Diffusion-osmotic controlled drug-release pharmaceutical...

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/24 (2006.01) A61K 9/00 (2006.01) A61K 47/30 (2006.01)

Patent

CA 2137426

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 therapeutic- ally 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 ammo- nium methacrylate copolymer as coating material and hydroxy- propyl-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. proprano- lol), calcium-antagonists (e.g. nifedipine), angiotensin convertase enzyme (ACE) inhibitors (e.g. captopril); prazo- sin; or nitroglycerol, all used in heart and circulation diseases; vasodilatory active agents (e.g. pentoxyfylline), nonsteroidal antiinflammatory agents (e.g. naproxene), anal- getic 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.

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