# US 2014/0155435 A1 · Kit for Treatment of Upper Gastrointestinal Tract Conditions

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- Number: US 2014/0155435 A1
- Document ID: US20140155435A1
- Status: Published application
- Kind: A1
- Application number: 13/705,215
- Filed: 2012-12-05
- Published: 2014-06-05
- Earliest claimed: 2012-12-05
- Assignees: The Procter & Gamble Company
- Applicants: The Procter & Gamble Company
- Inventors: Will Howard Mitchell; Linda Carol Jones; John Stephen Eadicicco; Beth Waggoner Russell
- Web page: https://patentgrep.com/patent/US20140155435A1

## CPC

- A61K 31/4439: containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole (nicotine A61K31/465)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

Disclosed herein are kits useful for facilitating compliance with a treatment regimen. In one embodiment, the kits are useful for compliance with a defined method of treatment which utilizes a composition comprising a gastric acid secretion inhibitor. In an alternative or additional embodiment, the kits comprise an outer container and at least two inner containers, wherein each of the inner containers comprise, independently, a plurality of unit doses of a composition comprising a therapeutically effective amount of a gastric acid secretion inhibitor.

## Claims

### Claim 1

A method of facilitating compliance with an over-the-counter heartburn treatment regimen comprising:
a. providing an outer container enclosing 2 inner containers wherein each inner container contains a blister pack and the blister pack contains 14 unit doses of a composition comprising a therapeutically effective amount of omeprazole or an omeprazole salt and wherein the outer container and each inner container further comprise a surface and wherein instructions for compliance with the heartburn treatment regimen are printed on the surface;
b. administering a treatment wherein one unit dose of the composition every day for 14 days; and
c. repeating the treatment after a period of about 75 days to about 135 days.

### Claim 2 (depends on 1)

The method of claim 1 wherein the outer container is intended for over-the-counter sale.

### Claim 3

(canceled)

### Claim 4 (depends on 1)

The method of claim 1 wherein the composition is in a form selected from the group consisting of tablets and capsules.

### Claim 5 (depends on 1)

The method of claim 1 wherein the composition is omeprazole.

### Claim 6 (depends on 1)

The method of claim 1 wherein the composition is an omeprazole salt selected from the group consisting of omeprazole lithium salts, omeprazole sodium salts, omeprazole potassium salts, omeprazole magnesium salts, omeprazole calcium salts, and mixtures thereof.

### Claim 7 (depends on 6)

The method of claim 6 wherein the omeprazole salt is omeprazole magnesium.

### Claim 8 (depends on 1)

The method of claim 1 wherein the period is 4 months.

### Claim 9 (depends on 1)

The method of claim 1 wherein each inner container is a box.

### Claim 10 (depends on 9)

The method of claim 9 wherein the outer container is a box.

### Claim 11

A method of facilitating compliance with an over-the-counter heartburn treatment regimen comprising:
a. providing an outer container enclosing 3 inner containers wherein each inner container contains a blister pack and the blister pack contains 14 unit doses of a composition comprising a therapeutically effective amount of omeprazole or an omeprazole salt and wherein the outer container and inner containers each further comprise a surface and wherein instructions for compliance with the heartburn treatment regimen are printed on the surface;
b. administering a treatment wherein one unit dose of the composition every day for 14 days; and
c. repeating the treatment after a period of about 75 days to about 135 days.

### Claim 12 (depends on 11)

The method of claim 11 wherein the outer container is intended for over-the-counter sale.

### Claim 13 (depends on 11)

The method of claim 11 wherein each inner container comprises one blister pack and the blister pack comprises the 14 unit doses.

### Claim 14 (depends on 11)

The method of claim 11 wherein the composition is in a form selected from the group consisting of tablets and capsules.

### Claim 15 (depends on 11)

The method of claim 11 wherein the composition is omeprazole.

### Claim 16 (depends on 11)

The method of claim 11 wherein the composition is an omeprazole salt selected from the group consisting of omeprazole lithium salts, omeprazole sodium salts, omeprazole potassium salts, omeprazole magnesium salts, omeprazole calcium salts, and mixtures thereof.

### Claim 17 (depends on 16)

The method of claim 16 wherein the omeprazole salt is omeprazole magnesium.

### Claim 18 (depends on 11)

The method of claim 11 wherein the period is 4 months.

### Claim 19 (depends on 11)

The method of claim 11 wherein each inner container is a box.

### Claim 20 (depends on 19)

The method of claim 19 wherein the outer container is a box.

### Claim 21 (depends on 1)

The method of claim 1 wherein each inner container comprises one blister pack and the blister pack comprises the 14 unit doses.