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Multivesicular emulsion topical delivery systems

A topical drug delivery and emulsion technology, applied in the digestive system, emulsion delivery, antipyretics, etc., can solve problems such as excessive dosage, skin irritation, lack of continuous and peak release monitoring

Inactive Publication Date: 2008-07-23
海尔斯波因特有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Furthermore, not only the lack of monitoring of sustained and peak release is a problem, but also the peak release may cause skin irritation due to overdose at the site of administration

Method used

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  • Multivesicular emulsion topical delivery systems
  • Multivesicular emulsion topical delivery systems
  • Multivesicular emulsion topical delivery systems

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0138] Products are prepared using the multifoam emulsions of the present invention. In particular, the pharmaceutically active agent is a 1% by weight suspension of the known antifungal econazole nitrate. It is used to include 3.5% by weight Behenyl TMS (25% by weight behenyltrimethylammonium methoxysulfate and 75% by weight cetearyl alcohol) was prepared in the multifoam emulsion system of the present invention. The multifoam emulsion system was mixed with sunflower oil, cetyl alcohol, stearyl alcohol, octyl hydroxystearate, water, glycerin and 1% by weight of econazole nitrate antifungal. After checking after high shear mixing to determine the formation of a foamy emulsion, the system appeared as a cream.

[0139] It was compared in this test to a known commercially available product, Johnson & Johnson's econazole product (Spectazole, an oil / water emulsion of the same drug). Both were also tested in a diffusion chamber. The results of the diffusion test show that the m...

Embodiment 2

[0141] The same emulsion system as Example 1 (minus the active) was studied to investigate the potential of the product to increase peripheral blood flow when applied to the skin. The study was performed on ten healthy subjects. A set amount of product is applied to the test subject's cheek. Baseline blood flow was assessed with laser Doppler measurements. Three to six hours after administration, the results showed a significant increase in blood flow with the product of the invention compared to baseline. It should be noted that increased peripheral blood flow corresponds to better metabolism, increased cellular nutrition, increased oxygenation, and faster cellular clearance, and increased blood flow is necessary for therapy and cell renewal. This test demonstrates that the multivesicular system increases blood flow compared to the baseline product. figure 2 Displays blood flow data.

Embodiment 3

[0143] This example measures transepidermal water loss when using the present invention. This is an important method for assessing the efficacy of the skin's protective barrier. Increased transepidermal water loss is a signal of a compromised skin protective barrier. In the clinical situation, various dermatitis or external factors, such as: solvents, detergents and other irritants increase transdermal water loss. Good topical products should not irritate the skin. They are supposed to enhance the function of the skin, maintain the health of the skin and help repair a damaged skin barrier. In this example, the recovery rate of peeled skin treated and untreated with the multifoam emulsion of the present invention was evaluated.

[0144] In detail, twenty healthy volunteers participated in this study. After measuring the baseline of epidermal water loss, the skin was repeatedly taped and peeled off (twenty times) until the epidermal water loss reached a selected value. The ...

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PUM

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Abstract

A topical delivery composition which employs a multivesicular emulsion in combination with a pharmaceutically / pharmacologically active agent is disclosed. The multivesicular emulsion is formed from a quaternary amine salt emulsifier such as behentrimonium methosulfate. The emulsion is multi-lamellar which is a series of concentric spheres or vesiculars of oil and water phase that can be seen microscopically. As a result, the active is time released over a sustained period rather than spike released as is common with most topicals.

Description

technical field [0001] The present invention relates to topical compositions having the unique properties of multifoam emulsions. technical background [0002] Of course, topical delivery systems are known which take advantage of the physical properties of creams, ointments and lotions ranging from solids to varying degrees of lubricity. The key to the success of topical drug delivery systems is how successful they are at delivering the so-called "active". For example: most topical active substances have a high or so-called "peak" release upon initial application which then decreases substantially over time. This is unsatisfactory because the initial peak dose is too high and lacks persistence over time, with consequent diminished potency. Furthermore, not only the lack of monitoring of sustained and peak release is a problem, but peak release may cause skin irritation due to overdosing at the site of administration. [0003] Topical products susceptible to peak doses and...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/107A61K8/06A61K8/36A61K8/40A01N25/04A01N25/30A01N43/50A61K8/00A61K8/14A61K8/25A61K8/30A61K8/34A61K8/41A61K8/49A61K8/68A61K8/73A61K9/06A61K9/10A61K31/164A61K31/4164A61K31/56A61K45/00A61K47/02A61K47/10A61K47/18A61K47/36A61K47/44A61P1/02A61P17/00A61P17/02A61P17/04A61P17/10A61P17/12A61P17/14A61P17/16A61P23/02A61P29/00A61P31/04A61P31/10A61P31/12A61P31/22A61P33/14A61P35/00A61P43/00A61Q1/00A61Q1/12A61Q5/00A61Q7/00A61Q11/00A61Q15/00A61Q17/04A61Q19/00A61Q19/04A61Q19/10
CPCA61K8/68A61Q19/04A61K47/186Y10S514/865A61K47/44A61K9/0014A61Q19/002Y10S514/817A61K8/14A61Q19/00Y10S514/887A61Q17/04Y10S514/859A61Q19/10A61K8/416Y10S514/938A61P1/02A61P17/00A61P17/02A61P17/04A61P17/10A61P17/12A61P17/14A61P17/16A61P23/02A61P29/00A61P31/04A61P31/10A61P31/12A61P31/22A61P33/14A61P35/00A61P43/00A61K9/107A61K9/127
Inventor R·爱泊诺沙
Owner 海尔斯波因特有限公司
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