Time-Release Sleep Aid Formulation for Multi-Phase Drug Delivery

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Solution Overview

Problem

Current sleep medications often develop tolerance, have side effects, or fail to maintain effectiveness over extended periods, leading to disrupted sleep patterns and associated health issues.

Innovation Solution

Compositions providing a modified release profile of active agents, including immediate and delayed bursts or sustained releases of sleep promoting, quality, recovery, and next day active agents, formulated with polymeric binders and encapsulation techniques to optimize sleep cycle modification and recovery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional sleep medications are used, then initial sleep improvement is achieved, but tolerance develops requiring increasingly higher dosages

Engineering Contradiction:

Improveeffectiveness of sleep medicationVSAvoidduration of medication effectiveness

Core Design Contradiction:

ReliabilityVSDuration of action of moving object

Solution Approach 1:

The patent segments the sleep medication into multiple active ingredients with different release profiles (immediate release and delayed/sustained release components). This segmentation allows different portions of the medication to act at different times, preventing tolerance development by providing continuous but varied stimulation to sleep receptors throughout the night.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The medication employs periodic action through its dual-release mechanism, delivering an initial dose for immediate sleep onset followed by delayed releases during the night. This periodic delivery pattern maintains effectiveness without requiring increasing dosages, as the body receives controlled amounts at intervals rather than a continuous escalating dose.

Inventive Principle:

Principle #19Periodic action

2Reliability

If higher dosages of sleep medications are administered, then sleep induction is improved, but side effects increase

Engineering Contradiction:

Improvesleep induction effectivenessVSAvoidside effects of medication

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent changes the temporal parameter of drug delivery by using immediate release and delayed release formulations. This allows the same total dosage to be distributed over time, achieving effective sleep induction without the need for high single-dose administrations that cause side effects.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

By administering medication in periodic pulses (immediate release followed by delayed releases), the patent achieves cumulative therapeutic effect at lower peak concentrations, reducing side effects while maintaining sleep induction effectiveness.

Inventive Principle:

Principle #19Periodic action

3Ease of operation

If single-dose sleep medications are used, then simplicity of administration is maintained, but extended period effectiveness is lost

Engineering Contradiction:

Improvesimplicity of medication administrationVSAvoidduration of sleep maintenance

Core Design Contradiction:

Ease of operationVSDuration of action of moving object

Solution Approach 1:

The patent incorporates multiple release mechanisms within a single dosage form, segmenting the medication into immediate and delayed release components. This allows the medication to maintain effectiveness throughout the night while requiring only a single administration, preserving ease of operation.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The patent merges immediate release and delayed release formulations into a single combined medication product. This consolidation maintains the simplicity of single-dose administration while achieving extended period effectiveness through the integrated multi-phase release system.

Inventive Principle:

Principle #5Merging (Combining)

4Reliability

If multiple separate medications are administered for different sleep phases, then comprehensive sleep coverage is achieved, but device complexity increases

Engineering Contradiction:

Improvecomprehensive sleep phase coverageVSAvoidcomplexity of medication regimen

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines multiple active ingredients with different release profiles into a single integrated medication formulation. This merging provides comprehensive coverage for sleep onset, maintenance, and recovery phases while maintaining the simplicity of a single medication regimen, avoiding the complexity of multiple separate medications.

Inventive Principle:

Principle #5Merging (Combining)

Data Source

PatentUS12419860B2Time release sleep aid system

Publication Date: 2025.09.23 NIGHTWISE LLC

AI summary

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 promoting active 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.