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Lipid emulsions and uses thereof

a technology of lipid emulsion and lipid emulsion, which is applied in the direction of anti-noxious agents, drug compositions, cardiovascular disorders, etc., can solve the problems of fat overload syndrome, volume overload of cardiovascular systems, and the decline of survival rate, so as to improve mitochondrial function and metabolism, improve tissue redox state, and improve the effect of mitochondrial function

Pending Publication Date: 2021-04-29
RESQ PHARMA INC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present patent relates to a lipid emulsion composition that can be used to treat drug toxicity, organ injury, and other related disorders. The composition contains at least 20% lipid, an emulsifier, tonicity modifier, water, and optionally other compounds such as vitamin K or CoQ10 that can improve cellular redox state and mitochondrial function. The particles in the emulsion have an average size of 200 nm to less than 300 nm. The technical effects of this invention include reducing drug toxicity, organ injury, and improving cellular redox state and mitochondrial function.

Problems solved by technology

However, data has shown that even if a hypotensive episode is treated with a compound(s) designed to increase blood pressure, the odds of surviving do not improve.
Lipid emulsions currently in use, however, suffer from several drawbacks, including the total volume needed to treat a subject, which can lead to either volume overload of the cardiovascular system or fat overload syndrome.

Method used

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  • Lipid emulsions and uses thereof
  • Lipid emulsions and uses thereof
  • Lipid emulsions and uses thereof

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0110]A lipid emulsion of the present disclosure containing 20% and 24% lipid is manufactured. Particle diameter and surface area (SA) of a prior art 20% lipid emulsion (row 1) is compared to the lipid emulsions of the example (row 2-3). The 20% lipid emulsion of the present disclosure has an increase in surface area for each droplet that is 43.5% greater than the prior art lipid emulsion.

TABLE A% lipidDiameterSA per 100 mLZeta(g / 100 mL)(nm)(×102 m2)potential20%3304.00−45mV20%2305.74−57.4mV24%2306.89Not determined

example 2

[0111]A lipid emulsion of the present disclosure containing 24% lipid was manufactured. (Of note—the same manufacturing protocol may be used to create an emulsion with 20% lipid, specifically, the amount of lipid would be decreased from 24% to 20% while the water would be analogously increased.) In this prep, sodium hydroxide 0.1 M was included at 36 ml to reach a higher pH value for the emulsion. Additionally, a homogenization pressure of about 1600 atm was used to support reduction of mean globule size, already obtained in a previous trial. Recirculation time was adjusted to guarantee at least 6 homogenization cycles. Furthermore, the N2 pressure used during homogenization was 1.0 atm.

TABLE BBATCH COMPOSITIONRaw materialAmountPercentagedescriptionper batchvaluesSojabean Oil, refined450.00g24.00%Purified Egg Phosphatide28.12g1.50%Glycerol Anhydrous35.62g1.90%NaOH 0.1M solution (~36 ml)36.0g1.60%W.F.I.1,325.26g71.00%Total1,875.00g100.00%N2 gas for blowing,1.0atmn.a.(for Homogenizati...

example 3

[0128]Experiments were performed to demonstrate the improved performance of a lipid composition of the present disclosure in a rat model of drug toxicity. The response of blood pressure in the intact anesthetized rat after 10 mg / kg bupivacaine is delivered intravenously over 10 sec followed by the infusion of 4 mL / kg of either Intralipid 20% or a composition of the present disclosure was determined. The time to recover baseline blood pressure was 3 minutes for the Intralipid composition (FIG. 1B) and only 40 sec (FIG. 1A) for a composition of the present disclosure. The responses were so different that different scales had to be used for FIG. 1A and FIG. 1B. This is evidence that a composition of the present disclosure with a greater surface area accelerates recovery from drug toxicity. Arterial pressure is an indication of the degree of toxicity caused by bupivacaine, a local anesthetic which for these purposes serves as a canonical cause of cardiac pharmacotoxicity. Thus the accel...

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Abstract

The present disclosure provides lipid emulsions comprising at least 20 percent (w / v) lipid with an average particle size of about 200 to about 300 nm, and use thereof to treat subjects in need of lipid emulsion therapy.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims priority to U.S. provisional application No. 62 / 836,394 filed Apr. 19, 2019, U.S. provisional application No. 62 / 803,932 filed Feb. 11, 2019 and U.S. provisional application No. 62 / 676,850, filed May 25, 2018, each of which is hereby incorporated by reference in their entirety.FIELD OF THE DISCLOSURE[0002]The present disclosure provides lipid emulsions comprising at least 20 percent (w / v) lipid with an average particle size of about 200 to about 300 nm, and use thereof to treat subjects in need of lipid emulsion therapy.BACKGROUND OF THE DISCLOSURE[0003]Current evidence has illustrated that mortality is higher in post-surgical patients that experienced a hypotensive episode or an ischemia-reperfusion injury. However, data has shown that even if a hypotensive episode is treated with a compound(s) designed to increase blood pressure, the odds of surviving do not improve. This is postulated to be correlated with the o...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/107A61P39/02A61P9/04A61K9/00
CPCA61K9/1075A61K9/0019A61P9/04A61P39/02A61K47/44A61K9/107A61K9/00A61K31/231A61K31/685A61K31/047A61P9/00A61K2300/00
Inventor WEINBERG, GUYBRYANT, CHRISTOPHER PIERS
Owner RESQ PHARMA INC