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Non-toxic vehicle to solubilize, deliver, and obtain biological activity of steroid hormones at cell, tissue, and organ targets, in vitro and in vivo

a steroid hormone and biological activity technology, applied in the field of animal models, can solve the problems of inability to dissolve steroid hormones in solvents, hampered use and application of steroid hormones in hormone therapy, and use of peg alon

Inactive Publication Date: 2019-12-26
THE GOVERNMENT OF THE UNITED STATES AS REPRSENTED BY THE SECRETARY OF THE AIR FORCE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides a non-toxic vehicle for hormone therapy that includes a cationic lipid or a neutral lipid and polyethylene glycol. The invention also provides a method of preparing a hormone treatment with non-toxic vehicle by combining an aqueous solution of a hormone and polyethylene glycol with a cationic lipid, a neutral lipid, or both, and polyethylene glycol. The technical effects of the invention include improved delivery of hormones and reduced side effects.

Problems solved by technology

However, the use and application of steroid hormones in hormone therapy has been hampered in conventional methodologies by two difficulties: 1) an inability to dissolve sufficient amounts of steroid hormones in a solvent and 2) a lack of delivery vehicle for which a measurable dose of hormone may be delivered to a target tissue that produces a biological effect or systemic response.
While some conventional mechanisms have utilized polyethylene glycol (“PEG”) for transmitting the hormone to the target tissue, there are disadvantages to using PEG alone, such as solubility and toxicity.

Method used

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  • Non-toxic vehicle to solubilize, deliver, and obtain biological activity of steroid hormones at cell, tissue, and organ targets, in vitro and in vivo
  • Non-toxic vehicle to solubilize, deliver, and obtain biological activity of steroid hormones at cell, tissue, and organ targets, in vitro and in vivo
  • Non-toxic vehicle to solubilize, deliver, and obtain biological activity of steroid hormones at cell, tissue, and organ targets, in vitro and in vivo

Examples

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example 1

[0054]A non-toxic vehicle for administration of androstene hormones according to embodiments of the present invention was prepared from a first solution and a second solution. The first solution, comprising liposomal formulation, was placed in PEG 300 to a concentration of 5% and heated in a sonicating water bath to about 45° C. The second solution, comprising a selected hormone (one or more of 5Δ-androsten-3β, 17α-diol, 5Δ-androsten-3β, 17β-diol, or 5Δ-androsten-3β,7β,17β-triol), was placed in PEG 300 and heated in a sonicating water bath to about 45° C. The first and second solutions were then combine and stirred until dissolved.

[0055]Biological function was tested in 293T cells, which is a human embryonic cell line transformed with Large T antigen or SV40. This hypotriploid (polyploid) cell line is particularly useful in such transformation studies and has very distinct phenotypes when grown. All androstene hormone treatment applications were at concentrations of 25 μM.

[0056]FIG....

example 2

[0066]Hormone dependent, noninvasive, epithelial phenotype (ER / PR positive MCF-7 breast cancer cells) and hormone independent, invasive, mesenchymal phenotype (ER / PR negative MDA-MB-231 breast cancer cell) cell suspensions were acquired and prepared in complete medium (DMEM / F12, 10% FBS, 1% penicillin / streptomycin (Gibco)). Cellular concentration was adjusted to 2×105 cells / mL.

[0067]Androstene hormone solutions according to embodiments of the present invention were prepared from a first solution and a second solution. For the first solution, 3.0 mg of β-AED or β-AET was added to warm PEG 300 to prepare 50 mM stock. For the second solution, 10 μL of LIPOFECTAMINE (3:1 DOSPA: DOPE) was introduced to 100 μL of PEG 300, mixed, and incubated in a water bath at 42° C. for 30 min. The first and second solutions were then mixed in a sonicator water bath at 42° C. for 1 hr. The final concentration was 50 mM β-AED (or AET, as used).

[0068]A β-estradiol solution was also prepared by adding 2.7 ...

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Abstract

A non-toxic vehicle for hormone therapy. The non-toxic vehicle includes a cationic lipid or a neutral lipid and polyethylene glycol.

Description

[0001]This application is a continuation of U.S. application Ser. No. 15 / 875,637, which claims the benefit of and priority to prior filed Provisional Application Ser. No. 62 / 449,205, filed Jan. 23, 2017. The contents of each application is expressly incorporated herein by reference in its entirety, each in its entirety.RIGHTS OF THE GOVERNMENT[0002]The invention described herein may be manufactured and used by or for the Government of the United States for all governmental purposes without the payment of any royalty.FIELD OF THE INVENTION[0003]The present invention relates generally to animal models and, more particularly, to animal models for educational and investigational uses.BACKGROUND OF THE INVENTION[0004]Steroid hormone therapy is generally considered the treatment with any steroid hormone, such as estrogen, progesterone, androgens, and the like. Such treatments have been found useful in combating the symptoms of menopause, supplementing cancer treatments, and hormone replac...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/127A61K31/573A61K31/565A61K9/00A61P35/00A61K31/568A61K47/10A61K47/24A61K39/39A61M1/00G09B23/30G09B23/34
CPCG09B23/306A61K31/565A61B17/32053A61K9/0019A61B10/02A61K31/573A61M1/0088A61K31/568A61K47/24A61K39/39A61K9/1271G09B23/34A61P35/00A61K47/10A61K2300/00A61B2017/00707A61M1/90
Inventor SHAAK, THOMASWANG, SUIZHAO
Owner THE GOVERNMENT OF THE UNITED STATES AS REPRSENTED BY THE SECRETARY OF THE AIR FORCE