IP Library Granted Patent US 6,884,437
Granted Patent B2
US 6,884,437 · App. 10/423,002 · Granted Apr 26, 2005

Administration form comprising an acid-labile active compound

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Quick Facts
Patent No.
US 6,884,437
App. No.
10/423,002
Granted
Apr 26, 2005
Kind
B2
Abstract

Novel administration forms for acid-labile active compounds are described. The novel administration forms have no enteric layers and are suitable for oral administration.

Claims (12)

1. A method of orally administering an effective amount of a stable form of acid-labile active compound to a subject in need of such therapy, wherein the active compound is in an enteric-coating-free oral administration form comprising a pharmaceutical auxiliary and a plurality of individual compound units, wherein the acid-labile active compound in the individual active compound units is a) a proton pump inhibitor, b) a salt of a proton pump inhibitor with a base or c) a hydrate of (b), surrounded by a mixture of at least one sterol and at least one polymer.

2. A method of orally administering an effective amount of a stable form of acid-labile active compound to a subject in need of such therapy, wherein the active compound is in an enteric-coating-free oral administration form comprising a pharmaceutical auxiliary and a plurality of individual compound units, wherein the acid-labile active compound in the individual active compound units is a) a proton pump inhibitor, b) a salt of a proton pump inhibitor with a base or c) a hydrate of (b), surrounded by at least one fatty alcohol.

3. A method of orally administering an effective amount of a stable form of acid-labile active compound to a subject in need of such therapy, wherein the active compound is a) a proton pump inhibitor, b) a salt of a proton pump inhibitor with a base or c) a hydrate of (b), in an enteric-coating-free oral administration form comprising a pharmaceutical auxiliary and a plurality of individual compound units, wherein the acid-labile active compound in the individual active compound units is surrounded by a mixture of at least one fatty alcohol and at least one polymer.

4. A method of orally administering an effective amount of a stable form of acid-labile active compound to a subject in need of such therapy, wherein the active compound is a) a proton pump inhibitor, b) a salt of a proton pump inhibitor with a base or c) a hydrate of (b), in an enteric-coating free oral administration form comprising a pharmaceutical auxiliary and a plurality of individual compound units, wherein the acid-labile active compound in the individual active compound units is surrounded by a mixture of at least one fatty alcohol and at least one sterol.

5. A method of orally administering an effective amount of a stable form of acid-labile active compound to a subject in need of such therapy, wherein the active compound is a) a proton pump inhibitor, b) a salt of a proton pump inhibitor with a base or c) a hydrate of (b), in an enteric-coating-free oral administration form comprising a pharmaceutical auxiliary and a plurality of individual compound units, wherein the acid-labile active compound in the individual active compound units is surrounded by a mixture of at least one fatty alcohol, at least one polymer and at least one sterol.

6. A method of orally administering an effective amount of a stable form of acid-labile active compound to a subject in need of such therapy, wherein the active compound is in an enteric-coating-free oral administration form comprising a pharmaceutical auxiliary and a plurality of individual compound units, wherein the acid-labile active compound in the individual active compound units is surrounded by a) at least one fatty alcohol, b) a mixture of at least one sterol and at least one polymer, or c) a mixture of at least one fatty alcohol and at least one polymer and/or at least one sterol, and wherein the acid-labile active compound is an acid labile proton pump inhibitor, a salt of an acid-labile proton pump inhibitor with a base, and a hydrate of a salt of an acid-labile proton pump inhibitor with a base.

7. A method of claim 6 , wherein the acid-labile active compound is pantoprazole, omeprazole, esomeprazole, lansoprazole or rabeprazole.

8. A method of claim 6 wherein the acid-labile active compound is in combination with a non-steroidal anti-inflammatory drug (NSAID).

9. A method of claim 6 which comprises separately administering an NSAID to the subject.

10. A method of claim 6 wherein the acid-labile active compound is in combination with an antimicrobially active compound.

11. A method of claim 6 which comprises separately administering an antimicrobially active compound to the subject.

12. A method of claim 6 which further comprises administering to the subject an antimicrobially active compound of a type and in an amount suitable to control Helicobacter pylori.