Systems, methods and apparatuses for manufacturing dosage forms

Abstract

Systems, methods and apparatuses for manufacturing dosage forms, and to dosage forms made using such systems, methods and apparatuses are provided. Novel compression, injection molding, and thermal setting molding modules are disclosed. One or more of such modules may be linked, preferably via a transfer device, into an overall system for making dosage forms. The injection molding module having at least one mold shell with an interior surface capable of producing non-uniform coatings over compressed cores or molded inserts contained therein.

1 . A method of making a coated dosage form comprising: 
 a) introducing a core into a mold shell;    b) injecting a flowable material under pressure into the mold shell;    wherein the mold shell has an interior surface capable of providing a discontinuous coating around said dosage form.    
     
     
         2 - 27 . (canceled)  
     
     
         28 . A method of making dosage forms, comprising the steps of: 
 a) compressing a powder into a compressed dosage form in a compression module;    b) transferring said compressed dosage form to a molding module;    c) molding a flowable material around said compressed dosage form in said molding module; and    d) hardening said flowable material so as to form a coating over said compressed dosage form;    wherein steps (a) through (d) are linked together such that essentially no interruption occurs between said steps.    
     
     
         29 . The method of  claim 28 , wherein one or more of said steps is performed on a continuous basis.  
     
     
         30 . The method of  claim 28 , wherein one or more of said steps is performed on an indexing basis.  
     
     
         31 . The method of  claim 28 , wherein said powder contains a medicant.  
     
     
         32 . The method of  claim 28 , wherein said flowable material contains a medicant.  
     
     
         33 . The method of  claim 28 , wherein steps (a) through (d) are performed simultaneously, such that while coatings are being hardened on a first group of compressed dosage forms in step (d), flowable material is being molded around a second group of compressed dosage forms in step (c), a third group of compressed dosage forms are being transferred to said molding module in step (b), and a fourth group of compressed dosage forms are being formed in step (a).  
     
     
         34 . The method according to  claim 28 , further comprises the steps of: 
 f) forming an insert; and    g) embedding said insert in said powder prior to compressing said powder into a compressed dosage form.    
     
     
         35 . The method according to  claim 34 , wherein at least one of said powder and flowable material comprises a first medicant and said insert comprises a second medicant.  
     
     
         36 . The method according to  claim 34 , wherein said insert comprises a thermal setting material.  
     
     
         37 . The method according to  claim 28 , wherein said flowable material comprises a polymer.  
     
     
         38 . The method according to  claim 28 , wherein said flowable material comprises a material selected from the group consisting of sucrose-fatty acid esters; fats, waxes, fat-containing mixtures, sugars, and low-moisture polymer solutions.  
     
     
         39 . The method according to  claim 37 , wherein said flowable material comprises a gelatin.  
     
     
         40 . The method according to  claim 28 , wherein step (c) comprises the steps of: 
 (i) molding a first flowable material around a first portion of said compressed dosage form; and    (ii) molding a second flowable material around a second portion of said compressed dosage form.    
     
     
         41 . The method according to  claim 28 , wherein a single motor drives steps (a) through (d).  
     
     
         42 . A dosage form made by the method of  claim 28 .  
     
     
         43 . A method of making dosage forms, comprising the steps of: 
 a) compressing a first powder into a compressed dosage form in a first compression module;    b) transferring said compressed dosage form to a molding module;    c) molding a flowable material around said compressed dosage form in said molding module;    d) hardening said flowable material so as to form a coating over said compressed dosage form;    e) transferring said coated compressed dosage form to a second compression module; and    f) compressing a second powder around said coated compressed dosage form in said second compression module to form a compressed, coated, compressed dosage form;    wherein steps (a) through (f) are linked together such that essentially no interruption occurs between said steps.    
     
     
         44 . The method of  claim 43 , wherein one or more of said steps is performed on a continuous basis.  
     
     
         45 . The method of  claim 43 , wherein one or more of said steps is performed on an indexing basis.  
     
     
         46 . The method of  claim 43 , further comprising the steps of: 
 g) transferring said compressed, coated, compressed dosage form to a second molding module;    h) molding a second flowable material around said compressed, coated, compressed dosage form in said second molding module;    i) hardening said flowable material so as to form a second coating over said dosage form.