CA2563162A1 - Dosage form containing pantoprazole as active ingredient - Google Patents
Dosage form containing pantoprazole as active ingredient Download PDFInfo
- Publication number
- CA2563162A1 CA2563162A1 CA002563162A CA2563162A CA2563162A1 CA 2563162 A1 CA2563162 A1 CA 2563162A1 CA 002563162 A CA002563162 A CA 002563162A CA 2563162 A CA2563162 A CA 2563162A CA 2563162 A1 CA2563162 A1 CA 2563162A1
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- dosage form
- form according
- pantoprazole
- pellet
- tablet
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Dosage forms for oral administration of the magnesium salt of pantoprazole are described.
Claims (37)
1. A dosage form for oral administration of pantoprazole magnesium salt comprising a therapeutically effective amount of the pantoprazole magnesium salt together with pharmaceutically acceptable excipients.
2. Dosage form according to claim 1, which is a solid dosage form in tablet or pellet form.
3. Dosage form according to claim 1, which is a delayed release dosage form comprising an enteric layer, which is soluble in neutral or alkaline conditions and at least one intermediate layer (subcoa-ting layer).
4. Dosage form according to claim 1, wherein the pantoprazole magnesium salt is pantoprazole magnesium dehydrate.
5. Dosage form according to claim 1, which is 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 mag-nesium dehydrate, the binder is polyvinylpyrrolidone and/or hydroxypropylmethylcellulose and, optionally, the filler is mannitol.
6. Dosage form according to claim 5 in tablet form, wherein polyvinylpyrrolidone and/or hydro-xypropylmethylcellulose is the binder and mannitol is the filler.
7. Dosage form according to claim 5 in pellet form, wherein polyvinylpyrrolidone and/or hydro-xypropylmethylcellulose is the binder.
8. Dosage form according to claim 5, 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.
9. Dosage form according to claim 8, wherein sodium carbonate is the basic, physiologically tolerated inorganic compound.
10. A dosage form according to claim 1 comprising low molecular weight polyvinylpyrrolidone as binder and one or more other suitable pharmaceutical excipients.
11. Dosage form according to claim 10, wherein the low molecular weight polyvinylpyrrolidone has an average molecular weight below 70 000.
12. Dosage form according to claim 10, wherein the low molecular weight polyvinylpyrrolidone has an average molecular weight below 60 000.
13. Dosage form according to claim 10, wherein the low molecular weight polyvinylpyrrolidone has an average molecular weight below 40 000.
14. Dosage form according to claim 1, comprising the pantoprazole magnesium salt together with polyvinylpyrrolidone in an alkaline pellet or tablet core.
15. Dosage form according to claim 14, comprising at least one subcoating (intermediate layer) and an outer enteric layer, which is soluble in the small intestine.
16. Dosage form according to claim 1, in tablet form, comprising as excipients for the tablet core sodium carbonate, mannitol, crospovidone, polyvinylpyrrolidone, and magnesium stearate.
17. Dosage form according to claim 1, in tablet form, comprising as excipients for the tablet core sodium carbonate, mannitol, crospovidone, polyvinylpyrrolidone, and calcium stearate.
18. Oral dosage form in pellet or tablet form for magnesium salt of pantoprazole comprising a therapeutically effective amount of the magnesium salt of pantoprazole together with one or more other pharmaceutical excipients in an alkaline pellet or tablet core, at least one subcoating (intermediate layer) and an outer enteric layer which is soluble in the small intestine.
19. Dosage form according to claim 1 containing between 5 and 100 mg, of the magnesium salt of pantoprazole.
20. Dosage form according to claim 19, which contain an amount of the magnesium salt of pantoprazole, which corresponds to 10, 20, 40, 50, 80 or 100 mg of pantoprazole (free acid).
21. Dosage form according to claim 20, which contain an amount of the magnesium salt of pantoprazole, which corresponds to 80 mg of pantoprazole (free acid).
22. Dosage form according, to claim 1 in pellet form, comprising a pellet core, an intermediate layer and an enteric coating, wherein the pellet core is formed from starter pellets, pantoprazole magnesium dehydrate, starch and optionally other excipients.
