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Nanoemulsion

A nanoemulsion and active agent technology, applied in the field of treatment of tumor diseases and/or psoriasis, diseases and diseases related to cell proliferation, can solve the problems of reduced contact area, impaired nanoemulsion penetration, and reduced penetration rate

Active Publication Date: 2009-11-25
BIOFRONTERA BIOSCIENCE GMBH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Larger particles cause reduced contact area between skin and nanoemulsion and cause lower penetration rate
Second, ethanol has a relatively low viscosity of 1.10 cp, which is not optimal for microemulsion stability
In addition, due to the relatively low hydrophobicity of ethanol, the penetration of nanoemulsions through the lipophilic physiological membrane layer of the skin may be impaired
Thus, the stability of the nanoemulsion as well as its bioavailability (i.e. penetration into tissues) is reduced
Also, ethanol is a very expensive alcohol compared to other kinds of alcohols such as isopropanol

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0097] Embodiment 1: the preparation of nanoemulsion BF200

[0098] The following table gives the qualitative and quantitative composition of nanoemulsion BF200.

[0099] Table 1. Composition of nanoemulsion BF200

[0100] Element

%(w / w)

Function

quality

Soy Lecithin

1.73

Surfactant

>94%

Phosphatidylcholine, for medicine

use, USP

Polysorbate 80

(polyoxyethylene sorbitan monooleate

ester)

3.40

co-surfactant

Ph. Eur.

Caprylic / Capric Triglycerides

3.45

lipid core

Ph. Eur.

Isopropanol

1.42

solvent

Ph. Eur.

10mM Phosphate Buffer, pH 6

make up to

100.00

solvent

Water for Injection:

Ph.Eur

Disodium Hydrogen Phosphate and Dihydrogen Phosphate

Sodium: Ph. Eur.

[0101] The production method of emulsion BF200 c...

Embodiment 2

[0115] Example 2: Preparation of aminolevulinic acid 1%, 3% and 10% gels and placebo gels

[0116] Qualitative and quantitative compositions of placebo gel and 1%, 3%, 10% aminolevulinic acid gel are given in the table below.

[0117] Table 3. Composition of Placebo Gels

[0118]

[0119] Table 4. Composition of Aminolevulinic Acid 1% Gel

[0120]

[0121] Table 5: Composition of Aminolevulinic Acid 3% Gel

[0122] Element

Amount per gram of gel

Function

quality

Aminolevulinic acid hydrochloride

30.0mg

drug substance

inside

xanthan gum

19.625mg

filler

Ph. Eur.

Nanoemulsion BF200

175.0mg

carrier

inside

Propylene Glycol

9.0mg

preservatives

Ph. Eur.

Methylparaben

0.7mg

preservatives

Ph. Eur.

Propylparaben

0.3mg

preservatives

Ph. Eur.

Water for Injection

765.375mg

solvent

Ph. Eur.

[0123]Table 6: Composition o...

Embodiment 3

[0145] Embodiment 3: the particle diameter of nanoemulsion BF-200

[0146] The average particle size of the produced nanoemulsions was less than 100 nm as assessed by Photon Correlation Spectroscopy, PCS (also known as Dynamic Laser Light Scattering, DLS). Furthermore, the nanoemulsions are characterized by a very narrow particle size distribution (see Figure 1 below).

[0147] The nanoemulsions are stable over a wide temperature range, but can be destroyed by freezing and autoclaving. Nanoemulsions are relatively insensitive to changes in pH and ionic strength, and due to their small size, they can be sterilized by filtration through a 0.2 μm filter. Nanoemulsions have the potential to improve the delivery of active substances into the skin, thus enhancing the efficacy of topically applied drugs.

[0148] Nanoemulsion BF-200 was produced using low energy techniques; that is, the preparation of nanoemulsions does not require high shear equipment such as sonicators or high pr...

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Abstract

The present invention relates to a nanoemulsion comprising at least one aqueous component and a carrier, wherein the carrier comprises at least one lipophilic component, at least one surfactant and at least one alcohol. The present invention further relates to a composition comprising the nanoemulsion and an active agent. In particular, the composition is present as a gel and the active agent is 5-aminolevulinic acid, a derivative, precursor and / or metabolite thereof. The invention further relates to the preparation of the nanoemulsion and / or composition and to their use for the treatment of dermatological diseases, virus-associated diseases as well as diseases associated with cell proliferation, in particular, tumor diseases and / or psoriasis. The present invention is further directed to the use of the nanoemulsion in cosmetics.

Description

technical field [0001] The present invention relates to a nanoemulsion comprising at least one aqueous component and a carrier, wherein the carrier comprises at least one lipophilic component, at least one surfactant and at least one alcohol. The invention further relates to compositions comprising said nanoemulsion and an active agent. In particular, said composition is present as a gel and said active agent is 5-aminolevulinic acid (ALA), its derivatives, its precursors and / or its metabolites. The invention furthermore relates to processes for the preparation of said nanoemulsions and / or compositions and to their use for the treatment of dermatological diseases, diseases associated with viruses and diseases associated with cell proliferation, in particular for the treatment of neoplastic diseases and / or psoriasis use. The invention additionally relates to the use of said nanoemulsions in cosmetics. Background technique [0002] Nanoemulsions constitute colloidal system...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K9/12A61K31/195A61K47/10A61K47/44
CPCA61K8/4993A61K8/06A61Q19/00A61K8/553A61K2800/21B82Y5/00A61K9/107A61K2800/413A61K8/34A61K8/44A61K8/375A61P17/00A61P17/02A61P17/06A61P17/10A61P17/12A61P31/12A61P31/14A61P31/20A61P35/00
Inventor M·福格特罗卡
Owner BIOFRONTERA BIOSCIENCE GMBH
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