Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Capsules
Reexamination Certificate
2000-06-16
2002-02-26
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Capsules
C424S451000, C424S453000, C424S454000
Reexamination Certificate
active
06350468
ABSTRACT:
FIELD OF THE INVENTION
This invention concerns a pharmaceutical dosage form consisting of a double capsule for the administration of active principles in multiple therapies. The double capsule consists in a capsule placed inside another one.
BACKGROUND OF THE INVENTION
Therapies for the administration of more than one active principle at a time or at short intervals of time are already well known. The most common pharmaceutical dosage form consists of tablets for the various active principles with coatings allowing the differentiated release of the chemical compounds.
Among said therapies, the most common ones are those concerning affections of the digestive system caused by the presence of the microorganisms Helicobacter Pylori, such as gastritis and gastroduodenal ulcers, which in due time can lead to tumoral forms. As known,
Helicobacter pylori
is a modern appellation of
Campilobacter pylori.
U.S. Pat. No. 5,196,205 (corresponding to patent application WO 89/03219) describes a method for the treatment of those pathological agents, consisting of the administration of a compound of bismuth, an antibiotic belonging to the group of penicillins and tetracycline and a second antibiotic such as metronidazole. The relevant therapy consists of the administration of three tables (one for each active principle) several times a day.
Consequently, this therapy results in being extremely complicated. The therapy described by U.S. Pat. No. 5,196,205 has been further modified by the addition of a fourth active principle, omeprazole which reduces the gastric secretion by inhibiting irreversibly enzyme H+/K+ATP. Omeprazole must be administered at a different time from the above-mentioned active principles, which are determined by the physician according to the seriousness of the disease, the age of the patient and other factors which could affect its efficacy.
Therefore, it can certainly be stated that therapies requiring a complicated posology such as multiple therapies, are subject to mistakes that can compromise the outcome of the therapy itself.
Other patents and patent applications describing single or multiple therapies for eradication of Helicobacter pylori are known such as U.S. Pat. No. 5,472,695, U.S. Pat. No. 5,560,912, U.S. Pat. No. 5,582,837, WO 92/11848 and WO 96/02237. None of these previous patents and patent applications overcome the problem of the interaction between active principles by using a way as simple and ingenious than the one proposed by the present invention.
U.S. Pat. No. 5,310,555 and U.S. Pat. No. 5,501,857 teach to use double capsules for the delivery of nutritional supplements to animals.
Patent JP 60-193917 teaches a soft capsule containing several smaller soft capsules.
Patent DE 2,729,068 teaches a standard hard gelatine capsule having an additional hard gelatine capsule inside, with the same or different dissolution characteristics.
Patent FR 2,524,311 teaches a double capsule and a triple capsule.
Patent FR 1,454,013 teaches a double capsule where the inner capsule has retarded released characteristics.
Patent application GB 2,103,564 teaches a capsule assembly for oral administration of a prophylactic drug characterized by a frangible outer capsule and an inner edible capsule with an air-space therebetween allowing the user to bite through the outer capsule and swallow the inner capsule intact.