23. Dosage form according to claim 22, wherein the starch is pregelatinized starch.
24. Dosage form according to claim 23, wherein a binder, a basic physiologically-tolerated inorganic compound and a wetting agent are present as additional excipients.
25. Dosage form according to claim 24, wherein PVP, sodium dodecylsulfate and sodium carbonate are present.
26. Dosage form according to claim 22 in pellet form, comprising a pellet core an intermediate layer and an enteric coating, wherein the pellet core is formed from sucrose starter pellets, pantoprazole magnesium dehydrate, sodium carbonate, PVP 25, pregelatinized starch and sodium dodecylsulfate, the intermediate layer is formed of HPMC, PVP 25, titanium dioxide and iron oxide yellow, and the enteric coating is formed of Eudragit L 30 D and triethyl citrate.
27. Dosage form according to claim 1 in tablet form comprising a tablet core, an intermediate layer and an enteric coating, wherein the tablet core comprises pantoprazole magnesium dehydrate, sodium carbonate, mannitol, crospovidone, PVP 90 (povidone) and calcium stearate, the intermediate layer is formed of HPMC, PVP 25, Titanium dioxide, iron oxide yellow and propylene glycol, and the enteric coating is formed of Eudragit L 30 D and triethyl citrate.
28. Method for the prophylaxis or treatment of a clinical condition in a mammal, such as a human, for which a proton pump inhibitor is indicated, which comprises administration of a therapeutically effective amount pantoprazole magnesium in a dosage form according to any of claims 1 to 27.
29. Method of treatment according to claim 28, wherein the clinical condition is selected from the group of benign gastric ulcer, gastro-oesophageal reflux disease, Zollinger-Ellison syndrome, duodenal ulcer, duodenal ulcer associated with Helicobacter pylori, prophylaxis of NSAID-associated gastric or duodenal ulcer in patients with an increased risk of gastroduodenal complication who require continued NSAID treatment and combination therapy with antibiotics in the eradication of Helicobacter pylori.
30. Method according to claim 29, wherein the clinical condition is gastro-oesophageal reflux disease (GERD).
31. Method according to claim 30, wherein the clinical condition is GERD I to III (according to Savary/Miller Classification).
32. Method according to claim 30 or 31, wherein the dosage form is a dosage form according to claim 26.
33. Method according to claim 28, wherein the effective amount of pantoprazole magnesium corresponds to 40 or 80 mg pantoprazole (free acid).
34. Method according to claim 33, wherein the treatment is a once daily treatment.
35. Method for production of a dosage form according to claim 1 in pellet form by spraying a suspension of the the magnesium salt of pantoprazole, starch and optionally other excipients in an aqueous solution of PVP on starter pellets, drying the pellets, and layering them with subcoating and enteric coating.
36. Method for production according to claim 35, wherein the starch is pregelatinized starch.
37. Method for production of a dosage form according to claim 1 in pellet form by spraying a suspension of the magnesium salt of pantoprazole, sodium carbonate, pregelatinized starch and sodium dodecylsulfate in an aqueous solution of PVP on starter pellets, drying the pellets, layering them with subcoating and enteric coating, mixing with glidants where applicable and filling into capsules.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP03010328 | 2003-05-08 | ||
| EP03010328.7 | 2003-05-08 | ||
| EP04001754.3 | 2004-01-28 | ||
| EP04001754 | 2004-01-28 | ||
| CA002489140A CA2489140C (en) | 2003-05-08 | 2004-05-07 | Dosage form containing pantoprazole as active ingredient |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002489140A Division CA2489140C (en) | 2003-05-08 | 2004-05-07 | Dosage form containing pantoprazole as active ingredient |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2563162A1 true CA2563162A1 (en) | 2004-11-18 |
| CA2563162C CA2563162C (en) | 2012-07-10 |
Family
ID=37480467
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2563162A Expired - Lifetime CA2563162C (en) | 2003-05-08 | 2004-05-07 | Dosage form containing pantoprazole as active ingredient |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA2563162C (en) |
-
2004
- 2004-05-07 CA CA2563162A patent/CA2563162C/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| CA2563162C (en) | 2012-07-10 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request |