Active pharmaceutical ingredients (API’s) are also known as bulk drug substances or active ingredients. The US Food and Drugs Administration (FDA) defines an API as “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.”
Companies use API’s at a number of stages of pharmaceutical development, including in stability sample testing, general analytical testing and method development, as GMP (Good Manufacturing Practice) API’s in clinical trials, and as source materials for manufacturing marketed drugs. API’s are used for preclinical or clinical trials, as well as for the production of finished drugs.
The pharmaceutical industry develops, manufactures, supplies and markets medications and drugs. There are various regulations regarding each segment and phase of drug development, production and marketing.
Four general categories of products make up pharmaceutical segmentation: consumer or prescription products, institutional market products (such as large hospitals who purchase in bulk directly from the pharma company), industrial market products (buyers of bulk drugs or API’s, including pharmaceutical machinery suppliers) and OTC (over the counter) or non-prescription products.
Darbox is active in the pharmaceutical market with leading packaging solutions for tablets, capsules, powders, granulates and more.
A leading European pharmaceutical company was bulk shipping tablets by air, in 12.5kg bags packed within a very expensive 15L plastic container. They knew that this approach, while “acceptable”, was logistically inefficient. And, their end user was starting to complain about the cost per kg shipped.
How could they pack more product per container and, at the same time, reduce the cost? Their first thought was larger bags in larger containers. However they knew, from previous tests, that any greater weight would cause pressure damage to the tablets at the bottom of the bag.
DARBOX SOLUTION:
Darbox helped them “Re-Think” their packaging problem. The solution – create two “virtual” 15L containers within a 30L one. A conical, nestable UN 30L container design was customized to include an easily removable, non-slip platter which created an upper and lower “virtual” 15L space within the container.
Now, the company can pack two 12.5kg bags inside one less expensive, but still heavy duty, 30L container without the risk of any weight related product damage. The integrity of the tablets is assured, packaging costs are improved, shipping and storage costs are minimized and both the company and their customer gain the benefit of the reduced price per kg.