Osmotica Corp.

Osmotica Kereskedelmi Es Szolgaltato Kft

Osmotica Kereskedelmi És Szolgáltató Korlátolt Felelösségû Társaság

Laboratorios Phoenix U.s.a., Inc.

Osmotica Kereskedelmi És Szolgáltató Korlátolt Feleõsségû Társaság

Osmotica Keresleedelmo És Szolgáltató Kft

Osmotica Kereskedelmi És Seolgáltató Kft

Osmotica Costa Rica Sociedad Anonima

Joaquina Faour

Juan A Vergez

Glenn A Meyer

Marcelo A Ricci

Ana C Pastini

Marcelo Fernando Befumo

Ana Cristina Pastini

Guido S Bigatti

Cristian R Franco

Hernan D Benedetti

Marcelo A Coppari

Ethel C Feleder

Marcelo F Befumo

Gustavo A Fischbein

Jorge Mayorga

Jorge E Mayorga

Alejandro Iseruk

Silvia Krasuk

Marcelo E Befumo

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.

Dose-dumping resistant controlled release dosage form

The present disclosure is directed to methods of treating neurological disorders in a patient such as Parkinson's disease, drug-induced extrapyramidal reactions, and/or levodopa-induced dyskinesia comprising administering to the patient once daily in the morning a pharmaceutical composition comprising about 50 mg to about 400 mg of extended-release amantadine or a pharmaceutically acceptable salt thereof.

Composition and method for treating neurological disease

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.

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.

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.

Rupturing controlled release device comprising a subcoat

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.

Osmotic device containing amantadine and an osmotic salt

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.

Osmotic device containing a venlafaxine salt and a salt having an ion in common

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.

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Buenos Aires, Argentina

Joaquina Faour