Tripulse Release Stimulant Formulation for ADHD

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Solution Overview

Problem

Patients treated with stimulants for disorders like ADHD often require multiple doses throughout the day to maintain therapeutic effects, as existing single dosage forms fail to provide sustained release.

Innovation Solution

A single dosage form featuring a tripulse release profile, comprising three dosage units that release stimulants in three distinct pulses over a prolonged period, providing immediate, delayed, and extended release.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of moving object

If a single dosage form releases stimulant in two discrete pulses (e.g., first pulse immediate release, second pulse delayed release 3-5 hours later), then the stimulant provides therapeutically effective levels for the first 8 hours or more, but patients still require an additional dose later in the day to maintain therapeutic effects throughout the entire waking hours

Engineering Contradiction:

Improveduration of stimulant therapeutic effectVSAvoiddosing frequency

Core Design Contradiction:

Duration of action of moving objectVSEase of operation

Solution Approach 1:

The single dosage form is segmented into three distinct dosage units, each designed to release stimulant at different time intervals. The first dosage unit provides immediate release, the second dosage unit provides delayed release 3-5 hours later, and the third dosage unit provides extended release 6-8 hours after initial administration, dividing the total stimulant load into three controlled pulses throughout the waking hours

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The dosage form implements periodic pulsed release of stimulant through three distinct release pulses spaced at different time intervals. This periodic action pattern (immediate pulse, delayed pulse 3-5 hours later, extended pulse 6-8 hours after) maintains therapeutic levels throughout the day without requiring multiple separate doses

Inventive Principle:

Principle #19Periodic action

2Duration of action of moving object

If patients take multiple separate dosage forms (e.g., immediate release and delayed release) to extend therapeutic effect throughout the day, then therapeutic coverage is improved, but the complexity of dosing regimen increases and patient compliance may be compromised

Engineering Contradiction:

Improveduration of stimulant therapeutic effectVSAvoidcomplexity of dosing regimen

Core Design Contradiction:

Duration of action of moving objectVSDevice complexity

Solution Approach 1:

Three separate dosage units with different release characteristics are merged into a single integrated dosage form. This combination allows the first immediate release unit, second delayed release unit, and third extended release unit to be administered as one single dose, simplifying the dosing regimen while maintaining extended therapeutic coverage throughout the waking hours

Inventive Principle:

Principle #5Merging (Combining)

3Productivity

If a single dosage form is designed with multiple dosage units for tripulse release, then dosing frequency is decreased and precise blood levels are controlled over prolonged time, but the manufacturing complexity and precision requirements increase

Engineering Contradiction:

Improvedosing frequencyVSAvoidprecision of release timing

Core Design Contradiction:

ProductivityVSManufacturing precision

Solution Approach 1:

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Each dosage unit within the single form is designed with different local properties to achieve specific release characteristics. The first unit has properties for immediate release, the second unit has properties for delayed release 3-5 hours later, and the third unit has properties for extended release 6-8 hours after, allowing precise control of release timing for each pulse

Inventive Principle:

Principle #3Local quality

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The tripulse release profile effectively maintains therapeutic levels of stimulants throughout a patient's waking hours, reducing the need for additional doses and minimizing crash episodes associated with dual-release formulations.

Implementation Method 1

the first dosage unit includes a first stimulant dose that is released substantially immediately following oral administration of the dosage form to a patient (i.e. immediate release or IR)... the first dosage unit reaches about 85% dissolution in less than about 20 minutes

Methodology Applied

Scientific EffectDissolution:

Implementation Method 2

the second dosage unit includes a second stimulant dose that is delayed in release until about 2 hours to about 5 hours following administration of the dosage form to a patient (i.e. delayed release or DR)

Methodology Applied

Scientific EffectDelayed release:

Implementation Method 3

the third dosage unit includes a third stimulant dose that is delayed in release until about 5 hours to about 9 hours following oral administration of the dosage form to a patient

Methodology Applied

Scientific EffectDelayed release:

Data Source

PatentUS20250049722A1Tripulse release stimulant formulations

Publication Date: 2025.02.13 CINGULATE THERAPEUTICS LLC

AI summary

A single dosage form that delivers a tripulse (i.e., three pulses) release profile is provided. The dosage form includes at least three dosage units inside the final dosage form. By providing a single dosage form with multiple dosage units, the dosing frequency is decreased since precise blood levels of the active over a prolonged time period are controlled and achieved.