Pancreatin micropellets prepared with polyethylene glycol 4000, paraffin and a lower alcohol by extrusion and rounding
Patent 5378462 Issued on January 3, 1995. Estimated Expiration Date: 
August 19, 2013. Estimated Expiration Date is calculated based on simple USPTO term provisions. It does not account for terminal disclaimers, term adjustments, failure to pay maintenance fees, or other factors which might affect the term of a patent.
August 19, 2013. Estimated Expiration Date is calculated based on simple USPTO term provisions. It does not account for terminal disclaimers, term adjustments, failure to pay maintenance fees, or other factors which might affect the term of a patent.Patent ReferencesPreparation of enteric coated digestive enzyme compositions Process for the production of pancreatin pellets Stabilization of enteric coated dosage form Controlled release delivery device for macromolecular proteins Enteric coated pharmaceutical compositions Patent #: 5225202 Inventors
AssigneeApplicationNo. 109051 filed on 08/19/1993US Classes:424/94.21, Pancreatin424/408, Capsule or pelleted or tablet435/175, Multi-enzyme system435/177, Enzyme or microbial cell is immobilized on or in an organic carrier435/180, Carrier is synthetic polymer435/182Enzyme or microbial cell is entrapped within the carrier (e.g., gel, hollow fibre)ExaminersPrimary: Naff, David M.Attorney, Agent or FirmForeign Patent References
International ClassesA61K 037/62A01N 025/34 C12N 011/08 C12N 011/18 Foreign Application Priority Data1992-08-19 DEAbstractPancreatin-containing micropellet cores which can be coated with a gastric juice-resistant film are prepared by extruding a mixture containing pancreatin, polyethylene glycol 4000 and a lower alcohol such as propan-2-ol to produce extrudates which break by themselves into fragments, rounding the fragments with the addition of highly liquid paraffin and drying. Propan-2-ol may be present with the paraffin during rounding. The micropellet cores contain 65-85% pancreatin, and have a bulk density of 0.6 g/ml to 0.85 g/ml, a spherical to ellipsoidal shape with a minor axis in the range of 0.7-1.4 mm and a particle size distribution in which at least 80% of the micropellet cores have a minor axis to major axis ratio in the range from 1:1 to 1:2.Other References
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