Pancreatin drug products
We supply pancreatin drug products in multiple forms: film-coated tablets,film-coated microtablets and sugar-coated tablets as well as capsules filled with film-coated microtablets or pellets.
Our coating method, especially developed for tablets and pellets, allows us to achieve excellent drying behaviour under mild temperature conditions, thus ensuring the required preservation of the enzyme activity.
We offer a broad range of products with different enzyme activities that can be custom-tailored to your needs. We offer those products in a large variety of tablet shapes and capsule sizes. If desired, we can manufacture your drug substances to the final ready-to-ship product.
Film-coated pancreatin microtablets – simple and accurate dosage
Contrary to pellets, microtablets are uniform in shape and the amount of active pharmaceutical ingredient of each tablet is exactly defined and identical. Therefore, microtablets can be accurately dosed by simple counting. We offer microtablet bulk in a glass container with a tab-drop system. This system consists of a counting spoon, with which tablets can be counted as if they were “solid drops”. These microtablets are particularly suitable for patients who have problems taking capsules.
Pancreatin pellets – lots of drug substance, minimal size
Compared to microtablets, pellets do not contain any adjuvants and aside from the protective coating, consist of 100% pancreatin. The advantage is clear, especially for patients requiring smaller capsules for comfortable administration - considerably more drug substance units can be contained in a capsule, than would be feasible with microtablets. This means that it is possible to use smaller capsules for the same amount of drug substance.
Comparison of microtablets to pellets
Pancreatin microtablets and pellets: Small amount, great effect
Pancreatin enzymes are designed to activate in the small intestine, after passing through the pylorus (the “gatekeeper” at the end of the stomach) and not in the stomach itself.
Novel drug forms, in which the active ingredient dose is distributed over several particles (multi-unit dose: MUD) offer distinct advantages compared to more traditional, larger film tablets, in which the full active ingredient dose is concentrated in a single formulation (single unit dosage: SUD).
To offer its clients the benefit of multi-unit doses Nordmark developed film-coated pancreatin microtablets and pellets. Administered in capsules that dissolve in the stomach, the small, enteric coated microtablets or pellets are released into the stomach and due to their small size, easily pass the pylorus regardless of its opening status. They quickly reach the small intestine, where the pancreatin is released and takes effect. In addition to offering the benefit of an easier passage compared to a single large tablet, the active ingredient contained in many small microtablets or pellets is also more broadly and regularly distributed.
|Basic production data|| |
Extrusion and spheronisation
Mix dried and ground pancreatin with adjuvants, prior to tabletting
|Active ingredient content (core)||100 %||Dependent on formulation|
|Coating||Water based, enteric coated||Water based, enteric coated|
|Particle size||Two classes:|
1.0 - 1.6 mm /
1.4 - 2.4 mm
|Specific activity (per gram)||Higher||Lower|
|Lipolytic activity dose / capsule|
(Ph. Eur. units)
|Up to 40.000/size 0 elongated||Up to 36.000/size 00|