Sublingual PDE5 Inhibitor Spray for Rapid Transmucosal Absorption

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Solution Overview

Problem

Oral administration of PDE5 inhibitors like sildenafil faces challenges such as variable absorption, adverse effects, and slow onset of action, making it inefficient for treating erectile dysfunction and pulmonary arterial hypertension.

Innovation Solution

A sublingual transmucosal delivery method using a pharmaceutical composition comprising a PDE5 inhibitor, such as sildenafil mesylate, in a carrier that is soluble or forms a suspension or emulsion, providing rapid absorption and minimizing gastrointestinal adverse effects.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If oral administration is used to deliver PDE5 inhibitors, then the drug can reach the site of action, but absorption is variable and gastrointestinal adverse effects occur

Engineering Contradiction:
Improveabsorption consistencyVSAvoidgastrointestinal adverse effects
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent introduces a sublingual spray formulation as an intermediary delivery system that bypasses the gastrointestinal tract. The spray delivers the PDE5 inhibitor directly to the sublingual mucosa, which serves as an alternative absorption pathway, eliminating exposure to gastric acid and intestinal enzymes while providing consistent absorption through the rich vascularization of the oral mucosa.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The invention transitions from the conventional oral gastrointestinal absorption pathway to a trans-mucosal absorption pathway in the oral cavity. This dimensional change in the delivery route allows the drug to enter systemic circulation directly through the sublingual vessels, avoiding the harmful gastrointestinal environment while maintaining reliable and consistent drug delivery.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

2Speed

If oral administration is used to deliver PDE5 inhibitors, then the drug can be delivered systemically, but the onset of action is slow

Engineering Contradiction:
Improveonset of actionVSAvoidtime to reach therapeutic concentration
Core Design Contradiction:
SpeedVSLoss of time

Solution Approach 1:

The sublingual spray formulation allows the PDE5 inhibitor to skip the slow processes of gastric emptying, intestinal transit, and hepatic first-pass metabolism. The drug is rapidly absorbed through the highly vascularized sublingual mucosa, rushing the active ingredient directly into systemic circulation and achieving therapeutic concentrations much faster than oral administration.

Inventive Principle:
Principle #21Skipping (Rushing through)

Solution Approach 2:

The spray formulation is designed to be applied directly to the sublingual area, where the drug is immediately available for absorption. This preliminary positioning of the drug at an optimal absorption site with rich blood supply ensures rapid uptake and quick onset of action, eliminating the delays associated with conventional oral delivery.

Inventive Principle:
Principle #10Preliminary action

3Ease of operation

If oral tablets are used for PDE5 inhibitor delivery, then the formulation is simple, but the drug may be lost from the mouth or stomach

Engineering Contradiction:
Improvedrug retention in mouthVSAvoiddrug loss
Core Design Contradiction:
Ease of operationVSLoss of substance

Solution Approach 1:

The invention replaces the mechanical swallowing action required for tablet administration with a spray delivery system that applies the drug directly to the sublingual mucosa. The spray formulation adheres to the mucosal surface, allowing absorption without requiring swallowing, thereby eliminating drug loss through vomiting or spitting while maintaining ease of administration.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

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 sublingual transmucosal delivery method achieves consistent and rapid absorption of PDE5 inhibitors, reducing adverse effects and improving treatment efficacy for erectile dysfunction and pulmonary arterial hypertension.

Implementation Method 1

sublingual transmucosal delivery method achieves consistent and rapid absorption of PDE5 inhibitors

Methodology Applied
Scientific EffectTransmucosal absorption: Absorption (physical)

Implementation Method 2

a carrier in which said PDE5 inhibitor is soluble or forms a suspension or emulsion

Methodology Applied
Scientific EffectSolubility: Solvation

Data Source

PatentEP2793857B1Drug delivery technology
Publication Date: 2018.06.13 LONDONPHARMA
  • EP2793857B1 patent drawingFigure 1

AI summary

The invention provides a pharmaceutical composition for the transmucosaldelivery of a PDE5 inhibitor, said composition comprising a PDE5 inhibitor and a carrier in which said PDE5 inhibitor is soluble or forms a suspension or emulsion. The invention also provides a pharmaceutical composition comprising a PDE5 inhibitor for use in inhibiting PDE activity in vivo, where in said use said composition is delivered by the transmucosal route.