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|Title:||Oral-administration forms of a medicament containing pantoprazol|
|Abstract:||The invention relates to oral presentation forms for pantoprazole, which consist of a core, an intermediate layer and an outer layer which is resistant to gastric juice.|
|Inventor(s):||Dietrich; Rango (Constance, DE), Ney; Hartmut (Constance, DE)|
|Assignee:||Byk Gulden Lomberg Chemische Fabrik GmbH (Konstanz, DE)|
1. An orally administerable medicament in pellet or tablet form which is resistant to gastric juice, and in which each pellet or tablet consists of
a core in which active compound or its physiologically-tolerated salt is in admixture with binder, filler and, optionally, a member selected from the group consisting of another tablet auxiliary and a basic physiologically-tolerated inorganic compound,
an inert water-soluble intermediate layer surrounding the core and
an outer layer which is resistant to gastric juice,
wherein the active compound is pantoprazole, the binder is polyvinylpyrrolidone and/or hydroxypropylmethylcellulose and, optionally, the filler is mannitol.
2. Medicament according to claim 1 in tablet form, wherein polyvinylpyrrolidone and/or hydroxypropylmethylcellulose is the binder and mannitol is the filler.
3. Medicament according to claim 1 in pellet form, wherein polyvinylpyrrolidone and/or hydroxypropylmethylcellulose is the binder.
4. Medicament according to claim 1, wherein pantoprazole-sodium is the physiologically tolerated active compound salt.
5. Medicament according to claim 1, wherein pharmacologically tolerated alkali metal, alkaline earth metal or earth metal salt of a weak acid or pharmacologically tolerated hydroxide or oxide of an alkaline earth or earth metal is the basic, physiologically tolerated inorganic compound.
6. Medicaments according to claim 1, wherein sodium carbonate is the basic, physiologically tolerated inorganic compound.
7. A core of an orally-administrable medicament in pellet or tablet form wherein pantoprazole or a physiologically-tolerated salt thereof, as an essential active component, is in admixture with binder, filler and, optionally, a member selected from the group consisting of another tablet auxiliary and a basic physiologically-tolerated inorganic compound;
the binder being polyvinylpyrrolidone and/or hydroxypropylmethylcellulose.
8. A core of claim 7 wherein the filler is mannitol.
9. A core of claim 7 wherein the core is the core of a tablet.
10. A core of claim 9 wherein the essential active component is pantoprazole-sodium.
11. An orally administrable medicament in pellet or tablet form and which is resistant to gastric juice, wherein each pellet or tablet consists of:
a) a core in which an active compound or a physiologically tolerated salt thereof is in admixture with binder, filler and, optionally, a member selected from the group consisting of another tablet auxiliary and a basic physiologically tolerated inorganic compound,
b) an inert, water soluble intermediate layer surrounding the core, and
c) an outer layer which is resistant to gastric juice;
the active compound being pantoprazole;
the binder being polyvinylpyrrolidone and/or hydroxypropylmethylcellulose; and
the core being substantially free from lactose, microcrystalline cellulose and hydroxypropylcellulose.
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