Sublingual Dispensing Device with Saliva-Blocking Shroud

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Solution Overview

Problem

Current drug delivery methods, particularly for opioids, face challenges in providing rapid, consistent, and controlled administration of pain relief with minimal risk of drug abuse and diversion, especially for acute and breakthrough pain, due to inefficiencies in absorption and potential for swallowing during oral transmucosal delivery.

Innovation Solution

A hand-held device for sublingual administration of bioadhesive small volume sufentanil-containing drug dosage forms, featuring a cartridge with a proboscis and shroud to prevent saliva ingress, a lock-out feature, and patient identification via RFID, ensuring safe and controlled delivery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Speed

If oral transmucosal delivery is used to achieve rapid onset and high bioavailability, then the onset time to maximal plasma concentration is shortened and bioavailability is improved, but the risk of swallowing the medication is enhanced due to saliva generation and backward flow

Engineering Contradiction:

Improveonset time to maximal plasma concentrationVSAvoidrisk of swallowing medication

Core Design Contradiction:

SpeedVSObject-affected harmful factors

Solution Approach 1:

The dosage form is segmented into small volume units (less than 1 mL) that can be precisely placed in the sublingual space, reducing the overall burden on the patient and minimizing saliva generation while maintaining rapid absorption through the highly vascularized sublingual mucosa

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

A dispensing device is introduced as an intermediary tool to precisely place the small volume dosage form in the sublingual space and prevent it from being displaced by saliva flow, ensuring the medication remains in contact with the absorption surface without being swallowed

Inventive Principle:

Principle #24Intermediary (Mediator)

2Quantity of substance

If larger dosage forms are used to ensure adequate drug delivery, then the drug amount is sufficient, but the saliva response is significant leading to swallowing or removal of the dosage form

Engineering Contradiction:

Improvedrug amountVSAvoidsaliva response leading to swallowing

Core Design Contradiction:

Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

The dosage form concentrates the drug in a small volume with high local concentration, utilizing the highly vascularized sublingual mucosa for rapid absorption, thereby achieving adequate drug delivery without the need for large volume forms that would trigger excessive saliva production

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The invention transitions from conventional oral GI delivery to sublingual transmucosal delivery, utilizing a different absorption pathway (mucosal membranes) that bypasses the gastrointestinal tract and first-pass metabolism, enabling sufficient drug delivery through a much smaller volume

Inventive Principle:

Principle #17Another dimension (Dimensionality change)

3Ease of operation

If conventional oral delivery is used to simplify administration, then the dosage form is easy to administer, but the absorption efficiency is low due to GI metabolism and first-pass metabolism

Engineering Contradiction:

Improveease of administrationVSAvoidabsorption efficiency

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The sublingual mucosa serves as an intermediary absorption surface that directly interfaces with the bloodstream, bypassing the gastrointestinal tract and liver first-pass metabolism, thereby maintaining ease of oral administration while significantly improving absorption efficiency and reliability

Inventive Principle:

Principle #24Intermediary (Mediator)

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 device achieves high bioavailability (>50%) with low variability in plasma concentrations and rapid onset of pain relief, minimizing GI uptake and reducing the risk of drug abuse, while providing controlled access and consistent pain management.

Implementation Method 1

The dispensing end of the device has a proboscis comprising a shroud for placing the dosage form and the shroud includes a means to prevent or retard saliva and other moisture ingress into the device

Methodology Applied

Scientific EffectPhysical barrier (shroud):

Implementation Method 2

A bioadhesive small volume sufentanil-containing drug dosage form is administered to the sublingual cavity of subject using a device

Methodology Applied

Scientific EffectBioadhesion: Adhesive

Implementation Method 3

the drug rapidly passes directly and efficiently through the epithelium of the highly vascularized mucosal tissue to the plasma, thus rapidly reaching the circulation

Methodology Applied

Scientific EffectDiffusion through mucosal tissue: Diffusion

Data Source

PatentUS9289583B2Methods for administering small volume oral transmucosal dosage forms using a dispensing device

Publication Date: 2016.03.22 ACEIRX PHARM INC

AI summary

Systems and methods for administration of small volume sufentanil drug dosage forms to the sublingual mucosa of a subject using a device are disclosed. The dispensing device includes a lock-out feature and a means to retard or prevent saliva and/or moisture ingress such that the drug dosage forms in the device remain dry prior to administration.