Pharmaceutical compositions

A composition and drug technology, applied in the field of treatment of movement disorders, can solve problems that have not been proved by experiments

Pending Publication Date: 2020-01-14
ADEPTIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It has been previously assumed that (+)-α-dihydrotetrabenazine is a metabolite of tetrabenazine, primarily responsible for its therapeutic effect (see WO 2015 / 171802 Neurocrine Biosciences, Inc.), but this has not been experimentally proven

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0465] A study of the properties of dihydrotetrabenazine metabolites formed after administration of tetrabenazine to human subjects

[0466] Pharmacokinetic studies were performed to determine the plasma concentrations of + / - alpha and + / - beta dihydrotetrabenazine in healthy adult male volunteers following oral administration of 25 mg tablets once and multiple times daily under fasting conditions Level. The data are summarized below.

[0467] Table 1 summarizes the pharmacokinetic data obtained after a single oral dose of tetrabenazine at a dose level of 25 mg (fasted, N=08).

[0468] Table 1

[0469]

[0470] Table 2 summarizes the pharmacokinetic data obtained after multiple oral administrations of tetrabenazine at the 25 mg dose level (fasted, N=07).

[0471] Table 2

[0472]

[0473] The data shown in Tables 1 and 2 indicate that, in humans, the major metabolites are the (-)-α-dihydrotetrabenazine isomer, which is essentially active as a VMAT2 binder, and (+)-β ...

Embodiment 2

[0476] Study of the Effects of Compositions of (+)-α-Dihydrotetrabenazine and (-)-α-Dihydrotetrabenazine on Locomotor Activity and Stereotyped Behavior in Rats

[0477] The effects of a combination of (+)-α-dihydrotetrabenazine and (-)-α-dihydrotetrabenazine on locomotor activity and stereotyped behavior in rats were studied and compared with those of (+)- The effects of α-dihydrotetrabenazine and (-)-α-dihydrotetrabenazine isomers were compared.

[0478] Materials and Methods

[0479] Open Fields, Med Associates Inc.

[0480] Plastic syringe 1ml, Terumo. No.: SS-01T1

[0481] Animal gavage needle 15G, Instech Solomon, catalog number: 72-4446

[0482] Sartorius electronic balance A22101, Sartorius Weighting Technology, Germany

[0483] Needle 27G Terumo Myjector, 0.5ml, number: 8300010463

[0484] Plastic syringe 3ml, Soft-Ject, number: 8300005761

[0485] BD Microtainer K2EDTA tube number: 365975

[0486] Matrix 0.75ml, Alphanum tube, Thermo Scientific, number: 4274

...

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Abstract

This invention relates to the use of (+)-beta-dihydrotetrabenazine and combinations of (+)-alpha-dihydrotetrabenazine, (-)-alpha-dihydrotetrabenazine and / or (+)-beta-dihydrotetrabenazine, for the treatment of movement disorders, such as Tourette's syndrome. The invention also provides dosage forms containing said dihydrotetrabenazine isomers.

Description

technical field [0001] The present invention relates to (+)-β-dihydrotetrabenazine and (+)-α-dihydrotetrabenazine, (-)-α-dihydrotetrabenazine and / or (+)-β- Use of a composition of dihydrotetrabenazine for the treatment of movement disorders (Tourette's syndrome). Background technique [0002] Movement disorders can generally be divided into two categories: hyperkinetic movement disorders and hypokinetic movement disorders. Hyperkinetic movement disorders are caused by increased muscle activity and can cause abnormal and / or excessive movements, including tremors, dystonia, chorea, tics, myoclonus, and stereotypic behavior. [0003] Hyperkinetic movement disorders are often psychological in nature, arising from improper regulation of amine neurotransmitters in the basal ganglia. [0004] Tourette syndrome is a specific hyperkinetic movement disorder, an inherited neurological disorder characterized by multiple physical and vocal tics. The tics are usually repetitive, but oc...

Claims

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Application Information

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IPC IPC(8): A61K31/4747A61K45/06A61P25/14
CPCA61K45/06A61K31/4747A61P25/14A61K2300/00A61K31/435
Inventor 安德鲁·约翰·达菲尔德阿南特·潘迪亚
Owner ADEPTIO PHARMA
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