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Claims for Patent: 6,350,468

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Claims for Patent: 6,350,468

Title: Double capsule for the administration of active principles in multiple therapies
Abstract:A pharmaceutical dosage form particularly suitable for the administration of active principles in multiple therapies is disclosed. The pharmaceutical dosage form is a double capsule where in an internal capsule is placed inside an external one. Each internal and external capsule includes one or more active principles. A double capsule according to the invention is preferably used in triple or quadruple therapies against the microorganisms Helicobacter Pylori. Advantages of this pharmaceutical dosage form consist in providing a simple posology for administration of two and more active principles, allowing the active principles to activate at the right intervals of time and in the preestablished quantities, and preventing interactions between active principles. In a preferred embodiment of the invention, the pharmaceutical dosage form has an external capsule containing bismuth subcitrate and metronidazole, and an internal capsule containing tetracycline and optionally omeprazole, which is used in therapy for eradication of Helicobacter pylori.
Inventor(s): Sanso; Giovanni (Milan, IT)
Assignee: Axcan Pharma Inc. (Quebec, CA)
Application Number:09/581,721
Patent Claims: 1. Method for carrying out a triple therapy against the microorganisms Helicobacter pylori in a mammal comprising the oral administration to said mammal of a pharmaceutical dosage form comprising an internal capsule placed inside an external capsule, wherein the external capsule comprises a soluble salt of bismuth and a first antibiotic, and the internal capsule comprises a second antibiotic.

2. Method as claimed in claim 1, wherein the internal capsule further comprises a K.sup.+ /Na.sup.+ ATPase inhibitor or anti-H.sub.2, whereby a quadruple therapy is carried out.

3. Method as claimed in claim 1, wherein the external capsule further comprises a K.sup.+ /Na.sup.+ ATPase inhibitor or anti-H.sub.2, whereby a quadruple therapy is carried out.

4. Method as claimed in claim 1, further comprising the administration of a second pharmaceutical dosage form comprising a K.sup.+ /Na.sup.+ ATPase inhibitor or anti-H.sub.2, whereby a quadruple therapy is carried out.

5. Method as claimed in claim 1, wherein:

the salt of bismuth is selected from the group consisting of bismuth subcitrate, bismuth aluminate, bismuth carbonate, bismuth citrate, colloidal bismuth subnitrate, bismuth germanate, bismuth germanium oxide, bismuth nitrate, bismuth oxide, bismuth oxychloride, bismuth phosphate, bismuth salicylate, bismuth subcarbonate, bismuth subnitrate, bismuth subsalicylate, bismuth tribromophenate, bismuth trioxyde, bismuth vanadate, and bismuth vanadium tetraoxide;

the first antibiotic is selected from the group consisting of the nitroimidazoles; and

the second antibiotic is selected from the group consisting of the macrolides and the compounds of the family of tetracyclines.

6. Method as claimed in claim 5, wherein:

the nitroimidazoles are selected from the group consisting of metronidazole, apronidazole, azomycine, benzonidazole, carnidazole, demetridazole, etanidazole, flunidazole, misonidazole, nimorazole, ornidazole, panidazole, ronidazole, and tinidazole;

the macrolides are selected from the group consisting of azithromycine, clarithromycine and erythromycine; and

the compounds of the family of tetracyclines are selected from the group consisting of tetracycline, chlortetracycline, doxycycline, glycocycline, guamecycline, lymecycline, methacycline and sancycline.

7. Method as claimed in claim 6, wherein:

the salt of bismuth is bismuth subcitrate;

the first antibiotic is metronidazole; and

the second antibiotic is tetracycline.

8. Method as claimed in claim 2, wherein:

the salt of bismuth is selected from the group consisting of bismuth subcitrate, bismuth aluminate, bismuth carbonate, bismuth citrate, colloidal bismuth subnitrate, bismuth germanate, bismuth germanium oxide, bismuth nitrate, bismuth oxide, bismuth oxychloride, bismuth phosphate, bismuth salicylate, bismuth subcarbonate, bismuth subnitrate, bismuth subsalicylate, bismuth tribromophenate, bismuth trioxyde, bismuth vanadate, and bismuth vanadium tetraoxide;

the first antibiotic is selected from the group consisting of the nitroimidazoles;

the second antibiotic is selected from the group consisting of the macrolides and the compounds of the family of tetracyclines; and

the K.sup.+ /Na.sup.+ ATPase inhibitor or anti-H.sub.2 is selected from the group consisting of BY841; cimetidine; ebrotidine; etintidine; famotidine; flunarizine; ICI-162,846; lansoprazole; metiamide; mifentidine; niperotidine; nizatidine; omeprazole; oxmetidine; pantoprazole; rabeprazole; ramixotidine; ranitidine; ritanserin; roxatidine acetate hydrochloride; ZKF-93479; SKF-94482; sufotidine; tiotidine; TY-11345; Wy-45,727; and zaltidine.

