Abstract: Provided herein are two-step, multi-step and double precipitation processes used to prepare HA-pancreatin having a specific lipase activity of at least 120 USP IU/mg. The present two-step processes include suspending pancreatin in an aqueous solvent and adding an organic solvent with a Hildebrand solubility parameter between about 38 and 45 (MPa)0.5 to precipitate HA-pancreatin. The present multi-step processes produce HA-pancreatin using additional solvents. Double precipitation processes are directed to the use of solvents having different Hildebrand solubility parameters to produce HA-pancreatin product for use as a therapeutic agent.

Abstract: Methods for screening pancrelipase for RNA virus contamination comprise removing free viral RNA from the pancrelipase, denaturing any viruses in the pancrelipase to release encapsidated RNA into the pancrelipase milieu, and detecting this released RNA. Removal of free viral RNA may comprise treating pancrelipase with RNase and DNase or precipitating the protein fraction of pancrelipase with a salt that precipitates the protein fraction while leaving nucleic acids such as RNA in solution. Pancrelipase substantially devoid of free nucleic acid is also provided.

Abstract: The invention is directed to a process for measuring the amount of digestive enzymes released from a solid composition in a dissolution medium by fluorescence spectroscopy. The invention is also directed to a combined method for measuring both the dissolution and gastroresistance of a solid compositions comprising pancrelipase.

Abstract: The present invention provides high potency pharmaceutical compositions comprising high activity pancreatin enzymes. The invention is also directed to a process of producing HA-pancreatin enzymes and its compositions or dosage forms, and methods for their use.

Abstract: Methods for screening pancrelipase for RNA virus contamination comprise removing free viral RNA from the pancrelipase, denaturing any viruses in the pancrelipase to release encapsidated RNA into the pancrelipase milieu, and detecting this released RNA. Removal of free viral RNA may comprise treating pancrelipase with RNase and DNase or precipitating the protein fraction of pancrelipase with a salt that precipitates the protein fraction while leaving nucleic acids such as RNA in solution. Pancrelipase substantially devoid of free nucleic acid is also provided.

Abstract: The present disclosure provides high potency pharmaceutical compositions comprising high activity pancreatin enzymes. The invention is also directed to a process of producing HA-pancreatin enzymes and its compositions or dosage forms, and methods for their use.

Abstract: The invention is directed to a process for measuring the amount of digestive enzymes released from a solid composition in a dissolution medium by fluorescence spectroscopy. The invention is also directed to a combined method for measuring both the dissolution and gastroresistance of a solid compositions comprising pancrelipase.

Abstract: The present invention is directed to a process for the preparation of a predigested nutritional formula as well as the predigested liquid nutritional formula and a kit for the preparation of a predigested nutritional formula. The predigested nutritional formula comprises digestive enzymes and a liquid nutritional composition comprising a mixture of carbohydrates, lipids, proteins and water.