Abstract: Dosage forms and methods for providing a modulated release of cyclobenzaprine are provided. The sustained release dosage forms provide therapeutically effective average steady-state plasma cyclobenzaprine concentrations when administered once per day. The present invention pertains to methods of enhancing release rates by modifying the geometry of core layer interfaces through inversion of the traditional compression sequence in order to alter the mixing of layers during operation and by modifying the composition of core layers such that the viscosity of the hydrated delay layer remains higher than the viscosity of the hydrated drug layer during operation. The result is greater uniformity in the release rate from the core providing a more optimal ascending release rate and consistent performance.

Abstract: Dosage forms and methods for providing a modulated release of cyclobenzaprine are provided. The sustained release dosage forms provide therapeutically effective average steady-state plasma cyclobenzaprine concentrations when administered once per day. The composition of the delay layer and the composition of the drug layer are characterized by the viscosity of the hydrated delay layer remaining higher than the viscosity of the hydrated drug layer during operation in one embodiment. The result is greater uniformity in the release rate from the core providing a more optimal ascending release rate. In other embodiments, the hydrated delay layer has a viscosity that is lower than the viscosity of the hydrated drug layer as well as a hydrated delay layer that is substantially similar to the hydrated drug layer.

Abstract: A nutritional system is disclosed, for delivering a colorant dye to a nutritional fluid that flows through the nutritional system.

Abstract: A nutritional system is disclosed, for delivering a colorant dye to a nutritional fluid that flows through the nutritional system.

Abstract: A dosage form is disclosed comprising means for lessening the tackiness and/or irritation of the components of the dosage form to mucosal tissue. The dosage form provides means for forming in the dosage form a floc comprising a drug, which floc, when delivered from the dosage form, lessens the tackiness and/or irritation of the mucosal tissue of a warm-blooded recipient.

Abstract: An osmotic device (10) for delivering a beneficial drug, such as an anti-fungal, into the mouth of a human patient is disclosed. The device (10) has a size and shape adapting it to be comfortably retained in the mouth for extended periods of time. The device (10) comprises a wall (12) surrounding a compartment (13) housing a layer of an agent (14) that is insoluble to very soluble in aqueous biological fluids, e.g., saliva, and a layer (16) of a fluid swellable, hydrophilic polymer. A passageway (17) in the wall (12) connects the agent (14) with the exterior of the device (10). The wall (12) is permeable to the passage of aqueous biological fluid but substantially impermeable to the passage of the hydrophilic polymer (16). In one embodiment the beneficial agent (14) has a different color than the hydrophilic polymer (16). The wall (12) is sufficiently translucent to permit the patient to see the amount of drug/beneficial agent (14) remaining to be delivered.

Abstract: An osmotic device is disclosed comprising an exterior coat comprising an estrogenic and a progestogenic steroid that are delivered immediately as a contraceptive pair for fertility regulation in a female, and a compartment comprising an estrogenic steroid that is delivered at a controlled rate over a prolonged period of time for fertility regulation in a female.

Abstract: A dosage form is disclosed comprising means for lessening the tackiness and/or irritation of the components of the dosage form to mucosal tissue. The dosage form provides means for forming in the dosage form a floc comprising a drug, which floc, when delivered from the dosage form, lessens the tackiness and/or irritation of the mucosal tissue of a warm-blooded recipient.

Abstract: An osmotic device (10) for delivering a beneficial drug, such as an anti-fungal, into the mouth of a human patient is disclosed. The device (10) has a size and shape adapting it to be comfortably retained in the mouth for extended periods of time. The device (10) comprises a wall (12) surrounding a compartment (13) housing a layer of an agent (14) that is insoluble to very soluble in aqueous biological fluids, e.g., saliva, and a layer (16) of a fluid swellable, hydrophilic polymer. A passageway (17) in the wall (12) connects the agent (14) with the exterior of the device (10). The wall (12) is permeable to the passage of aqueous biological fluid but substantially impermeable to the passage of the hydrophilic polymer (16). In one embodiment the beneficial agent (14) has a different color than the hydrophilic polymer (16). The wall (12) is sufficiently translucent to permit the patient to see the amount of drug/beneficial agent (14) remaining to be delivered.

