ADHD Drug Delivery System with Delayed Release Coating

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Solution Overview

Problem

Current treatments for ADHD and other CNS stimulant-responsive conditions face challenges in maintaining effective drug concentrations throughout the day, particularly in morning and afternoon when cognitive abilities are needed, due to the rapid release of medications leading to compliance issues and side effects.

Innovation Solution

Development of novel pharmaceutical compositions with a core comprising a CNS stimulant coated with a sustained release layer and a delayed release layer, allowing for a controlled release of the drug over 4 to 12 hours, enabling a therapeutic effect from waking to the active part of the day with a single evening dose, and customizable lag times.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Speed

If immediate release formulation is used, then rapid therapeutic effect is achieved, but compliance problems occur due to frequent dosing requirements

Engineering Contradiction:

Improvetherapeutic effect onset speedVSAvoidpatient compliance

Core Design Contradiction:

SpeedVSEase of operation

Solution Approach 1:

The patent segments the drug delivery system into multiple functional layers: an immediate release layer for rapid therapeutic effect, a sustained release layer for extended duration, and a delayed release outer layer for timing control. This segmentation allows the single dosage form to provide both rapid onset and prolonged effect, eliminating the need for frequent dosing and improving patient compliance.

Inventive Principle:

Principle #1Segmentation

2Ease of operation

If long-acting formulations are used, then compliance is improved with once-daily dosing, but drug concentration may not be sufficient during morning and afternoon cognitive activities

Engineering Contradiction:

Improvepatient complianceVSAvoideffective drug concentration

Core Design Contradiction:

Ease of operationVSQuantity of substance

Solution Approach 1:

The patent merges three distinct drug release mechanisms into a single integrated dosage form: immediate release for rapid onset, sustained release for extended duration, and delayed release for timing control. This combination ensures that therapeutic drug concentrations are maintained throughout the day, particularly during morning and afternoon cognitive activities, while requiring only once-daily dosing for compliance.

Inventive Principle:

Principle #5Merging (Combining)

3Loss of time

If delayed release coating is applied, then drug release is postponed to appropriate timing, but manufacturing complexity increases

Engineering Contradiction:

Improvedrug release timing controlVSAvoidformulation structure

Core Design Contradiction:

Loss of timeVSDevice complexity

Solution Approach 1:

The patent applies different coating properties to different regions and layers of the dosage form. The outer delayed release coating has specific pH-dependent dissolution characteristics that activate at different times than the inner sustained release layer. This local differentiation of coating properties enables precise temporal control of drug release while using well-established coating technologies, thereby managing manufacturing complexity.

Inventive Principle:

Principle #3Local quality

4Duration of action of moving object

If multiple layers are used for controlled release, then drug release profile is optimized, but manufacturing precision requirements increase

Engineering Contradiction:

Improvetherapeutic effect durationVSAvoidcoating thickness control

Core Design Contradiction:

Duration of action of moving objectVSManufacturing precision

Solution Approach 1:

The patent utilizes pH as a critical parameter to control drug release timing. The delayed release outer coating is designed to dissolve at specific pH conditions encountered in the gastrointestinal tract, automatically triggering drug release without requiring precise control of coating thickness during manufacturing. This parameter-based control mechanism reduces manufacturing precision requirements while maintaining optimized therapeutic effect duration.

Inventive Principle:

Principle #35Parameter changes

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

Provides a sustained therapeutic effect throughout the day with reduced side effects by maintaining a consistent drug level, allowing patients to wake up with a minimal therapeutic dose already active, and increasing plasma concentration gradually, improving ADHD-related behavior and cognitive abilities for 12 continuous hours.

Implementation Method 1

The delayed release layer can thus be a pH dependent layer that is insoluble in aqueous solution at a pH below 5.5 and soluble at the higher pH normally found in the ileum or colon

Methodology Applied

Scientific EffectpH-dependent dissolution:

Implementation Method 2

the sustained release layer includes a water-insoluble and water permeable polymer layer that controls the rate of absorption of water and release of the drug

Methodology Applied

Scientific EffectOsmosis: Osmosis

Data Source

PatentUS10292937B2Methods of treatment of attention deficit hyperactivity disorder

Publication Date: 2019.05.21 IRONSHORE PHARMA & DEV

AI summary

Therapeutic compositions and methods for treatment of attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD) include dosage forms that deliver a therapeutic amount of active drug in a delayed and controlled release formulation. The dosage form can be administered at night and drug release is delayed for from 5 to 7 hours or longer, followed by an ascending release rate. When administered at night the composition provides early morning improvement in symptoms of ADHD and sustained improvement over a period of at least 12 hours.