Compositions and methods for treating central nervous system disorders

A composition and barrier technology, which is applied in the directions of non-active components of polymer compounds, drug delivery, pharmaceutical formulations, etc.

Pending Publication Date: 2022-04-12
PAXMEDICA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For higher molecular weight compounds, this delivery across the blood-brain barrier is even more challenging

Method used

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  • Compositions and methods for treating central nervous system disorders
  • Compositions and methods for treating central nervous system disorders
  • Compositions and methods for treating central nervous system disorders

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0232] Example 1 : Composition for intranasal delivery

[0233] The following compositions were prepared using standard mixing equipment and procedures.

[0234]

[0235] *Based on suramin hexasodium salt having a molecular weight of 1429.15 g / mol

[0236] Dissolve suramin sodium salt in water by mixing gently. Add cyclodextrin with mixing until dissolved. The resulting solution was allowed to stand for 2 hours before use.

[0237] The composition can be packaged in a spray bottle for intranasal administration.

[0238] Alternatively, compositions were prepared substituting an equal weight of caprylic caprate macrogol-8 glyceride or 2-(2-ethoxyethoxy)ethanol for methyl beta-cyclodextrin.

[0239] The compositions are useful in the treatment of autism spectrum disorders.

Embodiment 2

[0240] Example 2 : Composition for intranasal delivery

[0241] The following compositions were prepared using standard mixing equipment and procedures.

[0242]

[0243] *Based on suramin hexasodium salt having a molecular weight of 1429.15 g / mol

[0244] Dissolve suramin sodium salt in water by mixing gently. Sodium chloride and hydroxypropyl methylcellulose were added with mixing. Add cyclodextrin with mixing until dissolved. The resulting solution was allowed to stand for 2 hours before use.

[0245] The composition can be packaged in a spray bottle for intranasal administration.

[0246] Alternatively, compositions were prepared substituting an equal weight of caprylic caprate macrogol-8 glyceride or 2-(2-ethoxyethoxy)ethanol for methyl beta-cyclodextrin.

[0247] The compositions are useful in the treatment of autism spectrum disorders.

Embodiment 3

[0248] Example 3 : Tissue penetration of suramin

[0249] Four formulations A-D were prepared using the methods of Examples 1 and 2 and were found to be stable for at least 4 weeks over a three month period at 25°C and 60% relative humidity.

[0250] Formulation A - 100 mg / mL suramin hexasodium salt in water (no excipients)

[0251] Formulation B - 100 mg / mL suramin hexasodium salt in water with 40% methyl beta-cyclodextrin (Methy betadex)

[0252] Formulation C - 100 mg / mL Suramin Hexasodium Salt in Water with 40% HP(Hydroxypropyl)-Cyclodextrin

[0253] Formulation D - 160 mg / mL suramin hexasodium salt in water (no excipients)

[0254] These formulations also contained 0.1% hydroxypropylmethylcellulose (ie, HPMC E5 from Dow Chemicals) as a solution thickener; and 0.75% sodium chloride as an osmolarity agent.

[0255] These four formulations were evaluated in an in vitro permeation study using cultured human airway tissue (EpiAirway AIR-100, purchased from MatTek Corpor...

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Abstract

The present invention provides compositions and methods for treating cognitive, social or behavioral disability and neurodevelopmental disorders such as autism spectrum disorder (ASD) and other central nervous system disorders such as fragile X syndrome (FXS), fragile X-related tremor / ataxia syndrome (FXTAS), chronic fatigue syndrome (CFS), and post traumatic stress syndrome (PTSD). The present invention provides compositions and methods for intranasal delivery (IN) of a therapeutically effective amount of an anti-purinenergetic agent, such as suramine, to treat a disorder in a patient thereof.

Description

technical field [0001] The present invention provides for the treatment of cognitive, social or behavioral disabilities and neurodevelopmental disorders such as autism spectrum disorder (ASD) and other central nervous system disorders such as fragile X syndrome (FXS), fragile X-related tremor / taxia Compositions and methods for disorder syndrome (FXTAS), chronic fatigue syndrome (CFS) and posttraumatic stress syndrome (PTSD). The present invention provides compositions for the delivery of therapeutically effective amounts of antipurinergic agents (such as suramin) and pharmaceutically acceptable salts, esters, solvates and prodrugs of these agents. The agent is delivered by intranasal (IN) administration. Background technique [0002] Autism is associated with a combination of genetic and environmental factors and is reported to occur in approximately 1 in 60 children in the United States. There are an estimated 25 million individuals with autism worldwide. Autism is also ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K9/12A61K31/185A61K45/06
CPCA61K31/185A61K9/0043A61K47/40A61K47/6951A61K47/02A61K47/38A61K9/08A61K47/14A61P25/00A61P25/28A61K47/12A61K47/186
Inventor H·S·坦M·德比Z·罗梅
Owner PAXMEDICA INC
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