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Improved methods and compositions for safe and effective treatment of telangiectasia

A kind of technology of brimonidine and brimonidine tartrate, applied in the field of compositions containing brimonidine for treating erythema

Inactive Publication Date: 2013-05-08
GALDERMA RES & DEV SNC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

No unacceptable drug-related adverse events were observed when treated with higher concentrations of the test brimonidine

Method used

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  • Improved methods and compositions for safe and effective treatment of telangiectasia
  • Improved methods and compositions for safe and effective treatment of telangiectasia
  • Improved methods and compositions for safe and effective treatment of telangiectasia

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0092] gel topical formulations

[0093] This example illustrates gel topical formulations useful in the present invention.

[0094] A first set of gel formulations is described in Table 1 below.

[0095] Element % (w / w) % (w / w) % (w / w) Brimonidine tartrate 0.3 – 0.6% 0.6 – 3% 3 – 10% Methylparaben NF 0.15% 0.20% 0.10% Propylparaben NF 0.03% 0.02% 0.04% Hydroxyethyl Cellulose NF 1.0% 1.25% 1.5% Butanediol 1,3 3.0% 6.0% 18.0% glycerin 2.0% 4.0% 12.0% Disodium EDTA USP 0.05% 0.05% 0.05% Purified water, USP QS QS QS total 100% 100% 100%

[0096] The pH of the formulation is adjusted to approximately 4.5 to 7.0.

[0097] A second set of gel formulations is described in Table 2 below.

[0098] Element % (w / w) % (w / w) % (w / w) Brimonidine tartrate 0.3 – 0.6% 0.6 – 3.0% 3.0 – 10% Methylparaben 0.20% 0.20% 0.20% Propylparaben 0.05% 0....

Embodiment 2

[0107] Comparative bioavailability and pharmacokinetic studies of brimonidine compositions

[0108] This study administered brimonidine tartrate (ophthalmic solution (0.2%) and topical gel (0.07%, 0.18 % and 0.50%)) randomized, assessor-blinded, intrasubject comparative pharmacokinetic study. Main inclusion criteria included a clinical diagnosis of moderate to severe facial erythema associated with rosacea, a CEA score ≥3, and an IOP level of 11-21 mmHg. Intra-subject comparisons of topical and ocular exposure following 1 day of treatment with brimonidine tartrate ophthalmic solution 0.2% were performed.

[0109] A total of 102 subjects were randomly assigned: 24, 26, 25 and 27 subjects were treated with 0.5% Gel QD, 0.18% Gel BID, 0.18% Gel QD and 0.07% Gel BID, respectively. At the Day 1 visit, administer 1 drop of brimonidine tartrate ophthalmic solution 0.2% to each eye every 8 hours during a 24-hour period. After a 2-day washout period, 1 gram of topical gel (brimoni...

Embodiment 3

[0128] Clinical study on brimonidine tartrate gel composition

[0129] clinical research

[0130] A single-dose, randomized, double-blind, parallel-group, vehicle-controlled, dose-determining study was conducted to evaluate three brimonidine tartrate containing three concentrations (ie, 0.07%, 0.18% and 0.50% by weight) of three Pharmacodynamics and safety of a gel formulation in stable patients with moderate-to-severe erythematotelangiectatic rosacea.

[0131] A total of 122 subjects were randomized to receive one of three topical gel formulations (0.5%, 0.18%, 0.07% N=31, N=31, N=28) or vehicle gel (N=32) One-time application. Apply to the face in a single application in the morning. Subjects remained on site for a mandatory 12-hour post-dose observation period. All 122 subjects completed the study and were included in the intention-to-treat (ITT) and safety populations. A total of 117 subjects (96%) were included in the population point (PP) population.

[0132] E...

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PUM

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Abstract

Improved methods and compositions for safe and effective treatment of telangiectasia or a symptom associated with telangiectasia in a subject are described. The methods involve topically applying to an affected skin area a topical composition comprising about 0.3% to about 10% by weight of brimonidine and a pharmaceutically acceptable carrier.

Description

[0001] Cross References to Related Applications [0002] This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 61 / 282,753, filed March 26, 2010, the contents of which are hereby incorporated by reference in their entirety. Background of the invention [0003] Telangiectasia is a very common skin disease. Telangiectasias are small red, purple, or blue superficial blood vessels that can be seen on the face, upper chest, neck, or other parts of the body. Telangiectatic blood vessels, which can include swollen vessels, spider veins, red skin patches, purple skin patches, or blue skin patches, are abnormal and not necessary for any essential bodily function. [0004] Telangiectatic vessels may or may not be present with prior or concurrent skin or medical disease. Telangiectasias can occur anywhere on the body, but are most easily seen on the skin. Telangiectasia includes basic or major telangiectasia, which includes vasodilation of...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/498A61P17/00A61K9/06A61K9/00
CPCA61K31/498A61K9/0014A61P9/00A61P17/00A61P17/10A61P17/16A61P35/00A61P43/00A61K9/06
Inventor M.格雷伯C.勒切P.弗雷登赖赫Y.刘M.J.利奥尼
Owner GALDERMA RES & DEV SNC
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