Single-Layer Biocompatible Film With Variable Dissolution Profile

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Solution Overview

Problem

Existing bi-layer and multilayer film systems for drug delivery are costly and complex to manufacture, as they require multiple film layers to be made and laminated, which is not feasible with single layer film production processes.

Innovation Solution

A single layer biocompatible film with a predetermined non-uniform distribution of components is created by depositing a fluid composition containing a bioactive agent and a film-forming material with immiscible components of varying densities, allowing for variable cross-sectional dissolution properties, mimicking the functionality of multilayer films without the complexity of traditional manufacturing methods.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If bi-layer or multilayer film systems are used to achieve variable dissolution properties, then drug delivery effectiveness is improved, but manufacturing complexity and cost increase

Engineering Contradiction:
Improvedrug delivery effectivenessVSAvoidmanufacturing complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines multiple functional layers into a single layer by incorporating immiscible components with different densities within one continuous matrix. The single layer contains both water-soluble and water-insoluble regions that provide differentiated dissolution rates, eliminating the need for separate layers while maintaining the functional benefits of multilayer systems

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The film uses a composite material system consisting of a film-forming material combined with immiscible components having different densities and solubilities. This composite approach allows the single layer to exhibit heterogeneous properties, with certain regions dissolving rapidly while others dissolve slowly or remain intact, thereby achieving variable dissolution characteristics without multiple layers

Inventive Principle:
Principle #40Composite materials

2Reliability

If bi-layer or multilayer film systems are used to achieve variable dissolution properties, then drug delivery effectiveness is improved, but manufacturing cost increases

Engineering Contradiction:
Improvedrug delivery effectivenessVSAvoidmanufacturing cost
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The patent combines multiple functional layers into a single layer by incorporating immiscible components with different densities within one continuous matrix. The single layer contains both water-soluble and water-insoluble regions that provide differentiated dissolution rates, eliminating the need for separate layers while maintaining the functional benefits of multilayer systems

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The invention creates a simplified copy of the multilayer functionality within a single layer structure. Instead of physically creating multiple layers that must be laminated, the patent uses density and solubility variations within one layer to replicate the functional effects of multiple layers, thereby reducing manufacturing steps and costs

Inventive Principle:
Principle #26Copying

3Reliability

If traditional lamination methods are used to create multilayer films, then variable dissolution properties are achieved, but additional manufacturing steps and expense are required

Engineering Contradiction:
Improvevariable dissolution propertiesVSAvoidmanufacturing steps
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines multiple functional layers into a single layer by incorporating immiscible components with different densities within one continuous matrix. The single layer contains both water-soluble and water-insoluble regions that provide differentiated dissolution rates, eliminating the need for separate layers while maintaining the functional benefits of multilayer systems

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The invention segments the single layer into distinct functional regions based on density and solubility variations. Immiscible components separate into different zones within the single layer during formation, creating regions with different dissolution characteristics without requiring physical separation into multiple layers

Inventive Principle:
Principle #1Segmentation

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 single layer film achieves effective drug delivery by maximizing absorption at the intended mucosal site and minimizing drug loss to unintended sites, while maintaining uniform bioactive content per dosage unit, suitable for buccal, sublingual, vaginal, and other drug delivery applications.

Implementation Method 1

a component which is immiscible with the film forming material has a predetermined non-uniform distribution in the thickness direction of the single layer

Methodology Applied
Scientific EffectImmiscibility: Emulsion

Implementation Method 2

at least one other component immiscible with the film forming material and having a density different than the film forming material

Methodology Applied
Scientific EffectDensity difference: Density Gradient

Data Source

PatentEP3381450B1Biocompatible film with variable cross-sectional properties
Publication Date: 2026.03.25 AQUESTIVE THERAPEUTICS INC

AI summary

A biocompatible film includes a single layer having a plurality of components, at least one of the plurality of components having a predetermined non-uniform distribution in the thickness direction of the single layer. The at least one of the plurality of components that has a non-uniform distribution in the thickness direction of the single layer may have a substantially uniform distribution in the longitudinal and lateral directions of the single layer. The biocompatible film can be made by depositing a fluid composition including a film fanning material and at least one other component immiscible with the film forming material and having a density different than the film forming material into a single layer, and drying the single layer such that the at least one other component has a predetermined non-uniform distribution in the thickness direction of the single layer after drying.