Nasal Dispensing Device with Conical Well for Rhinitis Treatment

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Solution Overview

Problem

There is a need for an easy-to-use, efficient, and reliable dispensing device for nasal administration that provides superior efficacy in treating rhinitis, particularly one that consistently delivers a combination of mometasone and olopatadine for effective symptom relief.

Innovation Solution

A dispensing device with a pharmaceutical composition containing mometasone, an ester thereof (e.g., mometasone furoate), or a salt thereof, and olopatadine or a salt thereof (e.g., olopatadine hydrochloride), featuring a container with a dip tube and a dispenser head that includes a pump or valve mechanism, a dispensing channel, and a dispensing orifice, which delivers a stable suspension with a hydrocolloid to maintain viscosity and prevent phase separation, ensuring consistent dosing and improved stability.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a simple container is used for nasal administration, then device complexity is reduced, but dosing consistency and delivery reliability cannot be achieved

Engineering Contradiction:
Improvedosing consistencyVSAvoiddevice complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The dispensing device is divided into distinct functional components: a container for holding the pharmaceutical composition, a dip tube for delivering the composition, and a dispenser head with pump/valve mechanism for controlled dispensing. This segmentation allows each component to perform its specific function reliably while maintaining overall system manageability.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The dip tube acts as an intermediary element connecting the container to the dispenser head, ensuring reliable transfer of the pharmaceutical composition from the storage container to the dispensing mechanism. This intermediary component enables consistent dosing by controlling the flow path and preventing direct contact between the user and the medication reservoir.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Stability of the object's composition

If a hydrocolloid suspension is used to maintain viscosity and prevent phase separation, then stability is improved, but manufacturing precision is required to achieve proper viscosity range

Engineering Contradiction:
Improvesuspension stabilityVSAvoidviscosity control
Core Design Contradiction:
Stability of the object's compositionVSManufacturing precision

Solution Approach 1:

The viscosity of the pharmaceutical composition is controlled by adjusting the concentration of hydrocolloid within a specific range (10-200 cps). This parameter change allows the formulation to maintain suspension stability while enabling consistent dispensing through the device's pump and valve mechanisms.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The pharmaceutical composition uses a composite formulation combining mometasone (in particulate or dissolved form), olopatadine (in dissolved form), and hydrocolloid. This composite material approach allows the different components to work together: the active ingredients provide therapeutic effect while the hydrocolloid provides suspension stability and viscosity control.

Inventive Principle:
Principle #40Composite materials

3Reliability

If a conically shaped container bottom with deepened well is used, then dosing consistency is improved by preventing residue, but device complexity increases

Engineering Contradiction:
Improvedosing consistencyVSAvoidcontainer geometry
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The container bottom is designed with a conical shape that curves downward to a central well, creating a geometry that naturally directs remaining pharmaceutical composition toward the dip tube opening. This curved geometry prevents medication residue from stagnating in flat areas, ensuring consistent dosing throughout the product's shelf life.

Inventive Principle:
Principle #14Spheroidality (Curvature)

4Measurement precision

If a pump or valve mechanism is included in the dispenser head, then dosing precision is achieved, but ease of operation may be reduced

Engineering Contradiction:
Improvedosing precisionVSAvoidease of operation
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The pump or valve mechanism in the dispenser head is designed to automatically control the dispensing of the pharmaceutical composition when the device is actuated. The mechanism self-regulates the flow rate and dosage amount, eliminating the need for the user to manually measure or control the dispensing parameters, thereby maintaining ease of operation while ensuring dosing precision.

Inventive Principle:
Principle #25Self-service

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 consistent and stable delivery of the active ingredients, providing faster onset of action and improved symptom relief for allergic rhinitis, with the hydrocolloid maintaining suspension stability and preventing phase separation, ensuring effective treatment over time.

Implementation Method 1

the pharmaceutical composition is an aqueous suspension containing a hydrocolloid, where the mometasone is present in particulate form and the olopatadine is in dissolved form

Methodology Applied
Scientific EffectSuspension: Suspension

Implementation Method 2

the hydrocolloid maintaining suspension stability and preventing phase separation

Methodology Applied
Scientific EffectPhase separation prevention: Emulsion

Implementation Method 3

a dip tube extending along the longitudinal axis of the container, the dip tube having a proximal end communicating with the dispenser head and an open distal end extending into the container

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Implementation Method 4

the distal end of the dip tube can extend into the well, or can be located at a top of the well

Methodology Applied
Scientific EffectGravity: Gravitation

Implementation Method 5

The container has a conically shaped internal bottom, where the internal bottom is angled downwardly from a side of the container toward a center

Methodology Applied
Scientific EffectGravity-driven flow: Gravitation

Data Source

PatentEP3468532B1Dispensing device and pharmaceutical composition for the treatment of rhinitis
Publication Date: 2020.09.23 GLENMARK SPECIALTY
  • EP3468532B1 patent drawingFigure 1
  • EP3468532B1 patent drawingFigure 2
  • EP3468532B1 patent drawingFigure 3

AI summary

A nasal dispensing device and pharmaceutical composition includes a container; a dispenser head having at least a pump, a dispensing channel, and a dispensing orifice; a dip tube; and a pharmaceutical composition comprising mometasone, an ester thereof (e.g., mometasone furoate), or a salt thereof and olopatadine or its salt (e.g., olopatadine hydrochloride). The container can have a conically shaped internal bottom, angled downwardly toward a center, and a further angularly deepened well, centrally located, with the dip tube extending into the well. An optional cap is provided that includes a sealing sleeve communicating in a seal tight manner with a perimeter of a lateral wall of the dispenser head.