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: Fumaric acid is added in amounts sufficient to reduce the burn sensation commonly associated with propionic acid derivatives.

Abstract: The invention relates to a tablet capable of being chewed or disintegrated in the oral cavity, which comprises a pharmaceutically active ingredient, and a matrix comprising directly compressible dextrose monohydrate and sucralose, said tablet being substantially fat free and said matrix being substantially free of non-saccharide, water soluble polymeric binders.

Abstract: An enrobed a core, such as a tablet core, that has a coating made of one or more patterned films each having portions that are visually distinct (e.g., differently colored) from one another and having a transition line segment between these visually distinct portions. At least a portion of an outer surface of the core is covered with the film or films, such that the transition line segments form a substantially continuous transition line on the coating and a film seam is formed which is different from the transition line. Where the patterned films are bi-colored, the resulting enrobed core can be bi-colored, or the resulting enrobed core can have a coating with at least four visually distinct portions alternately arranged thereon, thereby forming a “checkerboard” pattern on the coating. In either case, the film seam of the coating is different from the transition line of the coating.

Abstract: A pharmaceutical composition for oral administration comprising a core and a film coating on the core that exhibits enhanced disintegration characteristics is disclosed. The film coating comprises a film forming polymer, an organic solvent, a super-disintegrant and, optionally, an acid labile material.

Abstract: The present invention provides an oral dosage form for delivering active agents having a soft core with an active agent particles, which have an average size of greater than about 50 ?m, and a brittle shell encasing the soft core, wherein the weight ratio of drug particles to shell being from about 1.0:0.5 to about 1.0:15.

Abstract: The present invention features the present invention features a machine for the production of a solid dosage form including: (a) a die platen having one or more forming cavities each having an inner wall, a first opening at the surface of one side of the die platen, and a second opening at the surface on the opposite side of the die platen; (b) one or more first forming tools each adapted to move into one of the forming cavities through the first opening of the forming cavity; (c) one or more second forming tools each adapted to move adjacent to one of the second openings or into one of the forming cavities through the second opening of the forming cavity; (d) at least one first RF electrode operably associated with the one or more first forming tools, the one or more second forming tools, or the inner wall of the one or more forming cavities; and (e) at least one second RF electrode operably associated with the one or more first forming tools.

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: 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 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.

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: A process for making a nicotine-comprising chewing gum by (i) dispensing a powder portion from a gum-base-comprising powder, (ii) optionally shaping said powder portion into a powder aggregate, and (iii) applying sufficient electromagnetic energy (EM energy) to said powder portion or said powder aggregate to transform said powder portion or said powder aggregate into said chewing gum, whereby said EM energy is Radio Frequency (RF) energy, MicroWave (MW) energy, InfraRed (IR) energy or UltraViolet (UV) energy or combinations thereof. The invention also features a chewing gum made by such process. The chewing gum may comprise one or more deposits.

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 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: A composition comprising a high molecular weight, water soluble polymer having a cloud point from about 20 to about 90° C. and at least one carrageenan is provided. The composition may be used as a component of a pharmaceutical dosage form, such as the shell of a dosage form, to provide burst release of active ingredient contained therein.

Abstract: The present invention relates to a process for making orally disintegrating dosage forms and means for packaging such dosage forms.

Abstract: A method for reducing the friability of soft substrates by applying an effective amount of a water soluble, polymeric dispersion to at least a portion of a treatment surface of the substrate, such that less than about 90% of the exterior surface has the dispersion applied thereto.

Abstract: The present invention is directed to an edible film that contains two or more segmented portions and comprises an active ingredient that is distributed on a segmented portion or portions which comprise less than 50% of the cross sectional surface area of a major face of said film. The present invention also relates to methods of treatment for the treatment of various conditions and for taste-masking of pharmaceutical ingredients.

Abstract: The present invention features a method of manufacturing a tablet containing a pharmaceutically active agent by the steps of: (a) adding a powder containing a pharmaceutically-acceptable carrier to a die cavity; (b) injecting a liquid drug composition containing the pharmaceutically active agent into the die cavity such that the liquid drug composition contacts the powder; (c) compressing the combination of the powder and the liquid drug composition within the die cavity to form the tablet; and (d) removing the tablet from the die cavity.

Abstract: Water soluble, gelatin-free dip coatings for tablets and capsules comprising sucrose, glycerin and pre-gelatinized starch and/or tapioca dextrin or comprising hydroxypropyl starch, thickener, and plasticizer.