Elastomeric Drug Core Coating for Thin Membrane Adherence

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Solution Overview

Problem

Existing methods for coating drug-containing cores with elastomeric membranes are inadequate for very thin membranes, leading to insufficient drug release rates and adherence issues, particularly for poorly soluble drugs like NSAIDs, and are cumbersome in manufacturing.

Innovation Solution

A method involving dipping a core in a coating solution containing 5-40 wt-% elastomer and 60-95 wt-% solvent, with a filler like silica, to achieve a continuous coating thickness of 5-100 μm, using a pulling speed of 2.5-25 mm/s, and curing with light or heat to ensure adherence and controlled drug release.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If traditional coating methods (extrusion or vacuum expansion) are used, then coating can be applied to thicker membranes (150 μm or more), but these methods fail to achieve complete adherence and controlled release for very thin membranes (below 100 μm)

Engineering Contradiction:
Improvecoating adherenceVSAvoidmembrane thickness
Core Design Contradiction:
Manufacturing precisionVSLength of stationary object

Solution Approach 1:

The patent applies parameter changes by modifying the physical state of the coating material from solid rubber to dissolved state in a solvent. The coating material is dissolved in a solvent to create a coating solution that can be uniformly applied to thin membranes, enabling complete adherence even at thicknesses below 100 μm. After application, the solvent evaporates to leave the coating material adhered to the membrane.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent uses a solvent as an intermediary substance to facilitate the coating process. The solvent acts as a medium that carries the coating material to the membrane surface, enables uniform distribution, and then evaporates to leave the coating material properly adhered. This intermediary approach solves the adherence problem for thin membranes that cannot be coated by traditional direct methods.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of manufacture

If membrane thickness is increased to improve structural integrity, then manufacturing becomes easier, but drug release rate becomes insufficient particularly for poorly soluble drugs like NSAIDs

Engineering Contradiction:
Improvestructural integrityVSAvoiddrug release rate
Core Design Contradiction:
Ease of manufactureVSProductivity

Solution Approach 1:

The patent employs composite materials by combining the elastomeric membrane with a coating layer made of different material properties. The coating material (such as polyethylene vinyl acetate or polyurethane) has different permeability characteristics than the base membrane, creating a composite structure that controls drug release while maintaining structural integrity. This allows thin membranes to achieve both strength and controlled release performance.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent applies local quality by creating a distinct coating layer with specific properties on the surface of the membrane. This coating layer has different permeability and mechanical properties than the bulk membrane, allowing localized control of drug release at the membrane surface while the bulk membrane provides structural support. This enables thin membranes to have both integrity and controlled release.

Inventive Principle:
Principle #3Local quality

3Manufacturing precision

If filling is reduced to achieve thinner membranes, then drug release control improves, but manufacturing complexity increases and adherence problems occur

Engineering Contradiction:
Improverelease controlVSAvoidmanufacturing complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The patent replaces mechanical coating methods (extrusion, vacuum expansion) with a chemical/solution-based coating approach. Instead of mechanically forming and adhering a coating layer, the coating material is dissolved in a solvent, applied as a solution that penetrates and bonds to the membrane, then the solvent evaporates. This substitution simplifies the manufacturing process for thin membranes and eliminates adherence problems associated with mechanical methods.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

4Manufacturing precision

If coating material is applied to control initial release and limit burst effect, then drug release profile improves, but coating may not completely adhere to outer surface causing trouble during use

Engineering Contradiction:
Improverelease profile controlVSAvoidcoating adherence
Core Design Contradiction:
Manufacturing precisionVSReliability

Solution Approach 1:

The patent changes the physical state parameter of the coating material from solid to dissolved state during application. By applying the coating material as a solvent-based solution, it can uniformly penetrate and bond to the membrane surface at molecular level. After solvent evaporation, the coating material remains completely adhered, eliminating the partial adhesion problems that cause reliability issues during use.

Inventive Principle:
Principle #35Parameter changes

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 method enables complete adherence of the silicon-based membrane to the core, modifying drug release based on physicochemical properties, and achieving consistent drug delivery with membrane thicknesses of 10-100 μm, improving release rates for drugs like indomethacin.

Implementation Method 1

dipping the core to a coating solution contains 5-40 wt-% elastomer and 95-60 wt-% solvent... using a pulling speed suitable for providing a coating thickness of 5-100 μm

Methodology Applied
Scientific EffectDipping and pulling coating: Deposition (physical)

Implementation Method 2

curing the dipped core to provide a coated core

Methodology Applied
Scientific EffectCuring: Heat Treatment

Data Source

PatentUS11666552B2Method for modifying release of a therapeutically active agent from an elastomeric matrix
Publication Date: 2023.06.06 BAYER OY
  • US11666552B2 patent drawing
  • US11666552B2 patent drawing
  • US11666552B2 patent drawing

AI summary

The present invention relates to a method for modifying release of a therapeutically active agent from an elastomeric matrix, comprising providing a core comprising an elastomeric matrix and a therapeutically active agent; dipping the core to a coating solution of an elastomer, wherein the elastomer comprises 20-35 wt-% of a filler, calculated from the total amount of filler and elastomer; curing the dipped core to provide a coated core. In this method the dipping is provided as a continuous process by pulling the core through the coating solution, using a pulling speed suitable for providing a coating thickness of δ-IOO the filler is selected from silica, titanium dioxide, barium sulphate, carbon and mixtures thereof; the elastomer comprised in the core and the elastomer comprised in the coating solution are independently selected from poly(dimethyl) siloxanes, polyethylene vinyl acetates (EVAs), polyurethanes (PUs), polyhydroxyethyl methacrylates (PHEMAs) and polymethyl methacrylates (PMMAs).