9. Method as claimed in claim 8, wherein:

the nitroimidazoles are selected from the group consisting of metronidazole, apronidazole, azomycine, benzonidazole, carnidazole, demetridazole, etanidazole, flunidazole, misonidazole, nimorazole, ornidazole, panidazole, ronidazole, and tinidazole;

the macrolides are selected from the group consisting of azithromycine, clarithromycine and erythromycine; and

the compounds of the family of tetracyclines are selected from the group consisting of tetracycline, chlortetracycline, doxycycline, glycocycline, guamecycline, lymecycline, methacycline and sancycline.

10. Method as claimed in claim 9, wherein:

the salt of bismuth is bismuth subcitrate;

the first antibiotic is metronidazole;

the second antibiotic is tetracycline; and

the K.sup.+ /Na.sup.+ ATPase inhibitor or anti-H.sub.2 is omeprazole.

11. Method as claimed in claim 1, wherein:

the salt of bismuth is selected from the group consisting of bismuth subcitrate, bismuth aluminate, bismuth carbonate, bismuth citrate, colloidal bismuth subnitrate, bismuth germanate, bismuth germanium oxide, bismuth nitrate, bismuth oxide, bismuth oxychloride, bismuth phosphate, bismuth salicylate, bismuth subcarbonate, bismuth subnitrate, bismuth subsalicylate, bismuth tribromophenate, bismuth trioxyde, bismuth vanadate, and bismuth vanadium tetraoxide;

the first antibiotic is selected from the group consisting of the nitroimidazoles;

the second antibiotic is selected from the group consisting of the macrolides and the compounds of the family of tetracyclines; and

the K.sup.+ /Na.sup.+ ATPase inhibitor or anti-H.sub.2 is selected from the group consisting of BY841; cimetidine; ebrotidine; etintidine; famotidine; flunarizine; ICI-162,846; lansoprazole; metiamide; mifentidine; niperotidine; nizatidine; omeprazole; oxmetidine; pantoprazole; rabeprazole; ramixotidine; ranitidine; ritanserin; roxatidine acetate hydrochloride; ZKF-93479; SKF-94482; sufotidine; tiotidine; TY-11345; Wy-45,727; and zaltidine.

12. Method as claimed in claim 11, wherein:

the nitroimidazoles are selected from the group consisting of metronidazole, apronidazole, azomycine, benzonidazole, carnidazole, demetridazole, etanidazole, flunidazole, misonidazole, nimorazole, ornidazole, panidazole, ronidazole, and tinidazole;

the macrolides are selected from the group consisting of azithromycine, clarithromycine and erythromycine; and

the compounds of the family of tetracyclines are selected from the group consisting of tetracycline, chlortetracycline, doxycycline, glycocycline, guamecycline, lymecycline, methacycline and sancycline.

13. Method as claimed in claim 12, wherein:

the salt of bismuth is bismuth subcitrate;

the first antibiotic is metronidazole;

the second antibiotic is tetracycline; and

the K.sup.+ /Na.sup.+ ATPase inhibitor or anti-H.sub.2 is omeprazole.

14. Method as claimed in claim 4, wherein:

the salt of bismuth is selected from the group consisting of bismuth subcitrate, bismuth aluminate, bismuth carbonate, bismuth citrate, colloidal bismuth subnitrate, bismuth germanate, bismuth germanium oxide, bismuth nitrate, bismuth oxide, bismuth oxychloride, bismuth phosphate, bismuth salicylate, bismuth subcarbonate, bismuth subnitrate, bismuth subsalicylate, bismuth tribromophenate, bismuth trioxyde, bismuth vanadate, and bismuth vanadium tetraoxide;

the first antibiotic is selected from the group consisting of the nitroimidazoles;

the second antibiotic is selected from the group consisting of the macrolides and the compounds of the family of tetracyclines; and

the K.sup.+ /Na.sup.+ ATPase inhibitor or anti-H.sub.2 is selected from the group consisting of BY841; cimetidine; ebrotidine; etintidine; famotidine; flunarizine; ICI-162,846; lansoprazole; metiamide; mifentidine; niperotidine; nizatidine; omeprazole; oxmetidine; pantoprazole; rabeprazole; ramixotidine; ranitidine; ritanserin; roxatidine acetate hydrochloride; ZKF-93479; SKF-94482; sufotidine; tiotidine; TY-11345; Wy-45,727; and zaltidine.

