Compositions and methods of enhancing 5-hydroxytryptophan bioavailability

A technology of availability and biology, applied in the direction of drug combination, medical preparations containing active ingredients, drug delivery, etc., can solve problems such as broad-spectrum toxicity, physiological system impact, and impracticality

Pending Publication Date: 2020-11-06
DUKE UNIV
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

5-HTP alone as a molecule may not be suitable for drug therapy because of the rapid occurrence after administration associated with C Max associated adverse events, and require doses of 4-6 times per day to maintain reasonably stable 5-HTP exposure, a dosage requirement that is unrealistic and impractical in the general therapeutic setting (Jacobsen et al, 2016a)
Furthermore, in humans, congenital amino acid decarboxylase deficiency causes severe autonomic, motor, and other symptoms, suggesting that long-term PDI treatment may have broad-spectrum toxic effects (Manegold et al., 2009)
[0009] Overall, the long-term safety of PDI treatment without levodopa in otherwise healthy individuals has not been established, and the pharmacology of PDI may negatively affect various physiological systems in the periphery

Method used

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  • Compositions and methods of enhancing 5-hydroxytryptophan bioavailability
  • Compositions and methods of enhancing 5-hydroxytryptophan bioavailability
  • Compositions and methods of enhancing 5-hydroxytryptophan bioavailability

Examples

Experimental program
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Embodiment Construction

[0088] method

[0089] Mice: Using adult mice, wild-type (WT) mice with normal 5-HT levels and "5-HT" mice with reduced brain 5-HT synthesis and levels Hypo ” mice (Beaulieu et al., 2008). 5-HT Hypo Mice are a natural model of brain 5-HT deficiency, which is known to be a causative agent of several central nervous system disorders, such as depression and suicidality.

[0090] Drug therapy: Carbidopa is used as a PDI. To mimic the oral drug delivery that occurs in humans during treatment, 5-HTP and carbidopa were delivered via mouse chow (standard chow). This method distributes the drug over time, thereby providing a measure of "sustained release" (ie sustained release, extended release, time release, controlled release). The dose of 5-HTP was 200 mg / kg / day. In addition to 5-HTP, carbidopa was administered at doses of 2, 5, or 10 mg / kg / day to evaluate the effect of carbidopa on the outcome of 5-HTP treatment. To assess the effect of carbidopa alone, groups of mice were als...

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PUM

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Abstract

Provided are methods of enhancing bioavailability of enterally administered 5-hydroxytryptophan (5-HTP) in a subject in need thereof, said method comprising enterally co-administering low-dose carbidopa with said 5-HTP, as well as pharmaceutical formulations useful for the same. In some embodiments, the 5-HTP and / or low-dose carbidopa are provided as slow-release formulation(s).

Description

[0001] Statement of Government Support [0002] This invention was made with government support under Federal Grant 2R01MH079201-06A1 awarded by the National Institutes of Health (NIH). The government has certain rights in this invention. Background technique [0003] 5-Hydroxytryptophan (5-HTP) is the natural direct precursor of 5-hydroxytryptamine (aka, 5-hydroxytryptamine, 5-HT). 5-HTP has been reported to have therapeutic potential in a range of diseases related to central nervous system function (Turner et al., 2006a), but exhibits rapid absorption in humans (T Max ~1h) and rapid elimination (T 1 / 2 ~2h) (Gijsman et al., 2002; Westenberg et al., 1982). 5-HTP alone as a molecule may not be suitable for drug therapy because of the rapid occurrence after administration associated with C Max associated adverse events, and requiring doses of 4-6 times per day to maintain reasonably stable 5-HTP exposure, such dosage requirements are unrealistic and impractical in the genera...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/136A61K31/195A61K31/405
CPCA61K31/405A61K31/198A61K45/06A61K2300/00A61K31/343A61K9/0065A61P25/00A61P25/24A61K31/135A61K31/138A61K31/15A61K31/4406A61K31/4525A61K31/454A61K31/495A61K31/496
Inventor J·P.R.·雅各布森M·G·卡朗
Owner DUKE UNIV
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