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

In contrast to pellets (on the right in the picture) the proportion of the active ingredient in each individual microtablet (on the left in the picture) is exactly defined and identical. Simple counting is sufficient for accurate dosing with microtablets!
In contrast to pellets (on the right in the picture) the proportion of the active ingredient in each individual microtablet (on the left in the picture) is exactly defined and identical. Simple counting is sufficient for accurate dosing with microtablets!
Both capsules (on the left, size 2, with microtablets, on the right, size 3 with pellets) contain the same amount of active ingredient: 10,000 units lipase. If small capsule sizes are the goal, pellets are advantageous over microtablets.
Both capsules (on the left, size 2, with microtablets, on the right, size 3 with pellets) contain the same amount of active ingredient: 10,000 units lipase. If small capsule sizes are the goal, pellets are advantageous over microtablets.
Microtablets with counting spoons (Tab Drop System)
Microtablets with counting spoons (Tab Drop System)
Pancreatin film tablets
Pancreatin film tablets

Pancreatin microtablets and pellets: Small amount, great effect

The enzymes of enteric coating microtablets or pellets are released exactly where they are intended to work: in the small intestine.
The enzymes of enteric coating microtablets or pellets are released exactly where they are intended to work: in the small intestine.

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.  

A comparison of the properties of pancreatin pellets and film-coated microtablets
PelletsMicrotablets
Basic production data

Extrusion and spheronisation

 

Mix dried and ground pancreatin with adjuvants, prior to tabletting

 
Active ingredient content (core)100 %Dependent on formulation
CoatingWater based, enteric coatedWater based, enteric coated
Particle sizeTwo classes:
1.0  - 1.6 mm / 
1.4  -  2.4 mm
2 mm
Specific activity (per gram)HigherLower
Capsule sizeSmallerLarger
Lipolytic activity dose / capsule
(Ph. Eur. units)
Up to 40.000/size 0 elongatedUp to 36.000/size 00
Pancreatin Info Gallery

From drug substance to drug product: Pancreatin production at Nordmark