15. Method as claimed in claim 14, wherein:

the nitroimidazoles are selected from the group consisting of metronidazole, apronidazole, azomycine, benzonidazole, carnidazole, demetridazole, etanidazole, flunidazole, misonidazole, nimorazole, ornidazole, panidazole, ronidazole, and tinidazole;

the macrolides are selected from the group consisting of azithromycine, clarithromycine and erythromycine; and

the compounds of the family of tetracyclines are selected from the group consisting of tetracycline, chlortetracycline, doxycycline, glycocycline, guamecycline, lymecycline, methacycline and sancycline.

16. Method as claimed in claim 15, wherein:

the salt of bismuth is bismuth subcitrate;

the first antibiotic is metronidazole;

the second antibiotic is tetracycline; and

the K.sup.+ /Na.sup.+ ATPase inhibitor or anti-H.sub.2 is omeprazole.

17. Method as claimed in claim 1, wherein both internal and external capsules are stable at a temperature comprised between 5 and 50.degree. C. and at a humidity comprised between 35 and 65%.

18. Method as claimed in claim 1, wherein both internal and external capsules are made of hard gelatin.

19. Method as claimed in claim 1, wherein the internal capsule has a format between 2 or 3 and the external capsule has a format between 0+ or 1.

20. Method as claimed in claim 19, wherein the external capsule has a format of 0+ and the internal one has a format 3.

21. Pharmaceutical dosage form for the oral administration of active principles in a triple therapy against the microorganisms Helicobacter pylori, the pharmaceutical dosage form comprising an internal capsule placed inside an external capsule, wherein the external capsule comprises a soluble salt of bismuth and a first antibiotic, and the internal capsule comprises a second antibiotic.

22. Pharmaceutical dosage form as claimed in claim 21, wherein the internal capsule further comprises a K.sup.+ /Na.sup.+ ATP-ase inhibitor or anti-H.sub.2, whereby the pharmaceutical dosage form is for the oral administration of a quadruple therapy.

23. Pharmaceutical dosage form as claimed in claim 21, wherein the external capsule comprises a K.sup.+ /Na.sup.+ ATP-ase inhibitor or anti-H.sub.2, whereby the pharmaceutical dosage form is for the oral administration of a quadruple therapy.

24. Pharmaceutical dosage form as claimed in claim 21, wherein:

the salt of bismuth is selected from the group consisting of bismuth subcitrate, bismuth aluminate, bismuth carbonate, bismuth citrate, colloidal bismuth subnitrate, bismuth germanate, bismuth germanium oxide, bismuth nitrate, bismuth oxide, bismuth oxychloride, bismuth phosphate, bismuth salicylate, bismuth subcarbonate, bismuth subnitrate, bismuth subsalicylate, bismuth tribromophenate, bismuth trioxyde, bismuth vanadate, and bismuth vanadium tetraoxide;

the first antibiotic is selected from the group consisting of the nitroimidazoles; and

the second antibiotic is selected from the group consisting of the macrolides and the compounds of the family of tetracyclines.

25. Pharmaceutical dosage form as claimed in claim 24, wherein:

the nitroimidazoles are selected from the group consisting of metronidazole, apronidazole, azomycine, benzonidazole, carnidazole, demetridazole, etanidazole, flunidazole, misonidazole, nimorazole, ornidazole, panidazole, ronidazole, and tinidazole;

the macrolides are selected from the group consisting of azithromycine, clarithromycine and erythromycine; and

the compounds of the family of tetracyclines are selected from the group consisting of tetracycline, chlortetracycline, doxycycline, glycocycline, guamecycline, lymecycline, methacycline and sancycline.

26. Pharmaceutical dosage form as claimed in claim 25, wherein:

the salt of bismuth is bismuth subcitrate;

the first antibiotic is metronidazole; and

the second antibiotic is tetracycline.

27. Pharmaceutical dosage form as claimed in claim 22, wherein:

the salt of bismuth is selected from the group consisting of bismuth subcitrate, bismuth aluminate, bismuth carbonate, bismuth citrate, colloidal bismuth subnitrate, bismuth germanate, bismuth germanium oxide, bismuth nitrate, bismuth oxide, bismuth oxychloride, bismuth phosphate, bismuth salicylate, bismuth subcarbonate, bismuth subnitrate, bismuth subsalicylate, bismuth tribromophenate, bismuth trioxyde, bismuth vanadate, and bismuth vanadium tetraoxide;

the first antibiotic is selected from the group consisting of the nitroimidazoles;

the second antibiotic is selected from the group consisting of the macrolides and the compounds of the family of tetracyclines; and

the K.sup.+ /Na.sup.+ ATPase inhibitor or anti-H.sub.2 is selected from the group consisting of BY841; cimetidine; ebrotidine; etintidine; famotidine; flunarizine; ICI-162,846; lansoprazole; metiamide; mifentidine; niperotidine; nizatidine; omeprazole; oxmetidine; pantoprazole; rabeprazole; ramixotidine; ranitidine; ritanserin; roxatidine acetate hydrochloride; ZKF-93479; SKF-94482; sufotidine; tiotidine; TY-11345; Wy-45,727; and zaltidine.

