Abstract: A dosage form for delivering an antiepileptic drug to a gastrointestinal tract includes a compartment containing a drug formulation layer which comprises an antiepileptic drug. The dosage form further includes a semipermeable wall surrounding the compartment. The semipermeable wall has a passageway that allows communication between the compartment and an exterior of the dosage form. An internal lamina is formed on an inner surface of the semipermeable wall. The internal lamina is substantially soluble in water. The internal lamina in a hydrated state forms a gelatinous layer that lubricates the semipermeable wall, thereby preventing crack formation in the semipermeable wall while the dosage form is dispensing the drug.

Abstract: The present invention is directed to a multilayered dosage form which is adapted for retention in the stomach and useful for the prolonged delivery of an active agent to a fluid environment of use. The active agent dosage form is a multilayer core, often bilayer, formed of polymer matrices that swell upon contact with the fluids of the stomach. At least one layer of the multilayered dosage form includes an active agent. A portion of the polymer matrices are surrounded by a band of insoluble material that prevents the covered portion of the polymer matrices from swelling and provides a segment of the dosage form that is of sufficient rigidity to withstand the contractions of the stomach and delay expulsion of the dosage form from the stomach until substantially all of the active agent has been dispensed.

Abstract: An osmotic caplet is disclosed comprising an osmotic caplet exit for delivering a preselected dose of drug to a patient in need of therapy.

Abstract: The present invention provides a drug formulation and a dosage form. The drug formulation works to increase the bioavailability of hydrophobic drugs delivered to the gastro-intestinal tract (“GI tract”) of a desired subject. The drug formulation of the present invention is formulated as a self-emuslifying nanosuspension, which forms an emulsion in-situ upon introduction to an aqueous environment. The dosage form of the present invention may be formed using various different materials and may be configured to deliver the drug formulation of the present invention to the GI tract of a subject using any desired mechanism. A controlled release dosage form according to the present invention may be designed to deliver the drug formulation of the present invention at a desired rate over a desired period of time. If designed as a controlled release dosage form, the dosage form of the present invention may be an osmotic dosage form.

Abstract: A dosage form is disclosed comprising means for delaying the delivery of drug from the dosage form following the administration of the dosage form to a patient in need of drug therapy.

Abstract: Dosage forms and devices for enhancing controlled delivery of lowly soluble active agents including topiramate by use of a drug core composition that increases the solubility of the pharmaceutical agent are described. The present invention provides a drug core composition for delivering high doses of lowly soluble topiramate in solid oral drug delivery systems that are convenient to swallow, for once-a-day administration. The drug core composition contains topiramate, a surfactant and a carrier in ratios for optimal solubility and delivery.

Abstract: Dosage forms and devices for enhancing controlled delivery of pharmaceutical agents by use of a drug core composition that increases the solubility of the pharmaceutical agent are described. The present invention provides a means of delivering high doses of lowly soluble drug in oral drug delivery systems that are convenient to swallow, for once-a-day administration.

Abstract: The invention pertains to a dosage form 10 and to administering an antidepressant medicament 16 for an extended period of time in a rate-known dose.

Abstract: The present invention includes a dosage form that releases a liquid active agent formulation over a period of time at an ascending rate. The dosage form of the present invention includes a capsule or other reservoir capable of containing a liquid active agent formulation, a driving means for expelling the liquid active agent formulation from the capsule over an extended period of time and a rate altering means for increasing the rate at which the driving means expels liquid active agent formulation from the capsule. The present invention also includes a method of manufacturing a controlled release dosage form providing the release of liquid active agent formulation at an ascending rate.

Abstract: The invention pertains to a dosage form 10 and to administering an antidepressant medicament 16 for an extended period of time in a rate-known dose.

Abstract: A dosage form manufactured from an extruded polymer tube and method for manufacturing the dosage form are disclosed. The dosage form is preferably an osmotic dosage form and includes a therapeutic agent and an expandable composition contained within the lumen of the extruded polymer tube.

Abstract: The present invention is directed to an active agent dosage form and methods of its fabrication which is useful for the prolonged delivery of an active agent formulation to a fluid environment of use. The active agent dosage form is a matrix that has on its surface one or more insoluble bands located in complementary grooves. The invention is also directed to articles of manufacture, methods and systems for fabricating the active agent dosage form.

