Abstract: The present invention provides a simple and improved dosage form that provides a controlled release of methylphenidate contained in the core thereof. The invention also provides methods of administering the dosage form and of treating conditions that are therapeutically responsive to methylphenidate. The dosage form exhibits improved resistance to alcohol-related dose dumping.

Abstract: The present invention provides a simple and improved dosage form that is capable of providing a controlled release of methylphenidate contained in the core thereof. The invention also provides methods of administering the dosage form and of treating conditions that are therapeutically responsive to methylphenidate. The dosage form exhibits improved resistance to alcohol-related dose dumping.

Abstract: The present invention provides a simple and improved dose form that is capable of providing a controlled release of methylphenidate contained in the core thereof. The invention also provides methods of administering the dosage form and of treating conditions that are therapeutically responsive to methylphenidate. The dosage form exhibits improved resistance to alcohol-related dose dumping.

Abstract: The present invention provides a simple and improved dose form that is capable of providing a controlled release of methylphenidate contained in the core thereof. The invention also provides methods of administering the dosage form and of treating conditions that are therapeutically responsive to methylphenidate. The dosage form exhibits improved resistance to alcohol-related dose dumping.

Abstract: The present invention provides a simple and improved rupturing controlled release device that is capable of providing a controlled release of active agent contained in the core first through a preformed passageway and then through an in situ formed second passageway into an environment of use in a standardized release profile manner. The rupturing controlled release device comprises a core comprising at least one drug and at least one osmopolymer, a semipermeable membrane enclosing the core and having at least one preformed passageway there through, wherein the semipermeable membrane ruptures during use to form a second passageway in the semipermeable membrane at a location spaced away from the preformed passageway, and a release-controlling subcoat between the core and the semipermeable membrane.

Abstract: The osmotic devices of the present invention contain a unitary core comprising a salt of amantadine and an osmotic salt, wherein the two salts have an ion in common. The release rate of the amantadine is a sigmoidal release. The osmotic device includes a semipermeable membrane having a controlled porosity that can be adapted as needed to cooperate with the osmotic salt in providing a predetermined drug release profile. The osmotic salt need not be coated and it is in admixture with the amantadine salt. The osmotic device further includes a drug-containing coat external to the semipermeable membrane. The osmotic device can include one or more additional drugs in the core and/or the drug-containing coat.

Abstract: The osmotic devices of the present invention contain a unitary core comprising a salt of amantadine and an osmotic salt, wherein the two salts have an ion in common. The release rate of the amantadine is a sigmoidal release. The osmotic device includes a semipermeable membrane having a controlled porosity that can be adapted as needed to cooperate with the osmotic salt in providing a predetermined drug release profile. The osmotic salt need not be coated and it is in admixture with the amantadine salt. The osmotic device further includes a drug-containing coat external to the semipermeable membrane. The osmotic device can include one or more additional drugs in the core and/or the drug-containing coat.

Abstract: The osmotic devices of the present invention include a single core comprising a salt of a drug and an osmotic salt, wherein the drug salt and the osmotic salt have a common ion. The release rate of the active drug is reduced, and the release profile of the active drug is modified, from a first order release profile to a zero order, pseudo-zero order, or sigmoidal release profile, by increasing the amount of the sodium chloride in the core of the device. In one embodiment the sodium chloride is used to modify a controlled release profile to a delayed and controlled release profile.

Abstract: The osmotic devices of the present invention contain a unitary core comprising a salt of amantadine and an osmotic salt, wherein the two salts have an ion in common. The release rate of the amantadine is modified from a first order release profile to a zero order, pseudo-zero order or sigmoidal release profile by increasing the amount of the osmotic salt in the core of the device. The osmotic device includes a semipermeable membrane having a controlled porosity that can be adapted as needed to cooperate with the osmotic salt in providing a predetermined drug release profile. The osmotic salt need not be coated and it is in admixture with the amantadine salt.

Abstract: The present invention provides a simple and improved osmotic device that is capable of providing a controlled release of active agent contained in the core first through a preformed passageway and then through an in situ formed second passageway into an environment of use. One or both of the passageways optionally increases in size during use of the osmotic device. The preformed passageway and/or the second passageway increase the release rate of the active agent, enable the release of large particles containing active agent, and/or enable the release of active agents that are substantially insoluble in the environment of use. By virtue of the in situ formation of the second aperture, the device is able to release a greater overall percentage of active agent than it would release in absence of the second aperture.

Abstract: The present invention provides a laser drilling system for drilling holes or cavities in a solid, in particular a solid dosage form. The system includes a loading zone, firing zone, inspection zone and delivery zone. The system also includes optional components such as a process validation system, solids detector, color detector, solids rejection/repositioning means, accepted products receptacle, rejected products receptacle and/or solids inspection system. Operation of the laser device in the firing zone and of other optional equipment is synchronized with movement of a continuous solids indexer by way of an electronic synchronizer. A solids handling system includes an optional fill level detector that directly or indirectly controls solids loading means that fills a solids reservoir. The system can be run continuously, semicontinuously or batchwise.