28. Pharmaceutical dosage form as claimed in claim 27, wherein:

the nitroimidazoles are selected from the group consisting of metronidazole, apronidazole, azomycine, benzonidazole, carnidazole, demetridazole, etanidazole, flunidazole, misonidazole, nimorazole, ornidazole, panidazole, ronidazole, and tinidazole;

the macrolides are selected from the group consisting of azithromycine, clarithromycine and erythromycine; and

the compounds of the family of tetracyclines are selected from the group consisting of tetracycline, chlortetracycline, doxycycline, glycocycline, guamecycline, lymecycline, methacycline and sancycline.

29. Pharmaceutical dosage form as claimed in claim 28, wherein:

the salt of bismuth is bismuth subcitrate;

the first antibiotic is metronidazole;

the second antibiotic is tetracycline; and

the K.sup.+ /Na.sup.+ ATPase inhibitor or anti-H.sub.2 is omeprazole.

30. Pharmaceutical dosage form as claimed in claim 23, wherein:

the salt of bismuth is selected from the group consisting of bismuth subcitrate, bismuth aluminate, bismuth carbonate, bismuth citrate, colloidal bismuth subnitrate, bismuth germanate, bismuth germanium oxide, bismuth nitrate, bismuth oxide, bismuth oxychloride, bismuth phosphate, bismuth salicylate, bismuth subcarbonate, bismuth subnitrate, bismuth subsalicylate, bismuth tribromophenate, bismuth trioxyde, bismuth vanadate, and bismuth vanadium tetraoxide;

the first antibiotic is selected from the group consisting of the nitroimidazoles;

the second antibiotic is selected from the group consisting of the macrolides and the compounds of the family of tetracyclines; and

the K.sup.+ /Na.sup.+ ATPase inhibitor or anti-H.sub.2 is selected from the group consisting of BY841; cimetidine; ebrotidine; etintidine; famotidine; flunarizine; ICI-162,846; lansoprazole; metiamide; mifentidine; niperotidine; nizatidine; omeprazole; oxmetidine; pantoprazole; rabeprazole; ramixotidine; ranitidine; ritanserin; roxatidine acetate hydrochloride; ZKF-93479; SKF-94482; sufotidine; tiotidine; TY-11345; Wy-45,727; and zaltidine.

31. Pharmaceutical dosage form as claimed in claim 30, wherein:

the nitroimidazoles are selected from the group consisting of metronidazole, apronidazole, azomycine, benzonidazole, carnidazole, demetridazole, etanidazole, flunidazole, misonidazole, nimorazole, ornidazole, panidazole, ronidazole, and tinidazole;

the macrolides are selected from the group consisting of azithromycine, clarithromycine and erythromycine; and

the compounds of the family of tetracyclines are selected from the group consisting of tetracycline, chlortetracycline, doxycycline, glycocycline, guamecycline, lymecycline, methacycline and sancycline.

32. Pharmaceutical dosage form as claimed in claim 31, wherein:

the salt of bismuth is bismuth subcitrate;

the first antibiotic is metronidazole;

the second antibiotic is tetracycline; and

the K.sup.+ /Na.sup.+ ATPase inhibitor or anti-H.sub.2 is omeprazole.

33. Pharmaceutical dosage form as claimed in claim 21, wherein the internal capsule has a format between 2 or 3 and the external capsule has a format between 0+ or 1.

34. Pharmaceutical dosage form as claimed in claim 33, wherein the external capsule has a format of 0+ and the internal one has a format 3.

35. Pharmaceutical dosage form as claimed in claim 21, wherein the internal and external capsules are made of hard gelatin.

36. Pharmaceutical dosage form as claimed in claim 21, wherein the internal and external capsules contain respectively and independently one or more excipients.

37. Pharmaceutical dosage form as claimed in claim 17, wherein the excipients are selected from the group consisting of magnesium stearate; talc; cellulose and its derivates; silica and its derivates; sugars; polyethyglycols; wax, mono-, di- and tri-glycerids of hydrogenated fat acids; alcohols and acids at high molecular weight; and relevant mixtures thereof.
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