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A sterically stabilized carrier for subcutaneous, sublingual, and oral therapeutics, compositions and methods for treating a mammal

a carrier and sterically stabilized technology, applied in the direction of antibacterial agents, drug compositions, immunological disorders, etc., can solve the problems of poor clinical efficacy, poor treatment effect, and relatively short life of the mammal body, and achieve the effects of improving the therapeutic effect of food allergy, improving the therapeutic effect, and improving the therapeutic

Inactive Publication Date: 2019-02-14
VGSK TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent text describes a method for treating eosinophilic esophagitis and allergies using a sterically stabilized liposome carrier. The carrier encapsulates a therapeutically effective amount of at least one agent suitable for treating the condition or disorder. The method involves administering the liposome carrier to a subject in need thereof through various routes such as subcutaneously, sublingually, or orally. The therapeutic agents can include proton-pump inhibitors, corticosteroids, or antihistamines. The use of the liposome carrier allows for the safe and effective delivery of the therapeutic agents to the targeted areas in the body.

Problems solved by technology

Many existing methods and compositions for delivering therapeutics and treating disease states are not entirely satisfactory.
For example, a major drawback of using conventional liposomes in treating disease states is that they have a relatively short life in a mammal body.
In contrast to the increasing number of treatments for airway allergies, the therapeutic approach for food allergy remains very limited.

Method used

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  • A sterically stabilized carrier for subcutaneous, sublingual, and oral therapeutics, compositions and methods for treating a mammal
  • A sterically stabilized carrier for subcutaneous, sublingual, and oral therapeutics, compositions and methods for treating a mammal
  • A sterically stabilized carrier for subcutaneous, sublingual, and oral therapeutics, compositions and methods for treating a mammal

Examples

Experimental program
Comparison scheme
Effect test

example 1

and Methods

[0149]Animals

[0150]Six week-old male C57 black 6 mice were purchased from Charles River Laboratories, Inc., Wilmington, Mass. The animals were provided with an ovalbumin-free diet and water ad libitum and were housed in an environment-controlled, pathogen-free animal facility. All animal protocols were approved by the Animal Care Committee of the University of Illinois at Chicago, the Medical College of Wisconsin and the Zablocki Veterans Administration Medical Center, and were in agreement with the National Institute of Health's guidelines for the care and use of laboratory animals.

[0151]Ovalbumin Sensitization

[0152]The animals were sensitized with ovalbumin (OVA). On day 0, each mouse was anesthetized with methoxyflurane given by inhalation. A fragmented heat-coagulated OVA implant was inserted subcutaneously on the dorsal aspect of the cervical region.

[0153]For a ten-day period (days 14-24), each mouse was given a 30-minute aerosolization of a 6% OVA solution on altern...

example 2

mparison of BUD in the Carrier with Conventional Liposomes

[0178]

BUD 1: TREATMENT GROUPSNORMALUnsensitized, Untreated Normal miceSENSSensitized, Untreated miceDaily BUD20 μg of budesonide without Carrier given daily-StandardtherapyWK-S-BUD20 μg of budesonide in the Carrier given once a weekWK-C-BUD20 μg of budesonide encapsulated in Conventional Carriergiven once a weekWK-ESBuffer loaded empty Carrier without drug given oncea weekWK-BUD20 μg of budesonide without Carrier given once a weekBUD 1: RESULTSPB EosIgE levels(FIG. 2)(FIG. 3)NORMAL——SENS↑↑Daily BUD↓↓WK-S-BUD↓↓WK-C-BUDØØWK-ESØØWK-BUDØØLegend↑Ø↓—Moderate-SevereNo significantSignificantNoinflammationreduction inreduction ininflammationinflammationinflammation

[0179]In the set of data given for BUD 1, it was demonstrated that one dose of budesonide (BUD) encapsulated in the carrier given once a week (WK-S-BUD), reduced inflammation as effectively as the same dosage of BUD given once a day (Daily BUD) when compared to the Sensitize...

example 3

mparison of BUD in the Carrier with Free Drug / Free Carrier Administered Simultaneously

[0180]

BUD 2: TREATMENT GROUPSNORMALUnsensitized, Untreated Normal miceSENSSensitized, Untreated miceDaily BUD20 μg of budesonide without the Carrier given daily-Standard therapyWK-S-BUD20 μg of budesonide in the Carrier given oncea weekWK-ESBuffer loaded Empty Carrier without drug given oncea weekWK-BUD20 μg of budesonide without the Carrier given oncea weekWK-BUD & ESWK-ES and WK-BUD without encapsulation in theCarrier, given once a weekBUD 2: RESULTSPB EosIgE levels(FIG. 4)(FIG. 5)NORMAL——SENS↑↑Daily BUD↓↓WK-S-BUD↓↓WK-ESØØWK-BUDØØWK-BUD & ESØØ

[0181]In the set of data given for BUD 2, it was demonstrated that one dose of budesonide (BUD) encapsulated in the Carrier given once a week (WK-S-BUD), reduced inflammation as effectively as the same dosage of BUD given once a day (Daily BUD) when compared to the Sensitized Untreated group (SENS) and was comparable to the NORMAL group. Weekly treatments wi...

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PUM

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Abstract

Disclosed herein are pharmaceutical compositions and methods for oral, sublingual or subcutaneous administration comprising a sterically stabilized liposome carrier comprising: i) poly (ethylene glycol) distearoylphosphatidylethanolamine (PEG-DSPE); and ii) at least one of phosphatidylglycerol and phosphatidylcholine. Compositions and methods for treatment of food allergy and eosinophilic esophagitis are also described.

Description

CROSS-REFERENCE[0001]This application claims the benefit of U.S. Provisional Application No. 62 / 218,558, filed Sep. 14, 2015, which application is incorporated herein by reference in its entirety.STATEMENT AS TO FEDERALLY SPONSORED RESEARCH[0002]This invention was made with government support under Grant no. 1R41HL73668-1A1 awarded by National Heart, Lung and Blood Institute. The government has certain rights in the invention.BACKGROUND OF THE INVENTION[0003]Many existing methods and compositions for delivering therapeutics and treating disease states are not entirely satisfactory. For example, a major drawback of using conventional liposomes in treating disease states is that they have a relatively short life in a mammal body. Accordingly, there is a need for new and improved methods and compositions. Compositions, methods, and kits of using a sterically stabilized liposome carrier can be used to extend the life of liposomes in a mammal body. Also, most applications of conventional...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/127A61K31/573A61K31/58A61K45/06A61K47/34A61P29/00A61P37/08A61P31/06
CPCA61K9/1271A61K31/573A61K31/58A61K45/06A61K47/34A61P29/00A61P37/08A61P31/06A61K9/127
Inventor KONDURI, KAMESWARIDUZGUNES, NEJATPATTISAPU, JOGIPATTISAPU, RAM
Owner VGSK TECH
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