Abstract: Systems, methods and apparatuses for manufacturing dosage forms, and to dosage forms made using such systems, methods and apparatuses are provided. Novel compression, thermal cycle molding, and thermal setting molding modules are disclosed. One or more of such modules may be linked, preferably via novel transfer device, into an overall system for making dosage forms.

Abstract: In one aspect, the present invention features a method of manufacturing a solid dosage form, the method including the steps of: (a) measuring an amount of a first powder blend within a dosing nozzle, wherein the first powder blend includes a pharmaceutically active agent; (b) discharging the measured amount of a first powder blend from the dosing nozzle into a forming cavity within a die block, the forming cavity having an inner wall, a first opening at the surface of one side of the die block, and a second opening at the surface on the opposite side of the die block; (c) moving a first forming tool into the forming cavity through the first opening of the forming cavity such that the first powder blend is formed into the shape of the dosage form within the forming cavity between the inner wall, the first forming tool and a second forming tool within or adjacent to the cavity; (d) applying RF energy between a first electrode and a second electrode such that the energy heats the first powder blend within the fo

Abstract: In one aspect, the present invention features a tablet including a first region and a second region, wherein: (i) the first region and the second region each include at least 10%, by volume, of the tablet; (ii) the first region includes a pharmaceutically active agent and the composition of the first region is different from the composition of the second region; (iii) the first region has a density less than about 0.8 g/cc; and (iv) the first region disintegrates in the mouth when placed on the tongue in less than about 30 seconds; wherein the shape of the tablet includes two opposing major faces separated by a side wall, and the interface between the first region and the second region is along at least one major face of the tablet.

Abstract: In one aspect, the present invention features a machine for the production of a solid dosage form wherein the machine is adapted to form a dosage form between a first forming tool and a second forming tool within a forming cavity and wherein the first RF electrode and the second RF electrode are arranged within the machine such that when RF energy is applied between the first RF electrode and the second RF electrode, the RF energy passes through the portion of the forming cavity adapted to form the dosage form.

Abstract: A dosage form comprises: (a) at least one active ingredient: (b) a core having a first surface portion upon which resides a first coating and a second surface portion which is substantially free of the first coating; and (c) a shell which resides upon at least a portion of the second surface portion, wherein the shell comprises a different material from the first coating. In another embodiment, the dosage form comprises: (a) at least one active ingredient; (b) a core comprising a center portion having an exterior surface and an annular portion having an exterior surface and an interior surface, wherein the annular portion interior surface is in contact with at least a portion of the center portion exterior surface, and a coating resides on at least a portion of the annular portion exterior surface; and (c) a shell which resides upon at least a portion of the exterior surface of the center portion, wherein the shell comprises a different material than the impermeable coating.

Abstract: The present invention features a process for making a lozenge product including the steps of forming a powder blend containing an amorphous carbohydrate polymer into the desired shape of the lozenge product and applying radiofrequency energy to the shape for a sufficient period of time to soften or melt said amorphous carbohydrate polymer to fuse the shape into said lozenge product.

Abstract: In one aspect, the present invention features a process for making a tablet including a pharmaceutically active agent wherein the tablet has both an immediate release region and a modified release region. The method includes the steps of: (a) forming a tablet shape including a powder blend containing a pharmaceutically active agent and a thermally-sensitive material; and (b) applying energy in different amounts to different regions of the tablet shape to form the tablet in a manner such that: (i) a first region of the tablet shape is exposed to said energy for a sufficient period of time to melt the thermally-sensitive material within the first region to form said modified release region of said tablet; and (ii) a second region of said tablet shape is not so exposed to the energy such that said second region forms the immediate release region of said tablet.

Abstract: Systems, methods and apparatuses for manufacturing dosage forms, and to dosage forms made using such systems, methods and apparatuses are provided. Novel compression, thermal cycle molding, and thermal setting molding modules are disclosed. One or more of such modules may be linked, preferably via novel transfer device, into an overall system for making 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, thermal cycle molding, and thermal setting molding modules are disclosed. One or more of such modules may be linked, preferably via novel transfer device, into an overall system for making dosage forms.

