Egis Gyogyszergyar Rt.

Gyorgy Ujfalussy

Attila Mandi

Pal Fekete

Imre Klebovich

Sandor Drabant

Denes Bezzegh

Erzsebet Barczay

Maria Krisztian

Maria Kiraly Nee Ignacz

Biborka Maroshelyi, Nee Kovacs

Zsuzsa Szlavy, Nee Szell

Magdolna Gora Nee Hernyes

Zsuzsanna Jambor Nee Hoffmann

Marta Szanto

Gizella Kiss Nee Szabo

Gabor Sipos

Erzsebet Fellner, Nee Kohalmi

Magdolna Gora, Nee Hernyes

Andrea Sandorfalvy

The invention relates to oral solid pharmaceutical composition containing as active ingredient gemfibrozil and conventional pharmaceutical auxiliary agents comprising as surfactant bis-(2-ethyl-hexyl)-sodium-sulfosuccinate in an amount of 0.05-0.5% by weight relative to gemfibrozil content of the composition. The pharmaceutical compositions according to the present invention contain a relatively small amount of a surfactant, provide uniform dissolution of the active ingredient among the different batches and the standard deviation of the dissolution rate is low.

Gemfibrozil containing pharmaceutical compositions

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

Gyorgy Ujfalussy