Enzyme Delivery Systems and Methods of Preparation and Use

Abstract

This invention relates to coated digestive enzyme preparations and enzyme delivery systems and pharmaceutical compositions comprising the preparations. This invention further relates to methods of preparation and use of the systems, pharmaceutical compositions and preparations to treat persons having ADD, ADHD, autism, cystic fibrosis and other behavioral and neurological disorders.

1 - 59 . (canceled) 
     
     
         60 . A method of producing a pellet or a micropellet consisting of pancreatin, which pellet contains no auxiliary substances and binding agents, comprising the steps of:
 a.) comminuting the pancreases of pigs or cattle and conducting autolysis;   b.) obtaining a sieved filtrate by filtration of the intermediate product obtained in step a);   c.) precipitating the enzymes from the sieved filtrate;   d.) filtering the mixtures obtained in step c) to obtain a filter cake;   e.) grinding and vacuum-drying the filter cake until a residual moisture of 0.1 to 0.3% by weight is obtained, whereby the pancreatin product with 0.1 to 0.3% by weight of residual moisture constitutes the dried end product; whereas the extrudable filter cake mass contains more residual moisture and/or organic solvent residues, which are of the order of 50%;   f.) thermally treating the filter cake at 80° C. or at a temperature below 80° C.;   g.) extruding the thermally treated filter cake having sufficient plasticity and having no additives and/or binding agents in order to form strands; and   h.) spheronising the extrusion of step g) without additives and/or binding agents or auxiliary substances so as to obtain spherical, elliptical or drop-shaped pellets or micropellets.   
     
     
         61 . The method of  claim 60 , wherein the auxiliary substances comprise additives, extenders, colorants, dyes, or flow enhancers. 
     
     
         62 . The method of  claim 60 , wherein the pancreatin is obtained from the pancreas of a mammal. 
     
     
         63 . The method of  claim 60 , further comprising i.) coating the pellet or micropellet. 
     
     
         64 . The method of  claim 63 , wherein the coating comprises hypromellose phthalate, dimethicone 1000, and dibutyl phthalate, monoglycerides, or an emulsifiable lipid.