Manufacturing Stages Pancreatin
Nordmark produces the active pharmaceutical ingredient pancreatin as a powder and in the form of pellets and processes both forms into finished medicinal products in its own manufacturing plant via intermediate stages. We supply you with every possible manufacturing stage, from the active pharmaceutical ingredient to the finished medicinal product and even with your own package design.
In doing so, we consider individual customer requirements and provide a wide range of enzyme specifications. The various product qualities can be supplied in compliance with PhEur or USP, depending on customer requirements.
With our coating process, specifically developed and refined for micro tablets and pellets, we ensure the enteric-coating of the enzymes in our pellets and micro tablets.
Enteric-coated pellets – lots of API, small size!
The core of our pancreatin pellets is free of additional excipients and, apart from the coating, consists of 100 per cent active pharmaceutical ingredient. The advantage: Significantly more API activity units fit into one capsule compared to using enteric-coated micro tablets. In consequence, you can work with smaller capsules to deliver the same activity unit dosage of active pharmaceutical ingredient.
Enteric-coated micro tablets – simple and accurate dosage
Unlike pellets, micro tablets have a uniform shape and the active ingredient content of each tablet is precisely defined and similar. The advantage: micro tablets can be dosed easily and precisely by counting.
Packaging of capsules with enteric-coated micro tablets or pellets
The desired amount of active ingredient per capsule, spread out over many small units (multiple-units) within each capsule, is achieved by filling the capsule with a multitude of enteric-coated micro tablets or pellets. The amount of micro tablets or pellets per capsule is dosed volumetrically or counted, according to the respective regulatory approval. Nordmark supplies enteric-coated micro tablets and pancreatin pellets in a wide variety of capsule sizes.
We package solid dosage forms in glass or plastic bottles.
Primary packaging: packaging system for pancreatin products
Nordmark has developed a packaging system especially for pancreatin products, as pancreatin is very sensitive to moisture. Optimal protection from moisture absorption is ensured by filling capsules into glass bottles sealed with a special aluminium foil under the actual lid.