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Intranasal carbetocin formulations and methods for the treatment of autism

A carbetocin, autism technology, used in the treatment of neurological and psychiatric disorders, to solve the problems of asymptomatic or unsuccessful children and adults

Inactive Publication Date: 2010-03-24
NASTECH PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Unfortunately, current treatments for the autism spectrum and related disorders are primarily symptomatic and have proven unsuccessful in rendering such children and adults asymptomatic or symptomatic

Method used

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  • Intranasal carbetocin formulations and methods for the treatment of autism
  • Intranasal carbetocin formulations and methods for the treatment of autism
  • Intranasal carbetocin formulations and methods for the treatment of autism

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0093] Permeability of Carbetocin Preparations

[0094] Permeability studies of different carbetocin formulations were done using tracheal / bronchial epithelial cell membrane inserts. Samples were evaluated for appearance, color, clarity, pH, osmolality, cell viability (measured using MTT), cytotoxicity (measured using LDH), and transepithelial electrical resistance (TER) and permeability.

[0095] Samples were prepared according to the recipe in Table 1. Abbreviations used for test adjuvants include: Me-β-CD is methyl β-cyclodextrin (Wacker, Munich, Germany), DDPC is didecanoyl L-α-phosphatidylcholine (NOF Corp., White Plains, NY), EDTA is disodium edetate (JTBaker, Phillipsburg, NJ), MP / PP is sodium methylparaben / sodium propylparaben (Spectrum, Gardena, CA), and CB is chlorobutyl alcohol, and Arg is arginine.

[0096] Table 1

[0097] Sample composition of carbetocin preparations

[0098]

[0099]

[0100]

[0101]

[0102] pH was measured using a Cole Parmer...

Embodiment 2

[0113] First pharmacokinetic study in rabbits

[0114] Rabbits were treated with carbetocin by intranasal administration of the pharmaceutical composition. Table 2 shows the formulations tested:

[0115] Table 2

[0116] Carbetocin formulations for PK studies

[0117]

Group#

Cabetian contractions

white

(mg / ml)

Me-β-

cd

(mg / ml)

EDTA

(mg / ml)

Arg

(mM)

Sorbitose

Alcohol

(mM)

NaCl

(mM)

CB (mg / ml)

pH

Carbetocin

%marked amount

1

0.03

0

0

10

0

150

0

7

87.1

2

2

0

3.5

10

0

57

5

4

101.2

3

2

10

3.5

10

0

52

5

4

110.2

4

2

10

3.5

10

104

0

5

4

103.0

5

2

20

3.5 ...

Embodiment 3

[0138] Intramuscular Second Pharmacokinetic Study in Rabbits Intranasal administration of carbetocin

[0139] In order to replicate the formulations evaluated in our first human clinical study, a second rabbit PK study was performed to test the effect of increasing the content of Me-β-CD (about 10 to about 40 mg / ml), evaluated in the tonicity modifier Bioavailability of carbetocin in the presence of sorbitol and NaCl, testing the effect of increasing osmolality (about 170 to about 220 mOsm / kgH2O) and testing the effect of ethanol on % BA. In this study, the dose concentration of carbetocin was also increased to 60 μg / kg (ie 4 μg / ml of carbetocin). The formulations tested are shown in Table 7.

[0140] Before starting this second in vivo study, we evaluated the in vitro, listed in Table 7, according to the method outlined in Example 1, using a tracheal / bronchial epithelial membrane system (EpiAirway, MatTek Corp., Ashland, MA). The ability of formulations to reduce transe...

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PUM

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Abstract

Methods and compositions containing oxytocin or an oxytocin analog, such as carbetocin, are provided for the prevention and treatment of autism spectrum disorders, related disorders and symptoms of such disorders. The methods and compositions of this disclosure are effective in the treatment of social withdrawal, eye contact avoidance, repetitive behaviors, anxiety, attention deficit, hyperactivity, depression, loss of speech, verbal communication difficulties, aversion to touch, visual difficulties, comprehension difficulties, and sound and light sensitivity. Additional compositions and methods are provided which employ oxytocin or an oxytocin analog in combination with a secondary or adjunctive therapeutic agent to yield more effective treatment tools against autism spectrum disorders and related disorders.

Description

technical field [0001] The present invention relates to methods and compositions for the treatment of neurological and psychiatric disorders. In a specific embodiment, the invention relates to the use of carbetocin and related oxytocin analogs for the treatment of neurological and psychiatric disorders. Background technique [0002] Autism spectrum disorders are a group of disorders characterized by varying degrees of impairment of communication skills, interpersonal interactions, and restrictive, repetitive, and stereotyped behavioral patterns. These disorders differ in the time of onset, rate of symptom development, severity of symptoms, and precise nature of symptoms. These conditions range from mild to severe impairment and include such disorders as Autism, Asperger's Syndrome, PDD-NOS, Rett Syndrome, Child Disintegration Disorder, Verbal Communication Impairment, Nonverbal Learning Disorder, High Functioning Autism dyslexia, hyperreading, and some aspects of attention...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K9/12A61K38/11A61K9/00A61K38/095
CPCA61K38/11A61K9/0043A61K38/095A61P25/00A61P25/18A61P25/22A61P25/24
Inventor 亚历克西斯·凯斯·莱昂纳多乔舒亚·O·谢斯塔克亨利·R·康斯坦丁诺安东尼·P·西莱诺拉利特·拉伊·佩达科塔卡文·埃米尔·沙尔基加兰·M·贝拉米詹森·菲利普·格斯蒂
Owner NASTECH PHARMA
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