Abstract: The present invention provides a simple and improved rupturing controlled release device that is capable of providing a controlled release of active agent contained in the core first through a preformed passageway and then through an in situ formed second passageway into an environment of use in a standardized release profile manner. The rupturing controlled release device comprises a core comprising at least one drug and at least one osmopolymer, a semipermeable membrane enclosing the core and having at least one preformed passageway there through, wherein the semipermeable membrane ruptures during use to form a second passageway in the semipermeable membrane at a location spaced away from the preformed passageway, and a release-controlling subcoat between the core and the semipermeable membrane.

Abstract: The present invention provides an osmotic device containing controlled release venlafaxine in the core in combination with an anti-Alzheimer's or an anti-Parkinson's drug in a rapid release external coat. Memantine is used as an anti-Alzheimer's drug or an anti-Parkinson's drug. Particular embodiments of the invention provide osmotic devices having predetermined release profiles. One embodiment of the osmotic device includes an external coat that has been spray-coated rather than compression-coated onto the device. The device is useful for the treatment of symptoms associate with Alzheimer's disease and/or Parkinson's disease patients. The device and method can also be used to treat or ameliorate other symptoms associated with Alzheimer's disease, Parkinson's disease or any other neurological disorder. Other dosage forms that provide a controlled, sustained or extended release of venlafaxine in combination with a rapid or immediate release of memantine are useful in the invention.

Abstract: Aqueous ophthalmic solutions containing a combination of hyaluronic acid or a pharmaceutically acceptable salt thereof, e.g. sodium hyaluronate, and polyvinyl alcohol are disclosed. These solutions have a synergistic effect on viscosity and provide a statistically significant improvement over the prior art formulations. The solutions are used as artificial tear for the treatment of dry eye syndrome and ocular discomfort and may be administered whenever the use of artificial tears is advisable. The solutions are also suitable for use as vehicle for ophthalmic drugs.

Abstract: The invention provides a compressed tablet that provides a extended release tablet containing a extended release form of carbidopa and a extended release form of levodopa. The tablet optionally further comprises an immediate or rapid release composition of carbidopa and/or levodopa. The extended release composition in the tablet excludes a release rate-controlling polymer, and a release rate-controlling coating; however, the release of the carbidopa and/or levodopa is independently optionally delayed for a lag time. The invention also provides a tablet having a extended release form of levodopa and a rapid or immediate release form of carbidopa. A tablet can contain levodopa present in extended release form and rapid or immediate release form, and carbidopa present in extended release form and rapid or immediate release form. The tablet is used to treat Parkinson's disease and other movement related disorders, diseases or syndromes.

Abstract: The present invention provides a dual release solid dosage form containing a first composition that releases a neuraminidase inhibitor, such as oseltamivir, zanamivir, or peramivir, in a controlled manner and a second composition that releases an H1 antagonist in a rapid and/or immediate manner. A wide range of H1 antagonist antihistamines, especially fexofenadine and loratadine, can be used in this device. Particular embodiments of the invention provide osmotic devices having predetermined release profiles. The device is useful for the treatment of respiratory congestion and other viral infection associated symptoms.

Abstract: The present invention provides an osmotic device containing controlled release pseudoephedrine in the core in combination with a rapid release H1 antagonist in an external coat. A wide range of H1 antagonist antihistamines, especially fexofenadine, can be used in this device. Particular embodiments of the invention provide osmotic devices having predetermined release profiles. One embodiment of the osmotic device includes an external coat that has been spray coated rather compression coated onto the device. The device with spray coated external core is smaller and easier to swallow than the similar device having a compression coated external coat. The device is useful for the treatment of respiratory congestion related disorders and allergy related disorders. The present devices provide PS and an H1 antagonist according to specific release profiles in combination with specific formulations.

Abstract: The present invention provides a simple and improved osmotic device that is capable of providing a controlled release of active agent contained in the core first through a preformed passageway and then through an in situ formed second passageway into an environment of use. One or both of the passageways optionally increases in size during use of the osmotic device. The preformed passageway and/or the second passageway increase the release rate of the active agent, enable the release of large particles containing active agent, and/or enable the release of active agents that are substantially insoluble in the environment of use. By virtue of the in situ formation of the second aperture, the device is able to release a greater overall percentage of active agent than it would release in absence of the second aperture.

Abstract: The osmotic devices of the present invention contain a unitary core comprising a salt of amantadine and an osmotic salt, wherein the two salts have an ion in common. The release rate of the amantadine is modified from a first order release profile to a zero order, pseudo-zero order or sigmoidal release profile by increasing the amount of the osmotic salt in the core of the device. The osmotic device includes a semipermeable membrane having a controlled porosity that can be adapted as needed to cooperate with the osmotic salt in providing a predetermined drug release profile. The osmotic salt need not be coated and it is in admixture with the amantadine salt.

Abstract: The present invention provides a simple and improved multi-layered osmotic device (1) that is capable of delivering a first active agent in an outer lamina (2) to one environment of use and a second active agent in the core (5) to another environment of use. Particular embodiments of the invention provide osmotic devices in which the first and second active agents are similar or dissimilar. An erodible polymer coat (3) between an internal semipermeable membrane (4) and a second active agent-containing external coat (2) comprises poly(vinylpyrrolidone)-(vinyl acetate) copolymer. This particular erodible polymer results in an improved multi-layered osmotic device possessing advantages over related devices known in the art. The active agent in the core (5) is delivered through a pore (6) containing an erodible plug (7). The osmotic device (1) can be coated by a final finish coat (8).