Abstract: Modified or extended release formulations containing mesalamine compounds and associated methods are disclosed and described. In some aspects, such formulations may be substantially bioequivalent to known FDA approved mesalamine formulations such as PENTASA®.

Abstract: Rapid melt tablets that dissolve and release an active component in the oral cavity are comprised of a pharmaceutical active ingredient such as dextromethorphan complexed with a resin that is effective in taste-masking the otherwise bitter taste of the active making it convenient for oral administration. The drug/resin-complexed particles can be coated with water swellable or water insoluble polymers to impart controlled release properties to the active ingredient. A rapid melt tablet also comprises diluents, sweeteners, flavors, disintegrants and other excipients to form granules that can be compressed into tablets at low pressure without the need for a binding agent.

Abstract: The present invention is directed to multi-layered compositions for oral administration having at least one orally disintegrating layer and capable of maintaining layer cohesion. The present invention is also directed to methods of manufacturing such compositions.

Abstract: Modified or extended release formulations containing tolterodine and associated methods are disclosed and described. Methods for making and administering said modified release formulations are also disclosed.

Abstract: The invention relates to a modified release (e.g., extended release) tablet composition for oral administration comprising: (a) a dihydropyridine compound or a prodrug or salt thereof; (b) a first release control agent; (c) a second release control agent; and (d) a third release control agent; wherein said second release control agent has a higher viscosity than said first release control agent. The invention also relates to methods for making such modified release (e.g., extended release) tablet compositions. After tableting, such compositions exhibit a release profile that is approximately zero order without the need of a coating.

Abstract: Modified release diltiazem compositions and associated methods of preparation and administration are provided.

Abstract: Modified release niacin formulations, methods for making the formulations, and methods of using the formulations.

Abstract: Modified or extended release formulations containing mesalamine compounds and associated methods are disclosed and described. In some aspects, such formulations may be substantially bioequivalent to known FDA approved mesalamine formulations such as PENTASA®.

Abstract: A novel rapid-melt, semi-solid molded composition, including methods of making the same, and methods of using the same for the delivery of prophylactic and therapeutic active materials to a mammal wherein the prophylactic or therapeutic active is a psychotropic, a gastrointestinal therapeutic or a migraine therapeutic.

Abstract: A novel encapsulated product is provided and includes: at least one active ingredient; at least one compressible material; and at least one tableting material; wherein the encapsulated product is in the form of a caplet having a diameter of from about 1 millimeter to about 7 millimeters and a length from about 1 millimeter to about 7 millimeters. A method for preparing the encapsulated product is also provided. The encapsulated product may be incorporated into a food item, a confectionery product or chewing gum product.

Abstract: A sugar-free composition comprising a mixture of at least two polyols present in an amount from about 15 to 80% by weight, an emulsifier system present in an amount from about 1.0 to 30% by weight, an active agent in an amount from about 0.1 to 70% by weight and water in an amount from 0 to 15% by weight with optional components comprising colors, flavors and binders totalling 100%. Also, a method of preparing a sugar-free composition comprising the steps of mixing from about 15 to 80% by weight of at least two polyols with about 0 to 15% by weight water, heating the mixture to about 200-260° F. for about 5 to 10 minutes, cooling the mixture to about 175-240° F., adding to the mixture about 1.0 to 30% by weight an emulsifier system to form a further mixture, cooling the further mixture to about 100-110° F., and adding to the cooled further mixture about 0.1 to 70% by weight of an active ingredient to form the sugar-free composition.

Abstract: A novel process for preparing a stable solid delivery system in which the steps include: blending about 30.0 to 90.0% by weight a carbohydrate component with about 2.0 to 12.0% by weight a humectant component and remainder water in a heating vessel to form a mixture; heating the mixture to a final temperature of about 150° F. to about 300° F. to form a cooked mixture; cooling the cooked mixture while continually mixing to a temperature of about 175° F. to 250° F. to form a cooled mixture; blending about 0.5 to 30.0% by weight of an emulsifier system; maintaining a temperature of about 175° F. to 250° F. and blending said emulsifier system with the cooled mixture to form a delivery base; cooling the delivery base to a temperature below about 110° F. to form a stable solid delivery system; and mixing the stable solid delivery system with at least one active agent.

Abstract: A novel rapid-melt, semi-solid molded composition, including methods of making the same, and methods of using the same for the delivery of prophylactic and therapeutic active materials to a mammal wherein the prophylactic or therapeutic active is a psychotropic, a gastrointestinal therapeutic or a migraine therapeutic.

Abstract: A novel rapid-melt, semi-solid molded composition including at least one binder in an amount from about 0.01% to about 70% by weight; a salivating agent in an amount from about 0.05% to about 15% by weight, a diluent/bulking material in an amount from about 10% to about 90% by weight; and an active material in an amount from about 0.001% to about 70% by weight. Further, the inventive subject matter includes a method of preparing a rapid-melt, semi-solid molded composition comprising the steps of: melting at least one binder in an amount from about 0.01% to about 70% by weight with a salivating agent in an amount from about 0.05% to about 15% by weight, to form a mixture; mixing an active material with said mixture to form an active mixture; mixing a diluent/bulking material with said active mixture to form a final mixture; and molding said final mixture into said semi-solid molded composition.

Abstract: A novel encapsulated product is provided and includes: at least one active ingredient; at least one compressible material; and at least one tableting material; wherein the encapsulated product is in the form of a caplet having a diameter of from about 1 millimeter to about 7 millimeters and a length from about 1 millimeter to about 7 millimeters. A method for preparing the encapsulated product is also provided. The encapsulated product may be incorporated into a food item, a soft confectionery product, a hard confectionery product, a jelly gum confectionery product, and a dry beverage or chewing gum product.

Abstract: A novel rapid-melt, semi-solid molded composition, including methods of making the same, and methods of using the same for the delivery of prophylactic and therapeutic active materials to a mammal wherein the prophylactic or therapeutic active is a psychotropic, a gastrointestinal therapeutic or a migraine therapeutic.

Abstract: A novel rapid-melt, semi-solid molded composition, including methods of making the same, and methods of using the same for the delivery of prophylactic and therapeutic active materials to a mammal wherein the prophylactic or therapeutic active is a psychotropic, a gastrointestinal therapeutic or a migraine therapeutic.

Abstract: A novel encapsulated product is provided and includes: at least one active ingredient; at least one compressible material; and at least one tableting material; wherein the encapsulated product is in the form of a caplet having a diameter of from about 1 millimeter to about 7 millimeters and a length from about 1 millimeter to about 7 millimeters. A method for preparing the encapsulated product is also provided. The encapsulated product may be incorporated into a food item, a soft confectionery product, a hard confectionery product, a jelly gum confectionery product, and a dry beverage or chewing gum product.