System and process for providing at least one opening in dosage forms

Abstract

The present invention relates to apparatus, methods, and processes for making solid dosage forms comprising at least one active ingredient, a core and shell configuration, wherein the shell comprises a hardenable material, such as a thermal-gelling polymer, for example gelatin; and the shell is provided with at least one opening. The opening(s) are formed while the shell is still in a softened state.

1 - 24 . (canceled) 
   
   
       25 . A process for making a dosage form that comprises a core and a shell surrounding at least a portion of the core and having one or more openings comprising:
 a) providing a shell over at least a portion of the compressed core; and   b) providing at least one opening in said shell, wherein the shell is soft at the time the opening is provided in said shell.   
   
   
       26 . The process according to  claim 25 , wherein one or more openings contact the core. 
   
   
       27 . The process according to  claim 25 , wherein the soft shell has a water content at least 20% greater than its moisture content at equilibrium at 25° C. and 60% relative humidity. 
   
   
       28 . The process according to  claim 25 , wherein the core comprises at least one active ingredient. 
   
   
       29 . The process according to  claim 28 , wherein the dosage form provides for immediate release of at least one active ingredient contained in the core. 
   
   
       30 . The process according to  claim 25 , wherein the core comprises a compressed tablet. 
   
   
       31 . The process according to  claim 25 , wherein the compressed tablet has a hardness from about 1 to about 30 kp/cm2. 
   
   
       32 . The process according to  claim 25 , wherein the shell comprises gelatin. 
   
   
       33 . The process according to  claim 25 , wherein the average thickness of the shell, excluding uncoated or exposed areas, is in the range from about 100 to about 400 microns. 
   
   
       34 . The process according to  claim 25 , wherein the diameter or width of the one or more openings is from about 200 to about 2000 microns. 
   
   
       35 . The process according to  claim 26 , wherein the soft shell has a water content at least 20% greater than its moisture content at equilibrium at 25° C. and 60% relative humidity. 
   
   
       36 . The process according to  claim 26 , wherein the core comprises at least one active ingredient. 
   
   
       37 . The process according to  claim 36 , wherein the dosage form provides for immediate release of at least one active ingredient contained in the core. 
   
   
       38 . The process according to  claim 26 , wherein the core comprises a compressed tablet. 
   
   
       39 . The process according to  claim 26 , wherein the compressed tablet has a hardness from about 1 to about 30 kp/cm2. 
   
   
       40 . The process according to  claim 26 , wherein the shell comprises gelatin. 
   
   
       41 . The process according to  claim 26 , wherein the average thickness of the shell, excluding uncoated or exposed areas, is in the range from about 100 to about 400 microns. 
   
   
       42 . The process according to  claim 26 , wherein the diameter or width of the one or more openings is from about 200 to about 2000 microns. 
   
   
       43 . The process according to  claim 29 , wherein the average thickness of the shell, excluding uncoated or exposed areas, is in the range from about 100 to about 400 microns. 
   
   
       44 . The process according to  claim 37 , wherein the diameter or width of the one or more openings is from about 200 to about 2000 microns.