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Compositions for the treatment of inflammation of the gastrointestinal tract

a technology for the inflammation of the gastrointestinal tract and compositions, applied in the direction of drug compositions, immunological disorders, dispersed delivery, etc., can solve the problems of delayed treatment of patients with ee, significant secondary side effects on growth and bone development, and failure to thrive, so as to increase the interaction of compositions

Inactive Publication Date: 2009-06-11
MERITAGE PHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

"The present invention provides a method of treating inflammation of the gastrointestinal tract by orally administering a composition containing a corticosteroid, a preservative, a chelating agent, an isotonic agent, a surfactant, and an excipient that increases interaction with a mucosal layer. The corticosteroid is present in the composition in a specific amount and the preservative is present in a specific amount. The composition has a specific pH and may also contain a sweetener, flavoring agent, or both. The excipient may be a combination of microcrystalline cellulose and carboxymethyl cellulose sodium. The composition is formulated as a micronized suspension in an aqueous vehicle. The technical effect of the invention is to provide an effective and safe method for treating inflammation of the gastrointestinal tract."

Problems solved by technology

Symptoms of EE 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 EE for GERD often results in delayed treatment for patients with EE.
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, 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

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  • Compositions for the treatment of inflammation of the gastrointestinal tract
  • Compositions for the treatment of inflammation of the gastrointestinal tract

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0100]This example illustrates the increased interaction between a composition described herein and the esophagus when compared to a radiolabeled oral composition made by combining Pulmicort Respules® (4 mL) with 99mTc pertechnetate, and diluting with saline to about 7-8 mL (M0). The M0 composition has a viscosity of about 1 cP at 13.2 sec−1. Also administered to a population of healthy individuals was a radiolabeled budesonide composition (Rhinocort Aqua®, M1), which has a viscosity of about 39 at 13.2 sec−1. Increased interaction of the budesonide composition was determined by measuring the amount of radiolabel present in the esophagus following oral administration of the M1 budesonide composition. FIG. 1 illustrates the percent amount of composition present in the esophagus as a function of time following oral administration (by measuring the amount of radiolabel present in the esophagus).

[0101]The area under the curve (AUCr) of the percent of the dose administered as a function ...

example 2

[0102]This example details the efficacy and safety of once daily and twice daily use of budesonide 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 EE. A number of children (e.g., 20 per budesonide 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.

[0103]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 review. Patients are defined a...

example 3

[0116]This example details the efficacy and safety of once daily and twice daily use of budesonide in a formulation described herein in inducing and maintaining remission of disease activity in individuals (children and / or adults) with GERD. Doses of 0-1 mg, 1-2 mg, 2-3 mg, 3-4 mg, 4-5 mg, and 5-6 mg per daily dose are administered once a day, b.i.d. or t.i.d. in volumes of 3, 5, 7, 10, 12, 15, or 17.5 mL. A number of individuals (e.g., 20 per budesonide dose frequency, amount, and volume) are evaluated to determine the symptoms prior to therapy, during therapy and following therapy. Administration is conducted for 7 days, 14 days, and 28 days. Primary Outcome Measures include complete resolution of heartburn and regurgitation (e.g., no more than one day with either mild heartburn or regurgitation over the seven days prior to the assessment time-point). Secondary Outcome Measures include: Number of days with heartburn (daytime and night-time); Number of days with regurgitation (dayt...

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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 December 06, 2007; U.S. Provisional Application No. 61 / 015,998, filed December 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 incre...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/58A61P29/00
CPCA61K31/41A61K31/573A61K45/06A61K2300/00A61K9/0095A61K9/06A61K31/58A61K31/341A61K31/4439A61P1/00A61P1/04A61P1/08A61P1/12A61P1/14A61P17/00A61P29/00A61P35/00A61P37/08A61P43/00A61P5/38A61P5/44A61K9/0053A61K9/006A61K9/0065A61K9/10A61K47/32A61K47/36A61K47/38A61K47/26A61K31/575A61K31/56
Inventor PHILLIPS, ELAINE
Owner MERITAGE PHARMA INC
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