Freeze-Dried Aripiprazole Cake Layout to Prevent Silicone Agglomeration

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Solution Overview

Problem

The presence of silicone-treated inner walls in storage containers causes agglomeration of aripiprazole during long-term storage, leading to increased particle size and reduced dissolution rate, affecting drug efficacy and causing clogging and physical stimulus at the injection site.

Innovation Solution

A medical device with a silicone-treated inner wall and a space between the inner wall and the cake composition is used to minimize contact and mixing of silicone, inhibiting agglomeration and ensuring quick resuspension.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If the storage container inner wall is treated with silicone to allow smooth sliding of sealing plugs, then the ease of operation is improved, but the aripiprazole particles agglomerate and mean particle size increases due to silicone mixing into the freeze-dried substance during long-term storage

Engineering Contradiction:

Improvesmooth sliding of sealing plugVSAvoidparticle size control

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The storage container is divided into two distinct spaces: a first space containing the freeze-dried cake composition and a second space containing the sealing plug. The silicone treatment is applied only to the inner wall of the second space, preventing direct contact between silicone and aripiprazole particles while maintaining smooth sliding functionality for the sealing plug.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

A partition wall or spatial separation acts as an intermediary barrier between the silicone-treated surface and the aripiprazole cake composition. This prevents silicone migration into the freeze-dried substance while allowing the silicone to fulfill its lubrication function for the sealing plug.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Duration of action of stationary object

If the cake composition is stored in the storage container for several months, then the storage duration is extended, but silicone mixes into the freeze-dried substance causing agglomeration and reduced dissolution rate

Engineering Contradiction:

Improvestorage durationVSAvoiddissolution rate

Core Design Contradiction:

Duration of action of stationary objectVSReliability

Solution Approach 1:

The storage container is segmented into separate compartments: one for the freeze-dried cake composition and another for the sealing plug with silicone treatment. This spatial segmentation allows long-term storage without silicone contamination of the aripiprazole particles, maintaining dissolution rate and particle size control throughout the storage period.

Inventive Principle:

Principle #1Segmentation

3Stability of the object's composition

If the cake composition contacts the silicone-treated inner wall during storage, then the storage stability is improved, but the aripiprazole particles undergo agglomeration and mean particle size increases

Engineering Contradiction:

Improvestorage stabilityVSAvoidparticle size control

Core Design Contradiction:

Stability of the object's compositionVSManufacturing precision

Solution Approach 1:

The storage container is divided into separate spaces: the first space holds the freeze-dried cake composition while the second space contains the sealing plug with silicone treatment. This segmentation maintains storage stability by preventing direct contact between aripiprazole particles and silicone, thereby controlling particle size and preventing agglomeration.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The partition or spatial separation serves as an intermediary that prevents silicone from migrating into the freeze-dried aripiprazole substance. This intermediary barrier maintains particle size control and prevents agglomeration while allowing the silicone to provide stability for the sealing plug during storage.

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 solution effectively suppresses agglomeration, maintains particle size, and ensures consistent drug efficacy by reducing silicone contact, preventing clogging, and minimizing physical stimulus.

Implementation Method 1

the pharmaceutical composition is suspended in a dispersion medium, and the thus-obtained suspension is freeze-dried, thereby preparing a cake composition

Methodology Applied

Scientific EffectFreeze-drying: Freeze Drying

Data Source

PatentUS20260054010A1Medical device containing a cake composition comprising aripiprazole as an active ingredient, and a cake composition comprising aripiprazole as an active ingredient

Publication Date: 2026.02.26 OTSUKA PHARM CO LTD

AI summary

The present invention provides a medical device containing a cake composition comprising aripiprazole as an active ingredient and capable of suppressing agglomeration of aripiprazole in a suspension obtained by resuspending a freeze-dried substance; and a cake composition comprising aripiprazole as an active ingredient. The present invention relates to a medical device containing, in a storage container whose inner wall is treated with silicone, a freeze-dried cake composition comprising separately prepared aripiprazole as an active ingredient, wherein there is a space between the inner wall and the cake composition; and a cake composition comprising aripiprazole as an active ingredient and having a strength of 5 to 100 N.