Among multiple therapies for eradication of
Helicobacter pylori
, the following combinations of active principles have been tested on humans, and published:
1. Amoxicilline, metronidazole and furazolidone;
2. Bi Subsalicylate, lansoprazole and clarithromycine;
3. Bi Subsalicylate, roxithromycine, metronidazole and ranitidine;
4. Clarithromycine, colloidal bismuth, subcitrate and furazoline;
5. Colloidal bismuth subcitrate, amoxicilline and metronidazole;
6. Ebrotidine, amoxicilline and metronidazole;
7. Lansoprazole, amoxicilline and azithromycine;
8. Lansoprazole, amoxicilline and clarithromycine;
9. Lansoprazole, amoxicilline and rebamipide;
10. Lansoprazole, clarithromycine and furazoline;
11. Lansoprazole, azithromycine and metronidazole;
12. Lansoprazole, miconazole and amoxicilline;
13. Lansoprazole and norfloxacine;
14. Metronidazole and dirithromycine;
15. Omeprazole, amoxicilline and azithromycine;
16. Omeprazole, amoxicilline, clarithromycine and metronidazole;
17. Omeprazole, amoxicilline, metronidazole and bismuth;
18. Omeprazole, amoxicilline and rebamipide;
19. Omeprazole, amoxicilline and tinidazole;
20. Omeprazole and amoxicilline;
21. Omeprazole and azithromycine;
22. Omeprazole, bismuth and ciprofloxacine;
23. Omeprazole, bismuth and clarithromycine;
24. Omeprazole, clarithromycine and tinidazole;
25. Omeprazole and dirithromycine;
26. Omeprazole, lansoprazole and rebamipide;
27. Omeprazole, metronidazole and amoxicilline;
28. Omeprazole, metronidazole and azithromycine;
29. Omeprazole, metronidazole and clarithromycine;
30. Omeprazole and norfloxacine;
31. Omeprazole, sucralfate, metronidazole and tetracycline;
32. Omeprazole, clarithromycine and tinidazole;
33. Pantoprazole, clarithromycine and amoxicilline;
34. Pantoprazole and clarithromycine;
35. Ranitidine bismuth citrate, clarithromycine and tetracycline;
36. Ranitidine bismuth citrate and clarithromycine;
37. Ranitidine bismuth citrate, metronidazole and clarithromycine;
38. Ranitidine bismuth citrate and cefuroxime;
39. Rifaximin and erythromycine;
40. Omeprazole, bismuth, tretracycline and metronidazole;
41. Omeprazole, bismuth subcitrate, tretracycline and metronidazole;
42. Bismuth subcitrate, tretracycline and metronidazole.
SUMMARY OF THE INVENTION
An object of the present invention is the use of a pharmaceutical dosage form comprising two capsules one placed inside the other for the administration of active principles in multiple therapies, in the therapy against the microorganisms
Helicobacter pylori.
In accordance with the present invention, that object is achieved with the use of a soluble salt of bismuth, a first antibiotic and a second antibiotic for the preparation of a pharmaceutical dosage form comprising two capsules one placed inside the other for a triple therapy against the microorganisms
Helicobacter pylori
, wherein the external capsule comprises the soluble salt of bismuth and the first antibiotic, and the internal capsule comprises the second antibiotic.
The object of the present invention is also achieved with the use of a soluble salt of bismuth, a first antibiotic, a second antibiotic, and a K
+
/Na
+
ATPase inhibitor or anti-H
2
, for the preparation of a pharmaceutical dosage form comprising two capsules one placed inside the other for a quadruple therapy against the microorganisms Helicobacter pylori, wherein the external capsule comprises the soluble salt of bismuth and the first antibiotic, and the internal capsule comprises the second antibiotic and the K
+
/Na
+
ATPase inhibitor or anti-H
2
.
The object of the present invention is further achieved with the use of a soluble salt of bismuth, a first antibiotic, a second antibiotic, and a K
+
/Na
+
ATPase inhibitor or anti-H
2
, for the preparation of a pharmaceutical dosage form comprising two capsules one placed inside the other for a quadruple therapy against the microorganisms Helicobacter pylori, wherein the external capsule comprises the soluble salt of bismuth, the first antibiotic, and the K
+
/Na
+
ATPase inhibitor or anti-H
2
, and the internal capsule comprises the second antibiotic.
The object of the present invention is also further achieved with the use of a soluble salt of bismuth, a first antibiotic, a second antibiotic, and a K
+
/Na
+
ATPase inhibitor or anti-H
2
, for the preparation of a first pharmaceutical dosage form and a second pharmaceutical dosage form, the first pharmaceutical dosage form comprising two capsules one placed inside the other for a quadruple therapy against the microorganisms Helicobacter pylori, wherein the external capsule comprises the soluble salt of bismuth and the first antibiotic, and the in
Axcan Pharma Inc.
Bennett Rachel M.
Myers Bigel Sibley & Sajovec P.A.
Page Thurman K.
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