Method for producing pancreatin pellets
In order to avoid compromising the pharmacological effect of pancreatin caused by the addition of auxiliary materials or binding agents, a pancreatin pellet having a 100% pancreatin content consists exclusively of pancreatin with a residual moisture content of less than 3% by weight, preferably less than 1% by weight or less than 0.5% by weight.
1. A method for producing a pancreatin pellet and/or micropellet, which pellet and/or micropellet has a spherical, ellipsoidal or drop shape, has an axis in the range 0.5 mm to 2.5 mm,
comprising the steps of
a) comminuting the pancreases of pigs or cattle and conducting autolysis;
b) obtaining a screen filtrate by filtration of the product obtained in step a);
c) precipitating the enzymes from the screen filtrate;
d) filtering the product of step c) to obtain a filter cake;
e) cooling the filter cake to a temperature between about −10° C. to about −40° C., to obtain a sufficient plasticity;
f) extruding the cooled filter cake, in the absence of additives and/or binding agents, to form extrudates, wherein extrudable filter cake mass contains residual moisture or organic solvent residues between about 30% to about 50% by weight;
g) spheronizing the extrusion obtained in step (f), in the absence of additives and/or binding agents or auxiliary substances, so as to obtain spherical, elliptical or drop-shaped pellets; and
h) vacuum drying the pellets obtained in step (g) until a residual moisture content of less than 3% by weight is obtained, so that a dried pancreatin product is produced with a residual moisture content of less than 3% by weight.
2. The method according to claim 1 , wherein the pellet produced has a pancreatin content of 100%.
3. The method according to claim 1 , which comprises the further step of coating the pancreatin pellet, so as to form a pancreatin core having a coating.
4. The method according to claim 3 , wherein the coating comprises an enteric material.
5. The method according to claim 3 , wherein the coating consists of pancreatin or is formed from auxiliary materials or binding agents.
6. The method according to claim 3 , wherein the coating has a first, inner layer which surrounds the pancreatin core, and further has a second, outer layer.
7. The method according to claim 6 , wherein the first layer is formed from auxiliary materials or binding agents.
8. The method according to claim 6 , wherein the second layer is formed from an enteric material, wherein the pellet is drop-shaped or spherical in shape.
9. The method according to claim 1 , wherein in step (e) the filter cake is cooled to about −30° C.
10. The method according to claim 1 , wherein in step (f) extrudable filter cake mass contains residual moisture or organic solvent of about 40% by weight.
11. The method according to claim 1 , wherein in step (h) the residual moisture content obtained is less than 1% by weight, so that a dried pancreatin product is produced with a residual moisture content of less than 1% by weight.
12. The method according to claim 1 , wherein in step (h) the residual moisture content obtained is less than 0.5% by weight, so that a dried pancreatin product is produced with a residual moisture content of less than 0.5% by weight.