Time release sleep aid system

A delayed release, sleep technology, applied in nervous system diseases, peptide/protein components, drug combinations, etc., can solve the problems of drugs that cannot continue to work for a long time, poor effect, side effects, etc.

Pending Publication Date: 2020-04-17
HARMONIX LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Other sleep medications either don't work as well, have serious side effects, or both
For example, some medicines do not last long enough to work, causing people to wake up during the night

Method used

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  • Time release sleep aid system
  • Time release sleep aid system
  • Time release sleep aid system

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0086] Example 1: Preparation of soft chewable tablet compositions

[0087] Capsules were prepared as detailed in Table 1 and as follows. Powders from each of the following active ingredients were prepared by mixing with the polymeric binder in a low shear planetary mixer for 3 minutes:

[0088] Valerian Root Extract

[0089] PHARMAGABA TM

[0090] 5-HTP (5-Hydroxytryptophan)

[0091] melatonin, and

[0092] SUNTHEANINE TM

[0093] Water is then added to the powder mixture to create a wet mass. The wet mass was passed through the extruder at 50 rpm. The extrudate was spheronized in a spheronizer at 1000 rpm for 1 minute to produce spherical beads. The spherical beads were dried until the moisture content was reduced to less than 5 wt%.

[0094] Prepare RELORA containing RELORA as described above TM Compositions with valerian root extract, except that a taste-masking agent is used instead of a polymeric binder.

[0095] By combining valerian root extract, PHARMAGABA...

example 2

[0103] Example 2: Preparation of soft chewable tablet compositions

[0104] Capsules were prepared as detailed in Table 2 and as follows. Powders from each of the following active ingredients were prepared by mixing with the polymeric binder in a low shear planetary mixer for 3 minutes:

[0105] 5-HTP (5-Hydroxytryptophan)

[0106] melatonin, and

[0107] SUNTHEANINE TM

[0108] Water is then added to the powder mixture to create a wet mass. The wet mass was passed through the extruder at 50 rpm. The extrudate was spheronized in a spheronizer at 1000 rpm for 1 minute to produce nanobeads. The nanobeads were mixed with various excipients and water in a low shear planetary mixer for 3 minutes to create a wet mass. The wet mass was passed through the extruder at 50 rpm. The extrudate was spheronized in a spheronizer at 1000 rpm for 1 minute to produce microbeads. The microbeads were dried until the moisture content was reduced to less than 5 wt%.

[0109] Capsules are p...

example 3

[0114] Example 3: Exemplary Compositions

[0115] Tables 4 to 6 show exemplary sleep-promoting active ingredients, sleep-quality active ingredients, sleep-restoring active ingredients, and next-day active ingredients, the amount and function of each ingredient.

[0116] Table 4: Exemplary Sleep Promoting Active Ingredients and Sleep Quality Active Ingredients

[0117]

[0118]

[0119]

[0120] Table 5: Exemplary Sleep Restoring Active Ingredients

[0121]

[0122]

[0123]

[0124] Table 6: Exemplary Next-Day Active Ingredients

[0125]

[0126]

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PUM

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Abstract

Compositions for treating a sleep disorder or modifying or improving the sleep-wake cycle in a subject are disclosed herein. In some examples, the composition can comprise one or more sleep promotingactive agents, one or more sleep quality active agents, one or more sleep recovery active agents, and optionally one or more next day active agents. The composition can provide an immediate burst release of the one or more sleep promoting active agents, a delayed burst or delayed sustained release of the one or more sleep quality active agents, a delayed burst or delayed sustained release of the one or more sleep recovery active agents, and a delayed burst or delayed sustained release of the one or more next day active agents. The composition can be provided as a daily oral uni-dosage form. Methods of making and using the compositions are also provided.

Description

technical field [0001] The present disclosure relates generally to sleep aids, and more particularly to extended release sleep aids. Background technique [0002] Sleep disorders such as insomnia or altered sleep-wake cycles are common in humans. Gallup polls show that 95% of adults suffer from insomnia (Rosekind, M., JClin. Psychiatry, 1992, 53:4-6). The current literature agrees that in any given year about one third of people have sleep problems. [0003] Sleep disturbances can have serious consequences in themselves and can lead to many other medical problems. Therefore, many therapies and methods have been created to deal with sleep disorders. See Treisman et al., "Insomnia", Johns Hopkins POC-IT Center, 2010 pp. 1-3. Some examples of sleep medications include over-the-counter medications such as TYLENOL PM TM ), compositions containing melatonin, herbal remedies, and drugs such as zolpidem, quetiapine, and many others. While some of these sleep medications may be...

Claims

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Application Information

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IPC IPC(8): A61K31/714A61K33/30A61K36/185
CPCA61K36/84A61K31/714A61K9/0056A61K9/1635A61K45/06A61K38/018A61K31/197A61K31/198A61K31/4045A61K31/405A61K31/4415A61K31/519A61K33/08A61P25/20A61K2300/00A61K31/675A61K33/06A61K36/185A61K36/53A61K36/756
Inventor 丹尼·里纳尔迪斯科特·福斯伯格
Owner HARMONIX LLC
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