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: This invention relates to films incorporating high amounts of pharmaceutical agents and methods for the preparation of the same. Moreover, 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. Desirably, the films 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 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.

Abstract: An edible water-soluble film is provided. The film includes at least one water-soluble polymer, and a foam reducing flavoring agent, wherein the film is free of added anti-foaming or defoaming agents.

Abstract: The invention relates to a fast-dissolving film product containing at least one drug; and a water soluble polymer composition. The invention further relates to methods of administering the film product. The method includes administering the film to the oral cavity of a subject in need of the drug; and administering a fluid in the oral cavity while the film is present therein to substantially dissolve the film and form a solution or dispersion thereof to be ingested by the subject. Desirably, ingestion of the thus-formed solution or dispersion provides increased blood levels of the drug as compared to the film taken without the fluid.

Abstract: The present invention is a method of preparing a system for delivering a bio-affecting agent and the composition prepared thereby. The invention includes forming a molecular dispersion of the bio-affecting agent in an increased energy state in a water-soluble polymer which is compatible with the bio-affecting agent. As a consequence of transforming the bio-affecting agent to an increased-energy condition and freezing it in such condition in a water-soluble polymer, the bio-affecting agent is made available (“bio-available”) to a bio-system upon dissolution of the polymer. This method and composition has been found extremely effective for delivery of otherwise substantially non-soluble drugs and other bio-affecting ingredients.

Abstract: The present invention is a process and apparatus for making a dosage unit by direct tableting of shearlite particles. The present invention also includes the dosage unit itself. Shearlite particles, which are prepared by subjecting a feedstock material to liquiflash processing, can be directly fed from a shearlite device to a tableting apparatus without the necessity of any intermediate steps or additional ingredients to facilitate flowability or tablet formation.

Abstract: The present invention is a method and a dosage unit for delivery of a controlled-release system. The dosage unit is a quick dissolve unit which can be prepared by mixing uncured shearform matrix and a controlled-release system, either molding or compacting a unit dosage form and curing the shearform matrix. The controlled-release systems used in the present invention include instantaneous release components, delayed release components, sustained release components, and combinations thereof.

Abstract: A recipient-dosage delivery system including shearlite particles of a bio-affecting agent for delivery to a recipient. The particles are provided in a metered dose and are packaged in a bi-functional vessel. The particles are produced under liquiflash conditions and exhibit sufficient flowability so as to allow administration of the metered dose to the recipient under the force of gravity.

Abstract: The present invention is a method of preparing a comestible unit which disperses quickly in the mouth. The present invention also includes the product resulting from the method. The method includes initiating crystallization of shearform matrix and combining with an additive, either before or after initiating crystallization, to form flowable, compactible micro-particulates. The combination is then subjected to compacting to form a comestible unit having high structural integrity, good appearance, and excellent release characteristics.

Abstract: The present invention is a new mesomorphic polycrystallite product and a process for making the same. In the present invention amorphous sugar is transformed to a mesomorphic product having polycrystallites therein by a completely anhydrous process rather than by hydrating and then dehydrating the sugar. The product of the present invention is unique in shape and size, and possesses a high degree of uniformity. The properties of the polycrystallite make it possible to replace some or all of the fat in comestibles such as frostings and fillings and to provide fondants of extraordinarily fine grain.

Abstract: The present invention involves an apparatus for making comestible units. The comestible units made in accordance with the present invention can include active ingredients and are capable of dissolving in the mouth of the consumer within several seconds. They are particularly useful as antacids and as delivery vehicles for biologically active ingredients, especially those which are ideally combined with antacid ingredients.

Abstract: The present invention is a comestible composition including a new spheroidal polycrystallite product. In the present invention amorphous sugar is transformed to crystalline sugar by hydrating rather than dehydrating sugar.

Abstract: The present invention is a method of preparing rapidly dissolving comestible units such as tablets. The present invention also includes an apparatus for making the comestible units and the units themselves. The product prepared in accordance with the present invention can include active ingredients and is capable of dissolving in the mouth of the consumer within several seconds. The unit dosage forms prepared in accordance with the present invention are particularly useful as antacids and as a delivery vehicle for biologically active ingredients, especially those which are ideally combined with antacid ingredients in order to ameliorate the effects of antacid environment.

Abstract: The present invention is a method and a dosage unit for delivery of a controlled-release system. The dosage unit is a quick dissolve unit which can be prepared by mixing uncured shearform matrix and a controlled-release system, either molding or compacting a unit dosage form and curing the shearform matrix. The controlled-release systems used in the present invention include instantaneous release components, delayed release components, sustained release components, and combinations thereof.

Abstract: The present invention is a method and a dosage unit for delivery of a controlled-release system. The dosage unit is a quick dissolve unit which can be prepared by mixing uncured shearform matrix and a controlled-release system, either molding or compacting a unit dosage form and curing the shearform matrix. The controlled-release systems used in the present invention include instantaneous release components, delayed release components, sustained release components, and combinations thereof.

Abstract: The present invention is a method of preparing rapidly dissolving comestible units such as tablets. The present invention also includes an apparatus for making the comestible units and the units themselves. The product prepared in accordance with the present invention can include active ingredients and is capable of dissolving in the mouth of the consumer within several seconds. The unit dosage forms prepared in accordance with the present invention are particularly useful as antacids and as a delivery vehicle for biologically active ingredients, especially those which are ideally combined with antacid ingredients in order to ameliorate the effects of antacid environment.

Abstract: The present invention is a method of making discrete particles by subjecting an organic feedstock to liquiflash conditions whereby the feedstock is transformed instantaneously from solid to liquiform to solid. Liquiform is a transient condition wherein the feedstock has substantially unimpeded internal flow. Shear force is imparted to the liquiform feedstock in an amount sufficient to separate tiny masses of feedstock. The tiny masses solidify as discretized particles. The present invention also includes unique products resulting from the process, e.g., a monodispersed microsphere product and coated particles prepared therefrom.

Abstract: The present invention is a new fondant product including spheroidal polycrystallite structures or monodispersed sugar crystallites released from the polycrystallite structures.

Abstract: The present invention is a method and a dosage unit for delivery of a controlled-release system. The dosage unit is a quick dissolve unit which can be prepared by mixing uncured shearform matrix and a controlled-release system, either molding or compacting a unit dosage form and curing the shearform matrix. The controlled-release systems used in the present invention include instantaneous release components, delayed release components, sustained release components, and combinations thereof.