Unlock instant, AI-driven research and patent intelligence for your innovation.

Compositions for the treatment of inflammation of the gastrointestinal tract

a technology of gastrointestinal tract and composition, applied in the direction of drug composition, nervous disorder, dispersed delivery, etc., can solve the problems of delayed treatment of patients with eoe, significant secondary side effects on growth and bone development, and failure to thriv

Inactive Publication Date: 2009-05-21
MERITAGE PHARMA INC
View PDF76 Cites 46 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The composition effectively reduces esophageal inflammation by prolonging contact time with the esophagus and improving the delivery of corticosteroids, providing a therapeutic benefit for eosinophilic esophagitis and other gastrointestinal disorders.

Problems solved by technology

Symptoms of EoE include, for example, abdominal pain, chest pain, choking, difficulty swallowing, failure to thrive, nausea, reflux not relieved by standard anti-flux therapy, skin rash or hives, vomiting, and weight loss.
The common occurrence regarding misdiagnosis of EoE for GERD often results in delayed treatment for patients with EoE.
Long term systemic steroid therapy can result in significant secondary side effects on growth and bone development.
Although treatment with anti-IL-5 monoclonal antibody has been reported to be successful in EE or EoE, this therapy is currently not approved for use in children (36).
Identifying true inciting food allergens can be difficult and elemental formulas are often unpalatable, thereby making dietary interventions complicated (1, 22).
Improvised puff and swallow techniques may be difficult for patients, especially smaller children, and especially children with developmental delays, to perform efficiently.
This may result in a less than effective dose of a topical steroid being delivered to the esophagus.

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Compositions for the treatment of inflammation of the gastrointestinal tract

Examples

Experimental program
Comparison scheme
Effect test

example 1

Treatment of Gastrointestinal Inflammation

[0104]A 4 mL oral dosage formulation is prepared comprising the following ingredients:

IngredientAmount (% w / w)Fluticasone propionate, microfine0.05Dextrose5.0Polysorbate 800.02MCC and CMC1.0-2.0Benzalkonium chloride0.02Phenylethyl alcohol0.25Waterto 100

[0105]The fluticasone propionate containing dosage formulation is administered orally for the treatment of gastrointestinal inflammation.

example 2

Treatment of Gastrointestinal Inflammation

[0106]A 2-4 mL oral dosage formulation is prepared comprising the following ingredients:

IngredientAmount (% w / w)Fluticasone propionate, microfine0.01-0.1Dextrose 4.0-6.0Polysorbate 800.001-5  MCC and CMC 0.1-10Benzalkonium chloride0.002-0.5 Phenylethyl alcohol0.05-0.4Waterto 100

[0107]The fluticasone propionate containing dosage formulation is administered orally for the treatment of gastrointestinal inflammation.

example 3

[0108]This example details the efficacy and safety of once daily and twice daily use of fluticasone propionate formulations described herein in 5 mL, 7 mL, 10 mL, 12 mL, 15 mL, or 17.5 mL doses in inducing and maintaining remission of disease activity in children with EoE. A number of children (e.g., 20 per fluticasone propionate dose frequency, amount, and volume) are evaluated to determine the highest eosinophil count (eos / hpf) and the mean highest eosinophil count for the group. Evaluation of the highest eosinophil count (eos / hpf) and the mean highest eosinophil count for the group is also determined following therapy. Symptom scores and mean symptom scores are also determined before and after therapy.

[0109]In some instances, individuals who received previous therapy with proton pump inhibitor, elimination diet based upon skin or blood allergy testing, or elimination diet or refused elimination diet, but continued to have ≧24 eos / hpf on esophageal biopsy are included in the revie...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

PropertyMeasurementUnit
temperatureaaaaaaaaaa
temperatureaaaaaaaaaa
viscosityaaaaaaaaaa
Login to View More

Abstract

Provided herein are methods for preventing or alleviating the symptoms of and inflammation associated with inflammatory diseases and conditions of the gastrointestinal tract, for example, those involving the esophagus. Also provided herein are pharmaceutical compositions useful for the methods of the present invention.

Description

CROSS-REFERENCE[0001]This application claims the benefit of U.S. Provisional Application No. 60 / 987,720, filed Nov. 13, 2007; U.S. Provisional Application No. 61 / 012,012, filed Dec. 6, 2007; U.S. Provisional Application No. 61 / 015,998, filed Dec. 21, 2007; U.S. Provisional Application No. 61 / 019,818, filed Jan. 8, 2008; U.S. Provisional Application No. 61 / 034,941, filed Mar. 7, 2008; U.S. Provisional Application No. 61 / 035,348, filed Mar. 10, 2008; U.S. Provisional Application No. 61 / 054,103, filed May 16, 2008; U.S. Provisional Application No. 61 / 054,104, filed May 16, 2008; U.S. Provisional Application No. 61 / 054,105, filed May 16, 2008; U.S. Provisional Application No. 61 / 054,106, filed May 16, 2008; U.S. Provisional Application No. 61 / 054,107, filed May 16, 2008; and U.S. Provisional Application No. 61 / 090,658, filed Aug. 20, 2008, which applications are incorporated herein by reference.BACKGROUND OF THE INVENTION[0002]Esophageal inflammation disorders are gaining increased reco...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/56A61P1/00
CPCA61K9/006A61K47/38A61K31/58A61K9/0065A61K47/36A61K47/32A61K45/06A61K31/575A61K9/0053A61K31/341A61K31/4439A61K9/0095A61K2300/00A61P1/00A61P1/06A61P25/00A61P29/00
Inventor PHILLIPS, ELAINE
Owner MERITAGE PHARMA INC