Abstract: The present invention relates to a method of making a film composition with an improved uniformity of active composition. The invention includes a method including the steps of forming a flowable film composition comprising an edible water-soluble polymer, a polar solvent and a particulate active suspended therein, where the ratio of solids to liquids is at least about 95 to about 5 and where the composition comprises a mixture having compositional uniformity per unit volume; directing the flowable film composition to a transfer trough, the transfer trough including a first rotating roller and a movable transfer substrate upon which to form the film; and maintaining uniformity of the flowable film composition during the residence time in the trough by maintaining the rate of composition entering the transfer trough and the level of the flowable film composition in the transfer trough at a substantially constant level. Methods of administering the active are also contemplated.

Abstract: The invention relates to pH modulated films and methods of their preparation. The film compositions include at least one component having a non-neutral pH when combined with water; and a pH modulated polymer system selected to reduce or prevent synerisis when combined with the non-neutral component in combination with aqueous media. The films demonstrate a non-self-aggregating uniform heterogeneity. Desirably, the films disintegrate in water and may be formed by a controlled drying process, extrusion process, or other process that maintains the required uniformity of the film.

Abstract: The invention relates to a pacifier and nipple member for delivery of active ingredients into the oral cavity of an infant or patient. The pacifier includes a porous nipple member and a base member adapted to remain outside the oral cavity of the infant. The porous nipple member includes at least one reservoir or chamber therein for receiving a thin-film containing an active ingredient. The base member may be removably attached to the neck of the nipple member, or the nipple and base members may form a single unit. Reusable and disposable forms are disclosed.

Abstract: The invention relates to a pacifier and nipple member for delivery of active ingredients into the oral cavity of an infant or patient. The pacifier includes a porous nipple member and a base member adapted to remain outside the oral cavity of the infant. The porous nipple member includes at least one reservoir or chamber therein for receiving a thin-film containing an active ingredient. The base member may be removably attached to the neck of the nipple member, or the nipple and base members may form a single unit. Reusable and disposable forms are disclosed.

Abstract: Compositions are provided that include water soluble or water dispersible film shreds, a carrier and an active, such as, but not limited to a drug, flavoring agent or coloring agent. Also provided are methods of use of the film shreds, such as in improving the dissolution, stability, aesthetics, or taste of a composition or its components, and in reducing a disease risk associated with an active.

Abstract: The present invention relates to packaging in the form of a pouch, which may contain active substances, such as food products, pharmaceutical agents, nutraceuticals and cosmetic agents, or the like. More specifically, in some embodiments, the present invention provides a pouch, which includes at least one porous substrate encompassing a closed volume and at least one water-soluble film at least partially embedded in the at least one porous substrate. The pouch may contain an active substance within the closed volume, as well as an active substance in the water-soluble film. The present invention also relates to methods of making and using the pouches.

Abstract: The packet dispenser includes a container structure having an interior cavity. The cavity has a sufficient dimension such that a packet structure may be stored therein. The container structure has an opening to the cavity through which the packet structure can be removed therefrom. A tear structure is connected to the container structure such that the packet structure may contact the tear structure to tear a portion thereof when the packet structure is removed from the cavity.

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 at least one additional polymer. The films may alternatively contain a polymer component which includes polyvinyl alcohol, optionally blended with at least one additional polymer. The films also may contain a pharmaceutical and/or cosmetic active agent.

Abstract: Disclosed in certain embodiments is a sustained release oral dosage form comprising an effective amount of torsemide or a pharmaceutically acceptable salt thereof and a sustained release excipient, wherein the dosage form provides a mean sodium (Na+) excretion and mean sodium (Na+) excretion rate as disclosed herein.

Abstract: The present invention relates to packaging in the form of a pouch, which may contain active substances, such as food products, pharmaceutical agents, nutraceuticals and cosmetic agents, or the like. More specifically, in some embodiments, the present invention provides a pouch, which includes at least one porous substrate encompassing a closed volume and at least one water-soluble film at least partially covering the at least one porous substrate. The pouch may contain an active substance within the closed volume, as well as an active substance in the water-soluble film. The present invention also relates to methods of making and using the pouches.

Abstract: The present invention relates to water-soluble films incorporating anti-tacking agents and methods of their preparation. Anti-tacking agents may improve the flow characteristics of the compositions and thereby reduce the problem of film adhering to a user's mouth or to other units of film. In particular, the present invention relates to edible water-soluble delivery systems in the form of a film composition including a water-soluble polymer, an active component selected from cosmetic agents, pharmaceutical agents, vitamins, bioactive agents and combinations thereof and at least one anti-tacking agent.

Abstract: The invention relates to a pacifier and nipple member for delivery of active ingredients into the oral cavity of an infant or patient. The pacifier includes a porous nipple member and a base member adapted to remain outside the oral cavity of the infant. The porous nipple member includes at least one reservoir or chamber therein for receiving a thin-film containing an active ingredient. The base member may be removably attached to the neck of the nipple member, or the nipple and base members may form a single unit. Reusable and disposable forms are disclosed.

Abstract: A sustained release pharmaceutical formulation comprising torsemide or pharmaceutically acceptable salt thereof.