Egis Gyogyszergyar

Egis Gyogyszergyar Rt.

Eva Tajthy

Maria Krisztian

Sandor Erdos

Aranka Hegedus

Frigyes Gorgenyi

Peter Tompe

Erzsebet Barczay

Jozsef Kenderfi

Zoltan Torma

Marton Fekete

Margit Csorgo

Attila Mandi

Pal Fekete

Imre Klebovich

Eva J Tajthy Nee Juhasz

Sandor Drabant

Maria Kiraly Nee Ignacz

Gyorgy Ujfalussy

Aranka Hegedus Nee Szima

Gabor Sipos

Zsuzsanna Jambor Nee Hoffmann

Magdolna Gora Nee Hernyes

Gizella Kiss Nee Szabo

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

The present invention relates to a process for the preparation of regulated release solid pharmaceutical compositions comprising 4-(2'-nitro-phenyl)-2,6-dimethyl-3,5-dimethoxycarbonyl-1,4-dihydro-pyridin e (referred to further on as 'nifedipine') as active ingredient which comprises admixing a solution or solutions of 1 part by weight of nifedipine, 0.1-1.5 parts by weight of one or more hydrophilizing agent(s) and 0.05-1.5 parts by weight of one or more retarding agent(s) formed with one or more identical or different solvent(s) completely or partly and applying the solution(s) thus obtained simultaneously or in succession onto an inert carrier, drying and sieving the product thus obtained and subsequently admixing the same with suitable conventional auxiliary agents and compressing the mixture thus obtained to tablets in a known manner and coating the tablets or filling the mixture into capsules.

Solid pharmaceutical composition and a process for preparing same

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Budapest, Hungary

Maria Krisztian