Auto-Injector for Risperidone Microspheres

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Solution Overview

Problem

There is a need for long-acting risperidone formulations that are easy to prepare and administer, with improved patient compliance, and that facilitate subcutaneous administration with reduced dosing frequency and burden.

Innovation Solution

A self-administration injection device in the form of an auto-injector that delivers long-acting risperidone microspheres suspended in a non-aqueous vehicle, such as medium chain triglycerides, allowing for subcutaneous administration with a low injection volume and injectable viscosity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of moving object

If Risperidone is formulated as long-acting injectable formulations (Risperdal Consta®, Perseris™), then the duration of action is extended and dosing frequency is reduced, but the device complexity and preparation steps increase

Engineering Contradiction:
Improveduration of actionVSAvoiddevice complexity
Core Design Contradiction:
Duration of action of moving objectVSDevice complexity

Solution Approach 1:

The injection device divides the medication into separate components: a pre-filled syringe containing risperidone powder and a separate syringe containing diluent. The patient or administrator performs a simple mixing operation by injecting the diluent into the powder-containing syringe, creating a suspension ready for administration. This segmentation allows the device to provide long-acting formulation benefits while keeping the preparation process simple and manageable.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device comes pre-prepared with all necessary components already in place: the risperidone powder is pre-loaded in one syringe and the diluent is pre-loaded in another. The only action required at administration time is to inject the diluent into the powder and then administer the mixture. This preliminary preparation eliminates complex setup procedures and reduces the skill level required for administration.

Inventive Principle:
Principle #10Preliminary action

2Duration of action of moving object

If Risperidone is administered via intramuscular injection (Risperdal Consta®), then sustained release is achieved, but patient anxiety and pain increase

Engineering Contradiction:
Improvesustained releaseVSAvoidpatient anxiety and pain
Core Design Contradiction:
Duration of action of moving objectVSObject-affected harmful factors

Solution Approach 1:

The invention changes the route of administration from intramuscular to subcutaneous injection. This parameter change in injection depth and location significantly reduces the pain and anxiety associated with the procedure while still achieving sustained release of the medication. The subcutaneous route is less invasive and more tolerable for patients, particularly for self-administration.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The device is specifically designed to enable patients to self-administer the injection subcutaneously. The simple two-syringe mixing system and subcutaneous injection capability empower patients to perform the procedure themselves without requiring clinical staff, reducing their exposure to painful procedures and increasing their control over the treatment process.

Inventive Principle:
Principle #25Self-service

3Ease of operation

If Risperidone is formulated as Perseris™ with two pre-filled syringes, then subcutaneous administration is enabled, but significant mixing and resuspension steps are required

Engineering Contradiction:
Improvesubcutaneous administrationVSAvoidmixing and resuspension steps
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The device is supplied with the risperidone powder already in a syringe and the diluent already in a separate syringe, both ready for use. The only mixing action required is to inject the diluent into the powder-containing syringe and gently swirl to suspend the powder. This preliminary preparation eliminates the need for complex resuspension steps and multiple transfers, making the process straightforward while enabling subcutaneous administration.

Inventive Principle:
Principle #10Preliminary action

4Reliability

If Risperidone is administered with frequent dosing, then therapeutic effectiveness is maintained, but patient compliance and treatment burden increase

Engineering Contradiction:
Improvetherapeutic effectivenessVSAvoidpatient compliance
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The invention provides a long-acting injectable formulation that dynamically releases risperidone over an extended period (weeks to months). This dynamic sustained release mechanism maintains therapeutic drug levels in the bloodstream without requiring frequent administrations. The patient receives one injection that continuously provides medication, dramatically improving compliance while maintaining therapeutic effectiveness.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The device enables continuous delivery of risperidone through a single subcutaneous injection that sustains therapeutic levels over an extended period. The slow release mechanism ensures continuous pharmacological action without interruption, eliminating the need for frequent dosing visits and significantly reducing treatment burden while maintaining reliable therapeutic effectiveness.

Inventive Principle:
Principle #20Continuity of useful action

Data Source

PatentUS20250064811A1Self-administration injection device for risperidone
Publication Date: 2025.02.27 ORBICULAR PHARMA TECH PTE LTD

AI summary

The present invention relates to an self-administration injection device, comprising drug reservoir of long-acting risperidone microspheres in non-aqueous liquid vehicle. The risperidone microspheres are suspended in non-aqueous liquid vehicle such as triglycerides. The self-administration injection device is auto-injector for single dose.