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

Abstract: A composition comprising a high molecular weight, water soluble polymer having a cloud point from about 20 to about 90° C. and a gelling polymer is provided. The composition may be used as a component of a pharmaceutical dosage form, such as the shell of a dosage form, or as an edible matrix, i.e., a pharmaceutical dosage form per se.

Abstract: Customizable dosage forms are provided. The flavor, color, sweetness, or texture of the dosage forms may be customized directly by the consumer.

Abstract: An immediate release tablet is provided. The tablet comprises at least 60 weight % of an active ingredient and powdered wax having a melting point greater than about 90° C. The tablet may advantageously be produced by direct compression. Although the wax is hydrophobic, the tablet has excellent disintegration.

Abstract: The present invention is directed to liquid coating compositions and dosage forms having a continuous shell portion of a first composition and at least one discontinuous shell portion that is compositionally different located within the continuous shell portion. The present invention also provides a process for preparing a dosage form, which comprises coating a core with a continuous shell portion having a first composition and at least one discontinuous shell portion that is compositionally different located within the continuous portion, and then cooling the coated core. The coating compositions are particularly suited for forming shell coatings on solid pharmaceutical dosage forms.

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

Abstract: A process for enrobing a core, such as a tablet core, uses a coating that is made of a patterned film 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, such that the transition line segment forms a substantially continuous transition line on the coating and such that a film seam is formed which is different from the transition line. Alternatively, the coating is formed from two such patterned films, in which case the outer surface of the core is covered with the two films such that the two transition line segments cooperate to form a substantially continuous transition line on the coating and a film seam is formed which is different from the transition line.

Abstract: Fondant-based pharmaceutical compositions comprising active ingredients and dosage forms made therefrom are provided.

Abstract: The invention relates to a process for preparing a soft tablet capable of being chewed or disintegrated in the oral cavity. The tablet is prepared by forming a tablet having a friability of less than about 2% from a mixture comprising a pharmaceutically active ingredient, an excipient in the form of a hydrate, and a water-swellable excipient, and then applying sufficient energy, preferably in the form of heat, to the tablet for a sufficient time to decrease the hardness of the tablet by at least about 20%.

Abstract: An edible product comprises at least about 50% by weight of a crystallizable carbohydrate based upon the weight of the product, wherein at least about 90% by weight of the crystallizable carbohydrate comprises crystals having an average particle size of about 100 microns or less, the product has a moisture content of not more than about 5% by weight loss on drying, at least about 30% of the cross-sectional area of the product is non-striated, and the edible product has a cross-sectional area in the range of about 1 to 900 sq. mm. A dosage form comprises at least one active ingredient and the edible product, or at least one active ingredient, a shell comprising the edible product, and a substrate such as a core. The shell or core or both may contain an active ingredient such as a pharmaceutically active ingredient.

Abstract: A dosage form comprises an active ingredient, a core having an outer surface and a first shape and a shell having outer and inner surfaces and a second shape, in which the shell surrounds at least a portion of the core, and the first and second shapes are substantially different. In one embodiment the shell comprises at least about 80% of a flowable material selected from the group consisting of film formers, gelling polymers, thermoplastic materials, low melting hydrophobic materials, non-crystallizable sugars, non-crystallizable sugar-alcohols, and mixtures thereof. In another embodiment the shell is substantially free of pores having a diameter of 0.5 to 5.0 microns. In another embodiment, the core and shell each having a different number of planes of symmetry with respect to the same reference axis.

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 invention relates to an immediate release tablet capable of being chewed or disintegrated in the oral cavity, which comprises a pharmaceutically active ingredient, and a matrix comprising polyethylene oxide having a weight average molecular weight of from about 500,000 to about 10,000,000. The tablet possesses exceptionally good mouthfeel and stability.

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: An immediate release tablet is provided. The tablet comprises at least 60 weight % of an active ingredient and powdered wax having a melting point greater than about 90° C. The tablet may advantageously be produced by direct compression. Although the wax is hydrophobic, the tablet has excellent disintegration.

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

Abstract: A composition comprising a high molecular weight, water soluble polymer having a cloud point from about 20 to about 90° C. and a gelling polymer is provided. The composition may be used as a component of a pharmaceutical dosage form, such as the shell of a dosage form, or as an edible matrix, i.e., a pharmaceutical dosage form per se.

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 process for enrobing a core, such as a tablet core, uses a coating that is made of a patterned film 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, such that the transition line segment forms a substantially continuous transition line on the coating and such that a film seam is formed which is different from the transition line. Alternatively, the coating is formed from two such patterned films, in which case the outer surface of the core is covered with the two films such that the two transition line segments cooperate to form a substantially continuous transition line on the coating and a film seam is formed which is different from the transition line.