Egis Gyogyszergyar Rt.

Gizella Kiss Nee Szabo

Attila Mandi

Imre Klebovich

Pal Fekete

Erzsebet Barczay

Sandor Drabant

Gyorgy Ujfalussy

Maria Krisztian

Maria Kiraly Nee Ignacz

Magdolna Gora Nee Hernyes

Zsuzsanna Jambor Nee Hoffmann

Gabor Sipos

The invention relates to a novel diffusion-osmotic controlled drug-release pharmaceutical composition containing a one-layer tablet core including a polymeric film-coat, a therapeutically active agent and a hydrophilic polymer; if desired, a two-layer tablet core including active agent and hydrophilic polymer in the first layer thereof and a hydrophilic polymer in the second layer thereof; at least one bore on the part of film-coat in contact with the core or core layer containing the active agent; and, if desired, containing one or more bore(s) in the part thereof in contact with the second layer containing the hydrophilic polymer, which comprises an ammonium methacrylate copolymer as coating material and hydroxypropyl-methylcellulose as hydrophilic polymer. The composition according to the invention is useful for preparing controlled drug-release tablets containing as active agents e.g. .beta.-adrenergic inhibitors (e.g. propranolol) calcium-antagonists (e.g. nifedipine), angiotensin convertase enzyme (ACE) inhibitors (e.g. captopril); prazosin; or nitroglycerol, all used in heart and circulation diseases; vasodilatory active agents (e.g. pentoxyfylline), nonsteroidal antiinflammatory agents (e.g. naproxene), analgetic drugs (e.g. morphine) and drugs acting on the central nervous system (e.g. amitriptyline, buspiron). The invention furthermore relates to a process for the preparation of the above compositions.

Diffusion-osmotic controlled drug-release pharmaceutical composition and

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Budapest, Hungary

Gizella Kiss Nee Szabo