Delayed-Release Methylphenidate Compositions for All-Day ADHD Coverage

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Solution Overview

Problem

Existing treatments for ADHD and other CNS stimulant-responsive conditions face challenges in maintaining effective drug concentrations throughout the day, particularly during morning and afternoon hours when cognitive abilities are needed, due to the limitations of immediate and long-acting formulations that require multiple daily administrations.

Innovation Solution

Development of novel oral pharmaceutical compositions with a delayed and sustained release formulation that allows a single evening dose, providing a therapeutic effect from 4 to 12 hours after administration, with a controlled lag time and sustained release pattern to maintain effective drug levels during the day.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Speed

If immediate release formulations are used for ADHD treatment, then the drug is quickly absorbed and provides rapid therapeutic effect, but the drug concentration drops quickly requiring multiple daily administrations

Engineering Contradiction:

ImproveDrug absorption speedVSAvoidTherapeutic effect duration

Core Design Contradiction:

SpeedVSDuration of action of moving object

Solution Approach 1:

The patent segments the drug delivery system into multiple distinct layers: an immediate release layer for rapid initial effect and a sustained release layer for prolonged therapeutic effect. This segmentation allows different portions of the drug to be released at different rates, resolving the contradiction between rapid absorption and extended duration.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The formulation employs periodic drug release through its layered structure, where the immediate release layer provides an initial burst of drug followed by the sustained release layer providing continued release over time. This periodic action pattern maintains therapeutic levels without requiring frequent re-administration.

Inventive Principle:

Principle #19Periodic action

2Duration of action of moving object

If long-acting formulations are used to extend therapeutic effect duration, then the drug maintains effective concentration for 8-14 hours, but the formulations require complex multi-layer structures

Engineering Contradiction:

ImproveTherapeutic effect durationVSAvoidFormulation structure complexity

Core Design Contradiction:

Duration of action of moving objectVSDevice complexity

Solution Approach 1:

The patent divides the formulation into functional segments (immediate release layer and sustained release layer) that work together to achieve extended duration. This segmentation provides a systematic approach to extending therapeutic effect while maintaining manufacturability through defined layer structures.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The formulation uses composite material structures combining different release mechanisms in a single dosage form. The composite nature of having both immediate and sustained release components in one tablet or capsule achieves long-acting effects without requiring multiple separate administrations or overly complex delivery systems.

Inventive Principle:

Principle #40Composite materials

3Reliability

If twice daily administration is required to maintain effective drug levels, then therapeutic coverage is improved, but patient compliance deteriorates

Engineering Contradiction:

ImproveTherapeutic coverageVSAvoidPatient compliance

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The patent merges the functions of multiple separate doses into a single combined formulation that provides both immediate and sustained release. This consolidation of multiple dosing events into one administration improves patient compliance while maintaining reliable therapeutic coverage throughout the day.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The single dosage form performs multiple functions: providing rapid initial therapeutic effect, maintaining drug levels throughout the day, and eliminating the need for multiple administrations. This multi-functionality in one product simultaneously achieves reliable coverage and ease of use.

Inventive Principle:

Principle #6Universality (Multi-functionality)

4Loss of time

If delayed release formulations are used to provide morning therapeutic effect from evening administration, then the lag time allows sleep undisturbed, but the drug release mechanism becomes more complex

Engineering Contradiction:

ImproveLag time before drug releaseVSAvoidRelease mechanism complexity

Core Design Contradiction:

Loss of timeVSDevice complexity

Solution Approach 1:

The formulation incorporates a delayed release mechanism that is pre-designed to maintain the drug in an undissolved state during the initial period after administration. This preliminary action of delaying release allows the patient to sleep undisturbed while the formulation is in place, with drug release beginning after the lag period when therapeutic effect is needed.

Inventive Principle:

Principle #10Preliminary action

Data Source

PatentUS12383506B2Compositions for treatment of attention deficit hyperactivity disorder

Publication Date: 2025.08.12 IRONSHORE PHARMA & DEV

AI summary

Therapeutic compositions deliver a therapeutic amount of methylphenidate in a delayed and extended release formulation. The dosage form exhibits a lag time prior to release of from 6 to 8 hours or longer, followed by a sustained release period.