Multilayer Blister Packaging for Moisture-Protected Lyophilized Tablets

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Solution Overview

Problem

Lyophilized orally disintegrating tablets face challenges related to heat transfer, structural integrity, moisture and oxygen transmission, and light exposure during packaging, which can damage the tablet's disintegrating ability and reduce shelf-life, especially for products like nicotine or cannabidiol.

Innovation Solution

A blister packaging with a multilayer structure comprising a lidding and well layer, including thermoplastic and aluminum layers, designed to minimize moisture and oxygen transmission, protect against light, and facilitate heat transfer during freezing and lyophilization, while forming pockets for the tablets.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional blister packaging is used for lyophilized orally disintegrating tablets, then the packaging structure is simple and easy to manufacture, but moisture and oxygen transmission damages the tablet's disintegrating ability and reduces shelf-life

Engineering Contradiction:
Improvetablet disintegrating abilityVSAvoidpackaging structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent employs a multilayer blister packaging structure comprising a base layer, intermediate layer, and lid layer, where each layer serves specific protective functions. The base layer provides structural support, the intermediate layer offers moisture and oxygen barrier properties, and the lid layer ensures hermetic sealing. This composite structure effectively prevents moisture and oxygen transmission that would otherwise damage the tablet's disintegrating ability, while maintaining manufacturability through standardized lamination processes.

Inventive Principle:
Principle #40Composite materials

2Reliability

If conventional blister packaging is used, then manufacturing is simple, but light exposure damages active therapeutic ingredients and reduces efficacy

Engineering Contradiction:
Improvedrug efficacyVSAvoidpackaging structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The multilayer packaging structure includes light-blocking layers with opaque and metallized coatings integrated into the base, intermediate, and lid layers. These light-blocking layers prevent light exposure that would otherwise damage active therapeutic ingredients such as nicotine or cannabidiol, thereby maintaining drug efficacy. The light protection is achieved through material selection and layer configuration rather than adding separate components, keeping the manufacturing process relatively simple.

Inventive Principle:
Principle #40Composite materials

3Reliability

If the packaging provides complete light shielding and low moisture transmission, then product protection is improved, but heat transfer during freezing and lyophilization is hindered

Engineering Contradiction:
Improveproduct protectionVSAvoidheat transfer
Core Design Contradiction:
ReliabilityVSTemperature

Solution Approach 1:

The packaging structure applies different material properties to different layers: the base layer uses materials with good heat transfer properties to facilitate heat transfer during freezing and lyophilization processes, while the intermediate and lid layers incorporate opaque and metallized materials that provide light shielding and moisture barrier functions. This local differentiation of material qualities allows simultaneous achievement of thermal performance during manufacturing and protective performance during storage.

Inventive Principle:
Principle #3Local quality

4Productivity

If the packaging structure is optimized for heat transfer during freezing, then lyophilization efficiency is improved, but structural integrity of the packaging may be compromised

Engineering Contradiction:
Improvelyophilization efficiencyVSAvoidpackaging structural integrity
Core Design Contradiction:
ProductivityVSStrength

Solution Approach 1:

The multilayer structure combines materials with complementary properties: the base layer incorporates materials optimized for heat transfer to improve lyophilization efficiency, while the intermediate and lid layers provide structural reinforcement through metallized and opaque materials. The lamination process creates strong interlayer bonds that maintain overall packaging integrity even when the base layer is optimized for thermal performance. This composite approach allows the packaging to meet both processing and storage requirements.

Inventive Principle:
Principle #40Composite materials

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 packaging maintains the disintegrating ability of the tablets, enhances structural integrity, and extends shelf-life by reducing moisture and oxygen ingress, ensuring effective protection and rapid disintegration.

Implementation Method 1

an aluminum lidding layer... an aluminum well layer

Methodology Applied
Scientific EffectLight blocking: Absorption (EM radiation)

Implementation Method 2

designed to minimize moisture and oxygen transmission

Methodology Applied
Scientific EffectMoisture barrier: Permeation

Implementation Method 3

designed to minimize moisture and oxygen transmission

Methodology Applied
Scientific EffectOxygen barrier: Permeation

Data Source

PatentUS12383494B2Packaging for rapidly infusing composition
Publication Date: 2025.08.12 ORCOSA INC
  • US12383494B2 patent drawing
  • US12383494B2 patent drawing
  • US12383494B2 patent drawing

AI summary

A container for a lyophilized rapidly infusing composition is described. The container comprises a planar lidding layer attached to a well layer comprising pockets for the therapeutic product. The lidding layer may comprise an aluminum layer, a thermoplastic polymer layer, and a labeling layer. The well layer may comprise an aluminum layer, two polyamide layers, and two thermoplastic polymer layers. A drug product assembly is also disclosed, which includes at least one therapeutic product sealed within the at least one pocket of the container.