Abstract: A dosage form is disclosed comprising a wall that surrounds a bilayer core with exit passageway for communicating with the bilayer core in the wall.

Abstract: A process is disclosed and claimed for preparing a therapeutic composition comprising asteroid or a dosage form comprising the composition, which therapeutic composition or dosage form is indicated for human administration.

Abstract: An osmotic device (10) for delivering an ergot alkaloid into the mouth of a human patient is disclosed. The device (10) has a size and shape adapting it to be comfortably retained in the mouth for extended periods of time. The device (10) comprises a wall (12) surrounding a compartment (13) housing a layer of an ergot alkaloid (14) and a layer (16) of a fluid swellable, hydrophilic polymer. A passageway (17) in the wall (12) connects the ergot alkaloid (14) with the exterior of the device (10). The wall (12) is permeable to the passage of aqueous biological fluid but substantially impermeable to the passage of the hydrophilic polymer (16). In one embodiment the ergot alkaloid (14) has a different color than the hydrophilic polymer (16). The wall (12) is sufficiently translucent to permit the patient to see the amount of ergot alkaloid (14) remaining to be delivered.

Abstract: An osmotic system is disclosed for delivering a beneficial agent formulation to an environment of use. The osmotic system comprises (a) an outside semipermeable wall, (b) a middle osmotically active layer, (c) a capsule comprising a beneficial agent, and (d) a passageway for dispensing the beneficial agent from the osmotic system.

Abstract: A dosage form is disclosed comprising means for lessening the tackiness and/or irritation of the components of the dosage form to mucosal tissue. The dosage form provides means for forming in the dosage form a floc comprising a drug, which floc, when delivered from the dosage form, lessens the tackiness and/or irritation of the mucosal tissue of a warm-blooded recipient.

Abstract: A dosage form is disclosed comprising a wall surrounding a compartment, which comprises a first composition comprising a carboxymethylcellulose and a second composition comprising a higher molecular weight carboxymethylcellulose. The first composition comprises a dosage amount of drug that delivers from the dosage form at a controlled rate over time.

Abstract: An osmotic system is disclosed for delivering a beneficial agent formulation to an environment of use. The osmotic system comprises (a) an outside semipermeable wall, (b) a middle osmotically active layer, (c) a capsule comprising a beneficial agent, and (d) a passageway for dispensing the beneficial agent from the osmotic system.

Abstract: A dosage form is disclosed comprising means for lessening the tackiness and/or irritation of the components of the dosage form to mucosal tissue. The dosage form provides means for forming in the dosage form a floc comprising a drug, which floc, when delivered from the dosage form, lessens the tackiness and/or irritation of the mucosal tissue of a warm-blooded recipient.

Abstract: A dosage form is disclosed comprising means for lessening the tackiness and/or irritation of the components of the dosage form to mucosal tissue. The dosage form provides means for forming in the dosage form a floc comprising a drug, which floc, when delivered from the dosage form, lessens the tackiness and/or irritation of the mucosal tissue of a warm-blooded recipient.

Abstract: An osmotic device (10) for delivering a beneficial drug, such as an anti-fungal, into the mouth of a human patient is disclosed. The device (10) has a size and shape adapting it to be comfortably retained in the mouth for extended periods of time. The device (10) comprises a wall (12) surrounding a compartment (13) housing a layer of an agent (14) that is insoluble to very soluble in aqueous biological fluids, e.g., saliva, and a layer (16) of a fluid swellable, hydrophilic polymer. A passageway (17) in the wall (12) connects the agent (14) with the exterior of the device (10). The wall (12) is permeable to the passage of aqueous biological fluid but substantially impermeable to the passage of the hydrophilic polymer (16). In one embodiment the beneficial agent (14) has a different color than the hydrophilic polymer (16). The wall (12) is sufficiently translucent to permit the patient to see the amount of drug/beneficial agent (14) remaining to be delivered.

Abstract: A dosage form is disclosed comprising a wall surrounding a compartment, which comprises a first composition comprising a carboxymethylcellulose and a second composition comprising a higher molecular weigh carboxymethylcellulose. The first composition comprises a dosage amount of drug that delivers from the dosage form at a controlled rate over time.