Water-Soluble Adhesive Layer for Multilayer Oral Film
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Solution Overview
Problem
Existing multilayer oral active ingredient films face issues with thermal and chemical stress exposure of active ingredients due to multiple coatings, instability, and propagation of errors in layer production, leading to potential disintegration and inefficiencies in production.
Innovation Solution
A multilayer oral active ingredient film comprising non-adhesive layers with hydrophilic polymers and a water-soluble adhesive layer containing a water-soluble polymer and plasticizer, where the adhesive layer is placed between non-adhesive layers to create a stable bond without exposing the active ingredient to multiple stresses, allowing for separate production and storage of layers for modular assembly.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If multiple layers are applied sequentially by laminating additional layers onto an existing one, then multilayered drug films can be produced, but the pharmaceutically active ingredient is subjected to greater thermal and chemical stress due to the multiple coatings
Solution Approach 1:
The invention applies preliminary action by pre-forming separate layers (including the active ingredient layer) before final assembly. Each layer is prepared independently with optimal processing conditions, then bonded together using a heat-activatable adhesive applied only to the bonding surfaces. This avoids subjecting the active ingredient to repeated thermal and chemical stress from multiple coating operations, while still enabling multilayer film production.
2Ease of manufacture
If multiple layers are applied sequentially by laminating additional layers onto an existing one, then multilayered drug films can be produced, but a composite formed by applying a layer to an existing one is often unstable and can easily deteriorate
Solution Approach 1:
The invention extracts the adhesive function from the layer materials themselves and places it in a separate, dedicated adhesive layer. This adhesive layer contains specific adhesive agents that are activated by heat to create strong bonds between layers. By separating the adhesive function, the structure becomes more stable and less prone to deterioration compared to relying on the inherent adhesive properties of the layer materials.
3Ease of manufacture
If multiple layers are applied sequentially by laminating additional layers onto an existing one, then multilayered drug films can be produced, but any defects in the coating, especially incorrect basis weights, are propagated by subsequent coatings
Solution Approach 1:
The invention segments the multilayer film production into independent layer preparations followed by assembly. Each layer is formed separately with controlled basis weight, then bonded together using an adhesive layer. This segmentation prevents defect propagation because each layer can be optimized and controlled independently, and errors in one layer do not affect the others during the lamination process.
4Quantity of substance
If a single layer with high basis weight is produced, then the drug film can achieve required thickness, but the drying time becomes significantly longer
Solution Approach 1:
The invention segments a high basis weight film into multiple thinner layers bonded together. Each thin layer has reduced drying time compared to a single thick layer, while the total basis weight is achieved through the combination of multiple layers. The adhesive layer bonds these thin layers together to create the equivalent of a single thick film with much faster overall production time.
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
This solution ensures a stable, non-sticky film that dissolves in the oral cavity, reduces drying time, and allows for diverse combinations of layers, enhancing the production efficiency and stability of the active ingredient delivery system.
Implementation Method 1
at least one water-soluble polymer and at least one plasticizer, wherein the at least one water-soluble polymer and the at least one plasticizer form a sticky mass
Implementation Method 2
each containing at least one hydrophilic polymer
Implementation Method 3
wherein the at least two non-adhesive layers and the at least one water-soluble adhesive layer alternate such that the at least one water-soluble adhesive layer is covered on both sides by at least one non-adhesive layer
Data Source
AI summary
Disclosed is a multi-layer oral film comprising at least two non-adhesive layers each containing at least one hydrophobic polymer, and at least one water-soluble adhesive layer containing at least one water-soluble polymer and at least one plasticizer, wherein at least one of the at least two non-adhesive layers and/or the at least one water-soluble adhesive layer contains a pharmaceutically active substance and the at least two non-adhesive layers and the at least one water-soluble adhesive layer alternate in such a way that the at least one water-soluble adhesive layer is covered on both sides by at least one non-adhesive layer.