Gastric acid secretion inhibiting composition

a technology of gastric acid and composition, applied in the direction of drug composition, dispersed delivery, antibacterial agents, etc., can solve the problems of not providing symptom resolution, e. complete relief of symptoms, etc., and achieve the effect of quick and lasting reli

Inactive Publication Date: 2008-02-07
OREXO AB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0014] It is an object of the invention to provide a medicine which provides quick and lasting relief to a patient suffering from conditions related to gastric acid secretion.
[0015] It is another object of the invention to provide a method for treating a patient suffering from conditions related to gastric acid secretion which provides quick and lasting relief.

Problems solved by technology

The main disadvantage of antacid agents and alginates is the extremely short duration of action and dosing has to be repeated frequently to keep the patients free of symptoms, further that antacids often do not provide symptom resolution, i.e. complete relief of symptoms.

Method used

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  • Gastric acid secretion inhibiting composition
  • Gastric acid secretion inhibiting composition
  • Gastric acid secretion inhibiting composition

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0069] Multiple unit tableted dosage form comprising magnesium omeprazole and ranitidine hydrochloride; batch size 400 tablets. For omeprazole Mg-salt pellet production (core material, separating layer, enteric coating layer and over-coating layer, see WO 97 / 25066, p. 22-23 under respective headings), see WO 97 / 25066, first two paragraphs, all of which is hereby incorporated by reference.

TabletsPrepared pellets comprising omeprazole Mg-salt31.3gMicrocrystalline cellulose300.0gCimetidine hydrochloride40.0gPotato starch50.0gWater200.0gPVP crosslinked38.0gSodium stearyl fumarate4.6g

[0070] A small amount of the potato starch is dissolved in purified hot water to form the granulation liquid. Cimetidine hydrochloride, the rest of potato starch and microcrystalline cellulose are dry mixed. The granulation liquid is added to the dry mixture and the mass is wet mixed. The wet mass is dried in an oven at 50° C. The prepared granulation is milled through sieve 1 mm in an oscillating mill equ...

example 2

[0072] Three-layered tableted dosage form. The tablet comprises the acid susceptible proton pump inhibitor omeprazole, a separating layer and a core layer comprising cimetidine hydrochloride. Batch size 1000 tablets.

First tablet layerCimetidine hydrochloride200.0gMicrocrystalline cellulose250.0gPVP crosslinked13.0gSodium stearyl fumarate3.8gSeparating layerMicrocrystalline cellulose80.0gSecond tablet layerEnteric coating layered pellets comprising78.3gomeprazole magnesium salt (same as inEXAMPLE 1)Microcrystalline cellulose174.0gPVP crosslinked26.0gSodium stearyl fumarate1.4g

[0073] The constituents of the first tablet layer are dry mixed and precompressed as a first layer in a tableting machine equipped with oval punches. Microcrystalline cellulose is filled on the top of the first layer to form a separating layer to the next layer. The constituents of the second tablet layer are dry mixed and filled on top of the separating layer. The three layers are compressed into a three laye...

example 3

[0074] Capsule dosage form. No. 1 hard gelatin capsules (16) (FIG. 5; volume 0.48 ml) were filled with enteric coated omeprazole pellets (15) containing 20 mg omeprazole recovered from commercially available omeprazole (Losec®) capsules and a dry mixture 14 of commercially available famotidine 20 mg for injection (Pepcidin®; containing 20 mg famotidine hydrochloride, 8 mg aspartic acid and 40 mg mannitol), and closed.

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Abstract

An oral pharmaceutical dosage form comprises pharmacologically effective amounts of an acid susceptible proton pump inhibitor or a salt thereof, an H2 receptor antagonist or a salt thereof and a pharmaceutically acceptable carrier. The dosage form is capable of raising gastric pH to above 4 within two hours after administration and to keep it at that level for at least 4 hours. Also disclosed is a method of manufacture of the dosage form, its use in treating dyspepsia and infection by Helicobacter pylori, and a method of treating disorders associated with gastric acid secretion.

Description

FIELD OF THE INVENTION [0001] The present invention relates to a gastric acid secretion inhibiting composition, to a method for its manufacture and to its use in treating conditions which are related to the secretion of gastric acid. BACKGROUND OF THE INVENTION [0002] Dyspepsia (acid dyspepsia) is a common disorder. Heartburn is a symptom of dyspepsia. It is estimated that 44% of Americans have heartburn at least once monthly but that only about 25% of them are seeing the doctor because of their dyspepsia problem. Symptoms associated with dyspepsia are for instance upper abdominal pain / discomfort and heartburn, indigestion, “sour” stomach, and gastro-esophageal reflux. [0003] Dyspepsia is a multi-factorial disease and may be associated with organic pathology such as duodenal ulcer, gastric ulcer, esophagitis, Barrett's esophagus or gastro-duodenal inflammation (e.g., Helicobacter pylori infection). Dyspepsia also includes conditions where no organic pathology can be found, e.g., non...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/28A61K31/34A61K31/4164A61K31/426A61P1/04A61P31/04A61K9/48A61K31/4439A61K9/16A61K9/00A61K9/20A61K9/24A61K9/50A61K31/341
CPCA61K9/0095A61K9/167A61K31/4439A61K31/426A61K31/4164A61K31/341A61K9/5084A61K9/5078A61K9/4808A61K9/2081A61K9/209A61K2300/00A61P1/04A61P1/14A61P31/04
Inventor PETTERSSON, ANDERS
Owner OREXO AB
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