Method of manufacturing modified release dosage forms

Abstract

In one embodiment, a dosage form comprises: (a) at least one active ingredient; (b) a molded core which is solid at room temperature; and (c) a shell which is in contact with at least a portion of the core, wherein the dosage form provides modified release of the active ingredient upon contacting of the dosage form with a liquid medium. In another embodiment of this invention, a dosage form comprises: (a) at least one active ingredient; (b) a molded core comprising a plurality of particles; and (c) a shell which is in contact with at least a portion of the core, wherein the dosage form provides modified release of the active ingredient upon contacting of the dosage form with a liquid medium.

1 . A dosage form comprising: (a) at least one active ingredient; (b) a molded core which is solid at room temperature; and (c) a shell which is in contact with at least a portion of the molded core, wherein the dosage form provides modified release of the active ingredient upon contacting of the dosage form with a liquid medium. 
     
     
         2 - 49 . (canceled) 
     
     
         50 . A method for manufacturing a dosage form comprising a core and a shell, wherein said method comprises injecting a matrix in flowable form into a molding chamber to form a core, applying a shell to said core such that said shell in contact with at least a portion of the outside of said core, wherein said matrix comprises polyethylene glycol having a molecular weight from about 100 to about 8000 Daltons and at least one active ingredient, wherein said core is solid at room temperature, and wherein the dosage form provides modified release of at least one of said at least one active ingredient upon contacting of the dosage form with a liquid medium. 
     
     
         51 . A method of  claim 50 , wherein said shell is applied by injection molding. 
     
     
         52 . A method of  claim 50  wherein said core is substantially free of pores having a diameter of 0.5 to 5.0 microns. 
     
     
         53 . The method of  claim 50 , in which said modified release is a time delay prior to the release of said at least one active ingredient. 
     
     
         54 . The method of  claim 50 , in which said modified release is a sustained release of said at least one active ingredient. 
     
     
         55 . The method of  claim 50 , in which the shell comprises a first active ingredient and the core comprises a second active ingredient which may be the same or different than the first active ingredient, and upon contacting of the dosage form with a liquid medium, immediate release of the first active ingredient occurs followed by sustained release of the second active ingredient. 
     
     
         56 . The method of  claim 50 , in which the level of active ingredient in the core is at least about 25 weight percent. 
     
     
         57 . The method of  claim 50 , in which the core comprises one or more release-modifying excipients selected from the group consisting of swellable erodible hydrophilic materials, pH-dependent polymers, insoluble edible materials, and pore-formers, copolymers, and combinations thereof. 
     
     
         58 . The method of  claim 57 , in which the release-modifying excipient is selected from the group consisting of shellac or croscarmellose sodium. 
     
     
         59 . The method of  claim 50 , in which the core comprises a plurality of particles which comprise said at least one active ingredient. 
     
     
         60 . The method of  claim 59 , in which at least a portion of the particles are coated with a coating capable of providing modified release of said at least one active ingredient contained therein upon contacting of the coated particles with a liquid medium. 
     
     
         61 . The method of  claim 59 , in which said portion of particles are coated with a coating comprising 10-100 wt. % of a release-modifying polymer selected from the group consisting of pH-dependent polymers, water-soluble polymers, water-insoluble polymers, and copolymers, and mixtures thereof. 
     
     
         62 . The method of  claim 50 , in which said matrix comprises said polyethylene glycol at a level from about 10 to about 100 weight percent of the matrix. 
     
     
         63 . The method of  claim 62 , in which the matrix further comprises a thermoplastic polyethylene oxide at a level of about 15 to about 25%. 
     
     
         64 . The method of  claim 50 , in which the shell comprises at least about 30 percent by weight of a thermal-reversible carrier having a melting point from about 20 to about 110° C. 
     
     
         65 . The method of  claim 50 , in which the shell comprises at least one of said at least one active ingredient. 
     
     
         66 . The method of  claim 50 , in which the shell has a thickness from about 300 to about 2000 microns. 
     
     
         67 . The method of  claim 50 , in which the weight of the shell is from about 50 to about 400 percent of the weight of the core. 
     
     
         68 . The method of  claim 50 , in which the shell comprises a film-former selected from the group consisting of cellulose acetate, ammonia methacrylate copolymer type B, shellac, hydroxypropylmethylcellulose, polyethylene oxide, and combinations thereof.