Abstract: The invention relates to the film products and methods of their preparation that demonstrate a non-self-aggregating uniform heterogeneity. Desirably, the films disintegrate in water and may be formed by a controlled drying process, or other process that maintains the required uniformity of the film. The films contain a polymer component, which includes polyethylene oxide optionally blended with hydrophilic cellulosic polymers. Desirably, the films also contain a pharmaceutical and/or cosmetic active agent with no more than a 10% variance of the active agent pharmaceutical and/or cosmetic active agent per unit area of the film.

Abstract: A biocompatible film includes a single layer having a plurality of components, at least one of the plurality of components having a predetermined non-uniform distribution in the thickness direction of the single layer. The at least one of the plurality of components that has a non-uniform distribution in the thickness direction of the single layer may have a substantially uniform distribution in the longitudinal and lateral directions of the single layer. The biocompatible film can be made by depositing a fluid composition including a film forming material and at least one other component immiscible with the film forming material and having a density different than the film forming material into a single layer, and drying the single layer such that the at least one other component has a predetermined non-uniform distribution in the thickness direction of the single layer after drying.

Abstract: The invention relates to the film products and methods of their preparation that demonstrate a non-self-aggregating uniform heterogeneity. Desirably, the films disintegrate in water and may be formed by a controlled drying process, or other process that maintains the required uniformity of the film. The films contain a polymer component, which includes polyethylene oxide optionally blended with hydrophilic cellulosic polymers. Desirably, the films also contain a pharmaceutical and/or cosmetic active agent with no more than a 10% variance of the active agent pharmaceutical and/or cosmetic active agent per unit area of the film.

Abstract: The invention relates to film products containing desired levels of active components and methods of their preparation. Desirably, the films disintegrate in water and may be formed by a controlled drying process, or other process that maintains the required uniformity of the film. Desirably, the films may be exposed to temperatures above that at which the active components typically degrade without concern for loss of the desired activity.

Abstract: The present invention relates to rapid dissolve thin film drug delivery compositions for the oral administration of active components. The active components are provided as taste-masked or controlled-release coated particles uniformly distributed throughout the film composition. The compositions may be formed by wet casting methods, where the film is cast and controllably dried, or alternatively by an extrusion method.

Abstract: The present invention relates to a method of optimizing self-supporting film production. The method includes the steps of: determining at least one scrap factor which relates to a total amount of scrap in processing a film product; correlating the at least one scrap factor to at least one processing parameter; and adjusting the at least one processing parameter to reduce the total amount of scrap in processing the film product. The present invention also relates to a system for optimizing film production.

Abstract: The present invention relates to packaged orally consumable film dosage units for delivery of actives into the oral cavity. In particular, the packaged pharmaceutical product contains a complexate including a complexing agent and an active, an orally consumable film for delivery of the complexate and a package for containing the orally consumable film. The package includes indicia associated therewith. The indicia identifies the complexate as the active ingredient contained in the film, which is as a regulatory approvable chemical entity. The present invention also relates to methods of labeling, pricing, marketing and satisfying governmental regulations for such packaged pharmaceutical products.

Abstract: The present invention relates to rapidly dissolving edible film dosage form incorporating a physical-chemical identifier and/or indicia. The physical-chemical identifier and/or indicia may correspond to an active ingredient that may be evenly distributed throughout the film. The physical-chemical identifier and/or indicia may be associated with at least one section of the film composition and/or associated with a sealed pouch or package containing the film composition and provide information to the consumer, practitioner, producer or regulator that is relevant to the edible film dosage form.

Abstract: The invention relates to the film products and methods of their preparation that demonstrate a non-self-aggregating uniform heterogeneity. Desirably, the films disintegrate in water and may be formed by a controlled drying process, or other process that maintains the required uniformity of the film. The films contain a polymer component, which includes polyethylene oxide optionally blended with hydrophilic cellulosic polymers. Desirably, the films also contain a pharmaceutical and/or cosmetic active agent with no more than a 10% variance of the active agent pharmaceutical and/or cosmetic active agent per unit area of the film.

Abstract: The dispenser assembly is for opening a pouch or packet structure. The dispenser assembly includes a container structure having an interior cavity. The cavity has a sufficient dimension such that the packet structure may be stored therein. The dispenser assembly includes a cutter for severing the pouch or packet structure. The cutter is secured to or removably stored in the container. The cutter may be constituted by a slider structure, guillotine cutter, or U-shaped member.

Abstract: The present invention is directed to steroid hormone delivery systems and methods of preparing the same. In particular, the steroid hormone delivery systems provided include a primary construct having one or more hydrophobic steroid hormone esters in the form of a liposome, a lipid particle, a micelle, an emulsion or a niosome which is then formulated into a secondary construct for administration. Exemplary secondary constructs include a film for sublingual or buccal administration.

Abstract: The present invention includes a pharmaceutical-based film system which includes various small-scale forms of pharmaceutically active agents, including tetrahydrolipstatin, in a film base. Such forms include nanoparticles, microparticles, and combinations thereof.

Abstract: The present invention includes a pharmaceutical-based film system which includes various small-scale forms of pharmaceutically active agents, including tetrahydrolipstatin, in a film base. Such forms include nanoparticles, microparticles, and combinations thereof. Methods of producing such film and providing a dosage of the pharmaceutical in a film are also provided.

Abstract: The present invention relates to methods and apparatuses for forming an active-containing film product, while significantly reducing the amount of wasted active material. The resulting product is an active-containing film product that meets the user's predetermined criteria of physical properties and is suitable for use.

Abstract: The present invention provides a process for making an edible film having a substantially uniform distribution of components, which includes the steps of combining a water-based film polymer solution and a slurry-type mixture comprising a water-active component and a solvent; mixing the polymer solution and slurry-type mixture for about 10 minutes or less; dispensing the mixed solution and slurry-type mixture to form a film; and drying the film to evaporate the water and solvent. Films made by the process are also provided.

Abstract: The invention relates to film products containing desired levels of active components and methods of their preparation. Desirably, the films disintegrate in water and may be formed by a controlled drying process, or other process that maintains the required uniformity of the film. Desirably, the films may be exposed to temperatures above that at which the active components typically degrade without concern for loss of the desired activity.

Abstract: The present invention is directed to a method of analyzing and establishing a proper dosage size in ingestible films for providing a more precise dosage delivery of an active ingredient.

Abstract: The present invention relates to methods for forming films. In particular, the present invention relates to the formation of films on a substrate via the use of individual pumps to deposit individual wet film products onto a substrate.

Abstract: The present invention relates to a method for forming a pharmaceutical product, such as a dissolvable film dosage form, onto a surface. Particularly, the present invention relates to a method of forming a pharmaceutical product directly onto the surface of a substrate.

Abstract: The present invention relates to rapidly dissolving edible film dosage form incorporating indicia. The indicia may correspond to an active ingredient that may be evenly distributed throughout the film. The indicia may be associated with at least one surface of the film composition and provide information to the consumer that is relevant to the edible film dosage form.