High potency pancreatin pharmaceutical compositions
OwnerStephen PERRETT, Robert BECKER +6inventors
InventorsStephen PERRETT, Robert BECKER, Luigi BOLTRI, Luigi GHIDORSI, Paula ARZUFFI, Vincenza PIRONTI, Michael TOTA, William WARD
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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.
Claims61
A high activity pancreatin (HA-pancreatin), wherein the said pancreatin comprises a specific lipase activity of at least about 120 USP IU/mg.
A process of preparing a high activity pancreatin (HA-pancreatin) having a specific lipase activity of at least about 120 USP IU/mg, comprising treating pancreatin with a solvent having Hildebrand solubility parameter comprised between 28 and 45 (MPa)0.5, wherein the said solvent is an organic solvent or an aqueous solvent or a mixture of organic solvents or a mixture of at least one organic solvent and at least one aqueous solvent, wherein the process temperature is below the room temperature.
The method of treating a patient subject to a physiological condition associated with pancreatic enzymatic insufficiency comprising administering to the patient a pharmaceutically acceptable amount of a composition comprising high activity pancreatin (HA-pancreatin).
A method of preparing HA-pancreatin comprising precipitating pancreatin from a solution of native pancreatin using ammonium sulfate.
Dependencies are inferred from the claim text.