Abstract: The present invention features the present invention features a process for making a tablet by compacting a powder blend in a die platen to form a tablet shape, wherein the powder blend includes a pharmaceutically active agent and a water-containing material, and applying energy to the tablet shape for a sufficient period of time to heat the water-containing material within the tablet shape above its dehydration temperature to form the tablet.

Abstract: The present invention features a tablet containing a first layer and a second layer, wherein: (i) the first layer includes a pharmaceutically active agent and the composition of the first layer is different from the composition of the second layer; (ii) the tablet has a density less than about 0.8 g/cc; and (iii) the tablet disintegrates in the mouth when placed on the tongue in less than about 30 seconds.

Abstract: The present invention features the present invention features a tablet including at least one pharmaceutically active ingredient, wherein the shape of said tablet includes at least one major face wherein: (i) the peak penetration resistance at the perimeter of said major face of the tablet is at least about 10% greater than the peak penetration resistance at the center of said major face; and (ii) the tablet disintegrates in the mouth when placed on the tongue in less than about 30 seconds, and a machine and method for manufacture of such tablet.

Abstract: The present invention features a process for making tablets containing one or more pharmaceutically active agent(s) and one or more binder(s), the method including the steps of (i) applying energy to a powder blend comprising the pharmaceutically active agent(s) and the binder(s) for a sufficient period of time to activate the binder(s) within the powder blend and (ii) forming a predetermined amount of the energy-applied powder blend into the tablets.

Abstract: In one embodiment a dosage form comprises at least one active ingredient and a molded matrix which comprises 10-100% of a material having a melting point of less than about 100 degrees C. selected from the stamp consisting of thermoplastic polyalkylene oxides, low melting hydrophobic materials, thermoplastic polymers, thermoplastic starches and combinations thereof, and the matrix is capable of providing modified release of the active ingredient upon contacting of the dosage form with a liquid medium. The dosage form may additionally comprise uncoated particles which may contain at least one active ingredient. In another embodiment, a dosage form comprises at least one active ingredient, a plurality of particles and a molded matrix, wherein at least a portion of the particles are coated.

Abstract: In one embodiment a dosage form comprises at least one active ingredient and a molded matrix which comprises 10-100% of a material having a melting point of less than about 100 degrees C. selected from the stamp consisting of thermoplastic polyalkylene oxides, low melting hydrophobic materials, thermoplastic polymers, thermoplastic starches and combinations thereof, and the matrix is capable of providing modified release of the active ingredient upon contacting of the dosage form with a liquid medium. The dosage form may additionally comprise uncoated particles which may contain at least one active ingredient. In another embodiment, a dosage form comprises at least one active ingredient, a plurality of particles and a molded matrix, wherein at least a portion of the particles are coated.

Abstract: The present invention features a tablet including one or more pharmaceutically active agent(s), one or more thickeners, and one or more binder(s), wherein the tablet includes at least 200 mg of the pharmaceutically active agent(s) and the tablet has been fused with the binder(s) such that the tablet (i) has a water permeation time of less than 60 seconds and (ii) has an in vitro disintegration time of greater than 60 seconds.

Abstract: The present invention features the present invention features a process for making a tablet by compacting a powder blend in a die platen to form a tablet shape, wherein the powder blend includes a pharmaceutically active agent and a water-containing material, and applying energy to the tablet shape for a sufficient period of time to heat the water-containing material within the tablet shape above its dehydration temperature to form the tablet.

Abstract: The present invention features a process for making a lozenge product including the steps of forming a powder blend containing an amorphous carbohydrate polymer into the desired shape of the lozenge product and applying radiofrequency energy to the shape for a sufficient period of time to soften or melt said amorphous carbohydrate polymer to fuse the shape into said lozenge product.

Abstract: The present invention features a process for making a chewing gum product including the steps of forming a powder blend containing a gum base into the desired shape of the chewing gum product and applying radiofrequency energy to the shape for a sufficient period of time to soften the gum base to fuse the shape into the chewing gum product.

Abstract: The present invention features a process for making a tablet by (i) compacting a powder blend in a die to form a tablet shape, wherein the powder blend contains a pharmaceutically active agent and a meltable binder and (ii) applying radiofrequency energy to the tablet shape for a sufficient period of time to soften or melt the binder within said tablet shape to form the tablet.