Respiratory Levodopa Delivery for Parkinson's Disease

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Solution Overview

Problem

Current methods for administering levodopa in Parkinson's disease treatment, such as oral and parenteral routes, face challenges with variable absorption and the need for concomitant use of dopa decarboxylase inhibitors, leading to fluctuations in motor symptoms and dyskinesias, and difficulties in swallowing due to dysphagia.

Innovation Solution

A dry pharmaceutical composition comprising levodopa and a dopa decarboxylase inhibitor, suitable for respiratory tract delivery via intranasal or oral inhalation, which allows for rapid and reproducible absorption without the need for adjunctive oral dopa decarboxylase inhibitor administration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If oral administration of levodopa is used, then treatment of Parkinson's disease is achieved, but absorption is highly variable leading to fluctuations in plasma and brain levels

Engineering Contradiction:

Improveabsorption consistencyVSAvoidmotor function control

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The patent divides the levodopa administration into separate components: levodopa is delivered via inhalation while the DDI is delivered via nasal spray, allowing independent optimization of each delivery system and avoiding the absorption variability associated with oral combination pills

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The patent introduces a respiratory tract intermediary to deliver levodopa, bypassing the gastrointestinal tract and its variable absorption characteristics. The inhalation route serves as an intermediary pathway that provides more reliable and consistent levodopa delivery to the brain

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If parenteral administration of levodopa is used, then absorption reliability is improved, but concomitant oral administration of DDI is required

Engineering Contradiction:

Improvelevodopa absorptionVSAvoidadministration regimen

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines levodopa and DDI delivery in the respiratory tract, allowing both drugs to be administered through the same inhalation/nasal route rather than requiring separate oral and parenteral administrations. This merging simplifies the administration regimen while maintaining reliable levodopa absorption

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The respiratory tract delivery system serves multiple functions: it delivers both levodopa and DDI, and can be used for both maintenance therapy and treatment of OFF episodes, replacing the need for multiple separate administration routes

Inventive Principle:

Principle #6Universality (Multi-functionality)

3Ease of operation

If oral administration of levodopa/DDI combination is used, then treatment is simplified, but dysphagia makes ingestion increasingly difficult

Engineering Contradiction:

Improvetreatment administrationVSAvoidswallowing difficulty

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the mechanical swallowing action required for oral administration with a respiratory tract delivery mechanism. Levodopa is delivered via inhalation rather than swallowing, eliminating the mechanical difficulty of swallowing that plagues patients with dysphagia

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

4Object-affected harmful factors

If respiratory tract delivery of levodopa is used, then swallowing difficulties are overcome, but DDI must be co-administered

Engineering Contradiction:

Improveswallowing difficultyVSAvoiddrug combination requirement

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The patent merges levodopa and DDI delivery in the respiratory tract, allowing both drugs to be administered through the same inhalation/nasal route. This eliminates the need for separate administration systems and simplifies the overall treatment regimen while overcoming dysphagia

Inventive Principle:

Principle #5Merging (Combining)

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

This approach enables effective treatment of Parkinson's disease by achieving rapid and consistent plasma levodopa concentrations, reducing motor symptom fluctuations and dyskinesias, and overcoming swallowing difficulties, as demonstrated in animal and human studies.

Implementation Method 1

Respiratory tract delivery can be affected by intranasal administration or administration by oral inhalation

Methodology Applied

Scientific EffectInhalation:

Implementation Method 2

DOPA decarboxylase inhibitors can be delivered to the respiratory tract in amounts effective to permit rapid and reproducible absorption of therapeutic amounts of levodopa administered in combination

Methodology Applied

Scientific EffectAbsorption: Absorption (physical)

Data Source

PatentUS11690819B2Respiratory tract delivery of levodopa and DOPA decarboxylase inhibitor for treatment of Parkinson's disease

Publication Date: 2023.07.04 WOODWARD SPECIALTY LLC

AI summary

A dry pharmaceutical composition is provided that is suitable for respiratory tract delivery of levodopa and DDI for treatment of Parkinson's disease or Parkinson syndrome. The dry pharmaceutical composition comprises levodopa, a dopa decarboxylase inhibitor (DDI) and at least one excipient. A unit dosage form of the dry pharmaceutical composition and a method of treating a patient with Parkinson's disease or Parkinson syndrome by administering the dry pharmaceutical composition are also provided.