Abstract: The present invention includes an expandable osmotic layer and a coating suspension for providing an expandable osmotic layer, both of which are useful for the manufacture of controlled release dosage forms. The expandable osmotic layer of the present invention may be produced using the coating suspension of the present invention. Advantageously, the coating suspension of the present invention can be used to coat expandable osmotic layers under both wet and dry process conditions without sacrificing the quality of the expandable osmotic layers produced, and therefore provides a relatively robust coating suspension that facilitates commercial production of controlled release dosage forms including a coated expandable osmotic layer.

Abstract: The present invention provides a controlled release oral dosage form for the delivery of a liquid active agent formulation. The dosage form of the present invention includes a reservoir formed of a water impermeable material and filled with a liquid active agent formulation. The dosage form of the present invention also includes an expandable osmotic composition positioned within the reservoir, and, optionally, the expandable osmotic composition is separated from contact with the liquid active agent formulation by a barrier layer that is substantially impermeable to the passage of liquid. To facilitate expulsion of the liquid active agent formulation, the dosage form of the present invention also includes an exit orifice. The material make-up and design of the reservoir included in the dosage form of the present invention allow the manufacture of an oral dosage form capable of more consistently achieving a desired release rate or release rate profile of active agent from a liquid formulation.

Abstract: The present invention includes a formulation and controlled release dosage form that enable the controlled release of therapeutic agents showing reduced absorption in the lower gastrointestinal tract. The formulation of the present invention includes a therapeutic agent that exhibits greater absorption in the upper GI tract than in the lower GI tract and a permeation enhancer, which serves to increase absorption of the therapeutic agent in the lower GI tract. The formulation of the present invention further includes a carrier that allows the formulation to transition to a bioadhesive gel in-situ after the formulation is dispensed within the GI tract and has had some opportunity to reach the surface of the GI mucosal membrane. The bioadhesive gel formed by the formulation of the present invention works to present effective concentrations of both the therapeutic agent and the permeation enhancer at the surface of the GI mucosal membrane over a period.

Abstract: A dosage form is disclosed comprising means for delaying the delivery of drug from the dosage form following the administration of the dosage form to a patient in need of drug therapy.

Abstract: Controlled release of liquid, active agent formulations is provided by dispersing porous particles containing the liquid active agent formulation in osmotic, push-layer dosage forms. The dosage forms may provide for continuous or pulsatile delivery of active agents.

Abstract: The present invention includes a formulation and dosage form for enhancing the bioavailability of orally administered hydrophilic macromolecules. The formulation of the present invention includes a permeation enhancer, a hydrophilic macromolecule, and a carrier that exhibits in-situ gelling properties, such as a nonionic surfactant. The formulation of the present invention is delivered within the GI tract as a liquid having at least some affinity for the surface of the GI mucosal membrane. Once released, it is believed that the liquid formulation spreads across one or more areas of the surface of the GI mucosal membrane, where the carrier of the formulation then transitions into a bioadhesive gel in-situ.

Abstract: The present invention is directed to an active agent dosage form which is adapted for retention in the stomach and useful for the prolonged delivery of a liquid, active agent formulation to a fluid environment of use. The liquid, active agent formulation is sorbed into porous particles that are dispersed in a polymer matrix that swells upon contact with the fluids of the stomach. A portion of the polymer matrix may be surrounded by a band of insoluble material that prevents the covered portion of the polymer matrix from swelling and provides a segment of the dosage form that is of sufficient rigidity to withstand the contractions of the stomach and delay expulsion of the dosage form from the stomach until substantially all of the active agent has been dispensed.

Abstract: The present invention includes a dosage form that facilitates the controlled release of an active agent at a desired release rate or release rate profile. In each embodiment, the dosage form of the present invention includes a bi-layer membrane system and an osmotic core. The bi-layer membrane system includes a semipermeable membrane and an osmosensitive membrane and forms an internal compartment that is occupied by the osmotic core. The osmotic core of the dosage form of the present invention includes and active agent composition and a light push layer. The dosage form of the present invention additionally includes a passageway that is formed through the bi-layer membrane system and permits expulsion of the active agent composition from the dosage form during operation.