody drug conjugates — ADCs, and an increase in conventional drug manufacturing using high potent active pharmaceutical ingredients (HPAPIs) is driving the need for high potency handling capabilities, particularly high-containment manufacturing facilities.
Challenges for HPAPIs manufacturing
As per as the handling of high potency active ingredients are concern, cross contamination risk should be avoided. Specialist equipment should be employed to avoid cross contamination, product protection and to ensure operator and environmental safety.
One of the biggest challenges is choosing an appropriate solution based on a wide range of requirements. It is a matter of finding a balance that prioritizes protection whilst maintaining productivity and operability.
Also, extending capabilities can mean upgrading/investing in new equipment — a significant challenge for smaller manufacturers.
Also manufacturing unit should be equipped with offering higher levels of protection and less reliance on personal protection equipment (PPE) and respirators.
The increasing use of HPAPIs presents handling challenges and the need to invest in containment equipment to protect employees and the environment from exposure.
One of the biggest challenges is establishing and selecting the correct containment solution to suit the process operation. The selection, specification and compatibility of materials also has an important role to play.
The correct installation and set-up of the solution is of primary importance, as this will support employees in the safe and proper handling of the equipment. Additionally, training is essential alongside monitoring of operating methods to ensure maximum protection.
Frequent maintenance also helps safeguard the reliability of the solution.
Definition of Active Pharmaceutical Ingredient
Any substance or combination of substances used in a finished pharmaceutical product (FPP), intended to furnish pharmacological activity or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to have direct effect in restoring, correcting or modifying physiological functions in human beings.