Osmotica Kereskedelmi Es Szolgaltato Kft

Osmotica Corp.

Marcelo A Coppari

Glenn A Meyer

Marcelo A Ricci

Joaquina Faour

Ana C Pastini

Gustavo A Fischbein

Juan A Vergez

Ethel C Feleder

Marcelo F Befumo

Fernando G Toneguzzo

Guido S Bigatti

Marcelo E Befumo

This invention pertains to a multi-layered tablet for a triple combination release of active agents to an environment of use. More particularly, the invention pertains to a multi-layered tablet () comprising two external drug-containing layers (and) in stacked arrangement with respect to and on opposite sides of an oral dosage form () that provides a triple combination release of at least one active agent. In one embodiment of the invention the dosage form is an osmotic device. In another embodiment of the invention the dosage form is a gastro-resistant coated core. In yet another embodiment of the invention the dosage form is a matrix tablet. In a different embodiment the dosage form is a hard capsule.

Triple combination release multi-layered tablet

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 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.

The delivery devices described herein are capable of delivering one or more active substances by osmotic pumping through preformed passageways. An osmotic device according to the invention includes a first osmotic device enclosed within a second osmotic device. In some embodiments, the semipermeable membrane of one or both of the osmotic devices completely dissolves or degrades during use. This delivery device can include an immediate release outer coat.

Osmotic device within an osmotic device

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Buenos Aires, Argentina

Marcelo A Coppari