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Title:  Double capsule for the administration of active principles in multiple therapies

United States Patent:  6,350,468

Inventors:  Sanso; Giovanni (Milan, IT)

Assignee:  Axcan Pharma Inc. (Quebec, CA)

Appl. No.:  581721

Filed:  June 16, 2000

PCT Filed:  December 14, 1998

PCT NO:  PCT/EP98/08167

371 Date:  June 16, 2000

102(e) Date:  June 16, 2000

PCT PUB.NO.:  WO99/30693

PCT PUB. Date:  June 24, 1999

Foreign Application Priority Data:  Dec 17, 1997[IT] (MI97A2788)

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.

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-H2, 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-H2.

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-H2, 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-H2, 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-H2, 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 internal capsule comprises the second antibiotic; the second pharmaceutical dosage form comprising a K+/Na+ATPase inhibitor or anti-H2.

An advantage of the pharmaceutical dosage form of the invention is to be used in multiple therapies, which allows a simple and safe posology.

One of the major advantages of the pharmaceutical dosage form of the present invention is that it overcomes problems related with the interaction of the active principles by means of a physical barrier.

Claim 1 of 37 Claims

What is claimed is:

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.

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